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

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 reproducibili...

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Published in:BMC infectious diseases 2015-09, Vol.15 (1), p.398-398, Article 398
Main Authors: Patel, Eshan U, Manucci, Jordyn, Kahle, Erin M, Lingappa, Jairam R, Morrow, Rhoda Ashley, Piwowar-Manning, Estelle, James, Anelet, Maluzi, Kwitaka F, Cheeba, Maina M, Gray, Glenda, Kosloff, Barry, Delany-Moretlwe, Sinead, Inambao, Mubiana, Vwalika, Bellington, Quinn, Thomas C, Laeyendecker, Oliver
Format: Article
Language:English
Subjects:
Adult
Antibodies, Viral - blood
Area Under Curve
Calibration
Comparative analysis
Enzyme-linked immunosorbent assay
Enzyme-Linked Immunosorbent Assay - standards
Female
Health aspects
Herpes
Herpes Genitalis - complications
Herpes Genitalis - diagnosis
Herpes Genitalis - virology
Herpesvirus 2, Human - immunology
Herpesvirus diseases
HIV Infections - complications
Humans
Immunoglobulin G
Immunoglobulin G - blood
Laboratories - standards
Male
Physiological aspects
Reproducibility of Results
ROC Curve
Sensitivity and Specificity
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Summary: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. 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. Intra-assay variation was below 10 %. Intra-assay, intra-laboratory, and inter-laboratory correlation and agreement were significantly high (p 
ISSN:1471-2334
1471-2334
DOI:10.1186/s12879-015-1130-6