Performance evaluation of the point-of-care INSTI™ HIV-1/2 antibody test in early and established HIV infections

Abstract Background Experimental HIV-1 vaccines frequently elicit antibodies against HIV-1 which may react with commonly used HIV diagnostic tests, a phenomenon known as vaccine-induced seropositivity/seroreactivity (VISP/VISR). We sought to determine under clinic conditions if a patient-controlled HIV test, OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, detected HIV-1 vaccine-induced antibodies. Methods Plasma assessment of HIV-1 cross-reactivity was examined in end-of-study samples from 57 healthy, HIV-uninfected participants who received a candidate vaccine which has entered Phase 2B and 3 testing. We also screened 120 healthy, HIV-uninfected, unblinded HIV-1 vaccine participants with VISP/VISR for an assessment using saliva. These participants came from 21 different parent vaccine protocols representing 17 different vaccine regimens, all of which contained an HIV-1 envelope immunogen. OraQuick ADVANCE was compared to results from concurrent blood samples using a series of commercial HIV screening immunoassays. Results Fifty-seven unique participant plasma samples were assayed in vitro and only one (1.8%) was reactive by OraQuick ADVANCE. None of the 120 clinic participants (0%, [95% CI 0% to 3.7%]) tested positive by OraQuick ADVANCE and all were confirmed to be uninfected by HIV-1 viral RNA testing. 118 of the 120 (98.3%) participants had a reactive HIV test for VISP/VISR: 77 (64%) had at least one reactive fourth-generation HIV-1 diagnostic test (p<0.0001 vs no reactive OraQuick ADVANCE results) and 41 (34%) only had a reactive test by the less specific third-generation Abbott Prism assay. Conclusion These data suggest that this widely available patient-controlled test has limited reactivity to HIV-1 antibodies elicited by these candidate HIV-1 vaccines.

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Human anti-HIV IgM detection by the OraQuick ADVANCE® Rapid HIV 1/2 Antibody Test

PeerJ ◽

10.7717/peerj.4430 ◽

2018 ◽

Vol 6 ◽

pp. e4430 ◽

Cited By ~ 6

Author(s):

Geraldine Guillon ◽

Graham Yearwood ◽

Casey Snipes ◽

Daniel Boschi ◽

Michael R. Reed

Keyword(s):

Detection System ◽

Point Of Care ◽

Acute Infection ◽

Protein A ◽

Antibody Test ◽

Hiv Test ◽

Rapid Hiv Test ◽

Gold Conjugate ◽

Testing Environments ◽

Hiv 1

The Centers for Disease Control and Prevention (CDC) and many public health jurisdictions continue to advocate for the most sensitive rapid HIV test that is available. Currently, the recommendation is to utilize tests that can detect HIV infection biomarkers within 30 days of infection, when initial immune responses are mounted. The infected patient’s IgM response is often used to detect acute infection within a 20–25 days window after infection. This requirement applies to lab-based testing with automated analyzers and rapid, point of care (POC) testing used for screening in a non-clinical setting. A recent study has demonstrated that POC tests using a Protein A-based detection system can detect samples with predominantly HIV-1 IgM reactivity (Moshgabadi et al., 2015). The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test (OraQuick ADVANCE®) also uses Protein A as the detection protein in the antibody-binding colloidal gold conjugate, so it is expected that the OraQuick ADVANCE® Test will also detect samples with predominantly IgM reactivity. This report definitively demonstrates that the OraQuick ADVANCE® Test can detect IgM antibodies during an acute infection window period of approximately 20–25 days after infection, and is therefore suitable for use in testing environments requiring adherence to current CDC recommendations.

