Multisite Laboratory Evaluation of a Dual Human Immunodeficiency Virus (HIV)/Syphilis Point-of-Care Rapid Test for Simultaneous Detection of HIV and Syphilis Infection

Open Forum Infectious Diseases
Claire C BristowJeffrey D Klausner

Abstract

Recently, test developers have created rapid point-of-care tests that can simultaneously detect multiple infections within the same specimen using a single device. The SD BIOLINE Duo HIV/Syphilis rapid point-of-care test uses a solid-phase immunochromatographic assay to detect immunoglobulin (Ig)G, IgM, and IgA antibodies to human immunodeficiency virus (HIV)-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and recombinant Treponema pallidum antigen (17 kDa) in human serum. This study was a multisite laboratory-based evaluation of the performance of SD BIOLINE HIV/Syphilis Duo test using previously characterized sera in 6 countries. Laboratories in Ghana, Mexico, Laos, Togo, Kenya, and Myanmar participated in the evaluation during 2012-2013. Each site characterized sera using T pallidum particle agglutination assay or T pallidum hemagglutination assay and HIV enzyme immunoassay, Western blot, and/or HIV antibody rapid tests. Those gold standard test results were compared with SD BIOLINE Duo test results. We calculated the sensitivity and specificity of test performance and used the exact binomial method to calculate 95% confidence intervals (CIs). The sensitivity and specificity for the HIV antibody test component (n = 2336) w...Continue Reading

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Citations

Dec 10, 2015·Sexually Transmitted Diseases·Claire C BristowJeffrey D Klausner
May 16, 2015·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Yue-Ping YinXiang-Sheng Chen
Nov 5, 2015·Lancet·Claire C Bristow, Jeffrey D Klausner
Aug 20, 2015·BMC Infectious Diseases·Susan Tuddenham, Khalil G Ghanem
Jan 27, 2015·Sexual Health·Claire C BristowJeffrey D Klausner
Nov 8, 2014·Journal of Clinical Microbiology·Claire C BristowJeffrey D Klausner
Dec 17, 2015·Sexually Transmitted Infections·Claire C BristowJeffrey D Klausner
Aug 28, 2016·BMC Infectious Diseases·Geeta ShakyaKiran Regmi
Mar 28, 2017·Expert Review of Molecular Diagnostics·Luc Bissonnette, Michel G Bergeron
Jan 15, 2015·BMC Infectious Diseases·Yukari C ManabeElly Katabira
Dec 15, 2015·Journal of Clinical Microbiology·S R LeonJ D Klausner
Oct 10, 2014·Journal of Clinical Microbiology·Romney M HumphriesJeffrey D Klausner
Oct 24, 2018·International Journal of STD & AIDS·Keenan WithersJeffrey D Klausner
Nov 28, 2014·Clinical and Vaccine Immunology : CVI·Muhammad G Morshed, Ameeta E Singh
Feb 28, 2016·Sexually Transmitted Infections·Claire C BristowJeffrey D Klausner
Jan 5, 2019·BMC Infectious Diseases·Annelies Van Den HeuvelTania Crucitti
Sep 8, 2017·African Journal of Laboratory Medicine·Mireille B KalouBharat Parekh
Jul 1, 2017·International Journal of STD & AIDS·Jeffrey HoldenCharlotte A Gaydos

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Methods Mentioned

BETA
ELISA
enzyme-linked immunosorbent assay
Assay

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