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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Point-of-Care Testing for Disasters: Needs Assessment, Strategic Planning, and Future Design</title><author><name sortKey="Kost, Gerald J" sort="Kost, Gerald J" uniqKey="Kost G" first="Gerald J." last="Kost">Gerald J. Kost</name></author><author><name sortKey="Hale, Kristin N" sort="Hale, Kristin N" uniqKey="Hale K" first="Kristin N." last="Hale">Kristin N. Hale</name></author><author><name sortKey="Brock, T Keith" sort="Brock, T Keith" uniqKey="Brock T" first="T. Keith" last="Brock">T. Keith Brock</name></author><author><name sortKey="Louie, Richard F" sort="Louie, Richard F" uniqKey="Louie R" first="Richard F." last="Louie">Richard F. Louie</name></author><author><name sortKey="Gentile, Nicole L" sort="Gentile, Nicole L" uniqKey="Gentile N" first="Nicole L." last="Gentile">Nicole L. Gentile</name></author><author><name sortKey="Kitano, Tyler K" sort="Kitano, Tyler K" uniqKey="Kitano T" first="Tyler K." last="Kitano">Tyler K. Kitano</name></author><author><name sortKey="Tran, Nam K" sort="Tran, Nam K" uniqKey="Tran N" first="Nam K." last="Tran">Nam K. Tran</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">19840690</idno><idno type="pmc">7115727</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7115727</idno><idno type="RBID">PMC:7115727</idno><idno type="doi">10.1016/j.cll.2009.07.014</idno><date when="2009">2009</date><idno type="wicri:Area/Pmc/Corpus">000E99</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000E99</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Point-of-Care Testing for Disasters: Needs Assessment, Strategic Planning, and Future Design</title><author><name sortKey="Kost, Gerald J" sort="Kost, Gerald J" uniqKey="Kost G" first="Gerald J." last="Kost">Gerald J. Kost</name></author><author><name sortKey="Hale, Kristin N" sort="Hale, Kristin N" uniqKey="Hale K" first="Kristin N." last="Hale">Kristin N. Hale</name></author><author><name sortKey="Brock, T Keith" sort="Brock, T Keith" uniqKey="Brock T" first="T. Keith" last="Brock">T. Keith Brock</name></author><author><name sortKey="Louie, Richard F" sort="Louie, Richard F" uniqKey="Louie R" first="Richard F." last="Louie">Richard F. Louie</name></author><author><name sortKey="Gentile, Nicole L" sort="Gentile, Nicole L" uniqKey="Gentile N" first="Nicole L." last="Gentile">Nicole L. Gentile</name></author><author><name sortKey="Kitano, Tyler K" sort="Kitano, Tyler K" uniqKey="Kitano T" first="Tyler K." last="Kitano">Tyler K. Kitano</name></author><author><name sortKey="Tran, Nam K" sort="Tran, Nam K" uniqKey="Tran N" first="Nam K." last="Tran">Nam K. Tran</name></author></analytic><series><title level="j">Clinics in Laboratory Medicine</title><idno type="ISSN">0272-2712</idno><idno type="eISSN">1557-9832</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Objective evidence-based national surveys serve as a first step in identifying suitable point-of-care device designs, effective test clusters, and environmental operating conditions. Preliminary survey results show the need for point-of-care testing (POCT) devices using test clusters that specifically detect pathogens found in disaster scenarios. Hurricane Katrina, the tsunami in southeast Asia, and the current influenza pandemic (H1N1, “swine flu”) vividly illustrate lack of national and global preparedness. Gap analysis of current POCT devices versus survey results reveals how POCT needs can be fulfilled. Future thinking will help avoid the worst consequences of disasters on the horizon, such as extensively drug-resistant tuberculosis and pandemic influenzas. A global effort must be made to improve POC technologies to rapidly diagnose and treat patients to improve triaging, on-site decision making, and, ultimately, economic and medical outcomes.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Kost, G J" uniqKey="Kost G">G.J. Kost</name></author><author><name sortKey="Tran, N K" uniqKey="Tran N">N.K. Tran</name></author><author><name sortKey="Tuntideelert, M" uniqKey="Tuntideelert M">M. Tuntideelert</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Diiulio, R" uniqKey="Diiulio R">R. Diiulio</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Kost, G J" uniqKey="Kost G">G.J. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Clin Lab Med</journal-id><journal-id journal-id-type="iso-abbrev">Clin. Lab. Med</journal-id><journal-title-group><journal-title>Clinics in Laboratory Medicine</journal-title></journal-title-group><issn pub-type="ppub">0272-2712</issn><issn pub-type="epub">1557-9832</issn><publisher><publisher-name>Elsevier Inc.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">19840690</article-id><article-id pub-id-type="pmc">7115727</article-id><article-id pub-id-type="publisher-id">S0272-2712(09)00070-5</article-id><article-id pub-id-type="doi">10.1016/j.cll.2009.07.014</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Point-of-Care Testing for Disasters: Needs Assessment, Strategic Planning, and Future Design</article-title></title-group><contrib-group><contrib contrib-type="author" id="au1"><name><surname>Kost</surname><given-names>Gerald J.</given-names></name><degrees>MD, PhD, MS, FACB</degrees><email>gjkost@ucdavis.edu</email><xref rid="cor1" ref-type="corresp">∗</xref></contrib><contrib contrib-type="author" id="au2"><name><surname>Hale</surname><given-names>Kristin N.</given-names></name><degrees>BS, BA</degrees></contrib><contrib contrib-type="author" id="au3"><name><surname>Brock</surname><given-names>T. Keith</given-names></name><degrees>BS</degrees></contrib><contrib contrib-type="author" id="au4"><name><surname>Louie</surname><given-names>Richard F.</given-names></name><degrees>PhD</degrees></contrib><contrib contrib-type="author" id="au5"><name><surname>Gentile</surname><given-names>Nicole L.</given-names></name><degrees>BS</degrees></contrib><contrib contrib-type="author" id="au6"><name><surname>Kitano</surname><given-names>Tyler K.</given-names></name><degrees>BS</degrees></contrib><contrib contrib-type="author" id="au7"><name><surname>Tran</surname><given-names>Nam K.</given-names></name><degrees>PhD</degrees></contrib></contrib-group><aff>Department of Pathology and Laboratory Medicine, UC Davis-LLNL Point-of-Care Technologies Center [NIBIB, NIH], Point-of-Care Testing Center for Teaching and Research (POCT•CTR), School of Medicine, University of California, 3455 Tupper Hall, Davis, CA 95616, USA</aff><author-notes><corresp id="cor1"><label>∗</label>Corresponding author. <email>gjkost@ucdavis.edu</email></corresp></author-notes><pub-date pub-type="pmc-release"><day>17</day><month>10</month><year>2009</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on .</pmc-comment>
<pub-date pub-type="ppub"><month>9</month><year>2009</year></pub-date><pub-date pub-type="epub"><day>17</day><month>10</month><year>2009</year></pub-date><volume>29</volume><issue>3</issue><fpage>583</fpage><lpage>605</lpage><permissions><copyright-statement>Copyright © 2009 Elsevier Inc. All rights reserved.</copyright-statement><copyright-year>2009</copyright-year><copyright-holder>Elsevier Inc.</copyright-holder><license><license-p>Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.</license-p></license></permissions><abstract abstract-type="teaser"><p>Objective evidence-based national surveys serve as a first step in identifying suitable point-of-care device designs, effective test clusters, and environmental operating conditions. Preliminary survey results show the need for point-of-care testing (POCT) devices using test clusters that specifically detect pathogens found in disaster scenarios. Hurricane Katrina, the tsunami in southeast Asia, and the current influenza pandemic (H1N1, “swine flu”) vividly illustrate lack of national and global preparedness. Gap analysis of current POCT devices versus survey results reveals how POCT needs can be fulfilled. Future thinking will help avoid the worst consequences of disasters on the horizon, such as extensively drug-resistant tuberculosis and pandemic influenzas. A global effort must be made to improve POC technologies to rapidly diagnose and treat patients to improve triaging, on-site decision making, and, ultimately, economic and medical outcomes.</p></abstract><kwd-group><title>Keywords</title><kwd>Biohazard containment</kwd><kwd>Hurricane Katrina</kwd><kwd>Modular test design</kwd><kwd>Newdemics</kwd><kwd>Sampling method</kwd><kwd>Small-world network (SWN)</kwd><kwd>Tsunami</kwd></kwd-group></article-meta></front><body><sec id="sec1"><title>Goals and objectives</title><p id="para0125">The goals of point-of-care testing (POCT) are to facilitate rapid evidence-based decisions, to improve patient outcomes, and, ultimately, to be robust and reliable enough for on-site applications in emergency and disaster settings worldwide.</p><p id="para0130">The objectives of this article are (1) to review current POC technologies used in disaster and emergency care, (2) to understand first responder needs, (3) to outline device design criteria based on gap analysis, and (4) to present strategies for improving future POCT for efficiency, effectiveness, and targeted treatment during on-site field operations.