Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development
Identifieur interne : 000D12 ( Pmc/Corpus ); précédent : 000D11; suivant : 000D13Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development
Auteurs : Christine C. RobertsSource :
- Human Vaccines & Immunotherapeutics [ 2164-5515 ] ; 2019.
Abstract
Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.
Url:
DOI: 10.1080/21645515.2019.1634992
PubMed: 31268394
PubMed Central: 6816404
Links to Exploration step
PMC:6816404Le document en format XML
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<front><div type="abstract" xml:lang="en"><title>ABSTRACT</title>
<p>Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.</p>
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<back><div1 type="bibliography"><listBibl><biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Madore, Dv" uniqKey="Madore D">DV Madore</name>
</author>
<author><name sortKey="Meade, Bd" uniqKey="Meade B">BD Meade</name>
</author>
<author><name sortKey="Rubin, F" uniqKey="Rubin F">F Rubin</name>
</author>
<author><name sortKey="Deal, C" uniqKey="Deal C">C Deal</name>
</author>
<author><name sortKey="Lynn, F" uniqKey="Lynn F">F. Lynn</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Plotkin, Sa" uniqKey="Plotkin S">SA Plotkin</name>
</author>
<author><name sortKey="Gilbert, Pb" uniqKey="Gilbert P">PB Gilbert</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Muthumani, K" uniqKey="Muthumani K">K Muthumani</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Muthumani, K" uniqKey="Muthumani K">K Muthumani</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Griffin, Bd" uniqKey="Griffin B">BD Griffin</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Tebas, P" uniqKey="Tebas P">P Tebas</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Kudchodkar, Sb" uniqKey="Kudchodkar S">SB Kudchodkar</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Maslow, Jn" uniqKey="Maslow J">JN Maslow</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Rampling, T" uniqKey="Rampling T">T Rampling</name>
</author>
<author><name sortKey="Page, M" uniqKey="Page M">M Page</name>
</author>
<author><name sortKey="Horby, P" uniqKey="Horby P">P Horby</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Beskow, Lm" uniqKey="Beskow L">LM Beskow</name>
</author>
<author><name sortKey="Dombeck, Cb" uniqKey="Dombeck C">CB Dombeck</name>
</author>
<author><name sortKey="Thompson, Cp" uniqKey="Thompson C">CP Thompson</name>
</author>
<author><name sortKey="Watson Ormond, Jk" uniqKey="Watson Ormond J">JK Watson-Ormond</name>
</author>
<author><name sortKey="Weinfurt, Kp" uniqKey="Weinfurt K">KP Weinfurt</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Bossert, S" uniqKey="Bossert S">S Bossert</name>
</author>
<author><name sortKey="Kahrass, H" uniqKey="Kahrass H">H Kahrass</name>
</author>
<author><name sortKey="Heinemeyer, U" uniqKey="Heinemeyer U">U Heinemeyer</name>
</author>
<author><name sortKey="Prokein, J" uniqKey="Prokein J">J Prokein</name>
</author>
<author><name sortKey="Strech, D" uniqKey="Strech D">D Strech</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Kinkorova, J" uniqKey="Kinkorova J">J Kinkorova</name>
</author>
<author><name sortKey="Topolcan, O" uniqKey="Topolcan O">O Topolcan</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Lippi, G" uniqKey="Lippi G">G Lippi</name>
</author>
<author><name sortKey="Cadamuro, J" uniqKey="Cadamuro J">J Cadamuro</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Lippi, G" uniqKey="Lippi G">G Lippi</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="De Vries, J" uniqKey="De Vries J">J de Vries</name>
</author>
<author><name sortKey="Bull, Sj" uniqKey="Bull S">SJ Bull</name>
</author>
<author><name sortKey="Doumbo, O" uniqKey="Doumbo O">O Doumbo</name>
</author>
<author><name sortKey="Ibrahim, M" uniqKey="Ibrahim M">M Ibrahim</name>
</author>
<author><name sortKey="Mercereau Puijalon, O" uniqKey="Mercereau Puijalon O">O Mercereau-Puijalon</name>
</author>
<author><name sortKey="Kwiatkowski, D" uniqKey="Kwiatkowski D">D Kwiatkowski</name>
</author>
<author><name sortKey="Parker, M" uniqKey="Parker M">M Parker</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Staunton, C" uniqKey="Staunton C">C Staunton</name>
</author>
<author><name sortKey="Moodley, K" uniqKey="Moodley K">K Moodley</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Tindana, P" uniqKey="Tindana P">P Tindana</name>
</author>
<author><name sortKey="Molyneux, Cs" uniqKey="Molyneux C">CS Molyneux</name>
</author>
<author><name sortKey="Bull, S" uniqKey="Bull S">S Bull</name>
</author>
<author><name sortKey="Parker, M" uniqKey="Parker M">M Parker</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Mungwira, Rg" uniqKey="Mungwira R">RG Mungwira</name>
</author>
<author><name sortKey="Nyangulu, W" uniqKey="Nyangulu W">W Nyangulu</name>
</author>
<author><name sortKey="Misiri, J" uniqKey="Misiri J">J Misiri</name>
</author>
<author><name sortKey="Iphani, S" uniqKey="Iphani S">S Iphani</name>
</author>
<author><name sortKey="Ng Ng La, R" uniqKey="Ng Ng La R">R Ng’ong’ola</name>
</author>
<author><name sortKey="Chirambo, Cm" uniqKey="Chirambo C">CM Chirambo</name>
</author>
<author><name sortKey="Masiye, F" uniqKey="Masiye F">F Masiye</name>
</author>
<author><name sortKey="Mfutso Bengo, J" uniqKey="Mfutso Bengo J">J Mfutso-Bengo</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Barchi, F" uniqKey="Barchi F">F Barchi</name>
</author>
<author><name sortKey="Matlhagela, K" uniqKey="Matlhagela K">K Matlhagela</name>
</author>
<author><name sortKey="Jones, N" uniqKey="Jones N">N Jones</name>
</author>
<author><name sortKey="Kebaabetswe, Pm" uniqKey="Kebaabetswe P">PM Kebaabetswe</name>
</author>
<author><name sortKey="Merz, Jf" uniqKey="Merz J">JF Merz</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Lippi, G" uniqKey="Lippi G">G Lippi</name>
</author>
<author><name sortKey="Simundic, Am" uniqKey="Simundic A">AM Simundic</name>
</author>
<author><name sortKey="Rodriguez Manas, L" uniqKey="Rodriguez Manas L">L Rodriguez-Manas</name>
</author>
<author><name sortKey="Bossuyt, P" uniqKey="Bossuyt P">P Bossuyt</name>
</author>
<author><name sortKey="Banfi, G" uniqKey="Banfi G">G Banfi</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Giavarina, D" uniqKey="Giavarina D">D Giavarina</name>
</author>
<author><name sortKey="Lippi, G" uniqKey="Lippi G">G Lippi</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Marko Varga, G" uniqKey="Marko Varga G">G Marko-Varga</name>
</author>
<author><name sortKey="Baker, Ms" uniqKey="Baker M">MS Baker</name>
</author>
<author><name sortKey="Boja, Es" uniqKey="Boja E">ES Boja</name>
</author>
<author><name sortKey="Rodriguez, H" uniqKey="Rodriguez H">H Rodriguez</name>
</author>
<author><name sortKey="Fehniger, Te" uniqKey="Fehniger T">TE Fehniger</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Smith, Jf" uniqKey="Smith J">JF Smith</name>
</author>
<author><name sortKey="Kowalski, R" uniqKey="Kowalski R">R Kowalski</name>
</author>
<author><name sortKey="Esser, Mt" uniqKey="Esser M">MT Esser</name>
</author>
<author><name sortKey="Brown, Mj" uniqKey="Brown M">MJ Brown</name>
</author>
<author><name sortKey="Bryan, Jt" uniqKey="Bryan J">JT Bryan</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Nyan, Dc" uniqKey="Nyan D">DC Nyan</name>
</author>
<author><name sortKey="Swinson, Kl" uniqKey="Swinson K">KL Swinson</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Ghodbane, M" uniqKey="Ghodbane M">M Ghodbane</name>
</author>
<author><name sortKey="Stucky, Ec" uniqKey="Stucky E">EC Stucky</name>
</author>
<author><name sortKey="Maguire, Tj" uniqKey="Maguire T">TJ Maguire</name>
</author>
<author><name sortKey="Schloss, Rs" uniqKey="Schloss R">RS Schloss</name>
</author>
<author><name sortKey="Shreiber, Di" uniqKey="Shreiber D">DI Shreiber</name>
</author>
<author><name sortKey="Zahn, Jd" uniqKey="Zahn J">JD Zahn</name>
</author>
<author><name sortKey="Yarmush, Ml" uniqKey="Yarmush M">ML Yarmush</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Ronnberg, B" uniqKey="Ronnberg B">B Ronnberg</name>
</author>
<author><name sortKey="Gustafsson, " uniqKey="Gustafsson ">Å Gustafsson</name>
</author>
<author><name sortKey="Vapalahti, O" uniqKey="Vapalahti O">O Vapalahti</name>
</author>
<author><name sortKey="Emmerich, P" uniqKey="Emmerich P">P Emmerich</name>
</author>
<author><name sortKey="Lundkvist, " uniqKey="Lundkvist ">Å Lundkvist</name>
</author>
<author><name sortKey="Schmidt Chanasit, J" uniqKey="Schmidt Chanasit J">J Schmidt-Chanasit</name>
</author>
<author><name sortKey="Blomberg, J" uniqKey="Blomberg J">J Blomberg</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Wong, Sj" uniqKey="Wong S">SJ Wong</name>
</author>
<author><name sortKey="Furuya, A" uniqKey="Furuya A">A Furuya</name>
</author>
<author><name sortKey="Zou, J" uniqKey="Zou J">J Zou</name>
</author>
<author><name sortKey="Xie, X" uniqKey="Xie X">X Xie</name>
</author>
<author><name sortKey="Dupuis, Ap" uniqKey="Dupuis A">AP Dupuis</name>
</author>
<author><name sortKey="Kramer, Ld" uniqKey="Kramer L">LD Kramer</name>
</author>
<author><name sortKey="Shi, P Y" uniqKey="Shi P">P-Y Shi</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Taylor, Ct" uniqKey="Taylor C">CT Taylor</name>
</author>
<author><name sortKey="Mackay, I" uniqKey="Mackay I">I Mackay</name>
</author>
<author><name sortKey="Mcmahon, J" uniqKey="Mcmahon J">J McMahon</name>
</author>
<author><name sortKey="Wheatley, S" uniqKey="Wheatley S">S Wheatley</name>
</author>
<author><name sortKey="Moore, P" uniqKey="Moore P">P Moore</name>
</author>
<author><name sortKey="Finger, M" uniqKey="Finger M">M Finger</name>
</author>
<author><name sortKey="Hewitson, G" uniqKey="Hewitson G">G Hewitson</name>
</author>
<author><name sortKey="Moore, F" uniqKey="Moore F">F Moore</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Roberts, C" uniqKey="Roberts C">C Roberts</name>
</author>
<author><name sortKey="Green, T" uniqKey="Green T">T Green</name>
</author>
<author><name sortKey="Hess, E" uniqKey="Hess E">E Hess</name>
</author>
<author><name sortKey="Matys, K" uniqKey="Matys K">K Matys</name>
</author>
<author><name sortKey="Brown, Mj" uniqKey="Brown M">MJ Brown</name>
</author>
<author><name sortKey="Haupt, Rm" uniqKey="Haupt R">RM Haupt</name>
</author>
<author><name sortKey="Luxembourg, A" uniqKey="Luxembourg A">A Luxembourg</name>
</author>
<author><name sortKey="Vuocolo, S" uniqKey="Vuocolo S">S Vuocolo</name>
</author>
<author><name sortKey="Saah, A" uniqKey="Saah A">A Saah</name>
</author>
<author><name sortKey="Antonello, J" uniqKey="Antonello J">J Antonello</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Bryan, Jt" uniqKey="Bryan J">JT Bryan</name>
</author>
<author><name sortKey="Buckland, B" uniqKey="Buckland B">B Buckland</name>
</author>
<author><name sortKey="Hammond, J" uniqKey="Hammond J">J Hammond</name>
</author>
<author><name sortKey="Jansen, Ku" uniqKey="Jansen K">KU Jansen</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Cunningham, Al" uniqKey="Cunningham A">AL Cunningham</name>
</author>
<author><name sortKey="Wei, M" uniqKey="Wei M">M Wei</name>
</author>
<author><name sortKey="Sun, G" uniqKey="Sun G">G Sun</name>
</author>
<author><name sortKey="Wang, X" uniqKey="Wang X">X Wang</name>
</author>
<author><name sortKey="Li, M" uniqKey="Li M">M Li</name>
</author>
<author><name sortKey="Lin, Z" uniqKey="Lin Z">Z Lin</name>
</author>
<author><name sortKey="Li, Z" uniqKey="Li Z">Z Li</name>
</author>
<author><name sortKey="Li, Y" uniqKey="Li Y">Y Li</name>
