In the JournalsPerspective

Oral HIV self-testing kit demonstrates 100% specificity, 99.5% sensitivity

An oral fluid-based HIV self-testing kit demonstrated high diagnostic performance during a facility-based cross-sectional study in Ethiopia, and experts suggested in PLoS One that it has the potential to be used alongside the country’s traditional HIV testing services.

According to Wudinesh Belete, MPH, field supervisor at the Ethiopian Public Health Institute, and colleagues, Ethiopia plans to introduce HIV self-testing to existing, facility-based HIV-testing services as a “complementary approach” to broaden access to HIV testing for previously untested, hard-to-reach and test-averse populations.

“However, to date, there is no empirical evidence on the performance of [HIV self-testing] in Ethiopia to support the implementation of this strategy,” they wrote. “The World Health Organization (WHO) recommends evaluating the diagnostic performance of each kit to determine its accuracy and suitability in the context of a given country setting before use.”

Between December 2017 and February 2018, the researchers enrolled 400 participants to assess the diagnostic accuracy of OraQuick (OraSure Technologies), an oral fluid-based HIV self-testing kit, in 15 public health facilities in Addis Ababa, Ethiopia. Instructions and visual aids on how to perform HIV self-testing and interpret results were provided to participants, who were also screened via a blood-based rapid HIV antibody test, per the current national algorithm, Wudinesh and colleagues said.

According to the findings, 200 participants tested positive on the national algorithm test, and of those, 99.5% also tested positive using OraQuick, with one false-negative result. Of the 200 participants who tested negative on the national algorithm test, 100% tested negative using OraQuick. The researchers observed no false-positive results or invalid tests.

Compared with the national algorithm, OraQuick demonstrated 99.5% (95% CI, 97.26-99.99) sensitivity and 100% (95% CI, 98.18-100) specificity, Wudinesh and colleagues noted. They reported observing a high overall agreement between the two tests. The positive predictive value and negative predicative value of OraQuick were 100% and 99.5%, respectively (95%, CI 96.59-99.93).

“This HIV testing approach might avoid the barrier to the conventional blood-based [HIV testing services] and increase HIV testing uptake,” Wudinesh and colleagues wrote. “Therefore, although more data on feasibility, acceptability, and extents of linkage to service following [HIV self-testing are] needed, our finding shows that OraQuick [HIV self-testing] kit has a potential to be used as a complementary approach for HIV testing in Ethiopia.” – by Marley Ghizzone

Disclosures: The authors report no relevant financial disclosures.

An oral fluid-based HIV self-testing kit demonstrated high diagnostic performance during a facility-based cross-sectional study in Ethiopia, and experts suggested in PLoS One that it has the potential to be used alongside the country’s traditional HIV testing services.

According to Wudinesh Belete, MPH, field supervisor at the Ethiopian Public Health Institute, and colleagues, Ethiopia plans to introduce HIV self-testing to existing, facility-based HIV-testing services as a “complementary approach” to broaden access to HIV testing for previously untested, hard-to-reach and test-averse populations.

“However, to date, there is no empirical evidence on the performance of [HIV self-testing] in Ethiopia to support the implementation of this strategy,” they wrote. “The World Health Organization (WHO) recommends evaluating the diagnostic performance of each kit to determine its accuracy and suitability in the context of a given country setting before use.”

Between December 2017 and February 2018, the researchers enrolled 400 participants to assess the diagnostic accuracy of OraQuick (OraSure Technologies), an oral fluid-based HIV self-testing kit, in 15 public health facilities in Addis Ababa, Ethiopia. Instructions and visual aids on how to perform HIV self-testing and interpret results were provided to participants, who were also screened via a blood-based rapid HIV antibody test, per the current national algorithm, Wudinesh and colleagues said.

According to the findings, 200 participants tested positive on the national algorithm test, and of those, 99.5% also tested positive using OraQuick, with one false-negative result. Of the 200 participants who tested negative on the national algorithm test, 100% tested negative using OraQuick. The researchers observed no false-positive results or invalid tests.

Compared with the national algorithm, OraQuick demonstrated 99.5% (95% CI, 97.26-99.99) sensitivity and 100% (95% CI, 98.18-100) specificity, Wudinesh and colleagues noted. They reported observing a high overall agreement between the two tests. The positive predictive value and negative predicative value of OraQuick were 100% and 99.5%, respectively (95%, CI 96.59-99.93).

“This HIV testing approach might avoid the barrier to the conventional blood-based [HIV testing services] and increase HIV testing uptake,” Wudinesh and colleagues wrote. “Therefore, although more data on feasibility, acceptability, and extents of linkage to service following [HIV self-testing are] needed, our finding shows that OraQuick [HIV self-testing] kit has a potential to be used as a complementary approach for HIV testing in Ethiopia.” – by Marley Ghizzone

Disclosures: The authors report no relevant financial disclosures.

    Perspective

    In general, we found OraQuick to have good performance when compared with two finger-prick tests in our studies. The results mean that clinicians can use this test for patients in and outside the hospital setting.

    Augustine T. Choko, MSc

    Statistical epidemiologist
    Malawi-Liverpool Wellcome Trust Clinical Research Program