</p><p id="para0135">This article is evidence-based in that it presents preliminary results of a needs assessment survey in the United States. Readers are encouraged to participate in the needs assessment survey. Please see the instructions provided in <xref rid="tbl1" ref-type="table">Table 1</xref>.<table-wrap position="float" id="tbl1"><label>Table 1</label><caption><p>SurveyMonkey Instructions</p></caption><table frame="hsides" rules="groups"><thead><tr><th>Step</th><th>Instruction and Access</th></tr></thead><tbody><tr><td>One</td><td>Visit UC Davis-LLNL POCT.</td></tr><tr><td></td><td>Web site: <ext-link ext-link-type="uri" xlink:href="http://www.ucdmc.ucdavis.edu/pathology/poctcenter">http://www.ucdmc.ucdavis.edu/pathology/poctcenter</ext-link></td></tr><tr><td>Two</td><td>The Clinical Needs Assessment survey link appears in the top right corner of the navigation bar. It is the first item under POC Technologies Center. Please click on “Needs Assessment Survey”</td></tr><tr><td>Three</td><td>Please contact Keith Brock, Research Specialist, at 530 752 8471, email: <ext-link ext-link-type="uri" xlink:href="mailto:tkbrock@ucdavis.edu">tkbrock@ucdavis.edu</ext-link>, to receive an accession number</td></tr><tr><td>Four</td><td>Follow the instructions on the screen to complete the survey. <italic>Note:</italic> Your progress will be saved after pressing the “next” button at the end of each page. Please note, your progress online is managed through your web browser cookies. Please complete the survey on the same computer and do not delete the cookies on your web browser before completion of the online survey</td></tr><tr><td>Five</td><td>Thank you for your time and input on the survey!</td></tr></tbody></table></table-wrap></p><p id="para0140">The 2004 tsunami in Southeast Asia and Hurricane Katrina in the United States exposed the lack of disaster preparedness worldwide.<xref rid="bib1" ref-type="bibr"><sup>1</sup></xref> Although the feasibility of POCT was proven, and the disaster responses were extensive, follow-up studies showed rescue was slow and inadequate.<xref rid="bib1" ref-type="bibr"><sup>1</sup></xref> In Hurricane Katrina, flooded hospitals, roads, and communications hindered rescue efforts by first responders who carried limited POCT devices such as oxygen saturation monitors (pulse oximeters), blood glucose meters, and other small handhelds.<xref rid="bib1" ref-type="bibr"><sup>1</sup></xref> Furthermore, POCT instruments failed to operate effectively under adverse environmental conditions at respective disaster locations, where temperatures reached 110°F (43°C) or higher in hospitals.<xref rid="bib2" ref-type="bibr">2</xref>, <xref rid="bib3" ref-type="bibr">3</xref></p><p id="para0145">Broadly regional catastrophes, such as these recent “newdemics,”<xref rid="bib4" ref-type="bibr">4</xref>, <xref rid="bib5" ref-type="bibr">5</xref> lead to sequentially magnified setbacks. Others, such as the current novel H1N1 pandemic, threaten entire nations. Typically, communities lack the POCT resources necessary to effectively handle the disaster situations they face.<xref rid="bib1" ref-type="bibr"><sup>1</sup></xref> Conversely, newdemics highlight the significant potential for POCT to positively impact preparedness, disaster response, and patient outcomes. Current experiences, including the surprise appearance of the novel H1N1 pandemic in Mexico (unpublished observation), emphasize the need for new sturdy, handheld, and robust POC technologies capable of effectively operating in a variety of field locations.</p><p id="para0150">In the future, better prepared first responders will carry reliable POCT diagnostics wherever disaster and emergency situations arise. Thus, POC user needs are being established through objective evidence-based national surveys (see <xref rid="tbl1" ref-type="table">Table 1</xref>) as a first step in identifying suitable device designs, effective test clusters, and environmental operating conditions.<xref rid="bib6" ref-type="bibr"><sup>6</sup></xref> The preliminary survey results are reported.</p></sec><sec id="sec2"><title>Needs assessment survey: preliminary results</title><sec id="sec2.1"><title>Participants</title><p id="para0155">Forty disaster care experts were randomly selected from the editorial boards of the <italic>American Journal of Disaster Medicine</italic> (AJDM) and <italic>Disaster Medicine Public Health and Preparedness</italic> (DMPHP) using a random number generator (Minitab, State College, PA). This sample included physicians, public health officials, researchers, pathologists, first responders, and military personnel.</p></sec><sec id="sec2.2"><title>Development</title><p id="para0160">A survey was developed based on literature review and multidisciplinary consultations that included professors of bioengineering, emergency medicine, infectious diseases, and critical care medicine. “Visual logistics,” defined as graphics and pictorial media for common sense portrayal of questions, concepts, and designs, are introduced to build survey questions with the objective of generating easy to comprehend concepts without laborious text or lengthy explanation. Set theory (eg, Venn diagrams) was used whenever possible to compare 2 or more visual concepts, questions, and the results.</p><p id="para0165">To encourage participation and simplify distribution and return, a visual logistics web-based survey was developed (SurveyMonkey, Portland, Oregon). Paper-based and web-based surveys used identical graphics and questions. The survey was divided into 4 parts: (1) demographic questions, (2) device design questions in 10 sections, (3) pathogen test cluster design questions in 4 sections, and (4) trade-off blocks that led to heuristic ranking of POC design features. At the time of this preliminary report, parts 1 to 3 were implemented.</p></sec><sec id="sec2.3"><title>Procedures</title><p id="para0170">If possible, personal contact was initiated by phone followed by shipment of a FedEx package containing an invitation letter, the paper-based survey, and a prepaid return envelope. The invitation letter explained the goal of the survey, provided instructions for participation, and included a hyperlink to the web-based survey (see <xref rid="tbl1" ref-type="table">Table 1</xref>). Email also was used to distribute the survey request and hyperlink. This preliminary report reflects survey results obtained between March 1 and June 14, 2009. The survey was conducted in compliance with the UC Davis Institutional Review Board.</p></sec><sec id="sec2.4"><title>Statistics</title><p id="para0175">Data obtained from the survey were analyzed using nonparametric Pearson chi-square exact tests (SAS, Gary, North Carolina). Statistical significance was defined as: ∗, <italic>P</italic><.05; ∗∗, <italic>P</italic><.01; and ∗∗∗, <italic>P</italic><.001.</p><p id="para0180">Pathogen test cluster rank results were analyzed by assigning each pathogen a weighted score. The score for each rank was calculated using the following equation: <inline-formula><mml:math id="M1" altimg="si1.gif" overflow="scroll"><mml:mrow><mml:msub><mml:mtext>S</mml:mtext><mml:mtext>i</mml:mtext></mml:msub><mml:mo>=</mml:mo><mml:mrow><mml:mo>(</mml:mo><mml:mrow><mml:mn>11</mml:mn><mml:mo>−</mml:mo><mml:msub><mml:mtext>R</mml:mtext><mml:mtext>i</mml:mtext></mml:msub></mml:mrow><mml:mo>)</mml:mo></mml:mrow></mml:mrow></mml:math></inline-formula>. R<sub>i</sub> is defined as the rank of each pathogen assigned by a survey participant, such that <inline-formula><mml:math id="M2" altimg="si2.gif" overflow="scroll"><mml:mrow><mml:mtext>i</mml:mtext><mml:mrow><mml:mo>=</mml:mo></mml:mrow><mml:mo>[</mml:mo><mml:mn>1</mml:mn><mml:mo>,</mml:mo><mml:mtext>n]</mml:mtext></mml:mrow></mml:math></inline-formula>, where <italic>n</italic> is the number of ranks. When the respondent designated the same rank for 2 or more organisms, the average rank was calculated and assigned to each organism.</p><p id="para0185">The weighted score was calculated by summing the product of each score and corresponding frequency using the following equation: <inline-formula><mml:math id="M3" altimg="si3.gif" overflow="scroll"><mml:mrow><mml:msub><mml:mrow><mml:mtext>WS</mml:mtext></mml:mrow><mml:mtext>j</mml:mtext></mml:msub><mml:mo>=</mml:mo><mml:munder><mml:mo>∑</mml:mo><mml:mrow><mml:mtext>i</mml:mtext><mml:mo>=</mml:mo><mml:mn>1</mml:mn></mml:mrow></mml:munder><mml:mrow><mml:msub><mml:mtext>S</mml:mtext><mml:mtext>i</mml:mtext></mml:msub></mml:mrow><mml:mo>×</mml:mo><mml:msub><mml:mtext>F</mml:mtext><mml:mrow><mml:mtext>ij</mml:mtext></mml:mrow></mml:msub></mml:mrow></mml:math></inline-formula>. The frequency, F<sub>ij</sub> is defined as the number of times survey participants ranked a pathogen a specific value, such that <inline-formula><mml:math id="M4" altimg="si4.gif" overflow="scroll"><mml:mrow><mml:mtext>j</mml:mtext><mml:mrow><mml:mo>=</mml:mo></mml:mrow><mml:mo>[</mml:mo><mml:mn>1</mml:mn><mml:mo>,</mml:mo><mml:mtext>N]</mml:mtext></mml:mrow></mml:math></inline-formula>, where <italic>N</italic> is the number of pathogens.</p></sec></sec><sec id="sec3"><title>Preliminary results</title><sec id="sec3.1"><title>Demography</title><p id="para0190">Of the 40 disaster medicine experts surveyed, 25 responses were received, giving a response rate of 62%. The respondents included 8 physicians (32%), 9 public health officials/hospital managers (36%), 3 pathologists (12%), and 5 emergency room doctors (20%).