Potential for false positive HIV test results with the serial rapid HIV testing algorithm

Objectives. Bundling human immunodeficiency virus (HIV) testing with tests for other infectious diseases such as hepatitis C, syphilis, or gonorrhea has been proposed as a method to recruit at-risk individuals into HIV testing. The objectives of this study were to determine ( 1) the types of at-risk clients who choose the rapid vs. standard HIV test when bundled with hepatitis and sexually transmitted infection (STI) tests, and ( 2) whether clients receiving a rapid HIV test are more likely to return on time for hepatitis and STI test results. Methods. We recruited individuals from drug treatment programs, methadone maintenance programs, needle-exchange programs, a community-based agency serving the gay and lesbian community, and the Center for Behavioral Research and Services' office-based testing facility at California State University, Long Beach from January 2005 through November 2007. Results. A total of 2,031 clients from a multiple morbidities testing program in Long Beach, California, were tested between January 2005 and November 2007. For clients receiving hepatitis and STI testing, the majority chose the standard HIV test. Clients who received a rapid HIV test returned in significantly fewer days than clients who received a standard HIV test. Injection drug users and sex traders were more likely to choose the standard HIV test and more likely to fail to return for test results on time. Conclusion. The rapid HIV test, in conjunction with hepatitis and STI tests, results in clients being more likely to return on time for hepatitis and STI results. Public health efforts should focus on acquainting high-risk clients with rapid HIV testing.

Download Full-text

Evaluation of antenatal rapid human immunodeficiency virus testing in rural South Africa

Southern African Journal of HIV Medicine ◽

10.4102/sajhivmed.v19i1.771 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Tivani P. Mashamba-Thompson ◽

Pravi Moodley ◽

Benn Sartorius ◽

Paul K. Drain

Keyword(s):

Pregnant Women ◽

Hiv Testing ◽

Rapid Test ◽

Test Results ◽

Rapid Testing ◽

Hiv Test ◽

Hiv Rapid Testing ◽

Immunodeficiency Virus ◽

Rapid Tests ◽

Testing Algorithm

Introduction: South African guidelines recommend two rapid tests for diagnosing human immunodeficiency virus (HIV) using the serial HIV testing algorithm, but the accuracy and compliance to this algorithm is unknown in rural clinics. We evaluated the accuracy of HIV rapid testing and the time to receiving test results among pregnant women in rural KwaZulu-Natal (KZN).Method: We observed the accuracy of rapid HIV testing algorithms for 208 consenting antenatal patients accessing voluntary HIV testing services in nine rural primary healthcare (PHC) clinics in KZN. A PHC-based HIV counsellor obtained finger-prick whole blood from each participant to perform rapid testing using the Advanced Quality™ One Step anti-HIV (1&2) and/or ABON™ HIV 1/2/O Tri-Line HIV test. A research nurse obtained venous blood for an enzyme-linked immunosorbent assay (ELISA) HIV test, which is the gold standard diagnostic test. We recorded the time of receipt of HIV test results for each test.Results: Among 208 pregnant women with a mean age of 26 years, 72 women from nine rural PHC clinics were identified as HIV-positive by two rapid tests with an HIV-prevalence of 35% (95% Bayesian credibility intervals [BCI]: 28% – 41%). Of the 208 patients, 135 patients from six clinics were tested with the serial HIV testing algorithm. The estimated sensitivity and specificity for the 135 participants were 100% (95% confidence interval [CI]: 93% – 100%) and 99% (CI: 95% – 100%), respectively. The positive predictive value and negative predictive value were estimated at 98% (CI: 94% – 100%) and 95% (CI: 88% – 99%), respectively. All women received their HIV rapid test results within 20 min of testing. Test stock-out resulted in poor test availability at point-of-care, preventing performance of a second HIV test in three out of nine PHC clinics in rural KZN.Conclusion: Despite the poor compliance with national guidelines for HIV rapid testing services, HIV rapid test results provided to pregnant women in rural PHC clinics in KZN were generally accurate and timely. Test stock-out was shown to be one of the barriers to test availability in rural PHC clinics, resulting in poor compliance with guidelines. We recommend a compulsory confirmation HIV rapid test for all HIV-negative test results obtained from pregnant patients in rural and resource-limited settings.

Download Full-text

Repeated False-Positive HIV Test Results in a Patient Taking HIV Pre-Exposure Prophylaxis

Open Forum Infectious Diseases ◽

10.1093/ofid/ofy197 ◽

2018 ◽

Vol 5 (9) ◽

Cited By ~ 7

Author(s):

Joanne D Stekler ◽

Lauren R Violette ◽

Lisa Niemann ◽

Vanessa M McMahan ◽

David A Katz ◽

...

