TY - JOUR
T1 - Precision of the Kalon Herpes Simplex Virus Type 2 IgG ELISA
T2 - An international inter-laboratory assessment
AU - Patel, Eshan U.
AU - Manucci, Jordyn
AU - Kahle, Erin M.
AU - Lingappa, Jairam R.
AU - Morrow, Rhoda Ashley
AU - Piwowar-Manning, Estelle
AU - James, Anelet
AU - Maluzi, Kwitaka F.
AU - Cheeba, Maina M.
AU - Gray, Glenda
AU - Delany-Moretlwe, Sinead
AU - Inambao, Mubiana
AU - Vwalika, Bellington
AU - Quinn, Thomas C.
AU - Laeyendecker, Oliver
N1 - Publisher Copyright:
© 2015 Patel et al.
PY - 2015/9/30
Y1 - 2015/9/30
N2 - 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.
AB - 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.
KW - Accuracy
KW - HSV-2
KW - Herpes
KW - Kalon
KW - Precision
KW - Reproducibility
KW - Sensitivity
KW - South africa
KW - Specificity
KW - Zambia
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U2 - 10.1186/s12879-015-1130-6
DO - 10.1186/s12879-015-1130-6
M3 - Article
C2 - 26423888
AN - SCOPUS:84942609220
SN - 1471-2334
VL - 15
JO - BMC infectious diseases
JF - BMC infectious diseases
IS - 1
M1 - 398
ER -