</p></sec><sec id="sec3.2"><title>Device Design</title><p id="para0195"><xref rid="fig1" ref-type="fig">Fig. 1</xref>illustrates visual logistics, specifically pictorial media that introduced the survey question on what the respondent preferred with regard to instrument formats for given clinical settings. The results showed that in disaster settings, respondents showed a significant preference for handheld diagnostics (<xref rid="fig2" ref-type="fig">Fig. 2</xref>) and cited increased portability and versatility as the rationale.<fig id="fig1"><label>Fig. 1</label><caption><p>Device design format. Visual logistics were used to illustrate 3 device format selections for POCT instruments. (<italic>A</italic>) Transportable device on a cart. (<italic>B</italic>) Portable, bench-top device with a handle for carrying. (<italic>C</italic>) Small battery-operated handheld device.</p></caption><graphic xlink:href="gr1_lrg"></graphic></fig><fig id="fig2"><label>Fig. 2</label><caption><p>Selection of format by survey respondents. In disaster settings, participants preferred handheld devices (∗∗∗<italic>P</italic><.001). For urgent care and emergency-room settings, there were no statistically significant differences in preferences.</p></caption><graphic xlink:href="gr2_lrg"></graphic></fig></p><p id="para0200">When respondents were asked to choose between a device that tests multiple patient samples in parallel for a single pathogen versus a device that performs multiplex testing of several pathogens for a single patient sample (<xref rid="fig3" ref-type="fig">Fig. 3</xref>), respondents preferred a multiplex test in the urgent care and emergency room settings (<xref rid="fig4" ref-type="fig">Fig. 4</xref>). Participants cited the need to quickly screen a large volume of patients in a disaster setting, whereas a full workup is necessary in urgent care and emergency room settings. Several of the respondents who chose the device that parallel processes multiple patient samples for a single pathogen given a disaster setting, referenced biothreat or pandemic scenarios.<fig id="fig3"><label>Fig. 3</label><caption><p>Multiple patients versus multiplex pathogens. Visual logistics were used to illustrate 2 testing methods for POCT devices. (<italic>A</italic>) Testing multiple patients for 1 pathogen. (<italic>B</italic>) Multiplex pathogen testing, in which 1 patient sample is simultaneously tested for the presence of multiple pathogens (<italic>underline</italic>).</p></caption><graphic xlink:href="gr3_lrg"></graphic></fig><fig id="fig4"><label>Fig. 4</label><caption><p>Selection of testing method by survey respondents. In disaster settings, both approaches to pathogen detection may be useful. However, respondents preferred multiplex testing to testing multiple patients for 1 pathogen in urgent care (∗∗∗<italic>P</italic><.001) and emergency room (∗∗<italic>P</italic><.01) settings.</p></caption><graphic xlink:href="gr4_lrg"></graphic></fig></p><p id="para0205"><xref rid="fig5" ref-type="fig">Fig. 5</xref>shows 2 different sample collection methods, a test cassette and vacutainer. A test cassette provides a housing platform in which one can automate preanalytical processing steps that are critical to subsequent analytical steps that follow on the POC device. <xref rid="fig6" ref-type="fig">Fig. 6</xref>reflects general acceptance of test cassettes in disaster, urgent care, and emergency settings.<fig id="fig5"><label>Fig. 5</label><caption><p>Test cassettes versus vacutainers. Visual logistics were used to illustrate 2 sample collection methods for POCT instruments. (<italic>A</italic>) A vacutainer is used to collect the blood sample, allowing for multiple blood collection tubes to be drawn at one time. (<italic>B</italic>) Test cassette blood sample collection; blood is drawn directly into a disposable test cassette, processed, and a result given. Graphics updated for the survey currently in use.</p></caption><graphic xlink:href="gr5_lrg"></graphic></fig><fig id="fig6"><label>Fig. 6</label><caption><p>Selection of sample collection method by survey respondents. Test cassettes and vacutainers were equivalent in all but the disaster setting, but this result was not statistically significant in this preliminary survey report.</p></caption><graphic xlink:href="gr6_lrg"></graphic></fig></p><p id="para0210">Respondents were also asked to state their preference between 2 potential waste disposal methods (<xref rid="fig7" ref-type="fig">Fig. 7</xref>). The first scheme suggests an instrument that stores biohazard waste in a reusable waste storage reservoir to be emptied periodically. A test cassette, used to transport the sample to the instrument, would also need to be properly discarded after a single use. The second scheme shows an instrument that stores all biohazard waste in the disposable test cassette, which then is discarded after a single use. <xref rid="fig8" ref-type="fig">Fig. 8</xref>shows a statistically significant preference of respondents for the disposable test cassette in the second scheme across all 3 clinical settings, with a higher level of statistical significance (<italic>P</italic><.01) of the preference in disaster and emergency room settings.<fig id="fig7"><label>Fig. 7</label><caption><p>Biohazard disposal methods. Visual logistics were used to illustrate 2 biohazard disposal methods for POCT devices. (<italic>A</italic>) Biohazard waste in a reusable waste storage reservoir that must be emptied periodically, and a disposable test cassette for single use. (<italic>B</italic>) A device that stores all biohazard waste in a disposable test cassette that is discarded after a single use. Graphics updated for the survey currently in use.</p></caption><graphic xlink:href="gr7_lrg"></graphic></fig><fig id="fig8"><label>Fig. 8</label><caption><p>Uniform selection of waste disposal by disposable test cassette by survey respondents. There is a statistically significant preference for disposable test cassettes across all 3 clinical settings (<italic>P</italic><.01, 0.05, and 0.01). See <xref rid="fig6" ref-type="fig">Fig. 6</xref>. Disposable test cassettes have merit for sample collection and waste disposal in disaster settings. ∗<italic>P</italic><.05; ∗∗<italic>P</italic><.01.</p></caption><graphic xlink:href="gr8_lrg"></graphic></fig></p></sec><sec id="sec3.3"><title>Pathogen Test Cluster Design</title><p id="para0215"><xref rid="tbl2" ref-type="table">Table 2</xref>shows the weighted scores of the top 10 pathogens for each of 4 scenario sections. For a general disaster test cluster, <italic>Vibrio cholerae</italic> had the highest weighted score (117); whereas for a blood donor screening test cluster, HIV 1 and 2 had the highest weighted score (224). Depending on the clinical scenario, the specific pathogens a POC device would detect varies. For instance, methicillin-resistant <italic>Staphylococcus aureus</italic> (MRSA) had the highest weighted score at 147 for the bloodstream pathogen test cluster (see <xref rid="tbl2" ref-type="table">Table 2</xref>). However, in the pandemic test cluster, influenza A/B had the highest weighted score at 189, whereas MRSA was fifth with a weighted score of 112.5 (see <xref rid="tbl2" ref-type="table">Table 2</xref>).<table-wrap position="float" id="tbl2"><label>Table 2</label><caption><p>Pathogen test clusters</p></caption><table frame="hsides" rules="groups"><thead><tr><th></th><th>Weighted Score</th><th>Pathogen</th></tr></thead><tbody><tr><td rowspan="10">A. General disaster test cluster (n = 18)</td><td align="char">117</td><td><italic>Vibrio cholerae</italic></td></tr><tr><td align="char">108</td><td><italic>Escherichia coli</italic></td></tr><tr><td align="char">100</td><td><italic>Staphylococcus aureus</italic></td></tr><tr><td align="char">77</td><td>Yellow fever</td></tr><tr><td align="char">73</td><td><italic>Salmonella enterica</italic></td></tr><tr><td align="char">66</td><td><italic>Pseudomonas aeruginosa</italic></td></tr><tr><td align="char">62</td><td><italic>Plasmodium falciparum</italic></td></tr><tr><td align="char">54</td><td><italic>Enterobacter</italic> species</td></tr><tr><td align="char">49</td><td>Dengue fever virus</td></tr><tr><td align="char">38</td><td><italic>Klebsiella</italic> species</td></tr><tr><td rowspan="10">B. Blood donor screening test cluster (n = 23)</td><td align="char">224</td><td>HIV 1 and 2</td></tr><tr><td align="char">190</td><td>Hepatitis B</td></tr><tr><td align="char">190</td><td>Hepatitis C</td></tr><tr><td align="char">125.5</td><td>Human T cell lymphotropic virus 1 and 2 (HTLV 1 and 2)</td></tr><tr><td align="char">109.5</td><td>West Nile virus</td></tr><tr><td align="char">109</td><td><italic>Cytomegalovirus</italic></td></tr><tr><td align="char">93</td><td>Dengue fever</td></tr><tr><td align="char">77</td><td>Parvovirus B19</td></tr><tr><td align="char">74</td><td>Epstein-Barr virus</td></tr><tr><td align="char">46</td><td>Chikungunya</td></tr><tr><td rowspan="10">C. Bloodstream pathogen test cluster (n = 20)</td><td align="char">147</td><td>Methicillin-resistant <italic>Staphylococcus aureus</italic></td></tr><tr><td align="char">118</td><td><italic>Escherichia coli</italic></td></tr><tr><td align="char">91</td><td><italic>Pseudomonas aeruginosa</italic></td></tr><tr><td align="char">90.5</td><td><italic>Streptococcus pneumoniae</italic></td></tr><tr><td