Sensitivity of a rapid point of care assay for early HIV antibody detection is enhanced by its ability to detect HIV gp41 IgM antibodies

Moshgabadi, Noushin; Galli, Rick; Daly, Amelia C.; Ko, Sze Mun Shirley; Westgard, Tayla E.; Bulpitt, Ashley F.; Shackleton, Christopher R.

doi:10.1016/j.jcv.2015.08.005

Cited by 12 publications

(20 citation statements)

References 18 publications

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“…A previous study characterized samples in commercially available seroconversion panels as containing detectable levels of either IgG-only, IgG and IgM, or IgM-only by depleting all IgM antibodies from the sample then testing with a reference ELISA and a POC antibody test ( Moshgabadi et al, 2015 ). Due to limited sample availability from the vendor, 15 of the 20 samples identified as being predominantly IgM (greater than 50% of total immunoglobulin content) were utilized in this study.…”

Section: Methodsmentioning

confidence: 99%

“…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 ® Test also uses Protein A as the detection protein in the antibody-binding colloidal gold conjugate.…”

Section: Introductionmentioning

confidence: 99%

“…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.…”

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confidence: 99%

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

Guillon

Yearwood

Snipes

et al. 2018

PeerJ

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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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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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

Guillon

Yearwood

Snipes

et al. 2018

PeerJ

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“…One such test is INSTI, a rapid HIV test approved by the Food and Drug Administration (FDA), which has shown a high sensitivity and specificity in diagnosing HIV infection in whole blood samples [ 8 ]. The INSTI rapid test has also been reported to perform well in identifying individuals with early HIV infection [ 48 ].…”

Section: Discussionmentioning

confidence: 99%

Detection of Acute and Early HIV-1 Infections in an HIV Hyper-Endemic Area with Limited Resources

et al. 2016

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BackgroundTwo thirds of the world’s new HIV infections are in sub-Saharan Africa. Acute HIV infection (AHI) is the time of virus acquisition until the appearance of HIV antibodies. Early HIV infection, which includes AHI, is the interval between virus acquisition and establishment of viral load set-point. This study aimed to detect acute and early HIV infections in a hyper-endemic setting.MethodsThis was a cross-sectional diagnostic study that enrolled individuals who had negative rapid HIV results in five clinics in South Africa. Pooled nucleic acid amplification testing (NAAT) was performed, followed by individual sample testing in positive pools. NAAT-positive participants were recalled to the clinics for confirmatory testing and appropriate management. HIV antibody, p24 antigen, Western Blot and avidity tests were performed for characterization of NAAT-positive samples.ResultsThe study enrolled 6910 individuals with negative rapid HIV results. Median age was 27 years (interquartile range {IQR}: 23–31). NAAT was positive in 55 samples, resulting in 0.8% newly diagnosed HIV-infected individuals (95% confidence interval {CI}: 0.6–1.0). The negative predictive value for rapid HIV testing was 99.2% (95% CI: 99.0–99.4). Characterization of NAAT-positive samples revealed that 0.04% (95% CI: 0.000–0.001) had AHI, 0.3% (95% CI: 0.1–0.4) had early HIV infection, and 0.5% (95% CI: 0.5–0.7) had chronic HIV infection. Forty-seven (86%) of NAAT-positive participants returned for follow-up at a median of 4 weeks (IQR: 2–8). Follow-up rapid tests were positive in 96% of these participants.ConclusionsNAAT demonstrated that a substantial number of HIV-infected individuals are misdiagnosed at South African points-of-care. Follow-up rapid tests done within a 4 week interval detected early and chronic HIV infections initially missed by rapid HIV testing. This may be a practical and affordable strategy for earlier detection of these infections in resource-constrained settings. Newer molecular tests that can be used at the points-of-care should be evaluated for routine diagnosis of HIV in hyper-endemic settings.

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“…A system using immunochromatographic membrane assay to detect the antigen of a fusion protein secreted by the respiratory syncytial virus (RSV) was also commercialized (Thuy Tien et al, 2018). Also, a variety of rapid tests for the diagnosis of HIV have been developed in the form of POC systems, such as the OraQuick Rapid HIV-1/2 antibody test and the fourth-generation HIV tests detecting both the antigen and antibodies, such as the AR-CHITECT HIV Ag/Ab combo and the Alere Determine HIV 1/2 Ag/Ab combo (Moshgabadi et al, 2015). Also, a variety of rapid tests for the diagnosis of HIV have been developed in the form of POC systems, such as the OraQuick Rapid HIV-1/2 antibody test and the fourth-generation HIV tests detecting both the antigen and antibodies, such as the AR-CHITECT HIV Ag/Ab combo and the Alere Determine HIV 1/2 Ag/Ab combo (Moshgabadi et al, 2015).…”

Section: Commercial Rapid Devices For Viral Detectionmentioning

confidence: 99%

Recent advances in lab-on-a-chip technologies for viral diagnosis

Zhu

Fohlerová

Pekárek

et al. 2020

Biosensors and Bioelectronics

190

146

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A B S T R A C TThe global risk of viral disease outbreaks emphasizes the need for rapid, accurate, and sensitive detection techniques to speed up diagnostics allowing early intervention. An emerging field of microfluidics also known as the lab-on-a-chip (LOC) or micro total analysis system includes a wide range of diagnostic devices. This review briefly covers both conventional and microfluidics-based techniques for rapid viral detection. We first describe conventional detection methods such as cell culturing, immunofluorescence or enzyme-linked immunosorbent assay (ELISA), or reverse transcription polymerase chain reaction (RT-PCR). These methods often have limited speed, sensitivity, or specificity and are performed with typically bulky equipment. Here, we discuss some of the LOC technologies that can overcome these demerits, highlighting the latest advances in LOC devices for viral disease diagnosis. We also discuss the fabrication of LOC systems to produce devices for performing either individual steps or virus detection in samples with the sample to answer method. The complete system consists of sample preparation, and ELISA and RT-PCR for viral-antibody and nucleic acid detection, respectively. Finally, we formulate our opinions on these areas for the future development of LOC systems for viral diagnostics.

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Sensitivity of a rapid point of care assay for early HIV antibody detection is enhanced by its ability to detect HIV gp41 IgM antibodies

Abstract: The INSTI HIV-1/HIV-2 Antibody Test is shown to detect anti-HIV-1 IgM antibodies in early HIV infection which enhances its utility in early HIV diagnosis.

Cited by 12 publications

References 18 publications

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

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

Detection of Acute and Early HIV-1 Infections in an HIV Hyper-Endemic Area with Limited Resources

Recent advances in lab-on-a-chip technologies for viral diagnosis

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