</author>
<author><name sortKey="Fang, M" uniqKey="Fang M">M Fang</name>
</author>
<author><name sortKey="Zhang, J" uniqKey="Zhang J">J Zhang</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Baylor, Nw" uniqKey="Baylor N">NW Baylor</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Saah, A" uniqKey="Saah A">A Saah</name>
</author>
<author><name sortKey="Hoover, Dr" uniqKey="Hoover D">DR Hoover</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Pas, Sd" uniqKey="Pas S">SD Pas</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Shan, C" uniqKey="Shan C">C Shan</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Chua, A" uniqKey="Chua A">A Chua</name>
</author>
<author><name sortKey="Prat, I" uniqKey="Prat I">I Prat</name>
</author>
<author><name sortKey="Nuebling, Cm" uniqKey="Nuebling C">CM Nuebling</name>
</author>
<author><name sortKey="Wood, D" uniqKey="Wood D">D Wood</name>
</author>
<author><name sortKey="Moussy, F" uniqKey="Moussy F">F Moussy</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Alhetheel, A" uniqKey="Alhetheel A">A Alhetheel</name>
</author>
<author><name sortKey="Altalhi, H" uniqKey="Altalhi H">H Altalhi</name>
</author>
<author><name sortKey="Albarrag, A" uniqKey="Albarrag A">A Albarrag</name>
</author>
<author><name sortKey="Shakoor, Z" uniqKey="Shakoor Z">Z Shakoor</name>
</author>
<author><name sortKey="Mohamed, D" uniqKey="Mohamed D">D Mohamed</name>
</author>
<author><name sortKey="El Hazmi, M" uniqKey="El Hazmi M">M El-Hazmi</name>
</author>
<author><name sortKey="Somily, A" uniqKey="Somily A">A Somily</name>
</author>
<author><name sortKey="Barry, M" uniqKey="Barry M">M Barry</name>
</author>
<author><name sortKey="Bakhrebah, M" uniqKey="Bakhrebah M">M Bakhrebah</name>
</author>
<author><name sortKey="Nassar, M" uniqKey="Nassar M">M Nassar</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Balmaseda, A" uniqKey="Balmaseda A">A Balmaseda</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Wilder Smith, A" uniqKey="Wilder Smith A">A Wilder-Smith</name>
</author>
<author><name sortKey="Vannice, K" uniqKey="Vannice K">K Vannice</name>
</author>
<author><name sortKey="Durbin, A" uniqKey="Durbin A">A Durbin</name>
</author>
<author><name sortKey="Hombach, J" uniqKey="Hombach J">J Hombach</name>
</author>
<author><name sortKey="Thomas, Sj" uniqKey="Thomas S">SJ Thomas</name>
</author>
<author><name sortKey="Thevarjan, I" uniqKey="Thevarjan I">I Thevarjan</name>
</author>
<author><name sortKey="Simmons, Cp" uniqKey="Simmons C">CP Simmons</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Ohst, C" uniqKey="Ohst C">C Ohst</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Park, Sw" uniqKey="Park S">SW Park</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Corman, Vm" uniqKey="Corman V">VM Corman</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Faye, O" uniqKey="Faye O">O Faye</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Huzly, D" uniqKey="Huzly D">D Huzly</name>
</author>
<author><name sortKey="Hanselmann, I" uniqKey="Hanselmann I">I Hanselmann</name>
</author>
<author><name sortKey="Schmidt Chanasit, J" uniqKey="Schmidt Chanasit J">J Schmidt-Chanasit</name>
</author>
<author><name sortKey="Panning, M" uniqKey="Panning M">M Panning</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="L Uillier, Ag" uniqKey="L Uillier A">AG L’Huillier</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Steinhagen, K" uniqKey="Steinhagen K">K Steinhagen</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Waggoner, Jj" uniqKey="Waggoner J">JJ Waggoner</name>
</author>
<author><name sortKey="Gresh, L" uniqKey="Gresh L">L Gresh</name>
</author>
<author><name sortKey="Mohamed Hadley, A" uniqKey="Mohamed Hadley A">A Mohamed-Hadley</name>
</author>
<author><name sortKey="Ballesteros, G" uniqKey="Ballesteros G">G Ballesteros</name>
</author>
<author><name sortKey="Davila, Mj" uniqKey="Davila M">MJ Davila</name>
</author>
<author><name sortKey="Tellez, Y" uniqKey="Tellez Y">Y Tellez</name>
</author>
<author><name sortKey="Sahoo, Mk" uniqKey="Sahoo M">MK Sahoo</name>
</author>
<author><name sortKey="Balmaseda, A" uniqKey="Balmaseda A">A Balmaseda</name>
</author>
<author><name sortKey="Harris, E" uniqKey="Harris E">E Harris</name>
</author>
<author><name sortKey="Pinsky, Ba" uniqKey="Pinsky B">BA Pinsky</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Cdc, U" uniqKey="Cdc U">U CDC</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Plotkin, Sa" uniqKey="Plotkin S">SA Plotkin</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Wong, G" uniqKey="Wong G">G Wong</name>
</author>
<author><name sortKey="Qiu, X" uniqKey="Qiu X">X Qiu</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Burd, Em" uniqKey="Burd E">EM Burd</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Charrel, Rn" uniqKey="Charrel R">RN Charrel</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Yamaoka, Y" uniqKey="Yamaoka Y">Y Yamaoka</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Cabral Castro, Mj" uniqKey="Cabral Castro M">MJ Cabral-Castro</name>
</author>
<author><name sortKey="Cavalcanti, Mg" uniqKey="Cavalcanti M">MG Cavalcanti</name>
</author>
<author><name sortKey="Peralta, Rhs" uniqKey="Peralta R">RHS Peralta</name>
</author>
<author><name sortKey="Peralta, Jm" uniqKey="Peralta J">JM Peralta</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Barbe, B" uniqKey="Barbe B">B Barbe</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Waggoner, Jj" uniqKey="Waggoner J">JJ Waggoner</name>
</author>
<author><name sortKey="Pinsky, Ba" uniqKey="Pinsky B">BA Pinsky</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Saraswathy Subramaniam, Ts" uniqKey="Saraswathy Subramaniam T">TS Saraswathy Subramaniam</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Hashemzadeh, Ms" uniqKey="Hashemzadeh M">MS Hashemzadeh</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Singh, Rk" uniqKey="Singh R">RK Singh</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Uyeki, Tm" uniqKey="Uyeki T">TM Uyeki</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Perkins, Md" uniqKey="Perkins M">MD Perkins</name>
</author>
</analytic>
</biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Hum Vaccin Immunother</journal-id>
<journal-id journal-id-type="iso-abbrev">Hum Vaccin Immunother</journal-id>
<journal-id journal-id-type="publisher-id">KHVI</journal-id>
<journal-id journal-id-type="publisher-id">khvi20</journal-id>
<journal-title-group><journal-title>Human Vaccines & Immunotherapeutics</journal-title>
</journal-title-group>
<issn pub-type="ppub">2164-5515</issn>
<issn pub-type="epub">2164-554X</issn>
<publisher><publisher-name>Taylor & Francis</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">31268394</article-id>
<article-id pub-id-type="pmc">6816404</article-id>
<article-id pub-id-type="publisher-id">1634992</article-id>
<article-id pub-id-type="doi">10.1080/21645515.2019.1634992</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Review</subject>
</subj-group>
</article-categories>
<title-group><article-title>Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development</article-title>
<alt-title alt-title-type="running-authors">C. C. ROBERTS</alt-title>
<alt-title alt-title-type="running-title">HUMAN VACCINES & IMMUNOTHERAPEUTICS</alt-title>
</title-group>
<contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0003-4359-7946</contrib-id>
<name><surname>Roberts</surname>
<given-names>Christine C.</given-names>
</name>
<xref ref-type="corresp" rid="AN0001"></xref>
<xref ref-type="aff" rid="AFF0001"></xref>
</contrib>
<aff id="AFF0001"><institution>Clinical Laboratory Development, GeneOne Life Science, Inc.</institution>
, Blue Bell, PA,<country>USA</country>
</aff>
</contrib-group>
<author-notes><corresp id="AN0001">Contact Christine C. Roberts <email xlink:href="croberts@geneonels-us.com">croberts@geneonels-us.com</email>
<institution>Clinical Laboratory Development, GeneOne Life Science, Inc</institution>
., <addr-line>1040 DeKalb Pike, Suite 200</addr-line>
, Blue Bell, PA 19422, <country>USA</country>
.</corresp>
</author-notes>
<pub-date pub-type="collection"><year>2019</year>
</pub-date>
<pub-date pub-type="epub"><day>16</day>
<month>7</month>
<year>2019</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>16</day>
<month>7</month>
<year>2019</year>
</pub-date>
<pmc-comment> PMC Release delay is 0 months and 0 days and was based on the . </pmc-comment>
<volume>15</volume>
<issue>10</issue>
<fpage seq="7">2258</fpage>
<lpage>2263</lpage>
<history><date date-type="received"><day>04</day>
<month>4</month>
<year>2019</year>
</date>
<date date-type="rev-recd"><day>20</day>
<month>5</month>
<year>2019</year>
</date>
<date date-type="accepted"><day>17</day>
<month>6</month>
<year>2019</year>
</date>
</history>
<permissions><copyright-statement>© 2019 GeneOne Life Science, Inc. Published with license by Taylor & Francis Group, LLC.</copyright-statement>
<copyright-year>2019</copyright-year>
<copyright-holder>The Author(s)</copyright-holder>
<license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0/">http://creativecommons.org/licenses/by-nc-nd/4.0/</ext-link>
), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.</license-p>
</license>
<license><license-p>This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.</license-p>
</license>
</permissions>
<self-uri content-type="pdf" xlink:href="KHVI_15_1634992.pdf"></self-uri>
<abstract><title>ABSTRACT</title>
<p>Rapid vaccine development in response to an outbreak of a new emerging infectious disease (EID) is a goal targeted by public health agencies worldwide. This goal becomes more complicated when there are no standardized sets of viral and immunological assays, no accepted and well-characterized samples, standards or reagents, and no approved diagnostic tests for the EID pathogen. The diagnosis of infections is of critical importance to public health, but also in vaccine development in order to track incident infections during clinical trials, to differentiate natural infection responses from those that are vaccine-related and, if called for by study design, to exclude subjects with prior exposure from vaccine efficacy trials. Here we review emerging infectious disease biological standards development, vaccine clinical assay development and trial execution with the recent experiences of MERS-CoV and Zika virus as examples. There is great need to establish, in advance, the standardized reagents, sample panels, controls, and assays to support the rapid advancement of vaccine development efforts in response to EID outbreaks.</p>
</abstract>
<kwd-group kwd-group-type="author"><title>KEYWORDS</title>
<kwd>Emerging infectious disease</kwd>
<kwd>vaccines</kwd>
<kwd>immune response</kwd>
<kwd>virus detection</kwd>
<kwd>zika virus</kwd>
<kwd>flaviviruses</kwd>
<kwd>clinical trials</kwd>
</kwd-group>
<counts><ref-count count="73"></ref-count>
<page-count count="6"></page-count>
</counts>
</article-meta>
</front>
<body><sec sec-type="intro" id="S0001"><label>1.</label>
<title>Introduction</title>
<p>The World Health Organization (WHO) has published a list of priority pathogens<sup><xref rid="CIT0001">1</xref>
</sup>
as those diseases with high morbidity and mortality or with strong epidemic potential. One of the clear gaps affecting both public health efforts and vaccine development programs for any of these pathogens is a lack of standardized reagents and methods to test for evidence of current or prior infection.</p>
