Time Until Emergence of HIV Test Reactivity Following Infection With HIV-1: Implications for Interpreting Test Results and Retesting After Exposure

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

10.2196/preprints.16332 ◽

2019 ◽

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 RR1-10.2196/16332

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Absence of routine molecular testing and prevalence of HIV-2 infection in regions hardest-hit by HIV infection

The Journal of Infection in Developing Countries ◽

10.3855/jidc.2298 ◽

2012 ◽

Vol 6 (12) ◽

pp. 854-859 ◽

Cited By ~ 3

Author(s):

Joseph C Forbi ◽

Mathew D Esona ◽

Hellen O Iperepolu ◽

Moses P Adoga ◽

Simon M Agwale

Keyword(s):

Hiv Infection ◽

Sex Workers ◽

False Negative ◽

Rapid Test ◽

Molecular Testing ◽

Test Results ◽

Active Population ◽

Hiv Test ◽

In Series ◽

Hiv 1

Introduction: Investigating the incidence and dynamics of HIV-2 and false-negative HIV test results in a highly sexually active population where frequent opportunities exist for acquiring and transmitting infections provides additional understanding of the epidemiology of the virus in Africa. Methodology: The HIV status of 900 active female sex workers (FSWs) was determined using two lateral flow rapid assays in series. The second rapid test device incorporates type-specific recombinant peptides that discriminate between HIV-1 and HIV-2 infection. HIV sero-negative samples were re-tested for HIV infection and their viral loads determined using the NucliSENS real-time nucleic acid sequence-based amplification (NASBA) platform. Results: In total, 335 FSWs were determined to be HIV positive, the majority (227; 67.8%) of whom were between the ages of 20 and 30 years. Eighteen (5.4%) were found to have evidence of HIV-2 infection, 17 of whom were co-infected with HIV-1. Only one HIV-2 mono-infection was observed. Out of 565 HIV-negative individuals determined by serology, 11(1.9%; p>0.05) were found to be HIV-1 positive when tested via the NASBA platform. Conclusion: False negative test results, HIV-2 infection, and complex transmission networks among FSWs may aid in fueling the HIV epidemic in the Nigerian population. These findings demonstrate the need to reevaluate the quality of HIV serological diagnostics, control services, and stress the need for widespread introduction of molecular testing among high-risk populations in the country.

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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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HIV-Diagnostik in der Schweiz und ärztlicher Abklärungsgang von HIV-Infizierten

Therapeutische Umschau ◽

10.1024/0040-5930/a000537 ◽

2014 ◽

Vol 71 (8) ◽

pp. 451-460

Author(s):

Jörg Schüpbach ◽

Christoph Berger ◽

Jürg Böni ◽

Roberto F. Speck

Keyword(s):

Hiv Test ◽

Hiv 1

„HIV-positiv“ ist auch heute noch eine belastende Diagnose. Falsch positive wie falsch negative HIV-Test-Resultate herauszugeben, muss unbedingt vermieden werden. Das Bundesamt für Gesundheit (BAG) hat ein HIV-Testkonzept entworfen, das dieser Anforderung gerecht wird und darüber hinaus das Virus im betroffenen Patienten detailliert für eine optimale medizinische Betreuung charakterisiert. Das Testkonzept fordert hierzu die Beantwortung der folgenden vier Fragen: 1. Ist die getestete Person tatsächlich HIV-infiziert? 2. Handelt es sich um eine Infektion mit HIV-1 oder HIV-2, und im Falle von HIV-1, um welche Virusgruppe, M oder O? Sind Resistenzen gegenüber den antiretroviralen Medikamenten vorhanden? 3. Wie hoch ist die Viruslast? 4. Wie hoch ist der Anteil frischer HIV-Infektionen an den neu gemeldeten Fällen? In diesem Artikel werden wir das Testkonzept besprechen. Abschliessend werden wir in einer kurzen Übersicht darlegen, was der Arzt bei einer Erst- und Folgekonsultation bei einem HIV-infizierten Patienten abklären sollte.

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