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

Author(s):  
Karina Oganezova ◽  
Elvin J Fontana-Martinez ◽  
Jon A Gothing ◽  
Alisha Pandit ◽  
Esther Kwara ◽  
...  

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.

PeerJ ◽  
2018 ◽  
Vol 6 ◽  
pp. e4430 ◽  
Author(s):  
Geraldine Guillon ◽  
Graham Yearwood ◽  
Casey Snipes ◽  
Daniel Boschi ◽  
Michael R. Reed

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.


Intervirology ◽  
2014 ◽  
Vol 57 (1) ◽  
pp. 49-51 ◽  
Author(s):  
Sarah Maylin ◽  
Sébastien Fouéré ◽  
François Simon ◽  
Constance Delaugerre

2018 ◽  
Vol 12 (06) ◽  
pp. 471-476
Author(s):  
Théophile Mitima Kashosi ◽  
Céléstin Bisangamo Kyambikwa ◽  
Philémon Mbarabara Mulongo ◽  
Jean Bisimwa Nachega

Introduction: Rapid diagnostic tests (RDTs) are widely used for point-of-care. point-of-care diagnosis of HIV infection in resource-limited settings. However, there are no data about their field diagnostic performance in Eastern Democratic Republic of the Congo (DRC), especially in the context of blood banks screening for transfusion safety purpose. Methodology: Blood specimens were collected from blood donors in Bukavu, Eastern DRC, from May the 1st to June the 30th, 2015, to evaluate the accuracy of Alere Determine HIV-1/2, Trinity Biotech Uni‑Gold HIV, and DoubleCheckGold Ultra HIV 1& 2 compared to the laboratory-based 4th generation ELISA apDia HIV Ag/Ab assay. Sensitivity, specificity, positive and negative predictive values, and related 95% confidence intervals were calculated using MedCalc statistical software version 15.1. Reliability was evaluated using Cohen’s Kappa Statistic, κ. Results: Among 312 participants who provided blood bags, 96/312 (30.7%) were female and the mean age (SD) was 31.7 years (± 8.1years). Sensitivity for the three tests was 57.1% (95% CI: 18.4-90.1). The specificity was 99.7% (95% CI: 18.4-90.1) for Alere Determine HIV 1/2, 100% (95% CI: 98.8-100.0) for Uni-Gold HIV, and (100% (95% CI: 98.8-100.0) for DoubleCheckGold Ultra HIV 1&2. Cohen’s Kappa Statistic showed moderate agreement between the 4th generation ELISA apDia HIV Ag/Ab and RDTs Alere Determine HIV 1/2 and Uni-Gold HIV (κ = 0.66; 95% CI: 0.55- 0.76) but good agreement for DoubleCheckGold Ultra HIV1&2 (κ = 0.72; 95% CI: 0.61 – 0.82). Conclusions: Compared to the laboratory-based ELISA apDia HIV Ag/Ab assay, the currently used 3rd generation HIV RDTs showed poor field accuracy results in a context of blood donors screening. These data support the need for 4th generation Ag-Ab RDTs in transfusion blood qualification.


2020 ◽  
Vol 31 (9) ◽  
pp. 816-819
Author(s):  
Gary Whitlock ◽  
Nneka Nwokolo ◽  

A fourth-generation HIV test is conventionally performed at baseline for individuals given HIV post-exposure prophylaxis (PEP). However, early HIV infection may be missed by fourth-generation tests especially in settings of high HIV incidence, meaning that recently infected individuals are potentially at risk of transmitting HIV. In 2013, HIV incidence in PEP recipients at the 56 Dean Street clinic was 7.6 per 100 person-years. We therefore wished to see if using a point-of-care PCR HIV test in such individuals would shorten the testing window period and pick up early infections that would be undiagnosed by conventional tests. We compared HIV detection in PEP recipients using the Cepheid GeneXpert® HIV-1 Qual viral load (Qual VL) assay with the standard HIV tests used in our clinical service. Between March 2017 and August 2018, a Qual VL assay was performed in addition to standard baseline HIV tests in consented PEP recipients. Of 494 consented PEP recipients, 476 had valid Qual VL assay results. Of these, 474 (99.6%) had a negative Qual VL result and were also negative on standard baseline HIV tests. Two (0.4%) tested positive for HIV on Qual VL. One of these patients was also HIV-positive on all baseline HIV tests. The other had discordant baseline point-of-care HIV test results. Although no additional HIV infections were diagnosed in PEP recipients using Qual VL, in one individual, it provided confirmation of new HIV infection more quickly than the standard HIV testing pathway.


