Analysis of false-negative human immunodeficiency virus rapid tests performed on oral fluid in 3 international clinical research studies

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

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1663-1669
Number of pages7
JournalClinical Infectious Diseases
Volume64
Issue number12
DOIs
StatePublished - Jun 15 2017

Fingerprint

HIV
Nucleic Acid Amplification Techniques
Botswana
Research
Tenofovir
Viral Load
Immunoenzyme Techniques
HIV-1
Point-of-Care Systems
HIV-2
Virus Diseases
Thailand
Longitudinal Studies
Cohort Studies
Clinical Studies
Antibodies
Infection

Keywords

  • HIV
  • immunosorbent techniques
  • oral fluid
  • point-of-care testing.
  • serodiagnosis

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Analysis of false-negative human immunodeficiency virus rapid tests performed on oral fluid in 3 international clinical research studies. / Curlin, Marcel; 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.

In: Clinical Infectious Diseases, Vol. 64, No. 12, 15.06.2017, p. 1663-1669.

Research output: Contribution to journalArticle

Curlin, M, Gvetadze, R, Leelawiwat, W, Martin, M, Rose, C, Niska, RW, Segolodi, TM, Choopanya, K, Tongtoyai, J, Holtz, TH, Samandari, T & Mcnicholl, JM 2017, 'Analysis of false-negative human immunodeficiency virus rapid tests performed on oral fluid in 3 international clinical research studies', Clinical Infectious Diseases, vol. 64, no. 12, pp. 1663-1669. https://doi.org/10.1093/cid/cix228
Curlin, Marcel ; 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. / Analysis of false-negative human immunodeficiency virus rapid tests performed on oral fluid in 3 international clinical research studies. In: Clinical Infectious Diseases. 2017 ; Vol. 64, No. 12. pp. 1663-1669.
@article{1ddbc4f8ed1640909558019e38afda31,
title = "Analysis of false-negative human immunodeficiency virus rapid tests performed on oral fluid in 3 international clinical research studies",
abstract = "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.",
keywords = "HIV, immunosorbent techniques, oral fluid, point-of-care testing., serodiagnosis",
author = "Marcel Curlin and Roman Gvetadze and Wanna Leelawiwat and Michael Martin and Charles Rose and Niska, {Richard W.} and Segolodi, {Tebogo M.} and Kachit Choopanya and Jaray Tongtoyai and Holtz, {Timothy H.} and Taraz Samandari and Mcnicholl, {Janet M.}",
year = "2017",
month = "6",
day = "15",
doi = "10.1093/cid/cix228",
language = "English (US)",
volume = "64",
pages = "1663--1669",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "12",

}

TY - JOUR

T1 - Analysis of false-negative human immunodeficiency virus rapid tests performed on oral fluid in 3 international clinical research studies

AU - Curlin, Marcel

AU - Gvetadze, Roman

AU - Leelawiwat, Wanna

AU - Martin, Michael

AU - Rose, Charles

AU - Niska, Richard W.

AU - Segolodi, Tebogo M.

AU - Choopanya, Kachit

AU - Tongtoyai, Jaray

AU - Holtz, Timothy H.

AU - Samandari, Taraz

AU - Mcnicholl, Janet M.

PY - 2017/6/15

Y1 - 2017/6/15

N2 - 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.

AB - 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.

KW - HIV

KW - immunosorbent techniques

KW - oral fluid

KW - point-of-care testing.

KW - serodiagnosis

UR - http://www.scopus.com/inward/record.url?scp=85021108060&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85021108060&partnerID=8YFLogxK

U2 - 10.1093/cid/cix228

DO - 10.1093/cid/cix228

M3 - Article

C2 - 28369309

AN - SCOPUS:85021108060

VL - 64

SP - 1663

EP - 1669

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 12

ER -