Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria

Yin, Yue-Ping; Ngige, Evelyn; Anyaike, Chukwuma; Ijaodola, Gbenga; Oyelade, Taiwo A.; Vaz, Rui G.; Newman, Lori M.; Chen, Xiang-Sheng

doi:10.1016/j.ijgo.2015.04.004

Cited by 26 publications

(32 citation statements)

References 15 publications

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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: 90%

“…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)(6)(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.…”

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confidence: 99%

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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: 90%

mentioning

confidence: 99%

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

et al. 2016

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“…Previous studies evaluated dual tests for antibodies to HIV and T. pallidum, including the MedMira Multiplo (MedMira; Halifax, Nova Scotia, Canada), the SD BIOLINE HIV/Syphilis Duo test (Standard Diagnostics; Gyeonggi-do, Republic of Korea), and the Chembio DPP HIV-syphilis assay (Chembio Diagnostics; Medford, NY) (7,(14)(15)(16)(17)(18)(19)(20)(21)(22)(23). These dual tests demonstrated sensitivities and specificities for HIV antibody detection ranging from 93.8% to 100% and 91.9% to 100%, respectively.…”

mentioning

confidence: 99%

Laboratory Evaluation of a Point-of-Care Downward-Flow Assay for Simultaneous Detection of Antibodies to Treponema pallidum and Human Immunodeficiency Virus

et al. 2016

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dCombining the detection of syphilis and HIV antibodies into one point-of-care test integrates syphilis screening into already existing HIV screening programs, which may be particularly beneficial in settings such as antenatal care. Using the INSTI Multiplex downward-flow immunoassay, we tested 200 stored serum samples from high-risk patients enrolled in a longitudinal study on HIV infection and syphilis in Peruvian men who have sex with men and transgender women. This rapid assay detected HIV and Treponema pallidum serum antibodies with sensitivities of 100% (95% confidence interval [CI], 95.9% to 100%) and 87.4% (95% CI, 81.4% to 92.0%), respectively, and specificities of 95.5% (95% CI, 89.9% to 98.5%) and 97.0% (95% CI, 84.2% to 99.9%), respectively (n ‫؍‬ 200). The sensitivity for syphilis antibody detection was higher in patients with a rapid plasma reagin titer of >1:8 (97.3%) than in those with a titer of <1:4 (90%) or a nonreactive titer (66.7%). While syphilis, an infection caused by the spirochete Treponema pallidum, is a curable disease, it is estimated that there are 5.6 million new syphilis infections in adults annually (1) compared to approximately 2 million new HIV infections (2). Although new syphilis infections are more common, HIV screening has become a priority in low-and middle-income countries. Syphilis frequently presents atypically, which can make it difficult to clinically differentiate from other sexually transmitted infections; thus, effective diagnostic tests are crucial for correctly identifying and managing syphilis infections (3). Highly accurate diagnostic tests for HIV infection and syphilis exist, but they are often inaccessible to people living in areas with the highest burden of disease. Point-of-care tests provide an opportunity to reach those populations through tests that are inexpensive, easy to perform, and rapid, which enables same-day testing and treatment. Combining the detection of syphilis and HIV antibodies into one point-of-care test integrates syphilis screening into already existing HIV screening programs, which might be particularly beneficial in settings such as antenatal care (4).The INSTI Multiplex downward-flow immunoassay (bioLytical Laboratories, Inc., Canada) is for the simultaneous detection of HIV and T. pallidum antibodies. Results can be read in less than 1 min. Previous studies of the INSTI HIV-1/HIV-2 antibody test found it to be highly sensitive, specific, and easy to use (5-11). The INSTI Multiplex assay was developed recently, and no published data on its accuracy, feasibility, or acceptability exist yet.Using the INSTI Multiplex, we tested 200 stored (Ϫ80°C) serum samples from high-risk patients enrolled in a longitudinal study on HIV infection and syphilis in Peruvian men who have sex with men and transgender women (12). Genital lesions are a sign of primary syphilis, and 14 of the 200 serum samples were from patients who had primary syphilis, confirmed by T. pallidum DNA detection using PCR (12). The sera were tested for HIV and T. pallidum ant...

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“…In those studies, sensitivities of the POCTT varied from around 63 % in the first studies to almost 100 % [30][31][32][33]36,39,44,45], with specificities varying from around 90 % to 100 % in the most recent studies. The tests' increasing performance over the years is associated not only with the development of better tests but also with better quality control, one of the most important steps, especially when taking into consideration that these tests are to be used mainly in remote regions.…”

Section: Poc Tests' Performancementioning

confidence: 98%

“…Dual [25,36,39], triple [40][41][42], or quadruple [43] POCT for syphilis, HIV, and other STIs have recently been developed, and, for syphilis POCT alone, depending on the conditions and populations studied, quality control implementation and integration in local health facilities have shown to have good sensitivity and specificity for the tests included in the device.…”

Section: Syphilis Serological Diagnosis Algorithmsmentioning

confidence: 99%

The role of Point-of-Care testing in the diagnosis of syphilis

Castro¹,

Pereira²

2017

Point-of-Care Diagnostics - New Progresses and Perspectives

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Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria

Cited by 26 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

Laboratory Evaluation of a Point-of-Care Downward-Flow Assay for Simultaneous Detection of Antibodies to Treponema pallidum and Human Immunodeficiency Virus

The role of Point-of-Care testing in the diagnosis of syphilis

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