Performance of HerpeSelect and Kalon assays in detection of antibodies to herpes simplex virus type 2.
Identifieur interne : 000669 ( PubMed/Corpus ); précédent : 000668; suivant : 000670Performance of HerpeSelect and Kalon assays in detection of antibodies to herpes simplex virus type 2.
Auteurs : Jérôme Legoff ; Philippe Mayaud ; Gérard Gresenguet ; Helen A. Weiss ; Khonde Nzambi ; Eric Frost ; Jacques Pepin ; Laurent BelecSource :
- Journal of clinical microbiology [ 1098-660X ] ; 2008.
English descriptors
- KwdEn :
- Acyclovir (administration & dosage), Acyclovir (therapeutic use), Antibodies, Viral (blood), Antiviral Agents (administration & dosage), Antiviral Agents (therapeutic use), Central African Republic (epidemiology), DNA, Viral (analysis), DNA, Viral (isolation & purification), Enzyme-Linked Immunosorbent Assay (methods), Female, Ghana (epidemiology), Herpes Genitalis (diagnosis), Herpes Genitalis (drug therapy), Herpes Genitalis (epidemiology), Herpes Genitalis (virology), Herpesvirus 2, Human (genetics), Herpesvirus 2, Human (immunology), Herpesvirus 2, Human (isolation & purification), Humans, Polymerase Chain Reaction (methods), Reagent Kits, Diagnostic, Sensitivity and Specificity, Viral Envelope Proteins (immunology).
- MESH :
- chemical , administration & dosage : Acyclovir, Antiviral Agents.
- chemical , analysis : DNA, Viral.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Viral Envelope Proteins.
- chemical , isolation & purification : DNA, Viral.
- chemical , therapeutic use : Acyclovir, Antiviral Agents.
- geographic , epidemiology : Central African Republic, Ghana.
- diagnosis : Herpes Genitalis.
- drug therapy : Herpes Genitalis.
- epidemiology : Herpes Genitalis.
- genetics : Herpesvirus 2, Human.
- immunology : Herpesvirus 2, Human.
- isolation & purification : Herpesvirus 2, Human.
- methods : Enzyme-Linked Immunosorbent Assay, Polymerase Chain Reaction.
- virology : Herpes Genitalis.
- Female, Humans, Reagent Kits, Diagnostic, Sensitivity and Specificity.
Abstract
The performances of commercial enzyme-linked immunosorbent assays (ELISAs) in detecting herpes simplex virus type 2 (HSV-2) antibodies have been inconsistent for African and human immunodeficiency virus (HIV)-positive populations. We compared the performances of the HerpeSelect and Kalon glycoprotein G2 ELISAs for patients with genital ulcer disease in Ghana and the Central African Republic. Sera from 434 women were tested with the HerpeSelect assay, and a subsample (n = 199) was tested by the Kalon assay. Ulcer swabs and cervicovaginal lavage samples were tested for HSV-2 DNA by PCR. HSV-2-seronegative women with detectable genital HSV-2 DNA were retested for HSV-2 antibodies 14 and 28 days later by the two ELISAs. A total of 346 (80%) women were positive by HerpeSelect at baseline, and 225 (54%) had detectable genital (lesional or cervicovaginal) HSV-2 DNA. Sixty-six (19%) HerpeSelect-positive samples had low-positive index values (1.1 to 3.5), and 58% of these samples had detectable genital HSV-2 DNA. Global agreement between the two serological assays was 86%. Concordance was high (99%) for sera that were negative by HerpeSelect or had high index values (>3.5). Defining infection detected by HSV-2 DNA PCR and/or Kalon assay as true infection, 71% of sera with low-positive index values were associated with true HSV-2 infection. Twenty-five women were identified as having nonprimary first-episode genital HSV-2 infection. Rates of HSV-2 seroconversion at day 14 were 77% (10/13 patients) by HerpeSelect assay and 23% (3/13 patients) by Kalon assay, with four additional seroconversions detected by Kalon assay at day 28. HIV serostatus did not influence assay performance. Low index values obtained with the HerpeSelect assay may correspond to true HSV-2 infection, in particular to nonprimary first episodes of genital HSV-2 infection, and need to be interpreted in the context of clinical history.
