The Evaluation of a Rapid In Situ HIV Confirmation Test in a Programme with a High Failure Rate of the WHO HIV Two-Test Diagnostic Algorithm

2009

Evaluating a Rapid HIV Confirmation Test in a High Failure Rate Program

Sample size: 2864 publication 10 minutes Evidence: high

Author Information

Author(s): Klarkowski Derryck B., Wazome Joseph M., Lokuge Kamalini M., Shanks Leslie, Mills Clair F., O'Brien Daniel P.

Primary Institution: Public Health Department, Médecins Sans Frontières, Amsterdam, The Netherlands

Hypothesis

Can a practical field-based confirmation test reduce the false-positive rate of the WHO HIV two-test diagnostic algorithm?

Conclusion

The WHO HIV two-test diagnostic algorithm produced an unacceptably high level of false-positive diagnoses, especially for weakly positive results, but the OIC-HIV confirmation test proved to be practical and effective.

Supporting Evidence

The false-positive rate of the WHO two-test algorithm was found to be 10.5%.
17 weakly positive rapid test results were all negative or indeterminate by western blot.
The OIC-HIV test showed 99.1% agreement with western blot results.
3.3% of double strong RDT positive samples could not be confirmed by western blot.

Takeaway

This study found that many people wrongly diagnosed with HIV could be helped by a better test that checks results more carefully.

Methodology

Clients were tested using two rapid tests in parallel, followed by confirmation testing with OIC-HIV and western blot for those with double positive results.