<p>The need for fast and accurate diagnostic tests of infection in an outbreak situation is obvious: identify the source or epicenter so that appropriate health-care measures can be quickly instituted. Expanding that concept to the public health scale and attaining accurate infectious disease diagnoses allows for better understanding of the course and severity of an outbreak and aids decision-making for population-level countermeasure implementation.</p>
<p>The clinical assays with which the immune response and pathogen presence are measured in vaccine trials become part of the basis for licensure for all vaccine products.<sup><xref rid="CIT0002">2</xref>
</sup>
Because vaccines are tested in healthy populations through all phases of clinical development for immune response and/or pathogen presence, the methods selected to measure vaccine responses and endpoints are critical. While the identification of an immune correlate of protection for each new vaccine is highly desirable, it is not always attainable.<sup><xref rid="CIT0003">3</xref>
</sup>
</p>
<p>Here we will use our recent experiences with the Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Zika virus (ZIKV)<sup><xref rid="CIT0004">4</xref>
–<xref rid="CIT0009">9</xref>
</sup>
outbreaks and ensuing public health countermeasures for containment and vaccine development as examples of challenges faced during emerging infectious disease emergencies.</p>
</sec>
<sec id="S0002"><label>2.</label>
<title>Biological reference materials and international standards</title>
<p>International reference materials and standards allow for a common set of reagents for a given pathogen to be available for the evaluation of the quality and consistency of clinical assays and to enable comparisons of assay data between studies. Such reference materials are established with rigorous evaluation and collaborations between multiple international laboratories and are typically assigned an international unit of measure at the completion of this process.<sup><xref rid="CIT0010">10</xref>
</sup>
The WHO also provides guidance for the development of individual secondary standards and their calibration to accepted international standards.<sup><xref rid="CIT0011">11</xref>
</sup>
This allows individual laboratories to maintain their own standards material that is traceable to the accepted international standard and not deplete the limited supply of the standard prematurely.</p>
<p>Efforts are currently underway to alleviate the international standards issue for MERS-CoV and ZIKV. Antibody and nucleic acid standards are in development for MERS-CoV, though the additional source material is being sought.<sup><xref rid="CIT0010">10</xref>
</sup>
In 2016, the WHO initiated a collaborative study effort for the development of ZIKV nucleic acid standards<sup><xref rid="CIT0012">12</xref>
</sup>
and, in 2017, made available a plasma sample panel through the US Food and Drug Administration (FDA) for evaluation of ZIKV immunoassays.<sup><xref rid="CIT0013">13</xref>
</sup>
The acquisition, characterization, and standardization of relevant pathogen strains such that the strains reflect what is currently in circulation and not just a prototype strain is also of concern. For EIDs, there can be an added complication for sharing such material if the disease is caused by a select agent requiring enhanced biosafety measures.</p>
<p>Many of the priority pathogens identified by WHO cause outbreaks that are difficult to predict and may be sporadic in nature.<sup><xref rid="CIT0001">1</xref>
</sup>
This complicates efforts to establish processes ahead of any outbreak to collect valuable acute and convalescent samples from individuals naturally infected by the respective viruses. There was, and still is, a lack of well-characterized human specimens from naturally infected MERS-CoV and ZIKV subjects that vaccine development groups could use to for assay development and, eventually, to establish a recognized set of standards that can be maintained over time.<sup><xref rid="CIT0010">10</xref>
</sup>
</p>
<p>A potentially valuable source of relevant clinical samples is from ongoing epidemiological studies and clinical trials. Study designers should take care to incorporate proper language into the informed consents of participants to allow for the request of additional blood draws or sample collections and for the future use of their clinical samples for the purposes of standards and assay development.<sup><xref rid="CIT0014">14</xref>
–<xref rid="CIT0016">16</xref>
</sup>
Such studies should also ensure that well-established chain-of-custody, sample handling, and sample storage procedures are in place to maintain the quality of these valuable specimens.<sup><xref rid="CIT0017">17</xref>
,<xref rid="CIT0018">18</xref>
</sup>
A significant drawback of this approach is that often the samples may not have adequate characterization, may be of limited volume, and are proprietary to the study sponsors. It should also be taken into account that local laws or culture may be prohibitive to allowing specimens to be stored for future testing.<sup><xref rid="CIT0016">16</xref>
,<xref rid="CIT0019">19</xref>
–<xref rid="CIT0023">23</xref>
</sup>
A concerted effort and willingness among researchers and companies to share available clinical specimens would be a valuable step forward in EID preparedness.<sup><xref rid="CIT0024">24</xref>
</sup>
</p>
<p>Sample collection & handling are critical to the quality of the specimen and its ability to be used in assays, standards or controls.<sup><xref rid="CIT0025">25</xref>
</sup>
Even in vaccine studies conducted in developed nations, challenges to appropriate sample collection and handling can occur. We experienced an issue with the timing of specimen intake and handling at a biorepository used for our ZIKV trials which required immediate corrective action to de-risk samples collected at the remaining study time points and prior to initiation of a second study. Ensuring proper sample storage and shipping conditions, processing and aliquotting (with attention to contamination control), training of site and clinical research organization lab personnel, a clear chain of custody from collection to final application, intermediate quality control checks, and good data management is critical for collection of high quality samples that can be used in the future.<sup><xref rid="CIT0017">17</xref>
,<xref rid="CIT0026">26</xref>
,<xref rid="CIT0027">27</xref>
</sup>
</p>
</sec>
<sec id="S0003"><label>3.</label>
<title>Vaccine clinical assays, reference reagents, international controls</title>
<p>In the case of EIDs, it can be difficult to predict what assays will be most useful or informative or will perhaps even provide an immune correlate of protection for a vaccine in early development. Little may be known about the basic virology or immunology of a new pathogen, though the need for developing vaccines and therapeutics is urgent.<sup><xref rid="CIT0009">9</xref>
</sup>
Some typical methods used as vaccine clinical assays are antibody-binding ELISAs, virus neutralization or bactericidal immunoassays, IFNγ-ELISpot or related cellular immune methodology using the target antigen or antigen-derived peptide pools, and detection of the pathogen through molecular or culture assays. Vaccine clinical assays measuring humoral and cellular immune responses developed early in a program will likely evolve as clinical development progresses or as the scientific knowledge base of the pathogen and relevant immunology broadens. As improvements in technology occur over time, early vaccine assays are often re-designed and bridged to assays with higher throughput, multiplexed detection, reduction of sample volumes, and automation to support testing of large numbers of specimens for late-stage clinical trials.<sup><xref rid="CIT0028">28</xref>
–<xref rid="CIT0035">35</xref>
</sup>
Often, a variety of tests are evaluated early in the program and, based on the usefulness of the data, a down-selection occurs so that the most relevant few remain to support large Phase 3 clinical trials and licensure of the vaccine.<sup><xref rid="CIT0002">2</xref>
,<xref rid="CIT0035">35</xref>
,<xref rid="CIT0036">36</xref>
</sup>
</p>
<p>Accepted “gold standards” of immunoassays for use at the onset of an EID vaccine program are rare. Critical reagents, standards, and controls must be monitored for consistent sourcing, batch-to-batch variability and overall quality over time. The implementation of partnerships between governmental agencies, academic researchers and industry researchers to help secure these items for the identified priority pathogens before a need should arise is of great importance.</p>
<p>Reagents for newly emergent infectious diseases like MERS-CoV and ZIKV were not readily available from commercial vendors at the outset of vaccine development programs. As such, individual vaccine projects, including our own, had to rely on internally developed clinical assays to understand vaccine-related immune responses and to detect prior or current infections.<sup><xref rid="CIT0004">4</xref>
,<xref rid="CIT0005">5</xref>
</sup>
Lack of standardization, however, can confound the interpretation of results from studies using different “home brew” assays across multiple laboratories such that study results cannot be directly compared in the absence of an accepted international standard or a proficiency panel of samples.<sup><xref rid="CIT0002">2</xref>
,<xref rid="CIT0010">10</xref>
</sup>
</p>
<p>The vast experience of our DNA vaccine consortium allowed us to develop MERS-CoV- and ZIKV-specific tests such as ELISA, virus neutralization and ELISpot early in the development and pre-clinical testing of the respective plasmid DNA vaccine constructs.<sup><xref rid="CIT0004">4</xref>
–<xref rid="CIT0006">6</xref>
,<xref rid="CIT0008">8</xref>
</sup>
These assays were evaluated for consistent performance throughout pre-clinical studies and we were able to adapt their use to support our Phase 1 and Phase 1b/2a studies of GLS-5300 MERS-CoV vaccine and two Phase 1 GLS-5700 ZIKV vaccine clinical trials.<sup><xref rid="CIT0007">7</xref>
</sup>
As these vaccines move further into clinical development, work will need to continue to transition from our pre-clinical and early stage standards to well sourced and characterized human control reagents. The concern always remains, however, that the inability to use formally characterized and internationally accepted reagents and controls in early versions of vaccine clinical assays can result in maintenance challenges or regulatory hurdles later in the vaccine assays’ life cycle.<sup><xref rid="CIT0037">37</xref>
</sup>
</p>
</sec>
<sec id="S0004"><label>4.</label>
<title>Diagnostics for emerging infectious diseases</title>
<p>Diagnostic assays are often the same style tests as those used in vaccine development, like antibody binding or molecular detection. However, their intended purpose is to accurately identify the infecting pathogen to enable health-care professionals to initiate appropriate treatments and prevent further transmission of disease. Laboratory confirmation of a diagnosis for patient treatment must have sufficient clinical sensitivity and specificity to be useful, the criteria for which may be different than analytical sensitivity and specificity criteria specified by assays for use in vaccine trials.<sup><xref rid="CIT0038">38</xref>
–<xref rid="CIT0045">45</xref>
</sup>
</p>
<p>Very few tests have gained Emergency Use Authorization (EUA) from the FDA. There are 2 MERS-CoV diagnostic tests, both molecular-based viral RNA detection, which received EUA in 2013 in response to the recognition of the significant potential for a future public health emergency.<sup><xref rid="CIT0046">46</xref>