DOI: 10.1128/JCM.02332-07
PubMed: 18385443
Links to Exploration step
pubmed:18385443Le document en format XML
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Weiss</name></author><author><name sortKey="Nzambi, Khonde" sort="Nzambi, Khonde" uniqKey="Nzambi K" first="Khonde" last="Nzambi">Khonde Nzambi</name></author><author><name sortKey="Frost, Eric" sort="Frost, Eric" uniqKey="Frost E" first="Eric" last="Frost">Eric Frost</name></author><author><name sortKey="Pepin, Jacques" sort="Pepin, Jacques" uniqKey="Pepin J" first="Jacques" last="Pepin">Jacques Pepin</name></author><author><name sortKey="Belec, Laurent" sort="Belec, Laurent" uniqKey="Belec L" first="Laurent" last="Belec">Laurent Belec</name></author></analytic><series><title level="j">Journal of clinical microbiology</title><idno type="eISSN">1098-660X</idno><imprint><date when="2008" type="published">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acyclovir (administration & dosage)</term><term>Acyclovir (therapeutic use)</term><term>Antibodies, Viral (blood)</term><term>Antiviral Agents (administration & dosage)</term><term>Antiviral Agents (therapeutic use)</term><term>Central African Republic (epidemiology)</term><term>DNA, Viral (analysis)</term><term>DNA, Viral (isolation & purification)</term><term>Enzyme-Linked Immunosorbent Assay (methods)</term><term>Female</term><term>Ghana (epidemiology)</term><term>Herpes Genitalis (diagnosis)</term><term>Herpes Genitalis (drug therapy)</term><term>Herpes Genitalis (epidemiology)</term><term>Herpes Genitalis (virology)</term><term>Herpesvirus 2, Human (genetics)</term><term>Herpesvirus 2, Human (immunology)</term><term>Herpesvirus 2, Human (isolation & purification)</term><term>Humans</term><term>Polymerase Chain Reaction (methods)</term><term>Reagent Kits, Diagnostic</term><term>Sensitivity and Specificity</term><term>Viral Envelope Proteins (immunology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Acyclovir</term><term>Antiviral Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analysis" xml:lang="en"><term>DNA, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Viral Envelope Proteins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="isolation & purification" xml:lang="en"><term>DNA, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Acyclovir</term><term>Antiviral Agents</term></keywords><keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Central African Republic</term><term>Ghana</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Herpes Genitalis</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Herpes Genitalis</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Herpes Genitalis</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Herpesvirus 2, Human</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Herpesvirus 2, Human</term></keywords><keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en"><term>Herpesvirus 2, Human</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Enzyme-Linked Immunosorbent Assay</term><term>Polymerase Chain Reaction</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Herpes Genitalis</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Female</term><term>Humans</term><term>Reagent Kits, Diagnostic</term><term>Sensitivity and Specificity</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The performances of commercial enzyme-linked immunosorbent assays (ELISAs) in detecting herpes simplex virus type 2 (HSV-2) antibodies have been inconsistent for African and human immunodeficiency virus (HIV)-positive populations. We compared the performances of the HerpeSelect and Kalon glycoprotein G2 ELISAs for patients with genital ulcer disease in Ghana and the Central African Republic. Sera from 434 women were tested with the HerpeSelect assay, and a subsample (n = 199) was tested by the Kalon assay. Ulcer swabs and cervicovaginal lavage samples were tested for HSV-2 DNA by PCR. HSV-2-seronegative women with detectable genital HSV-2 DNA were retested for HSV-2 antibodies 14 and 28 days later by the two ELISAs. A total of 346 (80%) women were positive by HerpeSelect at baseline, and 225 (54%) had detectable genital (lesional or cervicovaginal) HSV-2 DNA. Sixty-six (19%) HerpeSelect-positive samples had low-positive index values (1.1 to 3.5), and 58% of these samples had detectable genital HSV-2 DNA. Global agreement between the two serological assays was 86%. Concordance was high (99%) for sera that were negative by HerpeSelect or had high index values (>3.5). Defining infection detected by HSV-2 DNA PCR and/or Kalon assay as true infection, 71% of sera with low-positive index values were associated with true HSV-2 infection. Twenty-five women were identified as having nonprimary first-episode genital HSV-2 infection. Rates of HSV-2 seroconversion at day 14 were 77% (10/13 patients) by HerpeSelect assay and 23% (3/13 patients) by Kalon assay, with four additional seroconversions detected by Kalon assay at day 28. HIV serostatus did not influence assay performance. Low index values obtained with the HerpeSelect assay may correspond to true HSV-2 infection, in particular to nonprimary first episodes of genital HSV-2 infection, and need to be interpreted in the context of clinical history.