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Performance evaluation of a point-of-care whole blood viral load test (SAMBA II HIV-1 Semi-Q Whole Blood) to optimise HIV treatment

http://isrctn.com/ ◽

10.1186/isrctn12803987 ◽

2016 ◽

Author(s):

Sarah Oakley-Mudge

Keyword(s):

Performance Evaluation ◽

Viral Load ◽

Whole Blood ◽

Point Of Care ◽

Hiv Treatment ◽

Load Test ◽

Viral Load Test ◽

Hiv 1 ◽

Blood Viral Load

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Rapid point-of-care (POC) testing for Hepatitis C antibodies in a very high prevalence setting: persons injecting drugs in Tallinn, Estonia

Harm Reduction Journal ◽

10.1186/s12954-021-00485-5 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Anneli Uusküla ◽

Ave Talu ◽

Jürgen Rannap ◽

David M. Barnes ◽

Don Des Jarlais

Keyword(s):

Hepatitis C ◽

Point Of Care ◽

Antibody Test ◽

Hcv Rna ◽

Test Results ◽

Blood Draw ◽

Persons Who Inject Drugs ◽

Oral Swab ◽

High Prevalence ◽

Hcv Antibody

Abstract Background Between December 2018 and January of 2019, we evaluated the accuracy of the point-of-care Hepatitis C (HCV) antibody test (POC; OraQuick HCV) used at a community-based needle and syringe exchange program serving persons who inject drugs in Tallinn, Estonia. Methods We compared the results of screening for HCV antibodies by OraQuick (oral swab) and enzyme immunoassay (EIA; blood draw) and assessed test results implications in a high prevalence setting. Findings Of the 100 participants, 88 (88%) had reactive POC test results, and 93 were HCV antibody positive on EIA testing. Sensitivity, specificity and negative predictive value (NPV) for the POC assay with EIA as the relevant reference test were as follows: 94.6% (95% CI 90.0–99.2%), 100% and 58.3% (95% CI 30.4–86.2%). Of the 12 testing, HCV-negative with the POC only 7 (58.3%) were true negatives. Conclusions Oral swab rapid testing HCV screening in this nonclinical setting was sensitive and specific but had unacceptably low NPV. In high prevalence settings, POC tests with high sensitivity and that directly measure HCV RNA may be warranted.

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Effect of an opt‐out point‐of‐care HIV‐1 nucleic acid testing intervention to detect acute and prevalent HIV infection in symptomatic adult outpatients and reduce HIV transmission in Kenya: a randomized controlled trial

HIV Medicine ◽

10.1111/hiv.13157 ◽

2021 ◽

Author(s):

Eduard J. Sanders ◽

Clara Agutu ◽

Elise Elst ◽

Amin Hassan ◽

Evanson Gichuru ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Nucleic Acid ◽

Hiv Infection ◽

Hiv Transmission ◽

Point Of Care ◽

Controlled Trial ◽

Nucleic Acid Testing ◽

Randomized Controlled ◽

Opt Out ◽

Hiv 1

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Surface Plasmon Resonance Assay for Label-Free and Selective Detection of HIV-1 p24 Protein

Biosensors ◽

10.3390/bios11060180 ◽

2021 ◽

Vol 11 (6) ◽

pp. 180

Author(s):

Lucia Sarcina ◽

Giuseppe Felice Mangiatordi ◽

Fabrizio Torricelli ◽

Paolo Bollella ◽

Zahra Gounani ◽

...

Keyword(s):

