Original Research

Laboratory evaluation of the Chembio Dual Path Platform HIV-Syphilis Assay

Mireille B. Kalou, Arnold Castro, Amy Watson, Heather Jost, Stacy Clay, Ye Tun, Cheng Chen, Kevin Karem, John N. Nkengasong, Ronald Ballard, Bharat Parekh
African Journal of Laboratory Medicine | Vol 5, No 1 | a433 | DOI: https://doi.org/10.4102/ajlm.v5i1.433 | © 2016 Mireille B. Kalou, Arnold Castro, Amy Watson, Heather Jost, Stacy Clay, Ye Tun, Cheng Chen, Kevin Karem, John N. Nkengasong, Ronald Ballard, Bharat Parekh | This work is licensed under CC Attribution 4.0
Submitted: 08 March 2016 | Published: 15 September 2016

About the author(s)

Mireille B. Kalou, International Laboratory Branch, Division of Global HIV and Tuberculosis, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States
Arnold Castro, Laboratory Reference and Research Branch, Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, US Centers for Disease Control and, United States
Amy Watson, International Laboratory Branch, Division of Global HIV and Tuberculosis, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States
Heather Jost, International Laboratory Branch, Division of Global HIV and Tuberculosis, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States
Stacy Clay, International Laboratory Branch, Division of Global HIV and Tuberculosis, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States
Ye Tun, Office of the Associate Director of Laboratory Science, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States
Cheng Chen, Laboratory Reference and Research Branch, Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States
Kevin Karem, Laboratory Reference and Research Branch, Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, US Centers for Disease Control and, United States
John N. Nkengasong, International Laboratory Branch, Division of Global HIV and Tuberculosis, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, Georgia
Ronald Ballard, Office of the Associate Director of Laboratory Science, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States
Bharat Parekh, International Laboratory Branch, Division of Global HIV and Tuberculosis, Center for Global Health, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States


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Abstract

Background: Use of rapid diagnostic tests for HIV and syphilis has increased remarkably in the last decade. As new rapid diagnostic tests become available, there is a continuous need to assess their performance and operational characteristics prior to use in clinical settings.

Objectives: In this study, we evaluated the performance of the Chembio Dual Path Platform (DPP®) HIV–Syphilis Assay to accurately diagnose HIV, syphilis, and HIV/syphilis co-infection.

Method: In 2013, 990 serum samples from the Georgia Public Health Laboratory in Atlanta, Georgia, United States were characterised for HIV and syphilis and used to evaluate the platform. HIV reference testing combined third-generation Enzyme Immunoassay and Western Blot, whereas reference testing for syphilis was conducted by the Treponema pallidum passive particle agglutination method and the TrepSure assay. We assessed the sensitivity and specificity of the DPP assay on this panel by comparing results with the HIV and syphilis reference testing algorithms.

Results: For HIV, sensitivity was 99.8% and specificity was 98.4%; for syphilis, sensitivity was 98.8% and specificity was 99.4%. Of the 348 co-infected sera, 344 (98.9%) were detected accurately by the DPP assay, but 11 specimens had false-positive results (9 HIV and 2 syphilis) due to weak reactivity.

Conclusion: In this evaluation, the Chembio DPP HIV–Syphilis Assay had high sensitivity and specificity for detecting both HIV and treponemal antibodies. Our results indicate that this assay could have a significant impact on the simultaneous screening of HIV and syphilis using a single test device for high-risk populations or pregnant women needing timely care and treatment.


Keywords

HIV; Syphilis; dual rapid diagnostic test

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Crossref Citations

1. A systematic review and meta-analysis of studies evaluating the performance and operational characteristics of dual point-of-care tests for HIV and syphilis
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doi: 10.1136/sextrans-2016-053069