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

PeerJ ◽  
2018 ◽  
Vol 6 ◽  
pp. e4430 ◽  
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.

scholarly journals Post-Study Point-of-Care Oral Fluid Testing in HIV-1 Vaccinees

2020 ◽  
Author(s):  
Karina Oganezova ◽  
Elvin J Fontana-Martinez ◽  
Jon A Gothing ◽  
Alisha Pandit ◽  
Esther Kwara ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Oral Fluid ◽  
Point Of Care ◽  
Antibody Test ◽  
Cross Reactivity ◽  
Fourth Generation ◽  
Hiv Screening ◽  
Hiv Test ◽  
Hiv 1

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.

Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care

2013 ◽  
Vol 58 ◽  
pp. e65-e69 ◽  
Author(s):  
Richard A. Galli ◽  
Kevin F. Green ◽  
Anthony La Marca ◽  
Lawrence F. Waldman ◽  
Ronald E. Powers ◽  
...  
Keyword(s):  
Point Of Care ◽  
Antibody Test ◽  
Ease Of Use ◽  
Hiv 1

scholarly journals Viral Loads Within 6 Weeks After Diagnosis of HIV Infection in Early and Later Stages: Observational Study Using National Surveillance Data (Preprint)

2018 ◽  
Author(s):  
Richard M. Selik ◽  
Laurie Linley
Keyword(s):  
Viral Load ◽  
Hiv Infection ◽  
Acute Infection ◽  
Antibody Test ◽  
Case Definition ◽  
Positive Test ◽  
Median Viral Load ◽  
Acute Hiv Infection ◽  
Viral Loads ◽  
Hiv 1

BACKGROUND Early (including acute) HIV infection is associated with viral loads higher than those in later stages. OBJECTIVE This study aimed to examine the association between acute infection and viral loads near the time of diagnosis using data reported to the US National HIV Surveillance System. METHODS We analyzed data on infections diagnosed in 2012-2016 and reported through December 2017. Diagnosis and staging were based on the 2014 US surveillance case definition for HIV infection. We divided early HIV-1 infection (stage 0) into two subcategories. Subcategory 0α: a negative or indeterminate HIV-1 antibody test was ≤60 days after the first confirmed positive HIV-1 test or a negative or indeterminate antibody test or qualitative HIV-1 nucleic acid test (NAT) was ≤180 days before the first positive test, the latter being a NAT or detectable viral load. Subcategory 0β: a negative or indeterminate antibody or qualitative NAT was ≤180 days before the first positive test, the latter being an HIV antibody or antigen/antibody test. We compared median earliest viral loads for each stage and subcategory in each of the first 6 weeks after diagnosis using only the earliest viral load for each individual. RESULTS Of 203,392 infections, 56.69% (115,297/203,392) were reported with a quantified earliest viral load within 6 weeks after diagnosis and criteria sufficient to determine the stage at diagnosis. Among 5081 infections at stage 0, the median earliest viral load fell from 694,000 copies/mL in week 1 to 125,022 in week 2 and 43,473 by week 6. Among 30,910 infections in stage 1, the median earliest viral load ranged 15,412-17,495. Among 42,784 infections in stage 2, the median viral load declined from 44,973 in week 1 to 38,497 in week 6. Among 36,522 infections in stage 3 (AIDS), the median viral load dropped from 205,862 in week 1 to 119,000 in week 6. The median earliest viral load in stage 0 subcategory 0α fell from 1,344,590 copies/mL in week 1 to 362,467 in week 2 and 47,320 in week 6, while that in subcategory 0β was 70,114 copies/mL in week 1 and then 32,033 to 44,067 in weeks 2-6. The median viral load in subcategory 0α was higher than that in subcategory 0β in each of the first 6 weeks after diagnosis (P<.001). CONCLUSIONS In the 1st week after diagnosis, viral loads in early infections are generally several times higher than those in later stages at diagnosis. By the 3rd week, however, most are lower than those in stage 3. High viral loads in early infection are much more common in subcategory 0α than in subcategory 0β, consistent with 0α comprising mostly acute infections and 0β comprising mostly postacute early infections. These findings may inform the prioritization of interventions for prevention.

