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Amplifying and Quantifying HIV-1 RNA in HIV Infected Individuals with Viral Loads Below the Limit of Detection by Standard Clinical Assays

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Potential for false positive HIV test results with the serial rapid HIV testing algorithm.

Steven Baveewo¹, Moses R Kamya, Harriet Mayanja-Kizza

¹Department of Medicine, Makerere University School of Medicine, Kampala, Uganda. baveewosteven@yahoo.co.uk

BMC Research Notes

|March 21, 2012

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Rapid HIV testing in Uganda revealed that nearly half of positive results from a tiebreaker test were false positives. This highlights the need for confirmatory testing to ensure accurate HIV diagnosis.

Area of Science:

Public Health
Infectious Diseases
Diagnostic Accuracy

Background:

Rapid HIV tests are crucial for same-day diagnosis in resource-limited settings.
Uganda employs a serial rapid testing algorithm (Determine, STAT-PAK, Uni-Gold) for HIV diagnosis.
A specific subgroup testing positive on Determine and Uni-Gold, but negative on STAT-PAK, requires further investigation.

Purpose of the Study:

To assess the accuracy of the serial rapid HIV testing algorithm in Uganda.
To investigate the potential for false positive results in a specific testing scenario.
To evaluate the need for confirmatory testing in a subset of individuals.

Main Methods:

Qualitative DNA PCR was used to re-test a subset of samples.
The study focused on individuals testing positive via a tiebreaker in the serial algorithm.

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Amplifying and Quantifying HIV-1 RNA in HIV Infected Individuals with Viral Loads Below the Limit of Detection by Standard Clinical Assays

Amplifying and Quantifying HIV-1 RNA in HIV Infected Individuals with Viral Loads Below the Limit of Detection by Standard Clinical Assays

Published on: September 26, 2011

Development of a Quantitative Recombinase Polymerase Amplification Assay with an Internal Positive Control

Development of a Quantitative Recombinase Polymerase Amplification Assay with an Internal Positive Control

Published on: March 30, 2015

A total of 29 samples were re-tested using DNA PCR.

Main Results:

Out of 3388 individuals tested, 29 were positive by the tiebreaker (Determine+, STAT-PAK-, Uni-Gold+).
DNA PCR testing revealed that 14 of these 29 samples (48.2%) were actually HIV negative.
This indicates a significant rate of false positives in this specific testing subgroup.

Conclusions:

The serial rapid HIV testing algorithm, particularly the tiebreaker scenario, may yield false positive results.
Confirmatory testing is recommended for individuals identified as positive through this specific tiebreaker result.
Further validation studies are needed to fully assess the accuracy of rapid HIV testing algorithms.