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Real Time RT-PCR

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Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics

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Rapid Testing Algorithm Performance in a Low-Prevalence Environment.

Eugene G Martin¹, Julia Cornett, Debbie Y Mohammed²

¹From the Department of Pathology and Laboratory Medicine, Rutgers University - Robert Wood Johnson Medical School, Somerset.

Sexually Transmitted Diseases

|January 25, 2020

Summary

This summary is machine-generated.

A statewide HIV rapid test algorithm effectively identified true positives in a low-prevalence area. Discordant results were rare, but some early infections had low viral loads, highlighting the algorithm's utility.

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Area of Science:

Infectious Diseases
Public Health
Diagnostic Medicine

Background:

Examined the 3-year performance of a statewide HIV rapid test algorithm (RTA) in a setting with 0.71% prevalence.
Evaluated an RTA involving an initial HIV-1/2 Ag/Ab Combo test (RT#1) and Ab verification with a second rapid test (RT#2).

Purpose of the Study:

To assess the effectiveness of a statewide HIV rapid test algorithm in a low-prevalence population.
To evaluate the algorithm's ability to facilitate linkage to care and identify early infections.

Main Methods:

Implemented an RTA with immediate referral for antigen-only-positive screens and RT#2 confirmation for antibody-positive screens.
Collected specimens for discordant RTA results and tested using CDC/APHL algorithm, supplemented by quantitative viral load testing.

Main Results:

Out of 310,785 tests, 2400 preliminary positives were identified, with 91.8% confirmed by RT#2.
Identified 14 true positives from discordant results (7.1%), with 5 having viral loads <1000 copies/mL.
Reported 3 false-positive RTAs among 2191 presumptive positives.

Conclusions:

The HIV rapid test algorithm demonstrated effectiveness in identifying true HIV positives and aiding linkage to care.
Discordant results were infrequent, but fingerstick antigen detection identified one early infection.
Subsequent positive cases from discordant results often had low viral loads (<1000 copies/mL).