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

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 ; Delany-Moretlwe, Sinead ; Inambao, Mubiana ; Vwalika, Bellington ; Quinn, Thomas C. ; Laeyendecker, Oliver (2015-09-30)

CITATION: 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.

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Background: 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.

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