The Diagnostic Accuracy of the HIV 1/2/Subtype O Tri-line
HIV Rapid Test in Comparison to ELISA: A Pilot Study

Shumani Manenzhe, Sizakele Ngwenya, Shangase Sindisiwe Londiwe, Govindrau Mohangi




Background: Accurate HIV diagnosis is critical and can save lives. A reliable Rapid Test (RT) is considered fundamental to HIV prevention and management. Some studies have found RT to be comparable with ELISA whilst others have reported on lower sensitivity.


Aim and study design: The aim of this retrospective comparative descriptive study was to evaluate the sensitivity and specificity of the Tri-line HIV rapid test device in comparison to ELISA on patient records from Wits Oral Health Centre (WOHC) between 2014 and 2016.


Method: The study population comprised records of patient's older than18 months who had Tri-Line HIV RT and blood drawn for ELISA on the same day. Descriptive analysis of the data was carried out.


Results: The sensitivity of Tri-line was 80% (CI: 59-93%) and specificity was 100% (CI: 83-100%). The PPV was 100% (CI: 83-100%) and NPV was 80% (CI: 65-90%). ROC area of 0.9 at 95% CI was determined.

Conclusion: Notwithstanding the low sample size in this study, the Tri-line showed less than 100% sensitivity. This is a concern, since HIV screening done in the wider community in South Africa is by means of rapid tests.