align="char">90</td><td><italic>Enterobacter</italic> species</td></tr><tr><td align="char">87.5</td><td>Methicillin-sensitive <italic>Staphylococcus aureus</italic></td></tr><tr><td align="char">79</td><td><italic>Klebsiella</italic> species</td></tr><tr><td align="char">61</td><td><italic>Enterococcus faecalis</italic></td></tr><tr><td align="char">50</td><td><italic>Streptococcus pyogenes</italic></td></tr><tr><td align="char">48</td><td>Coagulase-negative <italic>Staphylococcus</italic></td></tr><tr><td rowspan="10">D. Pandemic test cluster (n = 22)</td><td align="char">189</td><td><italic>Influenza</italic> A/B</td></tr><tr><td align="char">121.5</td><td><italic>Parainfluenza</italic> 1, 2, 3</td></tr><tr><td align="char">115.5</td><td><italic>Streptococcus pneumoniae</italic></td></tr><tr><td align="char">112.5</td><td>Respiratory syncytial virus</td></tr><tr><td align="char">112.5</td><td>Methicillin-resistant <italic>Staphylococcus aureus</italic></td></tr><tr><td align="char">100</td><td><italic>Haemophilus influenza</italic></td></tr><tr><td align="char">90.5</td><td><italic>Mycobacterium tuberculosis</italic></td></tr><tr><td align="char">87</td><td>Adenovirus</td></tr><tr><td align="char">57</td><td><italic>Mycoplasm pneumoniae</italic></td></tr><tr><td align="char">51.5</td><td>Metapneumovirus</td></tr></tbody></table></table-wrap></p></sec></sec><sec id="sec4"><title>Preliminary results versus current disaster pathogens</title><p id="para0220">Various POCT devices that test for a variety of analytes and pathogens are used during disaster and emergency situations, such as Hurricane Katrina. Emergency medical responders, disaster medical assistance teams (DMATs), international medical-surgical response teams (IMSuRTs), and other first responders deploy to disaster sites carrying POCT devices.<xref rid="bib6" ref-type="bibr"><sup>6</sup></xref> They use POCT devices to test, rapidly diagnose, and, as indicated, treat victims.<xref rid="bib6" ref-type="bibr"><sup>6</sup></xref> Depending on where responders are deployed, the pathogens they encounter will vary, possibly unpredictably and unexpectedly. <xref rid="tbl3" ref-type="table">Table 3</xref><xref rid="bib7" ref-type="bibr">7</xref>, <xref rid="bib8" ref-type="bibr">8</xref>, <xref rid="bib9" ref-type="bibr">9</xref>, <xref rid="bib10" ref-type="bibr">10</xref>, <xref rid="bib11" ref-type="bibr">11</xref>, <xref rid="bib12" ref-type="bibr">12</xref>, <xref rid="bib13" ref-type="bibr">13</xref>, <xref rid="bib14" ref-type="bibr">14</xref>, <xref rid="bib15" ref-type="bibr">15</xref>, <xref rid="bib16" ref-type="bibr">16</xref>, <xref rid="bib17" ref-type="bibr">17</xref>, <xref rid="bib18" ref-type="bibr">18</xref>, <xref rid="bib19" ref-type="bibr">19</xref>, <xref rid="bib20" ref-type="bibr">20</xref>, <xref rid="bib21" ref-type="bibr">21</xref>, <xref rid="bib22" ref-type="bibr">22</xref>, <xref rid="bib23" ref-type="bibr">23</xref>, <xref rid="bib24" ref-type="bibr">24</xref>, <xref rid="bib25" ref-type="bibr">25</xref>, <xref rid="bib26" ref-type="bibr">26</xref>, <xref rid="bib27" ref-type="bibr">27</xref>, <xref rid="bib28" ref-type="bibr">28</xref>, <xref rid="bib29" ref-type="bibr">29</xref>, <xref rid="bib30" ref-type="bibr">30</xref>, <xref rid="bib31" ref-type="bibr">31</xref>, <xref rid="bib32" ref-type="bibr">32</xref> documents the variety of pathogens present in several modern disasters, such as flooding, hurricanes, and earthquakes. When comparing the top 10 pathogens identified by preliminary needs assessment survey results in various disaster scenarios (see <xref rid="tbl2" ref-type="table">Table 2</xref>) with pathogens found in major disasters, there was substantial overlap.<table-wrap position="float" id="tbl3"><label>Table 3</label><caption><p>Pathogens in disasters</p></caption><table frame="hsides" rules="groups"><thead><tr><th>Scenario</th><th>Location, Year</th><th>Pathogens Detected (Isolation Site)</th><th>Path of Infection</th></tr></thead><tbody><tr><td rowspan="3">Drought</td><td rowspan="2">Florida, 5 epidemics since 1952<xref rid="bib7" ref-type="bibr">7</xref>, <xref rid="bib8" ref-type="bibr">8</xref></td><td>Saint Louis encephalitis (blood)</td><td>Vector borne</td></tr><tr><td>West Nile (blood)</td><td>Vector borne</td></tr><tr><td>Indonesia, 1997<xref rid="bib9" ref-type="bibr"><sup>9</sup></xref></td><td>Malaria (blood)</td><td>Vector borne</td></tr><tr><td rowspan="19">Earthquake</td><td>California, 1994<xref rid="bib10" ref-type="bibr"><sup>10</sup></xref></td><td><italic>Coccidioides immitis</italic> (skin)</td><td>Dust cloud</td></tr><tr><td rowspan="5">China, 2008<xref rid="bib11" ref-type="bibr"><sup>11</sup></xref></td><td><italic>Staphylococcus aureus</italic> (pus and wound)</td><td>Wound</td></tr><tr><td><italic>Escherichia coli</italic> (pus and wound)</td><td>Wound</td></tr><tr><td><italic>Acinetobacter baumannii</italic> (pus and wound)</td><td>Wound</td></tr><tr><td><italic>Enterobacter cloacae</italic> (pus and wound)</td><td>Wound</td></tr><tr><td><italic>Pseudomonas aeruginosa</italic> (pus and wound)</td><td>Wound</td></tr><tr><td rowspan="5">Turkey, 1999<xref rid="bib12" ref-type="bibr"><sup>12</sup></xref></td><td><italic>Pseudomonas aeruginosa</italic> (wound)</td><td>Wound</td></tr><tr><td><italic>Acinetobacter baumannii</italic> (wound)</td><td>Wound</td></tr><tr><td>Methicillin-resistant</td><td></td></tr><tr><td><italic>Staphylococcus aureus</italic> (wound)</td><td>Wound</td></tr><tr><td><italic>Candida</italic> species (wound)</td><td>Wound</td></tr><tr><td rowspan="8">Turkey, 1999<xref rid="bib13" ref-type="bibr"><sup>13</sup></xref></td><td><italic>Acinetobacter</italic> species (wound)</td><td>Wound</td></tr><tr><td><italic>Pseudomonas aeruginosa</italic> (wound, blood, urine)</td><td>Wound</td></tr><tr><td>Methicillin-resistant</td><td></td></tr><tr><td><italic>Staphylococcus aureus</italic> (wound, blood, urine)</td><td>Wound</td></tr><tr><td><italic>Serratia marcescens</italic> (wound)</td><td>Wound</td></tr><tr><td><italic>Klebsiella pneumoniae</italic> (wound)</td><td>Wound</td></tr><tr><td><italic>Enterobacter</italic> species (wound)</td><td>Wound</td></tr><tr><td><italic>Candida albicans</italic> (wound)</td><td>Wound</td></tr><tr><td rowspan="8">Flooding</td><td rowspan="2">Bangladesh, 2004<xref rid="bib14" ref-type="bibr"><sup>14</sup></xref></td><td><italic>Escherichia coli</italic> (blood)</td><td>Water, food borne</td></tr><tr><td><italic>Vibrio cholerae</italic> (stool)</td><td></td></tr><tr><td rowspan="4">Global, 1980–2008<xref rid="bib15" ref-type="bibr"><sup>15</sup></xref></td><td>Malaria (blood)</td><td>Vector borne</td></tr><tr><td>Yellow fever (blood)</td><td>Vector borne</td></tr><tr><td>West Nile (blood)</td><td>Vector borne</td></tr><tr><td>Dengue (blood)</td><td>Vector borne</td></tr><tr><td>Indonesia, 2004<xref rid="bib16" ref-type="bibr"><sup>16</sup></xref></td><td><italic>Salmonella paratyphi</italic> (blood)</td><td>Water, food borne</td></tr><tr><td>Nonspecific<xref rid="bib17" ref-type="bibr">17</xref>, <xref rid="bib18" ref-type="bibr">18</xref></td><td><italic>Streptococcus pneumoniae</italic> (blood)</td><td>Inhalation</td></tr><tr><td rowspan="16">Hurricanes/tornadoes</td><td rowspan="13">Katrina, 2005<xref rid="bib19" ref-type="bibr">19</xref>, <xref rid="bib20" ref-type="bibr">20</xref>, <xref rid="bib21" ref-type="bibr">21</xref>, <xref rid="bib22" ref-type="bibr">22</xref>, <xref rid="bib23" ref-type="bibr">23</xref></td><td>Nontoxigenic <italic>Vibrio cholerae</italic> O1 (blood)</td><td>Food borne</td></tr><tr><td><italic>Vibrio cholerae</italic> non-O1 (blood)</td><td>Water borne</td></tr><tr><td><italic>Vibrio vulnificus</italic> (blood)</td><td>Wound, food borne</td></tr><tr><td><italic>Vibrio parahaemolyticus</italic> (blood)</td><td>Wound, food borne</td></tr><tr><td>Methicillin-resistant</td><td>Wound</td></tr><tr><td><italic>Staphylococcus aureus</italic> (wound)</td><td></td></tr><tr><td>Norovirus (stool)</td><td>Water borne</td></tr><tr><td><italic>Vibrio</italic> species (lake surface water)</td><td>Water borne</td></tr><tr><td><italic>Legionella</italic> species (lake surface water)</td><td>Water borne</td></tr><tr><td><italic>Cryptosporidium</italic> (interior canal water)</td><td>Water borne</td></tr><tr><td><italic>Giardia</italic> (interior canal water)</td><td>Water borne</td></tr><tr><td><italic>Escherichia coli</italic> (shoreline canal water)</td><td>Water borne</td></tr><tr><td><italic>Bifidobacterium</italic> (shoreline canal water)</td><td>Water borne</td></tr><tr><td rowspan="3">Georgia, 2000<xref rid="bib24" ref-type="bibr"><sup>24</sup></xref></td><td><italic>Serratia marcescens</italic> (wound)</td><td>Wound</td></tr><tr><td><italic>Pseudomonas aeruginosa</italic> (wound)</td><td>Wound</td></tr><tr><td>Enterococcus (wound)</td><td>Wound</td></tr><tr><td rowspan="5">Low-resource settings/rural areas</td><td rowspan="3">Indonesia, 2001–2003<xref rid="bib16" ref-type="bibr"><sup>16</sup></xref></td><td><italic>Salmonella enterica</italic> (blood)</td><td>Food, water borne</td></tr><tr><td><italic>Salmonella paratyphi</italic> (blood)</td><td>Food, water borne</td></tr><tr><td><italic>Salmonella typhi</italic> (blood)</td><td>Food, water borne</td></tr><tr><td rowspan="2">Philippines, 1994–1996<xref