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

2017 ◽  
Vol 91 ◽  
pp. 90-94 ◽  
Author(s):  
Sarah Adams ◽  
Wei Luo ◽  
Laura Wesolowski ◽  
Stephanie E. Cohen ◽  
Philip J. Peters ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Point Of Care ◽  
Antibody Test ◽  
Hiv Infections ◽  
Hiv 1

scholarly journals Patterns of point-of-care test use among obstetricians and gynaecologists in the US

Sexual Health ◽  
2018 ◽  
Vol 15 (4) ◽  
pp. 318 ◽  
Author(s):  
Anne M. Rompalo ◽  
Neko Castleberry ◽  
Lea Widdice ◽  
Jay Schulkin ◽  
Charlotte A. Gaydos
Keyword(s):  
Test Performance ◽  
Point Of Care ◽  
Research Network ◽  
Becton Dickinson ◽  
Point Of Care Test ◽  
Hiv Test ◽  
Laboratory Test Results ◽  
Rapid Hiv Test ◽  
Sexually Transmissible Infections ◽  
Test Use

Background Point-of-care tests (POCTs) for reproductive health conditions have existed for decades. Newer POCTs for syphilis, HIV and trichomonas are currently available and easy to use. We surveyed practicing obstetricians and gynaecologists to determine current POCT use and perceived obstacles to use. Methods: Between June and August 2016, 1000 members of the American College of Obstetricians and Gynecologists were randomly selected and invited to complete a Qualtrics (222 West river Park Drive, Provo, Utah 84604, USA) survey; 600 of these were members of the Collaborative Ambulatory Research Network. Respondents who completed at least 60% of the survey were included in the analysis. Results: Of the 1000 selected members, 749 had valid emails and 288 (38%) of these participated in and completed the survey. Of the respondents, 70% were male with a mean of 18 years in practice. Detection of sexually transmissible infections (STIs) once or twice a week was reported by 30%, whereas 45% reported detecting STIs once or twice a month. POCTs used included pregnancy tests (83%), urine dipstick (83%), wet mount tests (79%) and the vagina pH test (54.8%). Few used Gram stain (5%) and stat rapid plasma regain tests (4%). Relatively newer US Food and Drug Administration-approved POCTs were used less frequently, with 25% of respondents reporting using the Affirm VPIII (Becton, Dickinson and Company, 1 Becton Drive, Franklin Lakes, NJ 07471, USA) test use and only 10% using a rapid HIV test. The most common perceived barriers to testing were the amount of reimbursement received for performing the test (61.9%) and the payment coverage from the patient (61.3%). Conclusions: US obstetricians and gynaecologists rely on laboratory test results and traditional POCTs to diagnosis STIs. Future development and marketing of POCTs should consider not only ease and time of test performance, but also the cost of the tests to the practice and the patient, as well as reimbursement.

The performance of the Alere HIV combo point-of-care test on stored serum samples; useful for detection of early HIV-1 infections?

2017 ◽  
Vol 94 (5) ◽  
pp. 331-333 ◽  
Author(s):  
Carla van Tienen ◽  
Sharona Rugebregt ◽  
Sandra Scherbeijn ◽  
Hannelore Götz ◽  
Corine Geurts van Kessel
Keyword(s):  
Hiv Infection ◽  
Point Of Care ◽  
Acute Infection ◽  
Rapid Test ◽  
Public Health Department ◽  
Laboratory Setting ◽  
Serum Samples ◽  
Point Of Care Test ◽  
P24 Antigen ◽  
Hiv 1

IntroductionThe Alere HIV-1/2 Antigen/Antibody Combo point-of-care test is a commercially available 4th-generation rapid test for the diagnosis of HIV infection, including acute infection. We evaluated the sensitivity of this test in samples from patients with acute, recent or chronic HIV-1 infection.MethodsA validation of the test was performed using 89 HIV-positive serum samples collected in 2008–2016, that were stored at −20°C. Twenty-three samples were only p24-positive (acute infection); 49 samples were antibody-positive and p24-positive (recent infection); 17 samples were only antibody-positive (chronic infection). HIV infection was confirmed by standard-of-care assays and PCR. Samples came from patients attending an outpatient clinic for STDs at the Public Health Department and from patients within the Erasmus Medical Center, Rotterdam, the Netherlands.ResultsThe overall sensitivity of the test for diagnosing HIV infection based on detection of p24 antigen and/or antibodies was 92% (95% CI 86% to 98%) (82/89). In acute sera with only p24 antigen positivity, the sensitivity of the test decreased to 65% (95% CI 46% to 85%) (15/23). When both antibody and antigen testing were positive, the p24 sensitivity was only 24% (95% CI 12% to 36%) (12/49), but in these sera the final test result was positive in all sera (49/49) due to the positive antibody component.ConclusionsIn a laboratory setting, this test has an overall sensitivity of 92% to detect any stage of HIV-1 infection using sera specimens. It performs relatively well in detecting early HIV and may be beneficial as an initial screening in patients with a recent exposure to HIV. Additional testing in a laboratory setting remains mandatory as a proportion of acute HIV-1 infections are missed with this test.

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

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.

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

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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