Baveewo et al.

BMC Research Notes 2012, 5:154

http://www.biomedcentral.com/1756-0500/5/154

RESEARCH ARTICLE Open Access

Potential for false positive HIV test results with

the serial rapid HIV testing algorithm
Steven Baveewo1*, Moses R Kamya1, Harriet Mayanja-Kizza1, Robin Fatch3, David R Bangsberg4, Thomas Coates5,
Judith A Hahn3 and Rhoda K Wanyenze2

Abstract
Background: Rapid HIV tests provide same-day results and are widely used in HIV testing programs in areas with
limited personnel and laboratory infrastructure. The Uganda Ministry of Health currently recommends the serial
rapid testing algorithm with Determine, STAT-PAK, and Uni-Gold for diagnosis of HIV infection. Using this
algorithm, individuals who test positive on Determine, negative to STAT-PAK and positive to Uni-Gold are reported
as HIV positive. We conducted further testing on this subgroup of samples using qualitative DNA PCR to assess the
potential for false positive tests in this situation.
Results: Of the 3388 individuals who were tested, 984 were HIV positive on two consecutive tests, and 29 were
considered positive by a tiebreaker (positive on Determine, negative on STAT-PAK, and positive on Uni-Gold).
However, when the 29 samples were further tested using qualitative DNA PCR, 14 (48.2%) were HIV negative.
Conclusion: Although this study was not primarily designed to assess the validity of rapid HIV tests and thus only
a subset of the samples were retested, the findings show a potential for false positive HIV results in the subset of
individuals who test positive when a tiebreaker test is used in serial testing. These findings highlight a need for
confirmatory testing for this category of individuals.
Keywords: False positive, HIV testing algorithm, Rapid diagnostic tests, Qualitative PCR testing

Background and specificity, rapid diagnostic tests have a rare potential

Rapid HIV tests provide quick results [1], usually in less for false negative and false positive test results [8].
than 30 minutes, can be performed by any adequately The World Health Organization HIV retesting guide-
trained health worker, do not require sophisticated lines [9] highlight the criteria for retesting persons with
equipment and can be stored at room temperature (20°C- indeterminate and negative HIV test results in order to
30°C); [2]. Yet, their diagnostic accuracy has been found reduce the likelihood of false negative HIV results in
to be comparable to that of Enzyme Linked Immunosor- early HIV infection [9]. However, these guidelines do not
bent Assay (ELISA) [1,3]. These advantages make the address the potential for false positive HIV results. This
rapid HIV tests suitable for use in geographically remote paper sought to identify the potential for false positive
areas with little or no laboratory infrastructure and in results in the serial HIV testing algorithm of Determine-
small hospitals that perform few HIV tests [4]. Determine STAT-PAK-Uni-Gold, specifically in the subset of indivi-
and Uni-Gold have a sensitivity of 100% [5,6] and STAT- duals who tested positive on Determine, negative on
PAK is 97.7% [7] sensitive. The specificities for Deter- STAT-PAK, and positive on Uni-Gold, by conducting
mine, Uni-Gold and STAT-PAK are 99.75% [5], 99.7% further testing using Deoxyribonucleic acid Polymerase
[6] and 99.9% [7] respectively. Despite the high sensitivity chain reaction Qualitative (DNA PCR QL) testing.

Methods
Study procedures
* Correspondence: baveewosteven@yahoo.co.uk The study was conducted as part of the HIV VCT and
1
Department of Medicine, Makerere University School of Medicine, Kampala,
Uganda Linkage to Care study in Mulago hospital [10]; a research
Full list of author information is available at the end of the article

© 2012 Baveewo et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Baveewo et al. BMC Research Notes 2012, 5:154 Page 2 of 4
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collaboration between Makerere University, University of counselor contacted the laboratory technician to draw
California Los Angeles (UCLA) and University of Califor- blood for HIV testing [11]. HIV testing was done using
nia San Francisco (UCSF). the serial testing algorithm using the Determine (Abbott
Adult patients (≥ 18 years) who had never tested for Laboratories, Abbott Park, IL), STAT-PAK (Chembio
HIV, or tested negative at least 1 year prior to recruit- Diagnostics), and Uni-Gold™ Recombigen® (Figure 1).
ment and willing to receive a HIV test were eligible [11]. Subjects that tested HIV negative on Determine were
Ethical approval was obtained from the collaborating reported as negative. Subjects that tested positive on
institutions’ Ethical Review boards as well as Uganda Determine, negative on STAT-PAK and negative on Uni-
National Council of Science and Technology and each Gold were also reported as negative. According to the
participant provided verbal and written informed consent national algorithm, samples that tested positive on Deter-
prior to enrolment into the study. mine, negative on STAT-PAK and then positive on a
Uni-Gold (tie-breaker test) would be reported as positive
Laboratory testing and not retested. However, we conducted further testing
HIV counseling and testing was offered after enrollment of the latter samples using Deoxyribonucleic acid Poly-
and baseline interview. Following pre-test counseling, the merase chain reaction Qualitative (DNA PCR QL) tests