rid="bib25" ref-type="bibr"><sup>25</sup></xref></td><td><italic>Streptococcus pneumoniae</italic> (blood)</td><td>Inhalation</td></tr><tr><td><italic>Haemophilus influenzae</italic> (blood)</td><td>Inhalation</td></tr><tr><td rowspan="16">Tsunamis</td><td rowspan="16">Thailand, 2004<xref rid="bib26" ref-type="bibr">26</xref>, <xref rid="bib27" ref-type="bibr">27</xref>, <xref rid="bib28" ref-type="bibr">28</xref>, <xref rid="bib29" ref-type="bibr">29</xref></td><td><italic>Aeromonas</italic> (pus and wound)</td><td>Wound</td></tr><tr><td><italic>Escherichia coli</italic> (stool)</td><td>Water, food borne</td></tr><tr><td><italic>Klebsiella pneumoniae</italic> (pus and wound)</td><td>Wound</td></tr><tr><td><italic>Pseudomonas aeruginosa</italic> (pus and wound)</td><td>Wound</td></tr><tr><td><italic>Burkolderia pseudomallei</italic> (blood)</td><td>Soil, water borne</td></tr><tr><td><italic>Acinetobacter baumannii</italic> (blood)</td><td>Soil, water borne</td></tr><tr><td><italic>Stenotrophomonas</italic> (blood)</td><td>Soil, water borne</td></tr><tr><td>Methicillin-resistant</td><td></td></tr><tr><td><italic>Staphylococcus aureus</italic> (wound)</td><td>Wound</td></tr><tr><td><italic>Staphylococcus aureus</italic> (wound)</td><td>Wound</td></tr><tr><td><italic>Candida</italic> species (blood)</td><td>Inhalation, wound</td></tr><tr><td><italic>Aspergillus</italic> species (blood)</td><td>Inhalation, wound</td></tr><tr><td><italic>Scedosporium</italic> species (blood)</td><td>Inhalation, wound</td></tr><tr><td><italic>Salmonella</italic> species (well water)</td><td>Water borne</td></tr><tr><td><italic>Clostridium</italic> species (wound)</td><td>Soil</td></tr><tr><td><italic>Aeromonas</italic> species (wound)</td><td>Water borne</td></tr><tr><td>World Trade Center disaster</td><td>New York, 2001<xref rid="bib30" ref-type="bibr">30</xref>, <xref rid="bib31" ref-type="bibr">31</xref>, <xref rid="bib32" ref-type="bibr">32</xref></td><td>Asthma and WTC cough (pathogens not named)</td><td></td></tr></tbody></table></table-wrap></p><p id="para0225">During Hurricane Katrina, for example, various pathogens were identified that also were selected and ranked by experts and surveyed as high priority for general disaster, blood donor screening, bloodstream pathogen, and pandemic test clusters. Specifically, in <xref rid="tbl2" ref-type="table">Table 2</xref> for the general disaster scenario and in <xref rid="tbl3" ref-type="table">Table 3</xref> for Hurricane Katrina, there is overlap for <italic>Vibrio cholerae</italic>, MRSA, and <italic>Escherichia coli</italic>. Thus, preliminary survey results demonstrate that survey experts identified pathogens encountered at disaster sites (see <xref rid="tbl3" ref-type="table">Table 3</xref>) as important for having POCT devices capable of detecting these organisms (see <xref rid="tbl2" ref-type="table">Table 2</xref>).</p><p id="para0230">A similar finding was observed when comparing pathogens detected at the tsunami disaster site in Southeast Asia (see <xref rid="tbl3" ref-type="table">Table 3</xref>) versus the general disaster and bloodstream pathogen test clusters ranked highly in <xref rid="tbl2" ref-type="table">Table 2</xref>. Survey results identified several pathogens in the general disaster and bloodstream pathogen test clusters, such as <italic>Escherichia coli</italic>, <italic>Klebsiella pneumoniae</italic>, <italic>Pseudomonas aeruginosa</italic>, MRSA, and <italic>Salmonella</italic> species. These pathogens also were detected at tsunami disaster sites in Southeast Asia. Having POCT devices capable of testing for these pathogens found at particular disaster sites can facilitate rapid diagnosis. Targeted therapy, in turn, can conserve drugs (eg, antimicrobials) that become depleted quickly during the initial crisis stages. These survey results should be used as a guide for development of new POCT devices capable of timely pathogen detection at disaster sites.</p></sec><sec id="sec5"><title>Current use of POCT in disasters in the United States</title><p id="para0235">New POC devices must be capable of testing for a variety of pathogens present at a particular disaster site, and also properly integrated and used to decrease response times and improve patient outcomes. During Hurricane Katrina, a variety of different locations and types of POCT were used featuring an array of POC tests covering chemistry, hematology, and other analyte categories.</p><p id="para0240"><xref rid="fig9" ref-type="fig">Fig. 9</xref>highlights POC instruments, including the various locations and POCT operators in Hurricane Katrina. Hospitals, evacuation sites, and local agencies were not prepared for the disaster and offered few POCT devices and tests. Hurricane Katrina is an example of a newdemic.<xref rid="bib5" ref-type="bibr"><sup>5</sup></xref> Supplies depleted quickly. Needs for chronic monitoring, such as outpatient glucose monitoring, were not met.<fig id="fig9"><label>Fig. 9</label><caption><p>Locations and types of POCT in Hurricane Katrina. Hospitals, evacuation sites, and local agencies were not prepared fully to assist quickly with POCT. They carried few POCT instruments. In contrast, US military ships and combat support units were equipped with POCT devices, including a variety of tests to facilitate rapid diagnosis and treatment. Donations of glucose meters proved valuable, but not fast enough or adequate for the large numbers of diabetic victims involved in the disaster. POC tests used during the disaster include: ALP, alkaline phosphatase; ALT, alanine aminotransferase; aPTT, activated partial thromboplastin time; AST, aspartate aminotransferase; BNP, B-type natriuretic peptide; BUN, blood (serum) urea nitrogen; CK, creatine kinase; cTn, cardiac troponin; GGT, γ-glutamyltransferase; Hb, hemoglobin; Hct, hematocrit; HDL, high-density lipoprotein; INR, international normalized ratio; LD, lactate dehydrogenase; MB, MB fraction of CK; PT, prothrombin time; SO<sub>2</sub>, oxygen saturation measured by pulse oximetry; TCO<sub>2</sub>, total carbon dioxide content; TP, total protein. Instrument identifications: Bayer Acsensia, <ext-link ext-link-type="uri" xlink:href="http://www.bayercarediabetes.com">http://www.bayercarediabetes.com</ext-link>; Cardiac STATus, <ext-link ext-link-type="uri" xlink:href="http://www.spectraldx.com">http://www.spectraldx.com</ext-link>; Cell-Dyn, <ext-link ext-link-type="uri" xlink:href="http://www.abbottdiagnostics.com">http://www.abbottdiagnostics.com</ext-link>; i-STAT, <ext-link ext-link-type="uri" xlink:href="http://www.i-stat.com">http://www.i-stat.com</ext-link>; Ortho Diagnostics blood typing, <ext-link ext-link-type="uri" xlink:href="http://www.orthoclinical.com">http://www.orthoclinical.com</ext-link>; Piccolo, <ext-link ext-link-type="uri" xlink:href="http://www.abaxis.com">http://www.abaxis.com</ext-link>; Rapidpoint coag, <ext-link ext-link-type="uri" xlink:href="http://www.bayer-poct.co.uk">http://www.bayer-poct.co.uk</ext-link>; and Triage, <ext-link ext-link-type="uri" xlink:href="http://www.biosite.com">http://www.biosite.com</ext-link>. (<italic>From</italic> Kost GJ, Tran NK, Tuntideelert M, et al. Hurricane Katrina, the tsunami and point-of-care testing: optimizing rapid response diagnosis in disasters. Am J Clin Pathol 2006;126:513–20. © 2006 American Society for Clinical Pathology; <italic>Courtesy of</italic> Knowledge Optimization, Davis, CA; with permission.)</p></caption><graphic xlink:href="gr9_lrg"></graphic></fig></p><p id="para0245"><xref rid="fig10" ref-type="fig">Fig. 10</xref>displays Hurricane Katrina disaster sites, arrival, and responses of mostly military assets, and a suggested optimal POCT plan (upper right in figure) for timely disaster response. <xref rid="fig10" ref-type="fig">Fig. 10</xref> also documents that the disaster response time was slow. Current POCT disaster preparation does not meet adequate standards and must be improved for future preparedness. Proper strategic placement of POCT, possibly in alternate medical care facilities, is needed to facilitate rapid diagnosis and treatment.<xref rid="bib33" ref-type="bibr"><sup>33</sup></xref><fig id="fig10"><label>Fig. 10</label><caption><p>Hurricane Katrina disaster areas, arrival times of military and civilian assets, sequential responses, and optimal POCT plan for disaster response. Mobile and military resources, including POCT, arrived on days 1, 3 to 5, 9, and 24. At the community and regional hospitals surveyed, beds averaged 154 (SD, 66; median, 173; range, 60–211) and 397 (SD, 249; median, 326; range, 174–763), respectively. Physicians ranged from 50 to 900. Displacement of 5944 physicians from the disaster area (223,000 km<sup>2</sup>) hampered an already devastated health care infrastructure. The authors recommend (<italic>upper right</italic>) optimizing disaster response by prepositioning POCT for emergency use during the first 2 critical days. ICU, intensive care unit; OR, operating room. (<italic>From</italic> Kost GJ, Tran NK, Tuntideelert M, et al. Hurricane Katrina, the tsunami and point-of-care testing: optimizing rapid response diagnosis in disasters. Am J Clin Pathol 2006;126:513–20. © 2006 American Society for Clinical Pathology; <italic>Courtesy of</italic> Knowledge Optimization, Davis, CA; with permission.)