</sup>
For ZIKV, currently, 5 serological kits and 14 viral diagnostic kits have been granted EUA status.<sup><xref rid="CIT0047">47</xref>
</sup>
For ZIKV in particular, the response to the need for diagnostics was quite rapid with all EUA approvals rolling out over approximately 19 months from February 2016 through September 2017,<sup><xref rid="CIT0046">46</xref>
</sup>
shortly after the declaration of a public health emergency. Outside the US, the WHO’s Emergency Use Assessment and Listing procedures (EUALs) recognizes the need and can grant authorization for use of diagnostic kits in emergency situations.<sup><xref rid="CIT0048">48</xref>
</sup>
Although no MERS-CoV or ZIKV diagnostic kit, serological or viral, have been fully approved by the FDA to date, the FDA has worked collaboratively with developers to accelerate the approval process when outbreak conditions warrant.<sup><xref rid="CIT0049">49</xref>
</sup>
A number of published studies have evaluated EUA tests independently for relevant sensitivity and specificity performance or in comparative studies<sup><xref rid="CIT0032">32</xref>
,<xref rid="CIT0039">39</xref>
,<xref rid="CIT0050">50</xref>
–<xref rid="CIT0056">56</xref>
</sup>
to aid in the selection of appropriate tests for the needs of epidemiological surveillance or public health diagnostics. Details outlining the relevant assay performance characteristics of each of the EUA-approved MERS-CoV and ZIKV assays can also be found on the FDA Medical Countermeasures webpage.<sup><xref rid="CIT0046">46</xref>
,<xref rid="CIT0057">57</xref>
,<xref rid="CIT0058">58</xref>
</sup>
</p>
<p>In the instance of MERS, EUA diagnostics approvals were limited to use with select respiratory tract specimens from individuals with signs and symptoms of infection with MERS-CoV or with epidemiological risk factors (i.e., contact with probable or confirmed MERS-CoV patient or having a history of travel to locations where MERS-CoV cases occur) for the detection of MERS-CoV.<sup><xref rid="CIT0046">46</xref>
</sup>
</p>
<p>For ZIKV, a number of complications in diagnostic tests such as cross-reactivity of immunological assays and short window of viremia in various bodily fluids required establishment of an algorithm to confirm ZIKV infection. This confirmatory algorithm guidance for health-care providers was based on not only clinical symptoms, risk factors, and diagnostic test results,<sup><xref rid="CIT0059">59</xref>
,<xref rid="CIT0060">60</xref>
</sup>
but also specifically for the use and interpretation of EUA diagnostic ZIKV IgM tests to indicate recent exposure with or without accompanying molecular ZIKV test results.<sup><xref rid="CIT0059">59</xref>
</sup>
The types of specimens and timing of collection of specimens that would provide the most reliable results was also a consideration in the ZIKV diagnosis algorithm.</p>
</sec>
<sec id="S0005"><label>5.</label>
<title>Future preparedness for EIDs</title>
<p>The Coalition for Epidemic Preparedness Innovations (CEPI) and others are working to ensure that rapid response mechanisms are in place to address emerging infectious diseases.<sup><xref rid="CIT0024">24</xref>
,<xref rid="CIT0061">61</xref>
,<xref rid="CIT0062">62</xref>
</sup>
The CEPI coalition was launched in 2017 as an innovative concept to establish global partnerships between public, private, philanthropic and civic organizations with the goal of accelerating the development of vaccines against emerging infectious diseases and strengthening vaccine access capabilities before an outbreak situation is encountered. Funding to support development teams building the infrastructure necessary for rapid vaccine design, manufacture, and clinical assessment is being provided to help ensure that we are prepared for EID outbreaks that may occur.<sup><xref rid="CIT0062">62</xref>
</sup>
</p>
<p>EID public health and countermeasure programs have unique challenges for diagnostic and vaccine clinical assay development purposes.<sup><xref rid="CIT0002">2</xref>
,<xref rid="CIT0039">39</xref>
,<xref rid="CIT0041">41</xref>
,<xref rid="CIT0063">63</xref>
–<xref rid="CIT0071">71</xref>
</sup>
There may be an incomplete understanding of the biology or epidemiology of a new pathogen, which can delay or confound the selection of a relevant vaccine target and the subsequent assay development to be used to evaluate the candidates. The field may suffer from a lack of available reagent sources or with inconsistency in quantity and quality of those available, especially early in the discovery and development process. The difficulty in obtaining or developing relevant human sample panels, reference materials and/or international standards for the evaluation of test methods add to the challenges to support assay performance from early vaccine development through licensure.<sup><xref rid="CIT0010">10</xref>
</sup>
</p>
<p>Although the speed at which the EID diagnostic or vaccine development field needs to move will be dependent upon the urgency of the pathogen outbreak and its impact on human life, scientific and quality principles must still apply when developing vaccine or diagnostic assays. Biological assay standardization is critical.<sup><xref rid="CIT0002">2</xref>
,<xref rid="CIT0010">10</xref>
,<xref rid="CIT0017">17</xref>
,<xref rid="CIT0071">71</xref>
,<xref rid="CIT0072">72</xref>
</sup>
At a minimum, the development of relevant biological assays with adequate sensitivity and specificity for the application should use biostatistics to establish and verify assay performance and to maintain the ability to produce stable and reproducible results over time to support diagnostic or vaccine program needs. The criteria for acceptability of any given test system will be dependent upon the nature of the pathogen, our understanding of the immunology to fight the pathogen (both of which may be poorly understood in an EID situation) and the assay platform. If assay performance consistency and quality are not demonstrated, the validity of clinical study results may be questioned. In the execution of vaccine clinical trials, assay methodology must be accurate, specific and robust with high-quality procedures in place for sample collection, processing, and storage to ensure success.<sup><xref rid="CIT0025">25</xref>
,<xref rid="CIT0026">26</xref>
,<xref rid="CIT0036">36</xref>
,<xref rid="CIT0037">37</xref>
</sup>
The translatability of assay methodology is also important if the acceleration of vaccine development is dependent upon the use of animal challenge studies to establish efficacy or to help define a correlate of protection for an EID pathogen.</p>
<p>Efforts to prepare reagents, collect well-characterized samples, develop research materials, and international standards in advance for EIDs for whom alerts have already been raised, such as the WHO priority pathogens, through collaborative partnerships with governmental and philanthropic agencies along with academic and industry-based researchers will make us better suited to respond with speed to an outbreak.<sup><xref rid="CIT0024">24</xref>
,<xref rid="CIT0061">61</xref>
,<xref rid="CIT0069">69</xref>
,<xref rid="CIT0073">73</xref>
</sup>
Assay standardization for these or any other newly emergent infectious disease will be challenging and take time to develop, collect and characterize quality reagents, to achieve sufficient sources samples for the establishment of serological or molecular standards.<sup><xref rid="CIT0010">10</xref>
</sup>
The commitment of researchers and companies invested in the research, diagnosis, treatment, and prevention of EIDs to participate and contribute to organized efforts to create and validate internationally recognized standardized reagents, assays and controls for priority pathogens in advance of an emergency is imperative and the time to start building this framework is now.</p>
</sec>
</body>
<back><sec><title>Acknowledgments</title>
<p>The author would like to acknowledge Inovio Pharmaceuticals with whom we co-develop the GLS-5300 MERS-CoV and GLS-5700 Zika DNA vaccines, the David Weiner Laboratory at the Wistar Institute, Philadelphia, PA, the Gary Kobinger Laboratory at Laval University, Quebec, Canada and the GeneOne Life Science Teams: Clinical Research in Blue Bell, PA and Basic Research & Development in Seoul, Korea.</p>
</sec>
<sec id="S0006"><title>Disclosure of potential conflicts of interest</title>
<p>Author is an employee of GeneOne Life Science, Inc.</p>
</sec>
<ref-list><title>References</title>
<ref id="CIT0001"><label>1.</label>
<mixed-citation publication-type="data"><person-group person-group-type="author"><collab>WHO. R&D Blueprint</collab>
</person-group>
<year>2018</year>
<article-title>List of priority diseases</article-title>
. [accessed 2018 Sep 06]. <ext-link ext-link-type="uri" xlink:href="https://www.who.int/blueprint/priority-diseases/en/">https://www.who.int/blueprint/priority-diseases/en/</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0002"><label>2.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Madore</surname>
<given-names>DV</given-names>
</name>
, <name name-style="western"><surname>Meade</surname>
<given-names>BD</given-names>
</name>
, <name name-style="western"><surname>Rubin</surname>
<given-names>F</given-names>
</name>
, <name name-style="western"><surname>Deal</surname>
<given-names>C</given-names>
</name>
, <name name-style="western"><surname>Lynn</surname>
<given-names>F.</given-names>
</name>
</person-group>
<article-title>Utilization of serologic assays to support efficacy of vaccines in nonclinical and clinical trials: meeting at the crossroads</article-title>
. <source>Vaccine</source>
. <year>2010</year>
;<volume>28</volume>
(<issue>4539–4547</issue>
). doi:<pub-id pub-id-type="doi">10.1016/j.vaccine.2010.04.094</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0003"><label>3.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Plotkin</surname>
<given-names>SA</given-names>
</name>
, <name name-style="western"><surname>Gilbert</surname>
<given-names>PB</given-names>
</name>
</person-group>
<article-title>Nomenclature for immune correlates of protection after vaccination</article-title>
. <source>Clin Infect Dis</source>
. <year>2012</year>
;<volume>54</volume>
(<issue>1615–1617</issue>
). doi:<pub-id pub-id-type="doi">10.1093/cid/cis238</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0004"><label>4.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Muthumani</surname>
<given-names>K</given-names>
</name>
</person-group>
, Falzarano D, Reuschel EL, Tingey C, Flingai S, Villarreal DO, Wise M, Patel A, Izmirly A, Aljuaid A, et al. <article-title>A synthetic consensus anti-spike protein DNA vaccine induces protective immunity against Middle East respiratory syndrome coronavirus in nonhuman primates</article-title>
. <source>Sci Transl Med</source>
. <year>2015</year>
;<volume>7</volume>
(<issue>301ra132</issue>
). doi:<pub-id pub-id-type="doi">10.1126/scitranslmed.aac7462</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0005"><label>5.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Muthumani</surname>
<given-names>K</given-names>
</name>
</person-group>
, Griffin BD, Agarwal S, Kudchodkar SB, Reuschel EL, Choi H, Kraynyak KA, Duperret EK, Keaton AA, Chung C, et al. <article-title>In vivo protection against ZIKV infection and pathogenesis through passive antibody transfer and active immunisation with a prMEnv DNA vaccine</article-title>
