Laboratory Evaluation of a Dual Rapid Immunodiagnostic Test for HIV and Syphilis Infection

Bristow, Claire; León, Segundo R.; Ramos, Lourdes B.; Vargas, Silver K.; Flores, Juan; Konda, Kelika A.; Caceres, Carlos F.; Klausner, Jeffrey D.

doi:10.1128/jcm.02763-14

Cited by 18 publications

(13 citation statements)

References 15 publications

(16 reference statements)

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“…For Treponema pallidum antibody detection, the electronic reader with the default cutoff value of 10 had the best sensitivity and specificity. Our results are comparable to those of laboratory evaluations that were conducted previously with different point-of-care tests for HIV and treponemal antibody detection in sera and whole blood, which also yielded high performance values for sensitivity and specificity (1,(5)(6)(7)(11)(12)(13). In our evaluation, the sensitivity of the Chembio DPP HIV-syphilis rapid test to detect HIV antibodies was somewhat greater than its sensitivity to detect syphilis antibodies, in concurrence with several other studies (5,6,11,12,14).…”

supporting

confidence: 78%

Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

et al. 2016

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eWe assessed the laboratory performance of the Chembio dual-path platform HIV-syphilis rapid immunodiagnostic test and electronic reader for detection of HIV and Treponema pallidum antibodies in 450 previously characterized serum specimens. For visual or electronic reader HIV antibody detection, the sensitivity was 100% and the specificity was 98.7%. For visual T. pallidum antibody detection, the test sensitivity was 94.7% and the specificity was 100.0%; with the electronic reader, the sensitivity was 94.7% and the specificity was 99.7%. Rapid multiplex point-of-care tests are increasingly available means to screen for syphilis and HIV infections (1-4). Dual screening tests for antibodies to HIV and Treponema pallidum have been evaluated in serum and venipuncture whole-blood samples, showing excellent sensitivity and specificity (5-7). We assessed the laboratory performance of the Chembio dual-path platform (DPP) HIV-syphilis rapid test and the Chembio digital electronic reader with stored serum samples collected from a cohort of men who have sex with men (MSM) and transwomen at high risk for HIV and syphilis infections.Serum specimens were collected between 2013 and 2014 from MSM and transwomen who had been recruited into an ongoing cohort study in Lima, Peru, and the specimens were stored at Ϫ20°C (8). HIV positivity was determined with the Genscreen Ultra HIV Ag-Ab test (Bio-Rad, Hercules, CA), a novel enzyme immunoassay (EIA) which detects HIV p24 antigen (Ag) and HIV antibodies in the same test (9). Positive EIA results were confirmed by Western blotting (New Lav Blot I; Bio-Rad). Specimens also underwent rapid plasma reagin (RPR) testing, using the BD Macro-Vue RPR card test kit (BD, Franklin Lakes, NJ), and Treponema pallidum particle agglutination (TPPA) testing (Serodia; Fujirebio Diagnostics Inc., Tokyo, Japan). All tests were used according to the manufacturers' instructions.The Chembio DPP HIV-syphilis test is a single-use, visual and qualitative immunochromatographic, dual rapid test for the detection of antibodies to HIV types 1 and 2 and Treponema pallidum in human serum, plasma, or venous or fingerprick wholeblood samples (10). A red control line confirms test validity. Visual observation of a red line in the HIV and/or syphilis detection zone is interpreted as a reactive result (10).Immediately after visual interpretation, tests were analyzed using the small, battery-powered, Chembio electronic reader, which was designed specifically to complement the Chembio DPP technology. The electronic reader scans the DPP test cartridge and displays a numerical value based on the test line intensity. If the electronic reader value is higher than the set cutoff value, then the result for the sample is reported as positive; the test result is reported as negative if the measured value is lower than the cutoff value.We estimated the sensitivity, specificity, and 95% confidence intervals (CIs) using the exact binomial method, and we calculated the concordance between the visual results of the Chembio DPP HIV-sy...

