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

BMC Infectious Diseases

Research Article

Erin M. Kahle¹  Rhoda Ashley Morrow²  Jordyn Manucci³  Anelet James⁴  Estelle Piwowar-Manning⁵  Jairam R. Lingappa⁶  Eshan U. Patel⁷  Thomas C. Quinn⁸  Oliver Laeyendecker⁹  Glenda Gray^1,10  Sinead Delany-Moretlwe^1,11  Kwitaka F. Maluzi^1,12  Maina M. Cheeba^1,12  Mubiana Inambao^1,13  Bellington Vwalika^1,14 

[1] Department of Epidemiology, University of Washington, Seattle, WA, USA;Department of Laboratory Medicine, University of Washington, Seattle, WA, USA;Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA;Department of Medicine, Johns Hopkins University, Baltimore, MD, USA;Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa;Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA;Departments of Medicine, Global Health, and Pediatrics, University of Washington, Seattle, WA, USA;Laboratory of Immunoregulation, Division of Intramural Research, NIAID, NIH, Baltimore, MD, USA;Laboratory of Immunoregulation, Division of Intramural Research, NIAID, NIH, Baltimore, MD, USA;Department of Medicine, Johns Hopkins University, Baltimore, MD, USA;Laboratory of Immunoregulation, Division of Intramural Research, NIAID, NIH, Baltimore, MD, USA;Department of Medicine, Johns Hopkins University, Baltimore, MD, USA;NIAID, NIH and SOM, JHU, 855 North Wolfe St., Rangos Building, Room 538A, 21205, Baltimore, MD, USA;Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa;Wits Reproductive Health and HIV Institute and University of the Witwatersrand, Johannesburg, South Africa;Zambart, Lusaka, Zambia;Zambia-Emory Research Project and Ndola Central Hospital, Ndola, Zambia;Zambia-Emory Research Project, Lusaka, Zambia;

关键词: Herpes;    HSV-2;    Kalon;    Precision;    Reproducibility;    Accuracy;    Sensitivity;    Specificity;    Zambia;    South Africa;   

DOI  :  10.1186/s12879-015-1130-6

 received in 2015-03-05, accepted in 2015-09-18,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsA 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.ResultsIntra-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).DiscussionKalon 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.ConclusionsIn populations with optimal diagnostic accuracy, Kalon is a reliable stand-alone method for on-site HSV-2 IgG antibody detection.

【 授权许可】

CC BY   
© Patel et al. 2015