. <source>NPJ Vaccines</source>
. <year>2016</year>
;<volume>1</volume>
(<issue>16021</issue>
). doi:<pub-id pub-id-type="doi">10.1038/npjvaccines.2016.21</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0006"><label>6.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Griffin</surname>
<given-names>BD</given-names>
</name>
</person-group>
, Muthumani K, Warner BM, Majer A, Hagan M, Audet J, Stein DR, Ranadheera C, Racine T, De La Vega MA, et al. <article-title>DNA vaccination protects mice against Zika virus-induced damage to the testes</article-title>
. <source>Nat Commun</source>
. <year>2017</year>
;<volume>8</volume>
(<issue>15743</issue>
). doi:<pub-id pub-id-type="doi">10.1038/ncomms15743</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0007"><label>7.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Tebas</surname>
<given-names>P</given-names>
</name>
</person-group>
, Roberts CC, Muthumani K, Reuschel EL, Kudchodkar SB, Zaidi FI, White S, Khan AS, Racine T, Choi H, et al. <article-title>Safety and Immunogenicity of an anti-zika virus DNA vaccine - preliminary report</article-title>
. <source>N Engl J Med</source>
. <year>2017</year>
. doi:<pub-id pub-id-type="doi">10.1056/NEJMoa1708120</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0008"><label>8.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Kudchodkar</surname>
<given-names>SB</given-names>
</name>
</person-group>
, Choi H, Reuschel EL, Esquivel R, Jin-Ah Kwon J, Jeong M, Maslow JN, Reed CC, White S, Kim JJ, et al. <article-title>Rapid response to an emerging infectious disease - Lessons learned from development of a synthetic DNA vaccine targeting Zika virus</article-title>
. <source>Microbes Infect</source>
. <year>2018</year>
. doi:<pub-id pub-id-type="doi">10.1016/j.micinf.2018.03.001</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0009"><label>9.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Maslow</surname>
<given-names>JN</given-names>
</name>
</person-group>
<article-title>Vaccines for emerging infectious diseases: lessons from MERS coronavirus and Zika virus</article-title>
. <source>Hum Vaccin Immunother</source>
. <year>2017</year>
;<volume>13</volume>
(<issue>2918–2930</issue>
). doi:<pub-id pub-id-type="doi">10.1080/21645515.2017.1358325</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0010"><label>10.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Rampling</surname>
<given-names>T</given-names>
</name>
, <name name-style="western"><surname>Page</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Horby</surname>
<given-names>P</given-names>
</name>
</person-group>
<article-title>International biological reference preparations for epidemic infectious diseases</article-title>
. <source>Emerg Infect Dis</source>
. <year>2019</year>
;<volume>25</volume>
(<issue>205–211</issue>
). doi:<pub-id pub-id-type="doi">10.3201/eid2502.180798</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0011"><label>11..</label>
<mixed-citation publication-type="book"><person-group person-group-type="author"><collab>WHO. World Health</collab>
</person-group>
<source>Organization manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards</source>
. <publisher-name>World Health Organization Expert Committee on Biological Standardization; 2017 [accessed 2019 Apr 03]</publisher-name>
<ext-link ext-link-type="uri" xlink:href="https://www.who.int/bloodproducts/norms/SecStandManWHO_TRS_1004_web_Annex_6.pdf?ua=1">https://www.who.int/bloodproducts/norms/SecStandManWHO_TRS_1004_web_Annex_6.pdf?ua=1</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0012"><label>12.</label>
<mixed-citation publication-type="web"><person-group person-group-type="author"><collab>WHO</collab>
</person-group>
<article-title>Collaborative study to evaluate a candidate world health organization international standard for zika virus for nucleic acid amplification technique (NAT)-based assays</article-title>
. 2016 [accessed 2019 Apr 03]. <ext-link ext-link-type="uri" xlink:href="http://www.who.int/iris/handle/10665/253051">http://www.who.int/iris/handle/10665/253051</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0013"><label>13.</label>
<mixed-citation publication-type="web"><article-title>FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection</article-title>
, <<ext-link ext-link-type="uri" xlink:href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572197.htm">https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572197.htm</ext-link>
> (<year>2017</year>
).</mixed-citation>
</ref>
<ref id="CIT0014"><label>14.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Beskow</surname>
<given-names>LM</given-names>
</name>
, <name name-style="western"><surname>Dombeck</surname>
<given-names>CB</given-names>
</name>
, <name name-style="western"><surname>Thompson</surname>
<given-names>CP</given-names>
</name>
, <name name-style="western"><surname>Watson-Ormond</surname>
<given-names>JK</given-names>
</name>
, <name name-style="western"><surname>Weinfurt</surname>
<given-names>KP</given-names>
</name>
</person-group>
<article-title>Informed consent for biobanking: consensus-based guidelines for adequate comprehension</article-title>
. <source>Genet Med</source>
. <year>2015</year>
;<volume>17</volume>
(<issue>226–233</issue>
). doi:<pub-id pub-id-type="doi">10.1038/gim.2014.102</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0015"><label>15.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Bossert</surname>
<given-names>S</given-names>
</name>
, <name name-style="western"><surname>Kahrass</surname>
<given-names>H</given-names>
</name>
, <name name-style="western"><surname>Heinemeyer</surname>
<given-names>U</given-names>
</name>
, <name name-style="western"><surname>Prokein</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Strech</surname>
<given-names>D</given-names>
</name>
</person-group>
<article-title>Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections</article-title>
. <source>BMC Med Ethics</source>
. <year>2017</year>
;<volume>18</volume>
(<issue>78</issue>
). doi:<pub-id pub-id-type="doi">10.1186/s12910-017-0232-7</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0016"><label>16.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Kinkorova</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Topolcan</surname>
<given-names>O</given-names>
</name>
</person-group>
<article-title>Biobanks in Horizon 2020: sustainability and attractive perspectives</article-title>
. <source>Epma J</source>
. <year>2018</year>
;<volume>9</volume>
(<issue>345–353</issue>
). doi:<pub-id pub-id-type="doi">10.1007/s13167-018-0153-7</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0017"><label>17.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Lippi</surname>
<given-names>G</given-names>
</name>
, <name name-style="western"><surname>Cadamuro</surname>
<given-names>J</given-names>
</name>
</person-group>
<article-title>Novel opportunities for improving the quality of preanalytical phase. A glimpse to the future?</article-title>
<source>J Med Biochem</source>
. <year>2017</year>
;<volume>36</volume>
:<fpage>293</fpage>
–<lpage>300</lpage>
. doi:<pub-id pub-id-type="doi">10.1515/jomb-2017-0029</pub-id>
.<pub-id pub-id-type="pmid">30581325</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0018"><label>18.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Lippi</surname>
<given-names>G</given-names>
</name>
</person-group>
, Baird GS, Banfi G, Bolenius K, Cadamuro J, Church S, Cornes MP, Dacey A, Guillon A, Hoffmann G, et al. <article-title>Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)</article-title>
. <source>Clin Chem Lab Med</source>
. <year>2017</year>
;<volume>55</volume>
(<issue>489–500</issue>
). doi:<pub-id pub-id-type="doi">10.1515/cclm-2017-0107</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0019"><label>19.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>de Vries</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Bull</surname>
<given-names>SJ</given-names>
</name>
, <name name-style="western"><surname>Doumbo</surname>
<given-names>O</given-names>
</name>
, <name name-style="western"><surname>Ibrahim</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Mercereau-Puijalon</surname>
<given-names>O</given-names>
</name>
, <name name-style="western"><surname>Kwiatkowski</surname>
<given-names>D</given-names>
</name>
, <name name-style="western"><surname>Parker</surname>
<given-names>M</given-names>
</name>
</person-group>
<article-title>Ethical issues in human genomics research in developing countries</article-title>
. <source>BMC Med Ethics</source>
. <year>2011</year>
;<volume>12</volume>
(<issue>5</issue>
). doi:<pub-id pub-id-type="doi">10.1186/1472-6939-12-5</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0020"><label>20.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Staunton</surname>
<given-names>C</given-names>
</name>
, <name name-style="western"><surname>Moodley</surname>
<given-names>K</given-names>
</name>
</person-group>
<article-title>Challenges in biobank governance in Sub-Saharan Africa</article-title>
. <source>BMC Med Ethics</source>
. <year>2013</year>
;<volume>14</volume>
(<issue>35</issue>
). doi:<pub-id pub-id-type="doi">10.1186/1472-6939-14-35</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0021"><label>21.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Tindana</surname>
<given-names>P</given-names>
</name>
, <name name-style="western"><surname>Molyneux</surname>
<given-names>CS</given-names>
</name>
, <name name-style="western"><surname>Bull</surname>
<given-names>S</given-names>
</name>
, <name name-style="western"><surname>Parker</surname>
<given-names>M</given-names>
</name>
</person-group>
<article-title>Ethical issues in the export, storage and reuse of human biological samples in biomedical research: perspectives of key stakeholders in Ghana and Kenya</article-title>
. <source>BMC Med Ethics</source>
. <year>2014</year>
;<volume>15</volume>
(<issue>76</issue>
). doi:<pub-id pub-id-type="doi">10.1186/1472-6939-15-76</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0022"><label>22.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Mungwira</surname>
<given-names>RG</given-names>
</name>
, <name name-style="western"><surname>Nyangulu</surname>
<given-names>W</given-names>
</name>
, <name name-style="western"><surname>Misiri</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Iphani</surname>
<given-names>S</given-names>
</name>
, <name name-style="western"><surname>Ng’ong’ola</surname>
<given-names>R</given-names>
</name>
, <name name-style="western"><surname>Chirambo</surname>
<given-names>CM</given-names>
</name>
, <name name-style="western"><surname>Masiye</surname>
<given-names>F</given-names>
</name>
, <name name-style="western"><surname>Mfutso-Bengo</surname>
<given-names>J</given-names>
</name>
</person-group>
<article-title>Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi</article-title>
. <source>BMC Med Ethics</source>
. <year>2015</year>
;<volume>16</volume>
(<issue>1</issue>
). doi:<pub-id pub-id-type="doi">10.1186/s12910-015-0077-x</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0023"><label>23.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Barchi</surname>
<given-names>F</given-names>
</name>
, <name name-style="western"><surname>Matlhagela</surname>
<given-names>K</given-names>
</name>
, <name name-style="western"><surname>Jones</surname>
<given-names>N</given-names>
</name>
, <name name-style="western"><surname>Kebaabetswe</surname>