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confidence: 78%

Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

et al. 2016

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“…Now, with the advent of point-of-care NAATs, the specificity and sensitivity of CT and NG tests are much higher and may be cost-effective to use in resource-limited countries. 24 As a testament to the success that can be had with STI screening, point-of-care rapid syphilis tests are now being integrated into antenatal care around the world, and some countries have even started to use a dual syphilis-HIV test, which has shown excellent performance. 25 Our study found that most of the syphilis testing was done with point-of-care tests, whereas none of the other STI tests were point of care.…”

Section: Discussionmentioning

confidence: 99%

Prevalence of Curable Sexually Transmitted Infections in Pregnant Women in Low- and Middle-Income Countries From 2010 to 2015

Davey¹,

Shull²,

Billings³

et al. 2016

Sexual Trans Dis

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Background Current literature comparing the prevalence rates of curable sexually transmitted infections (STIs) in pregnant women in various global regions is limited. As a result, antenatal screening practices for curable STIs in pregnant women, specifically Treponema pallidum (syphilis), Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV) vary around the world, differing by country and particular STI. Methods We conducted a systematic review of publications on STI prevalence among pregnant women in 30 different low- and middle-income countries. We searched PubMed for studies reporting prevalence of syphilis, CT, NG, and TV in pregnant women. English language studies published between January 1, 2010, and March 1, 2015, were included. The adjusted mean STI prevalence by region was calculated via multivariable linear regression adjusting for health care setting, women’s mean age, study sample size, and sensitivity of diagnostic test. Results We identified 75 studies that met inclusion criteria, providing 116 point prevalence estimates for curable STIs among 3,489,621 pregnant women. Adjusted mean prevalence for NG ranged from 1.2% (95% confidence interval [CI], 1.0–1.3) in Latin America to 4.6% (95% CI, 4.0–5.2) in Southern Africa; syphilis prevalence ranged from 1.1% (95% CI, 0.5–1.6) in Asia to 6.5% (95% CI, 4.7–6.3) in Southern Africa; CT ranged from 0.8% (95% CI, 0.4–1.1) in Asia to 11.2% (95% CI, 6.0–16.4) in Latin America; and TV ranged from 3.9% (95% CI, 2.2–5.6) in Latin America to 24.6% (95% CI, 17.9–31.4) in Southern Africa. Conclusions Although we observed a wide variation in STI burden in pregnancy after adjusting for age, test, and health care setting, further valid comparison may depend on adjustment for access to care and screening practices.

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“…192123 Additionally, a field evaluation of a dual HIV and syphilis test used in this cost-effectiveness analysis displayed excellent HIV antibody detection and very good treponemal antibody detection. 20 Those performance results are similar to evaluations of single rapid tests.…”

Section: Discussionmentioning

confidence: 90%

Cost-effectiveness of HIV and syphilis antenatal screening: a modelling study

2016

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Objectives The World Health Organization called for the elimination of maternal-to-child transmission (MTCT) of HIV and syphilis, a harmonized approach for the improvement of health outcomes for mothers and children. Testing early in pregnancy, treating seropositive pregnant women, and preventing syphilis re-infection can prevent MTCT of HIV and syphilis. We assessed the health and economic outcomes of a dual testing strategy in a simulated cohort of 100,000 antenatal care patients in Malawi. Methods We compared four screening algorithms: (1) HIV rapid test only, (2) dual HIV and syphilis rapid tests, (3) single rapid tests for HIV and syphilis, and (4) HIV rapid and syphilis laboratory tests. We calculated the expected number of adverse pregnancy outcomes, the expected costs, and the expected newborn disability adjusted life years (DALYs) for each screening algorithm. The estimated costs and DALYs for each screening algorithm were assessed from a societal perspective using Markov progression models. Additionally, we conducted a Monte Carlo multi-way sensitivity analysis, allowing for ranges of inputs. Results Our cohort decision model predicted the lowest number of adverse pregnancy outcomes in the dual HIV and syphilis rapid test strategy. Additionally, from the societal perspective, the costs of prevention and care using a dual HIV and syphilis rapid testing strategy was both the least costly ($226.92 per pregnancy) and resulted in the fewest DALYs (116,639) per 100,000 pregnancies. In the Monte Carlo simulation the dual HIV and syphilis algorithm was always cost saving and almost always reduced disability adjusted life years (DALYs) compared to HIV testing alone. Conclusion The results of the cost-effectiveness analysis showed that a dual HIV and syphilis test was cost saving compared to all other screening strategies. Adding dual rapid testing to the existing prevention of mother-to-child HIV transmission programs in Malawi and similar countries is likely to be advantageous.

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Laboratory Evaluation of a Dual Rapid Immunodiagnostic Test for HIV and Syphilis Infection

Cited by 18 publications

References 15 publications

Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

Prevalence of Curable Sexually Transmitted Infections in Pregnant Women in Low- and Middle-Income Countries From 2010 to 2015

Cost-effectiveness of HIV and syphilis antenatal screening: a modelling study

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