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">18385443</PMID><DateCreated><Year>2008</Year><Month>06</Month><Day>09</Day></DateCreated><DateCompleted><Year>2008</Year><Month>07</Month><Day>23</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1098-660X</ISSN><JournalIssue CitedMedium="Internet"><Volume>46</Volume><Issue>6</Issue><PubDate><Year>2008</Year><Month>Jun</Month></PubDate></JournalIssue><Title>Journal of clinical microbiology</Title><ISOAbbreviation>J. Clin. Microbiol.</ISOAbbreviation></Journal><ArticleTitle>Performance of HerpeSelect and Kalon assays in detection of antibodies to herpes simplex virus type 2.</ArticleTitle><Pagination><MedlinePgn>1914-8</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1128/JCM.02332-07</ELocationID><Abstract><AbstractText>The performances of commercial enzyme-linked immunosorbent assays (ELISAs) in detecting herpes simplex virus type 2 (HSV-2) antibodies have been inconsistent for African and human immunodeficiency virus (HIV)-positive populations. We compared the performances of the HerpeSelect and Kalon glycoprotein G2 ELISAs for patients with genital ulcer disease in Ghana and the Central African Republic. Sera from 434 women were tested with the HerpeSelect assay, and a subsample (n = 199) was tested by the Kalon assay. Ulcer swabs and cervicovaginal lavage samples were tested for HSV-2 DNA by PCR. HSV-2-seronegative women with detectable genital HSV-2 DNA were retested for HSV-2 antibodies 14 and 28 days later by the two ELISAs. A total of 346 (80%) women were positive by HerpeSelect at baseline, and 225 (54%) had detectable genital (lesional or cervicovaginal) HSV-2 DNA. Sixty-six (19%) HerpeSelect-positive samples had low-positive index values (1.1 to 3.5), and 58% of these samples had detectable genital HSV-2 DNA. Global agreement between the two serological assays was 86%. Concordance was high (99%) for sera that were negative by HerpeSelect or had high index values (>3.5). Defining infection detected by HSV-2 DNA PCR and/or Kalon assay as true infection, 71% of sera with low-positive index values were associated with true HSV-2 infection. Twenty-five women were identified as having nonprimary first-episode genital HSV-2 infection. Rates of HSV-2 seroconversion at day 14 were 77% (10/13 patients) by HerpeSelect assay and 23% (3/13 patients) by Kalon assay, with four additional seroconversions detected by Kalon assay at day 28. HIV serostatus did not influence assay performance. Low index values obtained with the HerpeSelect assay may correspond to true HSV-2 infection, in particular to nonprimary first episodes of genital HSV-2 infection, and need to be interpreted in the context of clinical history.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>LeGoff</LastName><ForeName>Jérôme</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Université Paris Descartes, Equipe Immunité et Biothérapie Muqueuse, Unité INSERM Internationale U743, Immunologie Humaine, Centres de Recherches Biomédicales des Cordeliers, Hôpital Européen Georges Pompidou, Paris, France. jerome.le-goff@sls.aphp.fr</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mayaud</LastName><ForeName>Philippe</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Gresenguet</LastName><ForeName>Gérard</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Weiss</LastName><ForeName>Helen A</ForeName><Initials>HA</Initials></Author><Author ValidYN="Y"><LastName>Nzambi</LastName><ForeName>Khonde</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Frost</LastName><ForeName>Eric</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Pepin</LastName><ForeName>Jacques</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Belec</LastName><ForeName>Laurent</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><CollectiveName>ANRS 12-12 Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>MRC_G0700837</GrantID><Agency>Medical Research Council</Agency><Country>United Kingdom</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D023362">Evaluation Studies</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2008</Year><Month>04</Month><Day>02</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Clin Microbiol</MedlineTA><NlmUniqueID>7505564</NlmUniqueID><ISSNLinking>0095-1137</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004279">DNA, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011933">Reagent Kits, Diagnostic</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014759">Viral Envelope Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>X4HES1O11F</RegistryNumber><NameOfSubstance UI="D000212">Acyclovir</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>J Clin Microbiol. 