<given-names>PM</given-names>
</name>
, <name name-style="western"><surname>Merz</surname>
<given-names>JF</given-names>
</name>
</person-group>
<article-title>The keeping is the problem”: A qualitative study of IRB-member perspectives in Botswana on the collection, use, and storage of human biological samples for research</article-title>
. <source>BMC Med Ethics</source>
. <year>2015</year>
;<volume>16</volume>
:<fpage>54</fpage>
. doi:<pub-id pub-id-type="doi">10.1186/s12910-015-0047-3</pub-id>
.<pub-id pub-id-type="pmid">26286519</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0024"><label>24.</label>
<mixed-citation publication-type="book"><person-group person-group-type="author"><collab>CEPI</collab>
</person-group>
<chapter-title>1st biological standards and assays workshop report</chapter-title>
In: <source>Coalition for Epidemic Preparedness Innovations</source>
. <publisher-name>2017 [accessed 2019 Apr 03]</publisher-name>
<ext-link ext-link-type="uri" xlink:href="https://cepi.net/research_dev/vaccine-science/">https://cepi.net/research_dev/vaccine-science/</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0025"><label>25.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Lippi</surname>
<given-names>G</given-names>
</name>
, <name name-style="western"><surname>Simundic</surname>
<given-names>AM</given-names>
</name>
, <name name-style="western"><surname>Rodriguez-Manas</surname>
<given-names>L</given-names>
</name>
, <name name-style="western"><surname>Bossuyt</surname>
<given-names>P</given-names>
</name>
, <name name-style="western"><surname>Banfi</surname>
<given-names>G</given-names>
</name>
</person-group>
<article-title>Standardizing in vitro diagnostics tasks in clinical trials: a call for action</article-title>
. <source>Ann Transl Med</source>
. <year>2016</year>
;<volume>4</volume>
(<issue>181</issue>
). doi:<pub-id pub-id-type="doi">10.21037/atm.2016.04.10</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0026"><label>26.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Giavarina</surname>
<given-names>D</given-names>
</name>
, <name name-style="western"><surname>Lippi</surname>
<given-names>G</given-names>
</name>
</person-group>
<article-title>Blood venous sample collection: recommendations overview and a checklist to improve quality</article-title>
. <source>Clin Biochem</source>
. <year>2017</year>
;<volume>50</volume>
(<issue>568–573</issue>
). doi:<pub-id pub-id-type="doi">10.1016/j.clinbiochem.2017.02.021</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0027"><label>27.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Marko-Varga</surname>
<given-names>G</given-names>
</name>
, <name name-style="western"><surname>Baker</surname>
<given-names>MS</given-names>
</name>
, <name name-style="western"><surname>Boja</surname>
<given-names>ES</given-names>
</name>
, <name name-style="western"><surname>Rodriguez</surname>
<given-names>H</given-names>
</name>
, <name name-style="western"><surname>Fehniger</surname>
<given-names>TE</given-names>
</name>
</person-group>
<article-title>Biorepository regulatory frameworks: building parallel resources that both promote scientific investigation and protect human subjects</article-title>
. <source>J Proteome Res</source>
. <year>2014</year>
;<volume>13</volume>
(<issue>5319–5324</issue>
). doi:<pub-id pub-id-type="doi">10.1021/pr500475q</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0028"><label>28.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Smith</surname>
<given-names>JF</given-names>
</name>
, <name name-style="western"><surname>Kowalski</surname>
<given-names>R</given-names>
</name>
, <name name-style="western"><surname>Esser</surname>
<given-names>MT</given-names>
</name>
, <name name-style="western"><surname>Brown</surname>
<given-names>MJ</given-names>
</name>
, <name name-style="western"><surname>Bryan</surname>
<given-names>JT</given-names>
</name>
</person-group>
<article-title>Evolution of type-specific immunoassays to evaluate the functional immune response to Gardasil: a vaccine for human papillomavirus types 16, 18, 6 and 11</article-title>
. <source>Hum Vaccin</source>
. <year>2008</year>
;<volume>4</volume>
:<fpage>134</fpage>
–<lpage>42</lpage>
. doi:<pub-id pub-id-type="doi">10.4161/hv.4.2.5261</pub-id>
.<pub-id pub-id-type="pmid">18388490</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0029"><label>29.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Nyan</surname>
<given-names>DC</given-names>
</name>
, <name name-style="western"><surname>Swinson</surname>
<given-names>KL</given-names>
</name>
</person-group>
<article-title>A novel multiplex isothermal amplification method for rapid detection and identification of viruses</article-title>
. <source>Sci Rep</source>
. <year>2015</year>
;<volume>5</volume>
(<issue>17925</issue>
). doi:<pub-id pub-id-type="doi">10.1038/srep17925</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0030"><label>30.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Ghodbane</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Stucky</surname>
<given-names>EC</given-names>
</name>
, <name name-style="western"><surname>Maguire</surname>
<given-names>TJ</given-names>
</name>
, <name name-style="western"><surname>Schloss</surname>
<given-names>RS</given-names>
</name>
, <name name-style="western"><surname>Shreiber</surname>
<given-names>DI</given-names>
</name>
, <name name-style="western"><surname>Zahn</surname>
<given-names>JD</given-names>
</name>
, <name name-style="western"><surname>Yarmush</surname>
<given-names>ML</given-names>
</name>
</person-group>
<article-title>Development and validation of a microfluidic immunoassay capable of multiplexing parallel samples in microliter volumes</article-title>
. <source>Lab Chip</source>
. <year>2015</year>
;<volume>15</volume>
(<issue>3211–3221</issue>
). doi:<pub-id pub-id-type="doi">10.1039/c5lc00398a</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0031"><label>31.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Ronnberg</surname>
<given-names>B</given-names>
</name>
, <name name-style="western"><surname>Gustafsson</surname>
<given-names>Å</given-names>
</name>
, <name name-style="western"><surname>Vapalahti</surname>
<given-names>O</given-names>
</name>
, <name name-style="western"><surname>Emmerich</surname>
<given-names>P</given-names>
</name>
, <name name-style="western"><surname>Lundkvist</surname>
<given-names>Å</given-names>
</name>
, <name name-style="western"><surname>Schmidt-Chanasit</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Blomberg</surname>
<given-names>J</given-names>
</name>
</person-group>
<article-title>Compensating for cross-reactions using avidity and computation in a suspension multiplex immunoassay for serotyping of Zika versus other flavivirus infections</article-title>
. <source>Med Microbiol Immunol</source>
. <year>2017</year>
;<volume>206</volume>
(<issue>383–401</issue>
). doi:<pub-id pub-id-type="doi">10.1007/s00430-017-0517-y</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0032"><label>32.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Wong</surname>
<given-names>SJ</given-names>
</name>
, <name name-style="western"><surname>Furuya</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Zou</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Xie</surname>
<given-names>X</given-names>
</name>
, <name name-style="western"><surname>Dupuis</surname>
<given-names>AP</given-names>
</name>
, <name name-style="western"><surname>Kramer</surname>
<given-names>LD</given-names>
</name>
, <name name-style="western"><surname>Shi</surname>
<given-names>P-Y</given-names>
</name>
</person-group>
<article-title>A multiplex microsphere immunoassay for zika virus diagnosis</article-title>
. <source>EBioMedicine</source>
. <year>2017</year>
;<volume>16</volume>
(<issue>136–140</issue>
). doi:<pub-id pub-id-type="doi">10.1016/j.ebiom.2017.01.008</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0033"><label>33.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Taylor</surname>
<given-names>CT</given-names>
</name>
, <name name-style="western"><surname>Mackay</surname>
<given-names>I</given-names>
</name>
, <name name-style="western"><surname>McMahon</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Wheatley</surname>
<given-names>S</given-names>
</name>
, <name name-style="western"><surname>Moore</surname>
<given-names>P</given-names>
</name>
, <name name-style="western"><surname>Finger</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Hewitson</surname>
<given-names>G</given-names>
</name>
, <name name-style="western"><surname>Moore</surname>
<given-names>F</given-names>
</name>
</person-group>
<article-title>Detection of Specific ZIKV IgM in travelers using a multiplexed flavivirus microsphere immunoassay</article-title>
. <source>Viruses</source>
. <year>2018</year>
:<volume>10</volume>
. doi:<pub-id pub-id-type="doi">10.3390/v10050253</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0034"><label>34.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Roberts</surname>
<given-names>C</given-names>
</name>
, <name name-style="western"><surname>Green</surname>
<given-names>T</given-names>
</name>
, <name name-style="western"><surname>Hess</surname>
<given-names>E</given-names>
</name>
, <name name-style="western"><surname>Matys</surname>
<given-names>K</given-names>
</name>
, <name name-style="western"><surname>Brown</surname>
<given-names>MJ</given-names>
</name>
, <name name-style="western"><surname>Haupt</surname>
<given-names>RM</given-names>
</name>
, <name name-style="western"><surname>Luxembourg</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Vuocolo</surname>
<given-names>S</given-names>
</name>
, <name name-style="western"><surname>Saah</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Antonello</surname>
<given-names>J</given-names>
</name>
</person-group>
<article-title>Development of a human papillomavirus competitive luminex immunoassay for 9 HPV types</article-title>
. <source>Hum Vaccin Immunother</source>
. <year>2014</year>
;<volume>10</volume>
(<issue>2168–2174</issue>
). doi:<pub-id pub-id-type="doi">10.4161/hv.29205</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0035"><label>35.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Bryan</surname>
<given-names>JT</given-names>
</name>
, <name name-style="western"><surname>Buckland</surname>
<given-names>B</given-names>
</name>
, <name name-style="western"><surname>Hammond</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Jansen</surname>
<given-names>KU</given-names>
</name>
</person-group>
<article-title>Prevention of cervical cancer: journey to develop the first human papillomavirus virus-like particle vaccine and the next generation vaccine</article-title>
. <source>Curr Opin Chem Biol</source>
. <year>2016</year>
;<volume>32</volume>
(<issue>34–47</issue>
). doi:<pub-id pub-id-type="doi">10.1016/j.cbpa.2016.03.001</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0036"><label>36.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Cunningham</surname>
<given-names>AL</given-names>
</name>
, <name name-style="western"><surname>Wei</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Sun</surname>
<given-names>G</given-names>
</name>
, <name name-style="western"><surname>Wang</surname>
<given-names>X</given-names>
</name>
, <name name-style="western"><surname>Li</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Lin</surname>
<given-names>Z</given-names>
</name>
, <name name-style="western"><surname>Li</surname>
<given-names>Z</given-names>
