Evaluation of OraQuick® HIV-1/2 as Oral Rapid Test.

A Djikeng,Cn Nkenfou,En Ndzie,Es Temgoua,I Donkam,Je Kembou,Lm Mouafo,M Sanousobzé,V Colizzi

doi:10.4314/ajid.v7i2.2

Abstract

As Cameroon scales up its national HIV/AIDS control program, evaluating the performance of commercially available tests for accurate and cost effective diagnostics becomes essential. A cross-sectional study assessed the performance of an HIV oral rapid test. A total of 1520 participants consented to participate in the study. After counselling, they were tested for HIV using the national algorithm followed by OraQuick. Results of the national algorithm were compared to those of OraQuick, for sensitivity, specificity, positive predictive and negative predictive values. 62% of participants were male, and 1% was reported HIV-positive following the national algorithm. The OraQuick test had 93% sensitivity, 99% specificity, 99.93% NPV and 90% PPV (95% CI, Kappa 0.965). Though more expensive (2-6x) compared to the national algorithm tests, oral mucosal transudate-based test demonstrated good performance. Therefore, it could be implemented in resource-constrained settings if subsidized and could increase participation since less invasive with no blood accident exposure.

Highlights

HIV serology has evolved since 1980's, rising from 1st to 4th generation of diagnostic tests
Fourteen (14) (1%) samples were confirmed HIV-positive by the gold standard against 1506 (99%) participants confirmed HIV-negative
The OraQuick® HIV-1/2 Rapid oral mucosa transudate (OMT)-based test detected a total of 14 positive samples, of which 13 were true positives and 1 was a false positive; the sensitivity and positive predictive value of 93% and 92.86% respectively

Summary

Introduction

HIV serology has evolved since 1980's, rising from 1st to 4th generation of diagnostic tests. Newborns, immune-compromised and obese individuals in whom getting blood samples can be difficult (Alemnji et al, 2009), the use of blood as the sole medium for testing for HIV can be problematic; but this could be eased by using other body fluids such as oral fluid (Delaney et al, 2006; Sangare et al, 1997) because its collection involves non-invasive techniques, unlike phlebotomy and fingertip pricking This could be more adaptable for field use (Constantine and Zink, 2005; UNAIDS/WHO, 2001) and screening of high risk and far-to-reach populations (Keenan et al, 2005) or in resource-constrained settings with improved participant acceptability

Objectives

Methods

Results

Conclusion