Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care

Galli, Richard A.; Green, Kevin F.; Marca, Anthony La; Waldman, Lawrence F.; Powers, Ronald E.; Daly, Amelia C.; Shackleton, Christopher R.

doi:10.1016/j.jcv.2013.08.024

Cited by 18 publications

(9 citation statements)

References 11 publications

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“…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)(6)(7)(8)(9)(10)(11). The INSTI Multiplex assay was developed recently, and no published data on its accuracy, feasibility, or acceptability exist yet.…”

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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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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“…The excellent field performance of the INSTI test highlights that this test could be easily used by lay counselors at the SA POC facilities, and could be considered for home‐based HIV testing. The ease of use of the INSTI HIV test by untrained, nonprofessional lay users at POC facilities has been reported previously . In November 2018, the INSTI self‐test became the first blood‐based HIV test to be prequalified by World Health Organisation .…”

Section: Discussionmentioning

confidence: 71%

Field performance of the INSTI HIV‐1/‐2 antibody test in two South African antenatal clinics

Mayaphi

Martin

Quinn

et al. 2019

Journal of Medical Virology

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This was a prospective study that assessed field performance of the INSTI HIV-1/-2 antibody test (INSTI test) in two antenatal clinics in South Africa (SA). INSTI test was evaluated against rapid tests used at these clinics, and pooled nucleic acid amplification testing (NAAT) performed for individuals with negative rapid tests. Three hundred and eighty-six pregnant women were enrolled; 334 (86.5%) with negative results on the screening rapid test, and 52 (13.5%; 95% confidence interval [CI]: 10.2-17.3%) with positive results on screening and confirmatory rapid tests. INSTI test yielded the same results as other rapid tests in all participants, thus showing a 100% sensitivity (95% CI: 93.2-100.0%) and specificity (95% CI: 98.9-100.0%). Pooled NAAT was performed for 290 participants who had negative rapid tests, and yielded negative results in all pools. These data show excellent field performance of the INSTI test, and highlight that this test can be implemented at SA clinics.

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“…Despite their nonoptimal specificity and sensitivity, in the event of being positive, such techniques would enable the recommendation of peripartum preventive measures, with prior provision of the informed consent by the patient. Such emergency evaluations may be performed even by individuals lacking a specific training when other human resources are unavailable [33][34][35][36].…”

Section: Early Diagnosismentioning

confidence: 99%

Vertical Transmission of HIV — Medical Diagnosis, Therapeutic Options and Prevention Strategy

Rubio¹,

Gahona²

2015

Trends in Basic and Therapeutic Options in HIV Infection - Towards a Functional Cure

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Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care

Cited by 18 publications

References 11 publications

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

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

Field performance of the INSTI HIV‐1/‐2 antibody test in two South African antenatal clinics

Vertical Transmission of HIV — Medical Diagnosis, Therapeutic Options and Prevention Strategy

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