</p></caption><graphic xlink:href="gr10_lrg"></graphic></fig></p><p id="para0250">Pandemic influenza strains, such as novel H1N1, have the potential to significantly increase mortality and morbidity, as well as quickly deplete resources of current health care infrastructures. Thus, for example, rapidly diagnosing a particular influenza strain using POCT devices is advantageous. Furthermore, the World Health Organization (WHO) strongly recommends the use of POCT devices for quick influenza diagnosis. Commercially available POC tests for influenza A and B are listed in <xref rid="tbl4" ref-type="table">Table 4</xref>.<xref rid="bib34" ref-type="bibr">34</xref>, <xref rid="bib35" ref-type="bibr">35</xref>, <xref rid="bib36" ref-type="bibr">36</xref>, <xref rid="bib37" ref-type="bibr">37</xref>, <xref rid="bib38" ref-type="bibr">38</xref> Several of the tests currently available are immunoassays that target nucleoprotein or matrix protein to identify influenza A or B types, but rarely offer further subtyping.<table-wrap position="float" id="tbl4"><label>Table 4</label><caption><p>POC influenza diagnostic tests</p></caption><table frame="hsides" rules="groups"><thead><tr><th colspan="4">Instrument/Manufacturer<hr></hr></th><th colspan="4">Performance Characteristics (%)<hr></hr></th></tr><tr><th>Immunoassay Tests</th><th>Type</th><th>Target</th><th>Time</th><th>Sensitivity</th><th>Specificity</th><th>PPV</th><th>NPV</th></tr></thead><tbody><tr><td rowspan="2">3M Rapid Detection Flu A+B<xref rid="bib34" ref-type="bibr"><sup>34</sup></xref><xref rid="tblfn1" ref-type="table-fn">a</xref><ext-link ext-link-type="uri" xlink:href="http://www.3m.com">http://www.3M.com</ext-link>, St. Paul, MN</td><td rowspan="2">Chromatographic immunoassay</td><td>Influenza A</td><td rowspan="2">15 min</td><td>70</td><td>100</td><td>99</td><td>93</td></tr><tr><td>Influenza B (nucleoprotein)</td><td>87</td><td>99</td><td>88</td><td>98</td></tr><tr><td rowspan="2">BD Directigen EZ Flu A+B,<xref rid="tblfn1" ref-type="table-fn">a</xref><xref rid="tblfn2" ref-type="table-fn">b</xref><ext-link ext-link-type="uri" xlink:href="http://www.bd.com">http://www.bd.com</ext-link>, Franklin Lakes, NJ</td><td rowspan="2">Chromatographic immunoassay</td><td>Influenza A</td><td rowspan="2">15 min</td><td align="char">77–91</td><td align="char">86–99</td><td align="char">60–98</td><td align="char">93–95</td></tr><tr><td>Influenza B</td><td align="char">69–100</td><td align="char">99–100</td><td align="char">93–98</td><td align="char">93–100</td></tr><tr><td>BD Directigen Flu A Kit<xref rid="tblfn1" ref-type="table-fn">a</xref><xref rid="tblfn2" ref-type="table-fn">b</xref><ext-link ext-link-type="uri" xlink:href="http://www.bd.com">http://www.bd.com</ext-link>, Franklin Lakes, NJ</td><td>Immunoassay</td><td>Influenza A (nucleoprotein)</td><td>15 min</td><td align="char">67–96</td><td align="char">88–97</td><td>NA</td><td>NA</td></tr><tr><td rowspan="2">BD Directigen Flu A + BKit<xref rid="bib35" ref-type="bibr"><sup>35</sup></xref><xref rid="tblfn2" ref-type="table-fn">b</xref><ext-link ext-link-type="uri" xlink:href="http://www.bd.com">http://www.bd.com</ext-link>, Franklin Lakes, NJ</td><td rowspan="2">Immunoassay</td><td>Influenza A</td><td rowspan="2">15 min</td><td align="char">77–96</td><td align="char">90–91</td><td align="char">63–71</td><td align="char">94–99</td></tr><tr><td>Influenza B (nucleoprotein)</td><td align="char">71–88</td><td align="char">98–100</td><td align="char">82–100</td><td align="char">98–100</td></tr><tr><td rowspan="2">BinaxNOW Influenza A&B<xref rid="bib36" ref-type="bibr"><sup>36</sup></xref><sup>,</sup><xref rid="tblfn1" ref-type="table-fn">a</xref><xref rid="tblfn2" ref-type="table-fn">b</xref><xref rid="tblfn3" ref-type="table-fn">c</xref><ext-link ext-link-type="uri" xlink:href="http://www.binax.com">http://www.binax.com</ext-link>, Scarborough, ME</td><td rowspan="2">Chromatographic immunoassay</td><td>Influenza A</td><td rowspan="2">15 min</td><td align="char">77–83</td><td align="char">96–99</td><td align="char">88–97</td><td align="char">95–96</td></tr><tr><td>Influenza B (nucleoprotein)</td><td align="char">50–69</td><td>100</td><td align="char">82–100</td><td>99</td></tr><tr><td rowspan="2">ESPLINE Influenza A&B,<xref rid="bib36" ref-type="bibr"><sup>36</sup></xref><ext-link ext-link-type="uri" xlink:href="http://www.fujirebio.co.jp">http://www.fujirebio.co.jp</ext-link>, Tokyo, Japan</td><td rowspan="2">Chromatographic immunoassay</td><td>Influenza A</td><td rowspan="2">15 min</td><td>67</td><td>100</td><td>100</td><td>89</td></tr><tr><td>Influenza B (nucleoprotein)</td><td>30</td><td>100</td><td>100</td><td>96</td></tr><tr><td rowspan="4">fluID Rapid Influenza Test,<xref rid="tblfn4" ref-type="table-fn">d</xref><ext-link ext-link-type="uri" xlink:href="http://www.hxdiagnostics.com">http://www.hxdiagnostics.com</ext-link>, Emeryville, CA</td><td rowspan="4">Lateral flow immunoassay</td><td>Influenza A</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td></tr><tr><td>Influenza B</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td></tr><tr><td>Subtype A/H1</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td></tr><tr><td>Subtype A/H3</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td></tr><tr><td rowspan="2">Influ-A&B Respi-Strip, <ext-link ext-link-type="uri" xlink:href="http://www.corisbio.com">http://www.corisbio.com</ext-link>, Gembloux, Belgium</td><td rowspan="2">Chromatographic immunoassay</td><td>Influenza A</td><td rowspan="2">15 min</td><td>97</td><td>100</td><td>100</td><td>98</td></tr><tr><td>Influenza B (nucleoprotein)</td><td>97</td><td>100</td><td>100</td><td>98</td></tr><tr><td rowspan="2">OSOM Influenza A & B Test,<xref rid="tblfn1" ref-type="table-fn">a</xref><xref rid="tblfn3" ref-type="table-fn">c</xref><ext-link ext-link-type="uri" xlink:href="http://www.genzymediagnostics.com">http://www.genzymediagnostics.com</ext-link>, Framingham, MA</td><td rowspan="2">Chromatographic immunoassay</td><td>Influenza A</td><td rowspan="2">10 min</td><td>74</td><td>96</td><td>90</td><td>90</td></tr><tr><td>Influenza B (nucleoprotein)</td><td>60</td><td>96</td><td>73</td><td>94</td></tr><tr><td>panfluID Rapid Influenza Test,<xref rid="tblfn4" ref-type="table-fn">d</xref><ext-link ext-link-type="uri" xlink:href="http://www.hxdiagnostics.com">http://www.hxdiagnostics.com</ext-link>, Emeryville, CA</td><td>Lateral flow immunoassay</td><td>Avian Influenza</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td></tr><tr><td rowspan="2">QuickVue Influenza A+B Test,<xref rid="tblfn3" ref-type="table-fn">c</xref><ext-link ext-link-type="uri" xlink:href="http://www.quidel.com">http://www.quidel.com</ext-link>, San Diego, CA</td><td rowspan="2">Lateral flow immunoassay</td><td>Influenza A</td><td rowspan="2">10 min</td><td align="char">77–94</td><td align="char">89–99</td><td align="char">62–91</td><td align="char">95–99</td></tr><tr><td>Influenza B (nucleoprotein)</td><td align="char">62–82</td><td align="char">97–99</td><td align="char">80–90</td><td align="char">94–97</td></tr><tr><td rowspan="2">QuickVue Influenza Test,<xref rid="tblfn2" ref-type="table-fn">b</xref><xref rid="tblfn3" ref-type="table-fn">c</xref><ext-link ext-link-type="uri" xlink:href="http://www.quidel.com">http://www.quidel.com</ext-link>, San Diego, CA</td><td rowspan="2">Lateral flow immunoassay</td><td>Influenza A+B</td><td rowspan="2">10 min</td><td align="char">73–81</td><td align="char">96–99</td><td align="char">92–96</td><td align="char">85–93</td></tr><tr><td>No differentiation (nucleoprotein)</td><td></td><td></td><td></td><td></td></tr><tr><td>Rockeby Influenza A Test,<xref rid="bib36" ref-type="bibr"><sup>36</sup></xref><sup>,</sup><xref rid="tblfn2" ref-type="table-fn">b</xref><ext-link ext-link-type="uri" xlink:href="http://www.rockeby.com">http://www.rockeby.com</ext-link>, Singapore</td><td>Immunoassay</td><td>Influenza A (nucleoprotein)</td><td>10 min</td><td>10</td><td>100</td><td>100</td><td>74</td></tr><tr><td rowspan="2">SAS FluAlert, <ext-link ext-link-type="uri" xlink:href="http://www.sascientific.com">http://www.sascientific.com</ext-link>, San Antonio, TX</td><td rowspan="2">Chromatographic immunoassay</td><td>Influenza A</td><td>15 min</td><td>76</td><td>98</td><td>93</td><td>91</td></tr><tr><td>Influenza B (nucleoprotein)</td><td>15 min</td><td>91</td><td>99–100</td><td>100</td><td>99</td></tr><tr><td rowspan="2">Xpect Flu A&B Test Kit,<xref rid="bib37" ref-type="bibr"><sup>37</sup></xref><ext-link ext-link-type="uri" xlink:href="http://www.remelinc.com">http://www.remelinc.com</ext-link>, Lenexa, KS</td><td rowspan="2">Chromatographic immunoassay</td><td>Influenza A</td><td rowspan="2">15 min</td><td align="char">90–100</td><td>100</td><td>100</td><td align="char">97–100</td></tr><tr><td>Influenza B (nucleoprotein)</td><td align="char">83–100</td><td>100</td><td>100</td><td align="char">99–100</td></tr><tr><td colspan="8"><bold>Nucleic Acid Tests</bold></td></tr><tr><td>Primer design, <ext-link ext-link-type="uri" xlink:href="http://www.primerdesign.co.uk">http://www.primerdesign.co.uk</ext-link>, Southampton, UK</td><td>Real time qPCR</td><td>H1N1 (swine flu)</td><td><2 h</td><td>NA</td><td>NA</td><td>NA</td><td>NA</td></tr><tr><td rowspan="2">proFLU plus,<xref rid="tblfn2" ref-type="table-fn">b</xref><ext-link ext-link-type="uri" xlink:href="http://www.prodesse.com">http://www.prodesse.com</ext-link>, Waukesha, WI</td><td