Precision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA : an international inter-laboratory assessment

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dc.contributor.authorPatel, Eshan U.en_ZA
dc.contributor.authorManucci, Jordynen_ZA
dc.contributor.authorKahle, Erin M.en_ZA
dc.contributor.authorLingappa, Jairam R.en_ZA
dc.contributor.authorMorrow, Rhoda Ashleyen_ZA
dc.contributor.authorPiwowar-Manning, Estelleen_ZA
dc.contributor.authorJames, Aneleten_ZA
dc.contributor.authorMaluzi, Kwitaka F.en_ZA
dc.contributor.authorCheeba, Maina M.en_ZA
dc.contributor.authorGray, Glendaen_ZA
dc.contributor.authorDelany-Moretlwe, Sineaden_ZA
dc.contributor.authorInambao, Mubianaen_ZA
dc.contributor.authorVwalika, Bellingtonen_ZA
dc.contributor.authorQuinn, Thomas C.en_ZA
dc.contributor.authorLaeyendecker, Oliveren_ZA
dc.date.accessioned2017-01-19T07:38:55Z
dc.date.available2017-01-19T07:38:55Z
dc.date.issued2015-09-30
dc.date.updated2016-12-09T11:59:42Z
dc.descriptionCITATION: Patel, Eshan U., et al. 2015. Precision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA : an international inter-laboratory assessment. BMC Infectious Diseases, 15:398, doi:10.1186/s12879-015-1130-6.
dc.descriptionThe original publication is available at http://bmcinfectdis.biomedcentral.com
dc.description.abstractBackground: The commercial Kalon HSV-2 IgG ELISA is currently recommended for research use in sub-Saharan Africa because of its superior accuracy compared to other serologic assays. However, there are no data on key precision parameters of Kalon such as inter-operator variation, repeatability, and reproducibility, thus contributing to a barrier for its acceptance and use in clinical trials in sub-Saharan Africa. We evaluated the analytical and field precision of the Kalon HSV-2 IgG ELISA. Methods: A total of 600 HIV-infected and uninfected serum samples from South Africa and Zambia, previously tested by the gold standard University of Washington HSV western blot (UW-WB), were tested using Kalon by two technologists in an United States reference laboratory. Aliquots of 183 samples were retested using Kalon by an on-site technologist in a South African laboratory and a Zambian laboratory. Results: Intra-assay variation was below 10 %. Intra-assay, intra-laboratory, and inter-laboratory correlation and agreement were significantly high (p < 0.01). In comparison to the UW-WB, accurate performance of Kalon was reproducible by each operator and laboratory. Receiver operating characteristic curve analysis indicated high selectivity of Kalon in the overall study population (area under the curve = 0.95, 95%CI = 0.92–0.97). Discussion: Kalon is a robust assay with high precision and reproducibility. Accordingly, operator errorlikely does not contribute to the variability observed in Kalon’s specificity throughout sera from sub-Saharan Africa. Conclusions: In populations with optimal diagnostic accuracy, Kalon is a reliable stand-alone method for on-site HSV-2 IgG antibody detection.en_ZA
dc.description.urihttp://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-015-1130-6
dc.description.versionPublisher's version
dc.format.extent9 pages
dc.identifier.citationPatel, Eshan U., et al. 2015. Precision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA : an international inter-laboratory assessment. BMC Infectious Diseases, 15:398, doi:10.1186/s12879-015-1130-6
dc.identifier.issn1471-2334 (online)
dc.identifier.otherdoi:10.1186/s12879-015-1130-6
dc.identifier.urihttp://hdl.handle.net/10019.1/100489
dc.language.isoen_ZAen_ZA
dc.publisherBioMed Central
dc.rights.holderAuthors retain copyright
dc.subjectImmunoglobulin Gen_ZA
dc.subjectHerpes simplex virusen_ZA
dc.subjectKalon assayen_ZA
dc.subjectSerodiagnosisen_ZA
dc.subjectHIV infections -- Diagnosisen_ZA
dc.subjectHIV-antibodiesen_ZA
dc.subjectEnzyme-linked immunosorbent assayen_ZA
dc.titlePrecision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA : an international inter-laboratory assessmenten_ZA
dc.typeArticle
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