Analysis of False-Negative Human Immunodeficiency Virus Rapid Tests Performed on Oral Fluid in 3 International Clinical Research Studies

Curlin, Marcel E.; Gvetadze, Roman; Leelawiwat, Wanna; Martin, Michael; Rose, Charles; Niska, Richard W.; Segolodi, Tebogo M.; Choopanya, Kachit; Tongtoyai, Jaray; Holtz, Timothy H.; Samandari, Taraz; McNicholl, Janet M.

doi:10.1093/cid/cix228

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Analysis of False-Negative Human Immunodeficiency Virus Rapid Tests Performed on Oral Fluid in 3 International Clinical Research Studies

Published Date:

Jun 15 2017

Publisher's site:

http://dx.doi.org/10.1093/cid/cix228 New Site Icon

Source:

Clin Infect Dis. 64(12):1663-1669

Language:

English

[PDF-276.02 KB]

Details:

Alternative Title:

Clin Infect Dis

Personal Author:

Curlin, Marcel E. ; Gvetadze, Roman ; Leelawiwat, Wanna ; Martin, Michael ; Rose, Charles ; ... More ▼

Corporate Authors:

OraQuick Study Group

Description:

Background

The OraQuick Advance Rapid HIV-1/2 Test is a point-of-care test capable of detecting human immunodeficiency virus (HIV)-specific antibodies in blood and oral fluid. To understand test performance and factors contributing to false-negative results in longitudinal studies, we examined results of participants enrolled in the Botswana TDF/FTC Oral HIV Prophylaxis Trial, the Bangkok Tenofovir Study, and the Bangkok MSM Cohort Study, 3 separate clinical studies of high-risk, HIV-negative persons conducted in Botswana and Thailand.

Methods

In a retrospective observational analysis, we compared oral fluid OraQuick (OFOQ) results among participants becoming HIV infected to results obtained retrospectively using enzyme immunoassay and nucleic acid amplification tests on stored specimens. We categorized negative OFOQ results as true-negative or false-negative relative to nucleic acid amplification test and/ or enzyme immunoassay, and determined the delay in OFOQ conversion relative to the estimated time of infection. We used log-binomial regression and generalized estimating equations to examine the association between false-negative results and participant, clinical, and testing-site factors.

Results

Two-hundred thirty-three false-negative OFOQ results occurred in 80 of 287 seroconverting individuals. Estimated OFOQ conversion delay ranged from 14.5 to 547.5 (median, 98.5) days. Delayed OFOQ conversion was associated with clinical site and test operator (P < .05), preexposure prophylaxis (P = .01), low plasma viral load (P < .02), and time to kit expiration (P < .01). Participant age, sex, and HIV subtype were not associated with false-negative results. Long OFOQ conversion delay time was associated with antiretroviral exposure and low plasma viral load.

Conclusions

Failure of OFOQ to detect HIV-1 infection was frequent and multifactorial in origin. In longitudinal trials, negative oral fluid results should be confirmed via testing of blood samples.

Subject:

[+]

Pubmed ID:

28369309

Pubmed Central ID:

PMC6502462

Document Type:

Journal Article

Funding:

CC999999/Intramural CDC HHS/United States

Place as Subject:

Botswana ; Thailand ;

Collection(s):

CDC Public Access

Main Document Checksum:

[+]

Supporting Files:

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	NIHMS1012873-supplement-Supplemental.docx	application/vnd.openxmlformats-officedocument.wordprocessingml.document

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