Finger-Stick Whole Blood HIV-1/-2 Home-Use Tests Are More Sensitive than Oral Fluid-Based In-Home HIV Tests

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Abstract

Background

Several countries have recently recommended the expansion of anti-human immunodeficiency virus (HIV) antibody testing, including self-testing with rapid tests using oral fluid (OF). Several tests have been proposed for at-home use, but their diagnostic accuracy has not been fully evaluated.

Objective

To evaluate the performance of 5 rapid diagnostic tests for the detection of anti-HIV-1/2 antibodies, with 4 testing OF and 1 testing whole blood.

Methods

Prospective multi-center study in France. HIV-infected adults and HIV-uninfected controls were systematically screened with 5 at-home HIV tests using either OF or finger-stick blood (FSB) specimens. Four OF tests (OraQuick Advance Rapid HIV-1/2, Chembio DPP HIV 1/2 Assay, test A, and test B) and one FSB test (Chembio Sure Check HIV1/2 Assay) were performed by trained health workers and compared with laboratory tests.

Results

In total, 179 HIV-infected patients (M/F sex ratio: 1.3) and 60 controls were included. Among the HIV-infected patients, 67.6% had an undetectable HIV viral load in their plasma due to antiretroviral therapy. Overall, the sensitivities of the OF tests were 87.2%, 88.3%, 58.9%, and 28% (for OraQuick, DPP, test A, and test B, respectively) compared with 100% for the FSB test Sure Check (p<0.0001 for all comparisons). The OraQuick and DPP OF tests' sensitivities were significantly lower than that of the FSB-based Sure Check (p<0.05). The sensitivities of the OF tests increased among the patients with a detectable HIV viral load (>50 copies/mL), reaching 94.8%, 96.5%, 90%, and 53.1% (for OraQuick, DPP, test A, and test B, respectively). The specificities of the four OF tests were 98.3%, 100%, 100%, and 87.5%, respectively, compared with 100% for the FSB test.

Conclusion

An evaluation of candidates for HIV self-testing revealed unexpected differences in performance of the rapid tests: the FSB test showed a far greater reliability than OF tests.

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Most cited references 12

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Accuracy and User-Acceptability of HIV Self-Testing Using an Oral Fluid-Based HIV Rapid Test

Oon Tek Ng, Angela L P Chow, Vernon J. Lee … (2012)

Background The United States FDA approved an over-the-counter HIV self-test, to facilitate increased HIV testing and earlier linkage to care. We assessed the accuracy of self-testing by untrained participants compared to healthcare worker (HCW) testing, participants’ ability to interpret sample results and user-acceptability of self-tests in Singapore. Methodology/Principal Findings A cross-sectional study, involving 200 known HIV-positive patients and 794 unknown HIV status at-risk participants was conducted. Participants (all without prior self-test experience) performed self-testing guided solely by visual instructions, followed by HCW testing, both using the OraQuick ADVANCE Rapid HIV 1/2 Antibody Test, with both results interpreted by the HCW. To assess ability to interpret results, participants were provided 3 sample results (positive, negative, and invalid) to interpret. Of 192 participants who tested positive on HCW testing, self-testing was positive in 186 (96.9%), negative in 5 (2.6%), and invalid in 1 (0.5%). Of 794 participants who tested negative on HCW testing, self-testing was negative in 791 (99.6%), positive in 1 (0.1%), and invalid in 2 (0.3%). Excluding invalid tests, self-testing had sensitivity of 97.4% (95% CI 95.1% to 99.7%) and specificity of 99.9% (95% CI: 99.6% to 100%). When interpreting results, 96%, 93.1% and 95.2% correctly read the positive, negative and invalid respectively. There were no significant demographic predictors for false negative self-testing or wrongly interpreting positive or invalid sample results as negative. Eighty-seven percent would purchase the kit over-the-counter; 89% preferred to take HIV tests in private. 72.5% and 74.9% felt the need for pre- and post-test counseling respectively. Only 28% would pay at least USD15 for the test. Conclusions/Significance Self-testing was associated with high specificity, and a small but significant number of false negatives. Incorrectly identifying model results as invalid was a major reason for incorrect result interpretation. Survey responses were supportive of making self-testing available.

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Sensitivity of Five Rapid HIV Tests on Oral Fluid or Finger-Stick Whole Blood: A Real-Time Comparison in a Healthcare Setting

Juliette Pavie, Anne Rachline, Benedicte Loze … (2010)