Limit Of Detection ◽

Covalent Binding ◽

Hiv Infections ◽

Selectivity Ratio ◽

Selective Detection ◽

Label Free ◽

Self Assembled Monolayer ◽

Label Free Detection ◽

P24 Protein ◽

Hiv 1

The early detection of the human immunodeficiency virus (HIV) is of paramount importance to achieve efficient therapeutic treatment and limit the disease spreading. In this perspective, the assessment of biosensing assay for the HIV-1 p24 capsid protein plays a pivotal role in the timely and selective detection of HIV infections. In this study, multi-parameter-SPR has been used to develop a reliable and label-free detection method for HIV-1 p24 protein. Remarkably, both physical and chemical immobilization of mouse monoclonal antibodies against HIV-1 p24 on the SPR gold detecting surface have been characterized for the first time. The two immobilization techniques returned a capturing antibody surface coverage as high as (7.5 ± 0.3) × 1011 molecule/cm2 and (2.4 ± 0.6) × 1011 molecule/cm2, respectively. However, the covalent binding of the capturing antibodies through a mixed self-assembled monolayer (SAM) of alkanethiols led to a doubling of the p24 binding signal. Moreover, from the modeling of the dose-response curve, an equilibrium dissociation constant KD of 5.30 × 10−9 M was computed for the assay performed on the SAM modified surface compared to a much larger KD of 7.46 × 10−5 M extracted for the physisorbed antibodies. The chemically modified system was also characterized in terms of sensitivity and selectivity, reaching a limit of detection of (4.1 ± 0.5) nM and an unprecedented selectivity ratio of 0.02.

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Performance of Bio-Rad and Limiting Antigen Avidity Assays in Detecting Recent HIV Infections Using the Quebec Primary HIV-1 Infection Cohort

PLoS ONE ◽

10.1371/journal.pone.0156023 ◽

2016 ◽

Vol 11 (5) ◽

pp. e0156023 ◽

Cited By ~ 5

Author(s):

Bouchra Serhir ◽

Denis Hamel ◽

Florence Doualla-Bell ◽

Jean Pierre Routy ◽

Sylvie-Nancy Beaulac ◽

...

Keyword(s):

Hiv Infections ◽

Hiv 1

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Feasibility and Success of Hiv Point-of-Care Testing in an Emergency Department in an Urban Canadian Setting

Canadian Journal of Infectious Diseases and Medical Microbiology ◽

10.1155/2013/164797 ◽

2013 ◽

Vol 24 (1) ◽

pp. 27-31 ◽

Cited By ~ 15

Author(s):

Marissa L Becker ◽

Laura H Thompson ◽

Carla Pindera ◽

Natalie Bridger ◽

Carmen Lopez ◽

...

Keyword(s):

Emergency Department ◽

Hiv Testing ◽

Point Of Care ◽

Venous Blood ◽

Tertiary Care ◽

Antibody Test ◽

Cross Sectional Study ◽

Cross Sectional ◽

Post Test ◽

Centre Hospital

BACKGROUND: Approximately 26% of Canadians living with HIV are unaware of their status. Point-of-care (POC) HIV tests have been introduced to simplify and expand HIV testing.OBJECTIVE: To evaluate the feasibility and acceptability of POC testing in an emergency department (ED) setting in Winnipeg, Manitoba.METHODS: A cross-sectional study of unselected adults presenting to the ED at the Health Sciences Centre Hospital (Winnipeg, Manitoba) was performed. Study procedures included pre- and post-test counselling, administration of the INSTI HIV-1/HIV-2 Antibody Test (bioLytical Laboratories, Canada) and a brief questionnaire. Venous blood samples were collected from participants for confirmatory testing on all reactive and indeterminate specimens.RESULTS: In total, 501 adults participated in the study. The majority of participants were younger than 40 years of age, approximately one-half (48.5%) were women and 53% self-identified as Aboriginal. Nearly one-half (49.1%) of the participants had undergone previous HIV testing, although 63% of these tests were performed more than a year earlier. A total of seven individuals tested reactive with the POC test, all of whom were confirmed positive using serological testing (1.4%) and were linked to an HIV specialist within 24 h. Nearly all of the participants (96%) reported satisfaction with the test and believed it belonged in the ED (93%).CONCLUSIONS: Of the participants tested, 1.4% tested reactive for HIV, which is significantly higher than the reported prevalence in Manitoba and in other similar studies conducted in North America. Furthermore, all individuals were linked to timely care. The present study demonstrated that this particular busy tertiary care ED is an important and feasible location for HIV POC testing.

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