Keyword(s):

Hiv Testing ◽

False Positive ◽

Positive Test ◽

Test Results ◽

False Positive Test ◽

Hiv Test ◽

Exposure Prophylaxis

Abstract Regular HIV testing is required to ensure the safety of HIV pre-exposure prophylaxis (PrEP). We describe and discuss a series of false-positive HIV test results from an individual receiving PrEP. The expansion of PrEP will likely result in greater numbers of false-positive test results that may pose challenges for interpretation.

Download Full-text

Repeat HIV testing of individuals with discrepant HIV self-test results in Central Uganda

AIDS Research and Therapy ◽

10.1186/s12981-019-0243-1 ◽

2019 ◽

Vol 16 (1) ◽

Cited By ~ 1

Author(s):

Rose Kisa ◽

Joseph K. B. Matovu ◽

Esther Buregyeya ◽

William Musoke ◽

Caroline J. Vrana-Diaz ◽

...

Keyword(s):

Hiv Testing ◽

Hiv Positive ◽

Test Results ◽

Hiv Status ◽

Weak Band ◽

Rapid Hiv Testing ◽

Hiv Test ◽

Self Test ◽

Dna Pcr ◽

Hiv Negative

Abstract Background According to the user instructions from the manufacturer of OraQuick HIV self-test (HIVST) kits, individuals whose kits show one red band should be considered to be HIV-negative, no matter how weak the band is. However, recent reports show potential for a second false weak band after storage, thereby creating confusion in the interpretation of results. In this study, we re-tested individuals whose results were initially non-reactive but changed to weak reactive results to determine their true HIV status. Methods This study was nested within a large, cluster-randomized HIVST trial implemented among pregnant women attending antenatal care and their male partners in central Uganda between July 2016 and February 2017. Ninety-five initially HIV-negative respondents were enrolled into this study, including 52 whose kits developed a second weak band while in storage and 43 whose kits were interpreted as HIV-positive by interviewers at the next follow-up interview. Respondents were invited to return for repeat HIVST which was performed under the observation of a trained nurse counsellor. After HIVST, respondents underwent blood-based rapid HIV testing as per the national HIV testing algorithm (Determine (Abbot Laboratories), STAT-PAK (Chembio Diagnostic Systems Inc.) and Unigold (Trinity Biotech plc.) and dry blood spots were obtained for DNA/PCR testing. DNA/PCR was considered as the gold-standard HIV testing method. Results After repeat HIVST, 90 (94.7%) tested HIV-negative; 2 (2.1%) tested HIV-positive; and 3 (3.2%) had missing HIV test results. When respondents were subjected to blood-based rapid HIV testing, 97.9% (93/95) tested HIV-negative while 2.1% (2/95) tested HIV-positive. Finally, when the respondents were subjected to DNA/PCR, 99% (94/95) tested HIV-negative while 1.1% (1/95) tested HIV-positive. Conclusions Nearly all initially HIV-negative individuals whose HIVST kits developed a second weak band while in storage or were interpreted as HIV-positive by interviewers were found to be HIV-negative after confirmatory DNA/PCR HIV testing. These findings suggest a need for HIV-negative individuals whose HIVST results change to false positive while under storage or under other sub-optimal conditions to be provided with an option for repeat testing to determine their true HIV status.

Download Full-text

Potential for false-positive HIV test results using rapid HIV testing algorithms

African Journal of Laboratory Medicine ◽

10.4102/ajlm.v4i1.178 ◽

2015 ◽

Vol 4 (1) ◽

Cited By ~ 3

Author(s):

Rosemary A. Audu ◽

Rosemary N. Okoye ◽

Chika K. Onwuamah ◽

Fehintola A. Ige ◽

Adesola Z. Musa ◽

...