</name>
, <name name-style="western"><surname>Li</surname>
<given-names>Y</given-names>
</name>
, <name name-style="western"><surname>Fang</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Zhang</surname>
<given-names>J</given-names>
</name>
, et al</person-group>
<article-title>Vaccine development: from concept to early clinical testing</article-title>
. <source>Vaccine</source>
. <year>2016</year>
;<volume>34</volume>
(<issue>6655–6664</issue>
). doi:<pub-id pub-id-type="doi">10.1016/j.vaccine.2016.10.016</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0037"><label>37.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Baylor</surname>
<given-names>NW</given-names>
</name>
</person-group>
<article-title>The regulatory evaluation of vaccines for human use</article-title>
. <source>Methods Mol Biol</source>
. <year>2016</year>
;<volume>1404</volume>
(<issue>773–787</issue>
). doi:<pub-id pub-id-type="doi">10.1007/978-1-4939-3389-1_51</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0038"><label>38.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Saah</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Hoover</surname>
<given-names>DR</given-names>
</name>
</person-group>
<article-title>“Sensitivity” and “Specificity” Reconsidered: the meaning of these terms in analytical and diagnostic settings</article-title>
. <source>Ann Intern Med</source>
. <year>1997</year>
;<volume>126</volume>
:<fpage>91</fpage>
–<lpage>94</lpage>
. doi:<pub-id pub-id-type="doi">10.7326/0003-4819-126-1-199701010-00026</pub-id>
.<pub-id pub-id-type="pmid">8992938</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0039"><label>39.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Pas</surname>
<given-names>SD</given-names>
</name>
</person-group>
, Pas SD, Patel P, Reusken C, Domingo C, Corman VM, Drosten C, Dijkman R, Thiel V, Nowotny N, Koopmans MP, et al. <article-title>First international external quality assessment of molecular diagnostics for Mers-CoV</article-title>
. <source>J Clin Virol</source>
. <year>2015</year>
;<volume>69</volume>
(<issue>81–85</issue>
). doi:<pub-id pub-id-type="doi">10.1016/j.jcv.2015.05.022</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0040"><label>40.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Shan</surname>
<given-names>C</given-names>
</name>
</person-group>
, Xie X, Ren P, Loeffelholz MJ, Yang Y, Furuya A, Dupuis AP 2nd, Kramer LD, Wong SJ, Shi PY. <article-title>A rapid zika diagnostic assay to measure neutralizing antibodies in patients</article-title>
. <source>EBioMedicine</source>
. <year>2017</year>
;<volume>17</volume>
(<issue>157–162</issue>
). doi:<pub-id pub-id-type="doi">10.1016/j.ebiom.2017.03.006</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0041"><label>41.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Chua</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Prat</surname>
<given-names>I</given-names>
</name>
, <name name-style="western"><surname>Nuebling</surname>
<given-names>CM</given-names>
</name>
, <name name-style="western"><surname>Wood</surname>
<given-names>D</given-names>
</name>
, <name name-style="western"><surname>Moussy</surname>
<given-names>F</given-names>
</name>
</person-group>
<article-title>Update on zika diagnostic tests and WHO’s related activities</article-title>
. <source>PLoS Negl Trop Dis</source>
. <year>2017</year>
;<volume>11</volume>
(<issue>e0005269</issue>
). doi:<pub-id pub-id-type="doi">10.1371/journal.pntd.0005269</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0042"><label>42.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Alhetheel</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Altalhi</surname>
<given-names>H</given-names>
</name>
, <name name-style="western"><surname>Albarrag</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Shakoor</surname>
<given-names>Z</given-names>
</name>
, <name name-style="western"><surname>Mohamed</surname>
<given-names>D</given-names>
</name>
, <name name-style="western"><surname>El-Hazmi</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Somily</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Barry</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Bakhrebah</surname>
<given-names>M</given-names>
</name>
, <name name-style="western"><surname>Nassar</surname>
<given-names>M</given-names>
</name>
</person-group>
<article-title>Assessing the detection of middle east respiratory syndrome coronavirus IgG in suspected and proven cases of middle east respiratory syndrome coronavirus infection</article-title>
. <source>Viral Immunol</source>
. <year>2017</year>
;<volume>30</volume>
(<issue>649–653</issue>
). doi:<pub-id pub-id-type="doi">10.1089/vim.2017.0091</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0043"><label>43.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Balmaseda</surname>
<given-names>A</given-names>
</name>
</person-group>
, Zambrana JV, Collado D, Garcia N, Saborio S, Elizondo D, Mercado JC, Gonzalez K, Cerpas C, Nunez A, et al. <article-title>Comparison of four serological methods and two reverse transcription-PCR assays for diagnosis and surveillance of zika virus infection</article-title>
. <source>J Clin Microbiol</source>
. <year>2018</year>
;<volume>56</volume>
. doi:<pub-id pub-id-type="doi">10.1128/JCM.01785-17</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0044"><label>44.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Wilder-Smith</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Vannice</surname>
<given-names>K</given-names>
</name>
, <name name-style="western"><surname>Durbin</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Hombach</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Thomas</surname>
<given-names>SJ</given-names>
</name>
, <name name-style="western"><surname>Thevarjan</surname>
<given-names>I</given-names>
</name>
, <name name-style="western"><surname>Simmons</surname>
<given-names>CP</given-names>
</name>
</person-group>
<article-title>Zika vaccines and therapeutics: landscape analysis and challenges ahead</article-title>
. <source>BMC Med</source>
. <year>2018</year>
;<volume>16</volume>
(<issue>84</issue>
). doi:<pub-id pub-id-type="doi">10.1186/s12916-018-1067-x</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0045"><label>45.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Ohst</surname>
<given-names>C</given-names>
</name>
</person-group>
, Saschenbrecker S, Stiba K, Steinhagen K, Probst C, Radzimski C, Lattwein E, Komorowski L, Stocker W, Schlumberger W. <article-title>Reliable serological testing for the diagnosis of emerging infectious diseases</article-title>
. <source>Adv Exp Med Biol</source>
. <year>2018</year>
;<volume>1062</volume>
(<issue>19–43</issue>
). doi:<pub-id pub-id-type="doi">10.1007/978-981-10-8727-1_3</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0046"><label>46.</label>
<mixed-citation publication-type="web"><person-group person-group-type="author"><collab>FDA</collab>
</person-group>
<article-title>Current emergency use authorizations</article-title>
. 2019 [accessed 2019 Apr 03]. <ext-link ext-link-type="uri" xlink:href="https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm182568.htm#current">https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm182568.htm#current</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0047"><label>47.</label>
<mixed-citation publication-type="web"><person-group person-group-type="author"><collab>FDA</collab>
</person-group>
<article-title>Zika emergency use authorizations</article-title>
. [accessed 2018 Sep 06]. <ext-link ext-link-type="uri" xlink:href="https://www.fda.gov/medicaldevices/safety/emergencysituations/ucm161496.htm#zika">https://www.fda.gov/medicaldevices/safety/emergencysituations/ucm161496.htm#zika</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0048"><label>48.</label>
<mixed-citation publication-type="web"><person-group person-group-type="author"><collab>WHO. World Health Organization</collab>
</person-group>
<source>emergency use and listings procedures.</source>
[accessed 2018 Sep 06]. <ext-link ext-link-type="uri" xlink:href="http://www.who.int/medicines/news/public_consult_med_prods/en/">http://www.who.int/medicines/news/public_consult_med_prods/en/</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0049"><label>49.</label>
<mixed-citation publication-type="web"><article-title>FDA zika virus diagnostic development.</article-title>
[accessed 2018 Sep 21]. <ext-link ext-link-type="uri" xlink:href="https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMIssues/ucm494615.htm#support">https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMIssues/ucm494615.htm#pport</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0050"><label>50.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Park</surname>
<given-names>SW</given-names>
</name>
</person-group>
, Perera RA, Choe PG, Lau EH, Choi SJ, Chun JY, Oh HS, Song KH, Bang JH, Kim ES, et al. <article-title>Comparison of serological assays in human Middle East respiratory syndrome (MERS)-coronavirus infection</article-title>
. <source>Euro Surveill</source>
. <year>2015</year>
;<volume>20</volume>
. doi:<pub-id pub-id-type="doi">10.2807/1560-7917.ES.2015.20.41.30042</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0051"><label>51.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Corman</surname>
<given-names>VM</given-names>
</name>
</person-group>
, Rasche A, Baronti C, Aldabbagh S, Cadar D, Reusken CB, Pas SD, Goorhuis A, Schinkel J, Molenkamp R, et al. <article-title>Assay optimization for molecular detection of Zika virus</article-title>
. <source>Bull World Health Organ</source>
. <year>2016</year>
;<volume>94</volume>
(<issue>880–892</issue>
). doi:<pub-id pub-id-type="doi">10.2471/BLT.16.175950</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0052"><label>52.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Faye</surname>
<given-names>O</given-names>
</name>
</person-group>
, Faye O, Diallo D, Diallo M, Weidmann M, Sall AA. <article-title>Quantitative real-time PCR detection of Zika virus and evaluation with field-caught Mosquitoes</article-title>
. <source>Virol J</source>
. <year>2013</year>
;<volume>10</volume>
(<issue>311</issue>
). doi:<pub-id pub-id-type="doi">10.1186/1743-422X-10-311</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0053"><label>53.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Huzly</surname>
<given-names>D</given-names>
</name>
, <name name-style="western"><surname>Hanselmann</surname>
<given-names>I</given-names>
</name>
, <name name-style="western"><surname>Schmidt-Chanasit</surname>
<given-names>J</given-names>
</name>
, <name name-style="western"><surname>Panning</surname>
<given-names>M</given-names>
</name>
</person-group>
<article-title>High specificity of a novel Zika virus ELISA in European patients after exposure to different flaviviruses</article-title>
. <source>Euro Surveill</source>
. <year>2016</year>
:<volume>21</volume>
. doi:<pub-id pub-id-type="doi">10.2807/1560-7917.ES.2016.21.16.30203</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0054"><label>54.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>L’Huillier</surname>
<given-names>AG</given-names>
</name>
</person-group>
, Lombos E, Tang E, Perusini S, Eshaghi A, Nagra S, Frantz C, Olsha R, Kristjanson E, Dimitrova K, et al. <article-title>Evaluation of altona diagnostics realstar zika virus reverse transcription-PCR test kit for zika virus PCR testing</article-title>
. <source>J Clin Microbiol</source>
. <year>2017</year>
;<volume>55</volume>