Determine test
(n= 3388)

Positive Negative

STAT-PAK test Reported as Weakly reactive to either

(n=1275) HIV negative Determine or STAT-PAK
(n = 2105) or both tests (n=8)
Positive Negative

Reported as HIV Uni-Gold test

positive (n= 984) (n=291)

Positive Negative

Considered HIV Reported as

positive by National HIV negative
Algorithm (n= 29) (n=262)

DNA PCR QL
test
Positive Negative

HIV Positive HIV Negative

(n = 15) (n= 14)
Figure 1 Flow diagram of HIV testing algorithm.
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(Ampiclor HIV-1 DNA PCR Test version 1.5) [12]. The test results and mechanisms for minimizing this
29 samples that tested positive with the tie breaker were challenge.
not retested with rapid tests before the DNA PCR QL Conclusion Individuals who test positive on Deter-
testing. mine, negative on STAT-PAK and positive on Uni-Gold
should be considered inconclusive and be further tested
Statistical analysis using DNA PCR QL or other validated tests to minimize
Data captured in a Microsoft Excel spreadsheet was the occurrence of false positive HIV test results.
exported to SAS program for statistical analysis.
Acknowledgements
Results We thank the participants, the study team and the management of Mulago
Overall, 3,388 individuals were tested for HIV between hospital.
May 2008 and June 2011 and 1004 (29.6%) tested HIV Funding
This study was funded by National Institute of Mental Health (1 R01
positive (Figure 1). Twenty-four percent of men and MH077512), Division of AIDS and Health and Behavior Research, Center for
34% of women were HIV positive. Two thirds (62.1%, n Mental Health Research on AIDS. The funders had no role in the study
= 2105) of individuals tested negative on Determine and design, data collection and analysis, decision to publish, or preparation of
the manuscript.
were reported as negative. Of the 1275 that tested posi-
tive on Determine, 984 also tested positive on the Author details
1
STAT-PAK and were reported as positive, while 291 Department of Medicine, Makerere University School of Medicine, Kampala,
Uganda. 2Department of Disease Control and Environmental Health,
were negative on STAT-PAK and were retested with Makerere University School of Public Health, Kampala, Uganda. 3Department
Uni-Gold. Of the 291 that were retested with Uni-Gold, of Medicine San Francisco General Hospital, University of California San
262 tested negative and were reported as negative; and Francisco, San Francisco, California, USA. 4Massachusetts General Hospital
Center for Global Health and Harvard Medical School, Boston, Massachusetts,
29 tested positive. The 29 samples were further tested USA. 5Division of Infectious Diseases, David Geffen School of Medicine,
using DNA PCR QL, and 14 (48.2%) tested HIV nega- University of California Los Angeles, Los Angeles, California, USA.
tive. DNA PCR has a very high specificity of 99.5%,
Authors’ contributions
[95% CI 99.1-99.9], and is thus an ideal choice for iden- Conceived, designed and performed the experiments; SB, MRK, HMK, RF,
tifying false positive results [13,14]. Eight participants DBR, TC, HJA, RWK. Analyzed the data: SB, RF, JAH. Contributed reagents/
who were weakly reactive to the Determine and/or materials/analysis tools: SB, MRK, HMK, RF, DBR, TC, HJA, RWK. Wrote the
paper, proof read and approved the final manuscript: SB, MRK, HMK, RF, DBR,
STAT-PAK test were also further tested using DNA TC, JAH and RWK.
PCR QL, but were not included among the false positive
results in this study since they would have been retested Competing interests
The authors declare that they have no competing interests.
with ELISA, according to the current national algorithm
[15]. Received: 4 October 2011 Accepted: 19 March 2012
Published: 19 March 2012

Discussion
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doi:10.1186/1756-0500-5-154
Cite this article as: Baveewo et al.: Potential for false positive HIV test
results with the serial rapid HIV testing algorithm. BMC Research Notes
2012 5:154.

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