2013 ◽  
Vol 58 ◽  
pp. e65-e69 ◽  
Author(s):  
Richard A. Galli ◽  
Kevin F. Green ◽  
Anthony La Marca ◽  
Lawrence F. Waldman ◽  
Ronald E. Powers ◽  
...  

2013 ◽  
Vol 5 (1) ◽  
pp. 8 ◽  
Author(s):  
George Watt ◽  
Pacharee Kantipong ◽  
Thierry Burnouf ◽  
Cecilia Shikuma ◽  
Sean Philpott

Viral load generally rises in HIV-infected individuals with a concomitant infection, but falls markedly in some individuals with scrub typhus (ST), a common Asian rickettsial infection. ST infection appears to shift the viral population from CXCR4-using (X4) to CCR5-utilizing (R5) strains, and there is evidence of cross-reactivity between ST-specific antibodies and HIV-1. We examined the mechanism of ST suppression of HIV by measuring the effects of ST infection on X4 and R5 viruses <em>in vivo</em> and <em>in vitro</em>, and assessing the relative contributions of antibodies and chemokines to the inhibitory effect. <em>In vivo</em>, a single scrub typhus plasma infusion markedly reduced the subpopulation of HIV-1 viruses using the X4 co-receptor in all 8 recipients, and eliminated X4 viruses 6 patients. <em>In vitro</em>, the 14 ST sera tested all inhibited the replication of an X4 but not an R5 virus. This inhibitory effect was maintained if ST sera were depleted of chemokines but was lost upon removal of antibodies. Sera from ST-infected mice recognized a target that co-localized with X4 HIV gp120 in immunofluorescent experiments. These <em>in vivo </em>and <em>in vitro </em>data suggest that acute ST infection generates cross-reactive antibodies that produce potent suppression of CXCR4- but not CCR5-using HIV-1 viruses. ST suppression of HIV replication could reveal novel mechanisms that could be exploited for vaccination strategies, as well as aid in the development of fusion inhibitors and other new therapeutic regimens. This also appears to be the first instance where one pathogen is neutralized by antibody produced in response to infection by a completely unrelated organism.


2009 ◽  
Vol 45 (2) ◽  
pp. 150-152 ◽  
Author(s):  
África Holguín ◽  
Maite Gutiérrez ◽  
Nieves Portocarrero ◽  
Pablo Rivas ◽  
Margarita Baquero
Keyword(s):  

2021 ◽  
Vol 2021 ◽  
pp. 1-4
Author(s):  
Kelly A. Johnson ◽  
Sally Graglia ◽  
Elizabeth D. Lynch ◽  
Joanna De Mesa ◽  
Erin Antunez ◽  
...  

A 26-year-old male presented to the emergency department feeling unwell in February of 2021 with symptoms including diaphoresis, loose stools, and loss of taste sensation. Workup not only confirmed a diagnosis of COVID-19 but also revealed discordant HIV test results, with a reactive fourth-generation antigen/antibody test but a negative HIV-1/2 differentiation immunoassay. Subsequent HIV viral load testing obtained two days later ultimately established a diagnosis of acute HIV (AHI). Screening for HIV and other sexually transmitted infections decreased during the COVID-19 pandemic. It is critical that providers (1) continue recommended screening for HIV as an essential service; (2) consider acute HIV in the differential when evaluating patients with acute viral syndromes; (3) recognize that AHI can occur concurrently with other infections, including COVID-19; and (4) understand the differential diagnosis for discordant HIV test results and know when HIV viral load testing is needed to resolve such discordant results.


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