Keyword(s):

Western Blot ◽

False Positive ◽

Scale Up ◽

Rapid Test ◽

Test Results ◽

Rapid Testing ◽

Hiv Test ◽

Hiv Counselling And Testing ◽

Testing Algorithm ◽

Hiv 1

Background: In order to scale up access to HIV counselling and testing in Nigeria, an HIV diagnostic algorithm based on rapid testing was adopted. However, there was the need to further evaluate the testing strategy in order to better assess its performance, because of the potential for false positivity.Objectives: The objective of this study was to compare positive HIV test results obtained from the approved rapid testing algorithm with results from western blot tests performed on samples from the same patient.Methodology: A retrospective review was conducted of HIV screening and confirmatory results for patients seen between 2007 and 2008. Rapid test and western blot results were extracted and compared for concordance. Discordant results were further reviewed using a combination of HIV-1 RNA viral load and CD4+ cell count test results and clinical presentation from medical records.Results: Analysis of 2228 western blot results showed that 98.3% (n = 2191) were positive for HIV-1, 0.4% (n = 8) were positive for HIV-2 and 0.3% (n = 7) were dual infections (positive for both HIV-1 and HIV-2); 0.6% (n = 13) were indeterminate and 0.4% (n = 9) were negative. Further investigation of the 13 indeterminate results showed nine to be HIV-1 positive and four to be HIV-negative, for a total of 13 negative results. The positive predictive value of the HIV counselling and testing algorithm was 99.4%.Conclusion: Using the rapid testing algorithm alone, false positives were detected. Therefore, effective measures such as training and retraining of staff should be prioritised in order to minimise false-positive diagnoses and the associated potential for long-term psychological and financial impact on the patients.

Download Full-text

Predictive Factors for Positive HIV Test Results in a Hospital Setting

Archives of Clinical Infectious Diseases ◽

10.5812/archcid.101314 ◽

2021 ◽

Vol 16 (3) ◽

Author(s):

Sulmaz Ghahramani ◽

Hassan Joulaei ◽

Amir Human Hoveidaei ◽

Mohammad Reza Rajabi ◽

Kamran Bagheri Lankarani

Keyword(s):

Risk Factors ◽

Hospital Admission ◽

Hiv Testing ◽

General Hospital ◽

Hospital Setting ◽

Hiv Positive ◽

Control Group ◽

Test Results ◽

Hiv Test ◽

Test Result

Background: Hospital admission for any reason provides the situation for voluntary HIV testing and consultation. Identifying the predictors of positivity may lead to a cost-effective method while enhancing professionalism. Objectives: To find the predictors of HIV-positive test result in a general hospital in Shiraz compared to a control group. Methods: In this case-control study, the records of all patients who received HIV testing upon their hospitalization in a general hospital in Shiraz, south of Iran, from January 2017 to the end of December 2017 were reviewed. For each HIV-positive case, at least one control from the same ward in the hospital with negative HIV test result was randomly selected. Based on the best-fitted model of logistic regression, the probability of positive HIV test results was estimated for each participant according to the risk factors, and a receiver operating characteristic (ROC) curve was drawn. Results: Out of 7333 persons who accepted to be tested, 77 patients tested positive for HIV, of whom 55 (71.4%) were male with the mean age of 41.5 ± 9.5 years. None of the HIV-positive patients were intravenous drug users, nor had they a history of imprisonment. The odds ratio (OR) was 21 for hepatitis-positive patients (hepatitis B and/or C) compared to negative ones, which was seven times higher in opium addicts than non-opium addicts. We developed a model using age, sex, opium addiction, and HBV and HCV status to predict the probability of being positive for HIV with an AUC of 0.853 (95% confidence interval 0.797 to 0.909). Conclusions: Hospital admission could be an appropriate momentum for providing voluntary counseling and testing. Infection with HBV and HCV are important risk factors for HIV infection, and additional testing should be offered, especially to these patients.

Download Full-text

Correlates of perceived difficulty in potentially disclosing HIV-positive test results: a study of low-income women attending an urban clinic

Sexual Health ◽

10.1071/sh04044 ◽

2005 ◽

Vol 2 (2) ◽

pp. 103 ◽

Cited By ~ 7

Author(s):

Richard Crosby ◽

Elizabeth A. Bonney ◽

Lydia Odenat

Keyword(s):

