Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2014 May 27;1(1):ofu015.
doi: 10.1093/ofid/ofu015. eCollection 2014 Mar.

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

Claire C Bristow  1 , Yaw Adu-Sarkodie  2 , Raphael O Ondondo  3 , Elizabeth Anne Bukusi  4 , Claver Anoumou Dagnra  5 , Khin Yi Oo  6 , Eh Htoo Pe  6 , Chanthavysouk Khamsay  7 , Le Thi Houng  8 , Roberto Vázquez Campuzano  9 , Jason Estes  10 , Jeffrey D Klausner  11
Affiliations

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

Claire C Bristow et al. Open Forum Infect Dis. .

Abstract

Background: 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.

Methods: 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).

Results: The sensitivity and specificity for the HIV antibody test component (n = 2336) were estimated at 99.91% (95% CI, 99.51% and 100%) and 99.67% (95% CI, 99.16% and 99.91%), respectively. For the T pallidum test component (n = 2059), the sensitivity and specificity were estimated at 99.67% (95% CI, 98.82% and 99.96%) and 99.72% (95% CI, 99.29% and 99.92%), respectively.

Conclusions: The sensitivity and specificity of the SD BIOLINE HIV/Syphilis Duo test were consistently high across sera specimens from 6 countries around the world. Dual rapid tests should be considered for improved HIV and syphilis screening coverage.

Keywords: Dual testing; HIV; Syphilis; rapid test; test evaluation.

PubMed Disclaimer

References

    1. Newman L, Kamb M, Hawkes S, et al. Global estimates of syphilis in pregnancy and associated adverse outcomes: analysis of multinational antenatal surveillance data. PLoS Med. 2013;10:e1001396. - PMC - PubMed
    1. Klausner JD. The sound of silence: missing the opportunity to save lives at birth. WHO Bulletin. March 1, 2013; 91:158–158A. doi: 10.2471/BLT.13.118604. - PMC - PubMed
    1. Zetola NM, Klausner JD. Syphilis and HIV infection: an update. Clin Infect Dis. 2007;44:1222–8. - PubMed
    1. Santis MD, De Luca C, Mappa I, et al. Syphilis infection during pregnancy: fetal risks and clinical management. Infect Dis Obstet Gynecol. 2012;2012:430585. doi:10.1155/2012/430585. - DOI - PMC - PubMed
    1. Gomez GB, Kamb ML, Newman LM, et al. Untreated maternal syphilis and adverse outcomes of pregnancy: a systematic literature review and meta-analysis. Bull World Health Organ. 2013;91:217–26. - PMC - PubMed