rowspan="2">Real time RT-PCR</td><td>Influenza A (matrix)</td><td rowspan="2">3 h</td><td>100</td><td>93</td><td>71</td><td>100</td></tr><tr><td>Influenza B (nonstructural NS1 & NS2)</td><td>98</td><td>99</td><td>80</td><td>100</td></tr></tbody></table><table frame="hsides" rules="groups"><thead><tr><th colspan="4">Instrument/Manufacturer<hr></hr></th><th colspan="4">Performance Characteristics (%)<hr></hr></th></tr><tr><th>Nucleic Acid Tests</th><th>Type</th><th>Target</th><th>Time</th><th>Sensitivity</th><th>Specificity</th><th>PPV</th><th>NPV</th></tr></thead><tbody><tr><td rowspan="20">xTAG Respiratory viral panel,<xref rid="bib38" ref-type="bibr"><sup>38</sup></xref><xref rid="tblfn1" ref-type="table-fn">a</xref> Luminex, <ext-link ext-link-type="uri" xlink:href="http://www.luminexcorp.com">http://www.luminexcorp.com</ext-link>, Austin, TX</td><td rowspan="20">Flow through microsphere array</td><td>Influenza A</td><td rowspan="20"><4 h</td><td>98</td><td>100</td><td>99</td><td>100</td></tr><tr><td>H1</td><td></td><td></td><td></td><td></td></tr><tr><td>H3</td><td></td><td></td><td></td><td></td></tr><tr><td>H5<xref rid="tblfn2" ref-type="table-fn">b</xref></td><td></td><td></td><td></td><td></td></tr><tr><td>Influenza B</td><td>94</td><td>100</td><td>100</td><td>100</td></tr><tr><td>SARS<xref rid="tblfn2" ref-type="table-fn">b</xref></td><td></td><td></td><td></td><td></td></tr><tr><td>Corona virus NL63<xref rid="tblfn2" ref-type="table-fn">b</xref></td><td></td><td></td><td></td><td></td></tr><tr><td>Corona virus 229E<xref rid="tblfn2" ref-type="table-fn">b</xref></td><td></td><td></td><td></td><td></td></tr><tr><td>Corona virus OC43<xref rid="tblfn2" ref-type="table-fn">b</xref></td><td></td><td></td><td></td><td></td></tr><tr><td>Corona virus HKU1<xref rid="tblfn2" ref-type="table-fn">b</xref></td><td></td><td></td><td></td><td></td></tr><tr><td>RSV, subtype A</td><td></td><td></td><td></td><td></td></tr><tr><td>RSV, subtype B</td><td></td><td></td><td></td><td></td></tr><tr><td>Parainfluenza 1</td><td></td><td></td><td></td><td></td></tr><tr><td>Parainfluenza 2</td><td></td><td></td><td></td><td></td></tr><tr><td>Parainfluenza 3</td><td></td><td></td><td></td><td></td></tr><tr><td>Parainfluenza 4<xref rid="tblfn2" ref-type="table-fn">b</xref></td><td></td><td></td><td></td><td></td></tr><tr><td>Metapneumovirus</td><td></td><td></td><td></td><td></td></tr><tr><td>Rhinovirus/</td><td></td><td></td><td></td><td></td></tr><tr><td>Enterovirus</td><td></td><td></td><td></td><td></td></tr><tr><td>Adenovirus</td><td></td><td></td><td></td><td></td></tr></tbody></table><table-wrap-foot><fn id="simple-para0075"><p>Data shown in the table are from product inserts unless otherwise noted.</p></fn><fn id="simple-para0080"><p><italic>Abbreviations:</italic> BD, Becton-Dickinson; NA, not available; NPV, negative predictive value; PPV, positive predictive value; qPCR, quantitative polymerase chain reaction; RSV, respiratory syncytial virus; RT, reverse transcriptase; SARS, severe acute respiratory syndrome.</p></fn></table-wrap-foot><table-wrap-foot><fn id="tblfn1"><label>a</label><p>FDA-approved.</p></fn></table-wrap-foot><table-wrap-foot><fn id="tblfn2"><label>b</label><p>CE-approved.</p></fn></table-wrap-foot><table-wrap-foot><fn id="tblfn3"><label>c</label><p>CLIA-waived.</p></fn></table-wrap-foot><table-wrap-foot><fn id="tblfn4"><label>d</label><p>In development.</p></fn></table-wrap-foot></table-wrap></p><p id="para0255">However, nucleic acid recognition (NAR) for detection of influenza A or B has shown promising benefits (see <xref rid="tbl4" ref-type="table">Table 4</xref>). These NAR devices exhibit greater sensitivity and can provide subtyping data. Once a subtype of influenza is positively identified, health care personnel and public health workers have the ability to start surveillance of new strains in a particular area. In addition, subtyping of influenza has the ability to guide antiviral treatment by identifying particular influenza strains that may be resistant or sensitive to antiviral treatment.</p><p id="para0260">For instance, several H1N1 strains of influenza were resistant to oseltamivir in fall 2008; however, in spring 2009, the novel H1N1 influenza strain (“swine flu”) was sensitive to oseltamivir. Furthermore, in a recent study conducted by Dr Nishiura and colleagues,<xref rid="bib39" ref-type="bibr"><sup>39</sup></xref> the use of quarantine and rapid diagnostic testing to prevent or delay the spread of pandemic influenza across island nations was evaluated. In order for quarantine strategy to be effective in preventing or delaying the spread of pandemic influenza, rapid and reliable diagnostic testing must be used to positively identify index cases (first victims) with influenza.<xref rid="bib39" ref-type="bibr"><sup>39</sup></xref> Thus, the use of POCT to rapidly diagnose and subtype influenza has significant potential to refine pandemic disaster response and prevent newdemics from spreading outside the bounds of initial disaster or emergency locations.</p><p id="para0265">This concept is important for disasters on the horizon, such as extensively drug-resistant malaria and tuberculosis. Globally, tuberculosis represents a major problem, especially in low-resource settings, such as impoverished African nations. Current tests available often fail to correctly identify tuberculosis, are not rapid, and cannot identify drug resistance.<xref rid="bib40" ref-type="bibr"><sup>40</sup></xref> Rapid-liquid culture shows promising results for tuberculosis detection by improving the sensitivity, speed, reliability, and multidrug-resistant tuberculosis detection.<xref rid="bib40" ref-type="bibr"><sup>40</sup></xref> Future thinking is required for developing POCT devices that are proven to simultaneously be rapid, simple, reliable, and cost-effective for diagnosing extensively drug-resistant tuberculosis.<xref rid="bib40" ref-type="bibr"><sup>40</sup></xref></p></sec><sec id="sec6"><title>Preparedness: gap analysis</title><p id="para0270">POCT devices typically encounter harsh environmental conditions, temperature extremes, and high humidity in emergency and disaster care. Despite substantial improvements, gaps still exist between current POCT technologies and real-world needs. Inability of POCT instruments and reagents to withstand harsh conditions present at disaster and emergency sites compromises performance.<xref rid="bib6" ref-type="bibr"><sup>6</sup></xref> For example, glucose test strips and blood gas cartridges may not provide accurate measurements at disaster sites because thermal stresses adversely and inconsistently affect performance.<xref rid="bib6" ref-type="bibr"><sup>6</sup></xref> Because of these types of limitations and the obvious technical gaps in POC devices as we know them today, the United States and other countries are not prepared for disasters.</p><p id="para0275"><xref rid="tbox1" ref-type="boxed-text">Box 1</xref>highlights gaps between current POC devices and various problems with technologies currently available. Without durable and robust POCT equipment, diagnosis and treatment of victims at disaster sites becomes increasingly complicated and hindered. To effectively and efficiently diagnose, monitor, and treat patients, the current gaps in POCT technologies and devices must be closed. The POC Technologies Center (<ext-link ext-link-type="uri" xlink:href="http://www.ucdmc.ucdavis.edu/pathology/poctcenter">http://www.ucdmc.ucdavis.edu/pathology/poctcenter</ext-link>) is currently conducting static and dynamic environmental stress tests to understand the environmental limitations of POC devices and reagents in more detail.<boxed-text id="tbox1"><label>Box 1</label><caption><title>Strategic planning for POCT in disaster settings: gap analysis</title></caption><p id="para0005"><list list-type="simple" id="list0005"><title>Discovery</title><list-item id="list-item0005"><p id="para0010">Novel new POC technologies for complex POCT in different global settings</p></list-item></list><list list-type="simple" id="list0010"><title>Operational characteristics</title><list-item id="list-item0010"><p id="para0015">Native sample testing from complex matrices with minimal prenalytical processing</p></list-item><list-item id="list-item0015"><p id="para0020">Cassette-contained sample processing to avoid (pathogen) contamination</p></list-item><list-item id="list-item0020"><p id="para0025">Back-end biohazard disposal in the same cassette, which can be disposed of intact</p></list-item><list-item id="list-item0025"><p id="para0030">Internal, automated, and electronic quality control; external proficiency testing</p></list-item><list-item id="list-item0030"><p id="para0035">Battery operation with flexible multiple power supplies</p></list-item></list><list list-type="simple" id="list0015"><title>Format, licensing, and standardization</title><list-item id="list-item0035"><p id="para0040">Durable handheld and portable formats for different emergency settings</p></list-item><list-item id="list-item0040"><p id="para0045">Simple, fast, smart, and easy use codified to achieve CLIA-waived status</p></list-item><list-item id="list-item0045"><p id="para0050">Competency demonstrated beforehand as part of preparedness in disaster plan</p></list-item><list-item id="list-item0050"><p