Hiv Testing ◽

African American Women ◽

Low Income ◽

Contextual Factors ◽

Urgent Care ◽

Positive Test ◽

Hiv Positive ◽

Test Results ◽

Intrapersonal Factors ◽

Hiv Test

Background: The study identified correlates of women’s perception that testing positive for HIV would be very difficult to communicate to friends, family members and sex partners. We also determined whether perceived disclosure difficulty was associated with HIV-testing intent. Methods: Face-to-face interviews were conducted with 143 women attending an urgent care centre in Atlanta, Georgia. The centre served primarily low-income or indigent African–American women. A three-item scale (α = 0.81) assessed disclosure difficulty. Assessed correlates included selected social/contextual factors and intrapersonal factors. Results: In controlled multivariate analyses, only the social/contextual factors were associated with HIV disclosure difficulty. Women perceiving an inability to cope with positive results were more likely to report high disclosure difficulty (P = 0.01). Women perceiving an inadequate support system and those believing that HIV would substantially complicate their lives were more likely to anticipate high disclosure difficulty (P = 0.006 and P = 0.03, respectively). Disclosure difficulty was not associated with intent for HIV-testing ‘today’ (P = 0.50) or within the next 12 months (P = 0.27). Conclusion: Findings provide initial evidence suggesting that selected social/contextual factors rather than intrapersonal factors are associated with anticipated disclosure difficulty of HIV-positive test results among low-income minority women, residing in the urban south. High levels of anticipated disclosure difficulty may not preclude HIV test acceptance.

Download Full-text

Evaluation of Rapid Testing Algorithms for Venue-based Anonymous HIV Testing among Non-HIV-Positive Men Who Have Sex with Men, National HIV Behavioral Surveillance (NHBS), 2017

Journal of Community Health ◽

10.1007/s10900-020-00871-3 ◽

2020 ◽

Vol 45 (6) ◽

pp. 1228-1235

Author(s):

Shamaya Whitby ◽

◽

Amanda Smith ◽

Rebecca Rossetti ◽

Johanna Chapin-Bardales ◽

...

Keyword(s):

Hiv Testing ◽

Confirmatory Test ◽

Test Results ◽

Rapid Testing ◽

Behavioral Surveillance ◽

National Hiv Behavioral Surveillance ◽

Hiv Test ◽

Hiv Rapid Testing ◽

Testing Algorithms ◽

Sex With Men

Abstract HIV rapid testing algorithms (RTAs) using any two orthogonal rapid tests (RTs) allow for on-site confirmation of infection. RTs vary in performance characteristics therefore the selection of RTs in an algorithm may affect identification of infection, particularly if acute. National HIV Behavioral Surveillance (NHBS) assessed RTAs among men who have sex with men recruited using anonymous venue-based sampling. Different algorithms were evaluated among participants who self-reported never having received a positive HIV test result prior to the interview. NHBS project areas performed sequential or parallel RTs using whole blood. Participants with at least one reactive RT were offered anonymous linkage to care and provided a dried blood spot (DBS) for testing at CDC. Discordant results (RT-1 reactive/RT-2 non-reactive) were tested at CDC with lab protocols modified for DBS. DBS were also tested for HIV-1 RNA (VL) and antiretroviral (ARV) drug levels. Of 6500 RTAs, 238 were RT-1 reactive; of those, 97.1% (231/238) had concordant results (RT-1/RT-2 reactive) and 2.9% (7/238) had discordant results. Five DBS associated with discordant results were available for confirmation at CDC. Four had non-reactive confirmatory test results that implied RT-1 false reactivity; one had ambiguous confirmatory test results which was non-reactive in further testing. Regardless of order and type of RT used, RTAs demonstrated high concordant results in the population surveyed. Additional laboratory testing on DBS following discordant results confirmed no infection. Implementing RTAs in the context of anonymous venue-based HIV testing could be an option when laboratory follow-up is not practicable.

Download Full-text

Genetic Exceptionalism vs. Paradigm Shift: Lessons from HIV

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2001.tb00333.x ◽

2001 ◽

Vol 29 (2) ◽

pp. 141-148 ◽

Cited By ~ 15

Author(s):

Lainie Friedman Ross

Keyword(s):

Hiv Testing ◽

Paradigm Shift ◽

Test Results ◽

Public Officials ◽

Consent Forms ◽

Sexually Transmitted ◽

Anonymous Testing ◽

Hiv Test ◽

Immunodeficiency Virus ◽

Hiv Exceptionalism

The term “exceptionalism” was introduced into health care in 1991 when Bayer described “HIV exceptionalism” as the policy of treating the human immunodeficiency virus (HIV) different from other infectious diseases, particularly other sexually transmitted diseases. It was reflected in the following practices: pre- and post-HIV test counseling, the development of specific separate consent forms for HIV testing, and stringent requirements for confidentiality of HIV test results. The justification for these practices was the belief that testing was essential for prevention and that patients might not seek HIV testing if confidentiality were not guaranteed. Confidentiality was believed to be particularly important given the degree of discrimination and stigmatization associated with the illness. Anonymous testing was a further step in ensuring strict confidentiality, even though such a practice prevented public officials from contacting partners and others who were at risk.

Download Full-text