Routine HIV Test Results in 6 US Clinical Laboratories Using the Recommended Laboratory HIV Testing Algorithm With Geenius HIV 1/2 Supplemental Assay

BACKGROUND HIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. OBJECTIVE This paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. METHODS Project DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. RESULTS Between September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. CONCLUSIONS Studies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs. INTERNATIONAL REGISTERED REPORT RR1-10.2196/16332

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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.

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Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT

JMIR Research Protocols ◽

10.2196/16332 ◽

2020 ◽

Vol 9 (1) ◽

pp. e16332 ◽

Cited By ~ 1

Author(s):

Joanne D Stekler ◽

Lauren R Violette ◽

Hollie A Clark ◽

Sarah J McDougal ◽

Lisa A Niemann ◽

...

Keyword(s):

Hiv Infection ◽

Prospective Study ◽

Hiv Testing ◽

Transmitted Disease ◽

The United States ◽

Test Results ◽

Cross Sectional ◽

Hiv Test ◽

Hiv Acquisition ◽

Hiv 1

Background HIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. Objective This paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. Methods Project DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. Results Between September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. Conclusions Studies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs. International Registered Report Identifier (IRRID) RR1-10.2196/16332

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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.

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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.

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INCIDENCE OF HIV-1 AND HIV-2 ANTIBODIES IN HEMOPHILIACS

10.1055/s-0038-1644142 ◽

1987 ◽

Author(s):

W Schramm ◽

L G Gürtler ◽

H Pohlmann ◽

I Weigel ◽

J Eberie ◽

...

Keyword(s):

The Other ◽

Clotting Factor ◽

Test Results ◽

Clotting Factors ◽

Negative Results ◽

Group 12 ◽

Hiv Test ◽

In The Beginning ◽

Anti Hiv ◽

Hiv 1

The presence of antibodies to HIV-1 (anti-HIV-1) was tested in 167 hemophiliacs surveyed and treated at Munich hemophilia center. Increasing numbers of HIV infected patients were observed in the years 1981 to 1986 from 0% to 51,5% (86 positive patients in January 1987 of 167 followed patients). Most of the seroconver-sions occured between 1982 and 1984. The 150 clinically severe affected hemophiliacs (F-VIII-levels up to 5% and need of replacement therapy) showed positive HIV-test results in 55,3% (83 patients) and negative results in 44,7% (67 patients). 5 patients died since 1981, one because of AIDS. 17 patients were not seen since 1984, 14 of those belong to the severly affected group, 12 of them were negative. Since spring 1985 only heat or chemically treated clotting factor preparations are used for substitution. Despite this still 5 seroconversions were observed. Two may be attributed to the use of a preparation heat inactivated in dry state, this preparation is no longer used. The other 3 seroconversions possibly were caused by an occasional use of an noninactivated preparation in the beginning of the change to inactivated clotting factor preparations. 38 of the anti-HIV-1 positive sera were tested for the presence of HIV-2 antibodies also. The methods were ELISA,immunofluorescence and immunoblot. HIV-2 (LAV-2) for these tests was kindly provided by L. Montagnier. Antibodies specific for HIV-2 antigens were not detected, but crossreactions were observed between anti-HIV-1 with HIV-2 antigens particularly epitopes on HIV-2-p27.The data indicate that the use of adequately inactivated clotting factors can prevent infection of hemophilia patients by this route and that HIV-2 was not present in the clotting factor preparations used for the substitution of this group of patients. The incidence of full blown AIDS since 1981 in our group of hemophiliacs is still low (1,2%).

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Rapid HIV testing with same-day results: a field trial in Uganda

International Journal of STD & AIDS ◽

10.1258/0956462981921882 ◽

1998 ◽

Vol 9 (3) ◽

pp. 134-138 ◽

Cited By ~ 50

Author(s):

William J Kassler ◽

Mary Grace Alwano-Edyegu ◽

Elizabeth Marum ◽

Benon Biryahwaho ◽

Peter Kataaha ◽

...

Keyword(s):

Hiv Testing ◽

Test Performance ◽

Predictive Value ◽

Field Trial ◽

Time Frame ◽

Clinic Visit ◽

Post Test ◽

Testing Algorithm ◽

Aids Information ◽

Hiv 1

Rapid, on-site HIV testing with same-day results may improve services and increase the number of clients who learn their serostatus in developing countries. To validate test performance under field conditions and assess the change in the proportion of clients who learn their serostatus, we conducted a field trial using the Capillus HIV-1/HIV-2 assay (Cambridge Diagnostics) at the AIDS Information Centre counselling and testing sites in Uganda. Compared to the standard 2-EIA testing algorithm, the sensitivity of Capillus was 99.6% (95% CI; 98.5%, 99.9%), the specificity was 98.8% (95% CI; 98.1%, 99.3%), the positive predictive value was 96.5% (95% CI; 94.5%, 97.8%), and the negative predictive value was 99.9% (95% CI; 99.5%, 100%). It took less than 5 min to perform a single test, and results were returned to clients in less than an hour, during which time clients were counselled. This resulted in a 27% increase in the proportion of clients who learned their serostatus and received counselling. We conclude that simple, rapid HIV tests can be performed accurately on-site within the time frame of a clinic visit, increasing the number of clients who learn their serostatus and receive post-test counselling.

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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.

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Results from a Multiple Morbidities Testing Program Offering Rapid HIV Testing Bundled with Hepatitis and Sexually Transmitted Infection Testing

Public Health Reports ◽

10.1177/00333549081230s308 ◽

2008 ◽

Vol 123 (3_suppl) ◽

pp. 63-69 ◽

Cited By ~ 11

Author(s):

Grace L. Reynolds ◽

Dennis G. Fisher ◽

Lucy E. Napper ◽

Kimberly A. Marsh ◽

Christine Willey ◽

...

Keyword(s):

Hiv Testing ◽

Test Results ◽

Long Beach ◽

Transmitted Infection ◽

Testing Program ◽

Sexually Transmitted ◽

Rapid Hiv Testing ◽

Hiv Test ◽

Rapid Hiv Test ◽

Multiple Morbidities

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.

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