(<issue>1576–1584</issue>
). doi:<pub-id pub-id-type="doi">10.1128/JCM.02153-16</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0055"><label>55.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Steinhagen</surname>
<given-names>K</given-names>
</name>
</person-group>
, Probst C, Radzimski C, Schmidt-Chanasit J, Emmerich P, van Esbroeck M, Schinkel J, Grobusch MP, Goorhuis A, Warnecke JM, et al. <article-title>Serodiagnosis of Zika virus (ZIKV) infections by a novel NS1-based ELISA devoid of cross-reactivity with dengue virus antibodies: a multicohort study of assay performance, 2015 to 2016</article-title>
. <source>Euro Surveill</source>
. <year>2016</year>
;<volume>21</volume>
. doi:<pub-id pub-id-type="doi">10.2807/1560-7917.ES.2016.21.50.30426</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0056"><label>56.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Waggoner</surname>
<given-names>JJ</given-names>
</name>
, <name name-style="western"><surname>Gresh</surname>
<given-names>L</given-names>
</name>
, <name name-style="western"><surname>Mohamed-Hadley</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Ballesteros</surname>
<given-names>G</given-names>
</name>
, <name name-style="western"><surname>Davila</surname>
<given-names>MJ</given-names>
</name>
, <name name-style="western"><surname>Tellez</surname>
<given-names>Y</given-names>
</name>
, <name name-style="western"><surname>Sahoo</surname>
<given-names>MK</given-names>
</name>
, <name name-style="western"><surname>Balmaseda</surname>
<given-names>A</given-names>
</name>
, <name name-style="western"><surname>Harris</surname>
<given-names>E</given-names>
</name>
, <name name-style="western"><surname>Pinsky</surname>
<given-names>BA</given-names>
</name>
</person-group>
<article-title>Single-reaction multiplex reverse transcription PCR for detection of zika, chikungunya, and dengue viruses</article-title>
. <source>Emerg Infect Dis</source>
. <year>2016</year>
;<volume>22</volume>
(<issue>1295–1297</issue>
). doi:<pub-id pub-id-type="doi">10.3201/eid2207.160326</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0057"><label>57.</label>
<mixed-citation publication-type="web"><article-title>FDA zika EUA Table1 molecular assay performance characteristics</article-title>
. [accessed 2018 Sep 21]. <ext-link ext-link-type="uri" xlink:href="https://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM606289.pdf">https://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM606289.pdf</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0058"><label>58.</label>
<mixed-citation publication-type="web"><article-title>FDA zika eua table 2 summary molecular assay characteristics. [accessed 2018 Sep 06].</article-title>
<ext-link ext-link-type="uri" xlink:href="https://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM606290.pdf">https://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM606290.pdf</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0059"><label>59.</label>
<mixed-citation publication-type="web"><article-title>CDC zika testing guidance for healthcare providers</article-title>
. [accessed 2018 Sep 21]. <ext-link ext-link-type="uri" xlink:href="https://www.cdc.gov/zika/hc-providers/testing-guidance.html">https://www.cdc.gov/zika/hc-providers/testing-guidance.html</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0060"><label>60.</label>
<mixed-citation publication-type="web"><person-group person-group-type="author"><name name-style="western"><surname>CDC</surname>
<given-names>U</given-names>
</name>
</person-group>
<article-title>Interpretation of Nucleic Acid and Immunoassay test results for suspected Zika Infection.</article-title>
2017 [accessed 2018 Sep 06]. <ext-link ext-link-type="uri" xlink:href="https://www.cdc.gov/zika/laboratories/lab-guidance.html#table1">https://www.cdc.gov/zika/laboratories/lab-guidance.html#table1</ext-link>
.</mixed-citation>
</ref>
<ref id="CIT0061"><label>61.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Plotkin</surname>
<given-names>SA</given-names>
</name>
</person-group>
<article-title>Vaccines for epidemic infections and the role of CEPI</article-title>
. <source>Hum Vaccin Immunother</source>
. <year>2017</year>
;<volume>13</volume>
(<issue>2755–2762</issue>
). doi:<pub-id pub-id-type="doi">10.1080/21645515.2017.1306615</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0062"><label>62.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Wong</surname>
<given-names>G</given-names>
</name>
, <name name-style="western"><surname>Qiu</surname>
<given-names>X</given-names>
</name>
</person-group>
<article-title>Funding vaccines for emerging infectious diseases</article-title>
. <source>Hum Vaccin Immunother</source>
. <year>2018</year>
;<volume>14</volume>
(<issue>1760–1762</issue>
). doi:<pub-id pub-id-type="doi">10.1080/21645515.2017.1412024</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0063"><label>63.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Burd</surname>
<given-names>EM</given-names>
</name>
</person-group>
<article-title>Validation of laboratory-developed molecular assays for infectious diseases</article-title>
. <source>Clin Microbiol Rev</source>
. <year>2010</year>
;<volume>23</volume>
(<issue>550–576</issue>
). doi:<pub-id pub-id-type="doi">10.1128/CMR.00074-09</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0064"><label>64.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Charrel</surname>
<given-names>RN</given-names>
</name>
</person-group>
, Leparc-Goffart I, Pas S, de Lamballerie X, Koopmans M, Reusken, C. <article-title>Background review for diagnostic test development for Zika virus infection</article-title>
. <source>Bull World Health Organ</source>
. <year>2016</year>
;<volume>94</volume>
:<fpage>574</fpage>
–<lpage>584D</lpage>
. doi:<pub-id pub-id-type="doi">10.2471/BLT.16.171207</pub-id>
.<pub-id pub-id-type="pmid">27516635</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0065"><label>65.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Yamaoka</surname>
<given-names>Y</given-names>
</name>
</person-group>
, Matsuyama S, Fukushi S, Matsunaga S, Matsushima Y, Kuroyama H, Kimura H, Takeda M, Chimuro T, Ryo A. <article-title>Development of monoclonal antibody and diagnostic test for middle east respiratory syndrome coronavirus using cell-free synthesized nucleocapsid antigen</article-title>
. <source>Front Microbiol</source>
. <year>2016</year>
;<volume>7</volume>
(<issue>509</issue>
). doi:<pub-id pub-id-type="doi">10.3389/fmicb.2016.00509</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0066"><label>66.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Cabral-Castro</surname>
<given-names>MJ</given-names>
</name>
, <name name-style="western"><surname>Cavalcanti</surname>
<given-names>MG</given-names>
</name>
, <name name-style="western"><surname>Peralta</surname>
<given-names>RHS</given-names>
</name>
, <name name-style="western"><surname>Peralta</surname>
<given-names>JM</given-names>
</name>
</person-group>
<article-title>Molecular and serological techniques to detect co-circulation of DENV, ZIKV and CHIKV in suspected dengue-like syndrome patients</article-title>
. <source>J Clin Virol</source>
. <year>2016</year>
;<volume>82</volume>
(<issue>108–111</issue>
). doi:<pub-id pub-id-type="doi">10.1016/j.jcv.2016.07.017</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0067"><label>67.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Barbe</surname>
<given-names>B</given-names>
</name>
</person-group>
, Verdonck K, El-Safi S, Khanal B, Teav S, Lilo Kalo JR, Ravinetto R, Chappuis F, Boelaert M, Jacobs J. <article-title>Rapid diagnostic tests for neglected infectious diseases: case study highlights need for customer awareness and postmarket surveillance</article-title>
. <source>PLoS Negl Trop Dis</source>
. <year>2016</year>
;<volume>10</volume>
(<issue>e0004655</issue>
). doi:<pub-id pub-id-type="doi">10.1371/journal.pntd.0004655</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0068"><label>68.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Waggoner</surname>
<given-names>JJ</given-names>
</name>
, <name name-style="western"><surname>Pinsky</surname>
<given-names>BA</given-names>
</name>
</person-group>
<article-title>Zika Virus: diagnostics for an Emerging Pandemic Threat</article-title>
. <source>J Clin Microbiol</source>
. <year>2016</year>
;<volume>54</volume>
(<issue>860–867</issue>
). doi:<pub-id pub-id-type="doi">10.1128/JCM.00279-16</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0069"><label>69.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Saraswathy Subramaniam</surname>
<given-names>TS</given-names>
</name>
</person-group>
, Thayan R, Yusof MA, Suppiah J, Tg Abd Rashid TR, Zawawi ZM, Mat Rahim NA, Kassim F, Zain RM, Saat Z. <article-title>Sharing experiences from a reference laboratory in the public health response for Ebola viral disease, MERS-CoV and H7N9 influenza virus investigations</article-title>
. <source>Asian Pac J Trop Med</source>
. <year>2016</year>
;<volume>9</volume>
(<issue>201–203</issue>
). doi:<pub-id pub-id-type="doi">10.1016/j.apjtm.2016.01.016</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0070"><label>70.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Hashemzadeh</surname>
<given-names>MS</given-names>
</name>
</person-group>
, Rasouli R, Zahraei B, Izadi M, Tat M, Saadat SH, Najarasl M, Khansari Nejad B, Dorostkar R. <article-title>Development of dual taqman based one-step rRT-PCR assay panel for rapid and accurate diagnostic test of MERS-CoV: A novel human coronavirus, ahead of hajj pilgrimage</article-title>
. <source>Iran Red Crescent Med J</source>
. <year>2016</year>
;<volume>18</volume>
(<issue>e23874</issue>
). doi:<pub-id pub-id-type="doi">10.5812/ircmj.23874</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0071"><label>71.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Singh</surname>
<given-names>RK</given-names>
</name>
</person-group>
, Dhama K, Karthik K, Tiwari R, Khandia R, Munjal A, Iqbal HMN, Malik YS, Bueno-Mari R. <article-title>Advances in diagnosis, surveillance, and monitoring of zika virus: an update</article-title>
. <source>Front Microbiol</source>
. <year>2017</year>
;<volume>8</volume>
(<issue>2677</issue>
). doi:<pub-id pub-id-type="doi">10.3389/fmicb.2017.02677</pub-id>
</mixed-citation>
</ref>
<ref id="CIT0072"><label>72.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Uyeki</surname>
<given-names>TM</given-names>
</name>
</person-group>
, Erlandson KJ, Korch G, O'Hara M, Wathen M, Hu-Primmer J, Hojvat S, Stemmy EJ, Donabedian A. <article-title>Development of medical countermeasures to middle east respiratory syndrome coronavirus</article-title>
. <source>Emerg Infect Dis</source>
. <year>2016</year>
;<volume>22</volume>
. doi:<pub-id pub-id-type="doi">10.3201/eid2207.160022</pub-id>
.</mixed-citation>
</ref>
<ref id="CIT0073"><label>73.</label>
<mixed-citation publication-type="journal"><person-group person-group-type="author"><name name-style="western"><surname>Perkins</surname>
<given-names>MD</given-names>
</name>
</person-group>
, Dye C, Balasegaram M, Bréchot C, Mombouli J-V, Røttingen J-A, Tanner M, Boehme CC. <article-title>Diagnostic preparedness for infectious disease outbreaks</article-title>
. <source>The Lancet</source>
. <year>2017</year>
;<volume>390</volume>
(<issue>2211–2214</issue>
). doi:<pub-id pub-id-type="doi">10.1016/s0140-6736(17)31224-2</pub-id>
</mixed-citation>
</ref>
</ref-list>
</back>
</pmc>
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