2000 Sep;38(9):3274-9</RefSource><PMID Version="1">10970370</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>AIDS. 2007 Jul 31;21(12):1569-78</RefSource><PMID Version="1">17630552</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Sex Transm Dis. 2003 Apr;30(4):310-4</RefSource><PMID Version="1">12671550</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Infect Dis. 2003 May 15;187(10):1513-21</RefSource><PMID Version="1">12721931</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Microbiol. 2003 Nov;41(11):5212-4</RefSource><PMID Version="1">14605166</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Microbiol. 2004 Apr;42(4):1794-6</RefSource><PMID 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Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000998" MajorTopicYN="N">Antiviral Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002488" MajorTopicYN="N" Type="Geographic">Central African Republic</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004279" MajorTopicYN="N">DNA, Viral</DescriptorName><QualifierName UI="Q000032" MajorTopicYN="N">analysis</QualifierName><QualifierName UI="Q000302" MajorTopicYN="N">isolation & purification</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004797" MajorTopicYN="N">Enzyme-Linked Immunosorbent Assay</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005869" MajorTopicYN="N" Type="Geographic">Ghana</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006558" MajorTopicYN="N">Herpes Genitalis</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="Y">diagnosis</QualifierName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018258" MajorTopicYN="N">Herpesvirus 2, Human</DescriptorName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName><QualifierName UI="Q000302" MajorTopicYN="N">isolation & purification</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016133" MajorTopicYN="N">Polymerase Chain Reaction</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011933" MajorTopicYN="Y">Reagent Kits, Diagnostic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012680" MajorTopicYN="N">Sensitivity and Specificity</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014759" MajorTopicYN="N">Viral Envelope Proteins</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC2446869</OtherID><InvestigatorList><Investigator ValidYN="Y"><LastName>Agyarko-Poku</LastName><ForeName>Thomas</ForeName><Initials>T</Initials></Investigator><Investigator ValidYN="Y"><LastName>Asamoah-Adu</LastName><ForeName>Comfort</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>Dzokoto</LastName><ForeName>Agnes</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Khonde</LastName><ForeName>Nzambi</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bélec</LastName><ForeName>Laurent</ForeName><Initials>L</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bouhlal</LastName><ForeName>Hicham</ForeName><Initials>H</Initials></Investigator><Investigator ValidYN="Y"><LastName>Chemin</LastName><ForeName>Cécile</ForeName><Initials>C</Initials></Investigator><Investigator ValidYN="Y"><LastName>LeGoff</LastName><ForeName>Jérôme</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Si-Mohamed</LastName><ForeName>Ali</ForeName><Initials>A</Initials></Investigator><Investigator ValidYN="Y"><LastName>Deslandes</LastName><ForeName>Sylvie</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Frost</LastName><ForeName>Eric</ForeName><Initials>E</Initials></Investigator><Investigator ValidYN="Y"><LastName>Pépin</LastName><ForeName>Jacques</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Grésenguet</LastName><ForeName>Gérard</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Longo</LastName><ForeName>Jean-De-Dieu</ForeName><Initials>JD</Initials></Investigator><Investigator ValidYN="Y"><LastName>Hayes</LastName><ForeName>Richard</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Mabey</LastName><ForeName>David</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Mayaud</LastName><ForeName>Philippe</ForeName><Initials>P</Initials></Investigator><Investigator ValidYN="Y"><LastName>Weiss</LastName><ForeName>Helen 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