Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia

Abstract

This cross-sectional study of 3212 pregnant women assessed the field performance, acceptability, and feasibility of two dual HIV/syphilis rapid diagnostic tests, the Chembio DPP HIV-syphilis Assay and the SD Bioline HIV/syphilis Duo in antenatal clinics. Sensitivity and specificity for HIV and syphilis were calculated compared to the rapid Determine HIV-1/2 with Uni-Gold to confirm positive results for HIV and the Treponema pallidum particle agglutination assay for syphilis. RPR titers ≥1:4 were used to define active syphilis detection. Acceptability and feasibility were assessed using self-reported questionnaires. For Chembio, the HIV sensitivity was 90.6% (95%CI = 87.4, 93.0) and specificity was 97.2% (95%CI = 96.2, 97.8); syphilis sensitivity was 68.6% (95%CI = 61.9, 74.6) and specificity was 98.5% (95%CI = 97.8, 98.9). For SD Bioline, HIV sensitivity was 89.4% (95%CI = 86.1, 92.0) and specificity was 96.3% (95%CI = 95.3, 97.1); syphilis sensitivity was 66.2% (95%CI = 59.4, 72.4) and specificity was 97.2% (95%CI = 96.4, 97.9). Using the reference for active syphilis, syphilis sensitivity was 84.7% (95%CI = 76.1, 90.6) for Chembio and 81.6% (95%CI = 72.7, 88.1) for SD Bioline. Both rapid diagnostic tests were assessed as highly acceptable and feasible. In a field setting, the performance of both rapid diagnostic tests was comparable to other published field evaluations and each was rated highly acceptable and feasible. These findings can be used to guide further research and proposed scale up in antenatal clinic settings.

Keywords

HIV Africa diagnosis women

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References

Mabey

Peeling

RW.

Syphilis, still a major cause of infant mortality. Lancet Infect Dis 2011; 11: 654–655.

UNAIDS. AIDS by the numbers 2015, http://www.unaids.org/en/resources/documents/2015/AIDS_by_the_numbers_2015 (Accessed on 16 August 2017).

Wijesooriya

Rochat

Kamb

et al . Global burden of maternal and congenital syphilis in 2008 and 2012: a health systems modelling study. Lancet Glob Health 2016; 4: e525–e533.

UNICEF ZAMBIA. Prevention of mother-to-child transmission, FACT SHEETS, https://www.unicef.org/zambia/5109_8456.html 2010 (accessed 16 August 2017).

Strasser

Bitarakwate

Gill

et al . Introduction of rapid syphilis testing within prevention of mother-to-child transmission of HIV programs in Uganda and Zambia: a field acceptability and feasibility study. J Acquir Immune Defic Syndr 2012; 61: e40–e46.

Mwapasa

Rogerson

Kwiek

et al . Maternal syphilis infection is associated with increased risk of mother-to-child transmission of HIV in Malawi. AIDS 2006; 20: 1869–1877.

Swartzendruber

Steiner

Adler

et al . Introduction of rapid syphilis testing in antenatal care: a systematic review of the impact on HIV and syphilis testing uptake and coverage. Int J Gynecol Obstet 2015; 130: S15–S21.

Blencowe

Cousens

Kamb

et al . Lives saved tool supplement detection and treatment of syphilis in pregnancy to reduce syphilis related stillbirths and neonatal mortality. BMC Public Health 2011; 11: S9.

WHO. Mother-to-child transmission of HIV 2017, http://www.who.int/hiv/topics/mtct/about/en (2017, accessed 23 October 2017).

10.

CHEMBIO Diagnostic Systems INC. DPP® HIV-syphilis assay, http://chembio.com/products/human-diagnostics/dpp-hivsyphilis-assay (accessed 16 August 2017). 2006–2014.

11.

SD Biotin HIV/Syphilis Duo - Alere is now Abbott, https://www.alere.com/en/home/product-details/sd-bioline-hiv-syphilis-duo.html. 2015

12.

Bristow

Leon

Huang

et al . Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru. Sex Transm Infect 2016; 92: 182–185.

13.

Bristow

Severe

Pape

et al . Dual rapid lateral flow immunoassay fingerstick wholeblood testing for syphilis and HIV infections is acceptable and accurate, Port-au-Prince, Haiti. BMC Infect Dis 2016; 16: 302.

14.

Hess

Fisher

Reynolds

GL.

Sensitivity and specificity of point-of-care rapid combination syphilis-HIV-HCV tests. PLoS One 2014; 9: e112190.

15.

Black

Williams

Maseko

et al . Field evaluation of Standard Diagnostics' Bioline HIV/Syphilis Duo test among female sex workers in Johannesburg, South Africa. Sex Transm Infect 2016;92:495–498.

16.

Bowen

Lupoli

Chipungu

et al . A bundle of health-syphilis test performance in the field evaluation of a novel dual HIV/syphilis rapid test – Malawi, 2014–2015. Sex Transm Infect 2015; 43: S223.

17.

Gliddon

HDPR

Kamb

Toskin

et al . A systematic review and meta-analysis of studies evaluating the performance and operational characteristics of dual point-of-care tests for HIV and syphilis. A systematic review and meta-analysis of studies evaluating the performance and operational characteristics of dual point-of-care tests for HIV and syphilis. Sex Transm Infect 2017; 93: 1–13.

18.

Fakile

Hoover

Delaney

et al . Evaluation of five rapid point-of-care tests for syphilis: two treponemal only, and three dual treponemal/HIV assays. Sex Transm Infect 2015; 91: (Suppl 2):A29.doi:10.1136/sextrans-2015-052270.89

19.

Mabey

Peeling

Ballard

et al . Prospective, multi-centre clinic-based evaluation of four rapid diagnostic tests for syphilis. Sex Transm Infect 2006; 82: 13–16.

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