Background Health authorities in several countries recently recommended the expansion of human immunodeficiency virus (HIV) antibody testing, including the use of rapid tests. Several HIV rapid tests are now licensed in Europe but their sensitivity on total blood and/or oral fluid in routine healthcare settings is not known. Methods and Findings 200 adults with documented HIV-1 (n = 194) or HIV-2 infection (n = 6) were prospectively screened with five HIV rapid tests using either oral fluid (OF) or finger-stick whole blood (FSB). The OraQuick Advance rapid HIV1/2® was first applied to OF and then to FSB, while the other tests were applied to FSB, in the following order: Vikia HIV 1/2®, Determine HIV 1–2®, Determine® HIV-1/2 Ag/Ab Combo® and INSTI HIV-1/HIV-2®. Tests negative on FSB were repeated on paired serum samples. Twenty randomly selected HIV-seronegative subjects served as controls, and the results were read blindly. Most patients had HIV-1 subtype B infection (63.3%) and most were on antiretroviral therapy (68.5%). Sensitivity was 86.5%, 94.5%, 98.5%, 94.9%, 95.8% and 99% respectively, with OraQuick OF, OraQuick FSB, Vikia, Determine, Determine Ag/Ab Combo and INSTI (p<0.0001). OraQuick was less sensitive on OF than on FSB (p = 0.008). Among the six patients with three or more negative tests, two had recent HIV infection and four patients on antiretroviral therapy had undetectable plasma viral load. When patients positive in all the tests were compared with patients who had at least one negative test, only a plasma HIV RNA level <200 cp/ml was significantly associated with a false-negative result (p = 0.009). When the 33 rapid tests negative on FSB were repeated on serum, all but six (5 negative with OraQuick, 1 with INSTI) were positive. The sensitivity of OraQuick, Determine and Determine Ag/Ab Combo was significantly better on serum than on FSB (97.5%, p = 0.04; 100%, p = 0.004; and 100%, p = 0.02, respectively). Conclusion When evaluated in a healthcare setting, rapid HIV tests were less sensitive on oral fluid than on finger-stick whole blood and less sensitive on finger-stick whole blood than on serum.

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Will patients "opt in" to perform their own rapid HIV test in the emergency department?

Charlotte Gaydos, Yu-Hsiang Hsieh, Leah Harvey … (2011)

We evaluate the feasibility and accuracy of existing point-of-care HIV tests performed by an untrained patient compared with the routinely used HIV point-of-care test offered to patients in 2 urban emergency departments (EDs). From April 2008 through December 2009, patients who had completed a standard HIV oral fluid test performed by a trained health care professional and who were unaware of their results were recruited to perform a rapid point-of-care HIV test. Patients were given a choice of the oral fluid or the fingerstick blood point-of-care test. Evaluation of acceptability to perform the mechanics of the test was accessed by questionnaire. For the "self-test," the participant obtained his or her own sample and performed the test. The patient's results were compared with standard oral fluid results obtained by the health care professional. Overall, 478 of 564 (85%) patients receiving a standard oral fluid HIV test volunteered, with a mean age of 38 to 39 years. Ninety-one percent of participants chose oral fluid and 9% chose blood (P<.05). Self-test results were 99.6% concordant with health care professionals' test results. For the self-testers, 94% of oral fluid testers and 84.4% of blood testers reported trusting the self-administered test result "very much." Furthermore, 95.6% of the oral fluid group and 93.3% of the blood group would "probably" or "definitely" perform a test at home, if available. This study demonstrated that a significant proportion of patients offered a self-HIV point-of-care test volunteered and preferred using oral fluid. Patients' results agreed with standard HIV point-of-care results. The majority of participants trusted their results and would perform a point-of-care HIV test at home, given the opportunity. Copyright © 2011. Published by Mosby, Inc.

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Author and article information

Contributors

William R. Abrams: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Electronic): 1932-6203

Publication date Collection: 2014

Publication date (Electronic): 27 June 2014

Volume: 9

Issue: 6

Electronic Location Identifier: e101148

Affiliations

[1 ]CHR d'Orléans – La Source, Infectious and Tropical Diseases Department, Orléans, France

[2 ]CHU de Poitiers, Infectious and Tropical Diseases Department, Poitiers, France

[3 ]CH de La Rochelle, Infectious Diseases Department, La Rochelle, France

[4 ]CHR d'Orléans – La Source, Laboratory of Microbiology, Orléans, France

New York University, United States of America

Author notes

* E-mail: thierry.prazuck@ 123456chr-orleans.fr

Competing Interests: The authors declare that no competing interests exist with any firm and there is no conflict of interest.

Conceived and designed the experiments: TP GL LH. Performed the experiments: MJ TP AL AG DP MR PC. Analyzed the data: MJ TP LH. Wrote the paper: TP MJ LH.

Article

Publisher ID: PONE-D-14-06017

DOI: 10.1371/journal.pone.0101148

PMC ID: 4074152

PubMed ID: 24971842

SO-VID: 45b5a681-81fd-43e6-8140-d9171de63d89

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 8 February 2014

Date accepted : 3 June 2014

Page count

Pages: 5

Funding

This study was funded internally from the Centre Hospitalier Régional d'Orléans. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Finger-Stick Whole Blood HIV-1/-2 Home-Use Tests Are More Sensitive than Oral Fluid-Based In-Home HIV Tests

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Abstract

Background

Objective

Methods

Results

Conclusion

Related collections

Point-of-Care Testing for HIV

Most cited references 12

Accuracy and User-Acceptability of HIV Self-Testing Using an Oral Fluid-Based HIV Rapid Test

Sensitivity of Five Rapid HIV Tests on Oral Fluid or Finger-Stick Whole Blood: A Real-Time Comparison in a Healthcare Setting

Will patients "opt in" to perform their own rapid HIV test in the emergency department?

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