id="para0055">Standardized test results verified with “new math” (eg, LS MAD curves)</p></list-item></list><list list-type="simple" id="list0020"><title>Environmental robustness</title><list-item id="list-item0055"><p id="para0060">Sensors on board to document location and environmental conditions</p></list-item><list-item id="list-item0060"><p id="para0065">Durable reagents and equipment not susceptible to environmental stresses</p></list-item><list-item id="list-item0065"><p id="para0070">Environmental certification based on dynamic stress testing</p></list-item><list-item id="list-item0070"><p id="para0075">Suitability for meteorologic profiles of disaster sites worldwide</p></list-item></list><list list-type="simple" id="list0025"><title>Diagnostic performance</title><list-item id="list-item0075"><p id="para0080">Quantitative POC tests capable of satisfactory accuracy, sensitivity, and specificity</p></list-item><list-item id="list-item0080"><p id="para0085">Multiplex or multiple patient testing with needs-based test clusters</p></list-item><list-item id="list-item0085"><p id="para0090">Index case (eg, H1N1) and risk (eg, HIV 1/2 in emergency blood donors) identification</p></list-item><list-item id="list-item0090"><p id="para0095">Broad-spectrum pathogen surveillance for hazards (eg, World Trade Center [WTC] cough)</p></list-item><list-item id="list-item0095"><p id="para0100">Mutations and detection of multiresistant strains (eg, tuberculosis) in challenging environments</p></list-item></list><list list-type="simple" id="list0030"><title>Knowledge optimization</title><list-item id="list-item0100"><p id="para0105">Full user awareness of performance characteristics based on field evaluations</p></list-item><list-item id="list-item0105"><p id="para0110">Informatics compatibility, connectivity, and archival in small-world networks</p></list-item><list-item id="list-item0110"><p id="para0115">Risk indexing of diagnostic targets, wireless results reporting, and outcomes monitoring</p></list-item><list-item id="list-item0115"><p id="para0120">Cost-effectiveness for implementation in low-resource settings</p></list-item></list></p></boxed-text></p><p id="para0280">Dynamic tests simulate realistic meteorologic conditions found in world regions with high risk for newdemics. US Food and Drug Administration (FDA)-approved product labelings typically state temperature limits, but current limits are inadequate for most disaster conditions. Also, a POCT method that may be proven to work in environmental extremes must also be validated for critically ill patient populations, which few currently do.</p><p id="para0285">Problems with preanalytical processing present an additional major challenge for reliable POCT device performance. For example, in a recent study conducted by Dighe and colleagues,<xref rid="bib41" ref-type="bibr"><sup>41</sup></xref> unusually high false-positive potassium critical values led the laboratory to investigate the preanalytical processing after concluding that the instrument was not the source of the errors. Laboratory personnel noted that when false-positive potassium critical values were seen, a hemoglobin A1C test was also ordered.</p><p id="para0290">On investigation of the sample processing, Dighe and colleagues<xref rid="bib41" ref-type="bibr"><sup>41</sup></xref> found that both tubes were being packaged with ice and transported to the testing facility. Icing blood tubes has been shown to lyse red blood cells and falsely elevate potassium levels.<xref rid="bib41" ref-type="bibr"><sup>41</sup></xref> Laboratory technologists subsequently altered the transport requirement for hemoglobin A1C and observed a substantial decrease in potassium false-positive values in ensuing months.<xref rid="bib41" ref-type="bibr"><sup>41</sup></xref> When POCT devices are reliable, these types of preanalytical problems can be minimized or eliminated. To ensure best patient care, preanalytical processing methods used on field-worthy POCT devices should be self-contained and disposable, but free from confounding preanalytical errors.</p><p id="para0295"><xref rid="tbox1" ref-type="boxed-text">Box 1</xref> lists several other gaps that need to be addressed. For example, the introduction of locally smooth median absolute difference (LS MAD) curves as a mathematical statistical method to visually analyze the accuracy of POCT blood glucose meters shows that performance in hypoglycemic and hyperglycemic ranges of most blood glucose meters in current use exceeds error tolerance limits for adult critically ill patient populations.<xref rid="bib42" ref-type="bibr">42</xref>, <xref rid="bib43" ref-type="bibr">43</xref> POCT technologies intended for emergency and disaster settings and critically ill patient populations can be improved, standardized, and verified with this new math (see <xref rid="tbox1" ref-type="boxed-text">Box 1</xref>) to enable better performance and patient outcomes.</p><p id="para0300">The search and discovery of novel new POC technologies should be actively pursued by researchers. Devices are needed in various global environments across the world. In these different conditions, POCT will encounter new challenges to be overcome. As noted above, POCT instruments must be environmentally robust and capable of withstanding dynamic stresses (see <xref rid="tbox1" ref-type="boxed-text">Box 1</xref>). In addition, POCT devices should be capable of diagnosing multiple pathogens with adequate clinical sensitivity and specificity (see <xref rid="tbox1" ref-type="boxed-text">Box 1</xref>), ideally including extensively drug-resistant tuberculosis, malaria, and influenza. New and novel POCT devices will be created in the future featuring improved operational characteristics, environmental robustness, diagnostic performance, and knowledge optimization that enable disaster responders to rapidly diagnose and treat victims and fill current technology gaps.</p></sec><sec id="sec7"><title>Integration strategy: POCT and small-world networks</title><p id="para0305">Strategic placement of POCT devices within small-world networks (SWN) will effectively facilitate rapid evidence-based medical decisions.<xref rid="bib5" ref-type="bibr"><sup>5</sup></xref> SWNs enable information to be transmitted quickly from site to site and facilitate quick triage of patients to appropriate points of evaluation.<xref rid="bib5" ref-type="bibr"><sup>5</sup></xref> SWNs can help manage POCT operations to improve overall efficiency and cost-effectiveness by integrating health care delivery components, including home monitoring, primary care unit testing, mobile medical unit, alternate medical care site, triage, emergency room, and local hospital resources.<xref rid="bib5" ref-type="bibr"><sup>5</sup></xref></p><p id="para0310">Thus, when a disaster situation arises, such as Hurricane Katrina, the tsunami in Southeast Asia, or the novel H1N1 (swine flu) pandemic, SWNs can effectively allocate POCT resources to allow for rapid and cost-effective patient care or isolation of index cases, as needed, that is also efficient within the context of regional resources. This strategic integration of POCT into regional aspects of disaster and emergency response will ensure that patient care will be rapid and effective.</p></sec><sec id="sec8"><title>Summary</title><p id="para0315">Use of POCT in disaster and emergency situations will efficiently facilitate rapid evidence-based diagnosis at the site of patient care. A variety of tests are currently available for POCT in hospitals, but the spectrum of POC tests for emergency and disaster care must be broadened.</p><p id="para0320">The development of pathogen test clusters, based on needs assessment survey results, must be incorporated into new POCT device designs. Besides developing innovative POCT devices, current gaps in POCT technology and availability must be filled to ensure optimal patient care wherever the patient might be.</p><p id="para0325">Integration and global use of POCT in emergencies will help prevent newdemics from accelerating as seen during Hurricane Katrina and the current influenza pandemic (novel H1N1), while simultaneously improving immediate patient care.</p><p id="para0330">When a disaster or emergency strikes and as POCT use becomes standard for SWN preparedness, emergency medical responders, alternate medical facilities, and hospitals will be ready to deal effectively with the crises and avoid the pitfalls of the past, when adequate POCT was not available or not used efficiently.</p><p id="para0335">However, given current state-of-the-art POCT, the United States and other countries are not prepared. 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Figures and tables were provided with permission and courtesy of Knowledge Optimization, Davis, CA.</p></ack><fn-group><fn id="d32e2818"><p>This study was supported by the Point-of-Care Testing Center for Teaching and Research (POCT•CTR<sup>SM</sup>), School of Medicine, University of California, Davis, and by a NIBIB Point-of-Care Technologies Center grant (Dr Kost, PI, NIH U54 EB007959). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Biomedical Imaging and Bioengineering or the National Institutes of Health.</p></fn></fn-group></back></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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