The fourth generation Alere TM HIV Combo rapid test improves detection of acute infection in MTN-003 (VOICE) samples

Livant, Edward; Heaps, Amy; Kelly, Christopher S; Maharaj, Rashika; Samsunder, Natasha; Nhlangulela, Lindiwe; Karugaba, Patrick; Panchia, Ravindre; Marrazzo, Jeanne; Chirenje, Zvavahera M.; Parikh, Urvi M.

doi:10.1016/j.jcv.2017.06.006

Cited by 25 publications

(24 citation statements)

References 15 publications

(16 reference statements)

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“…Taking PrEP with undetected HIV could lead to drug resistance, but a recent review of PrEP studies found that resistance selection for tenofovir disoproxil fumarate and emtricitabine with PrEP use is infrequent [28]. Evaluations of HIV rapid diagnostic tests (RDTs) among PrEP users have found variable sensitivities and specificities, with specificities >98% [29][30][31][32][33]. An evaluation of OraQuick ADVANCE â Rapid HIV-1/2, the kit we used in our study, found that it had high specificity (99.99%) and high negative predictive value (99.94%) [32].…”

Section: Discussionmentioning

confidence: 99%

“…Evaluations of HIV rapid diagnostic tests (RDTs) among PrEP users have found variable sensitivities and specificities, with specificities >98% [29][30][31][32][33]. An evaluation of OraQuick ADVANCE â Rapid HIV-1/2, the kit we used in our study, found that it had high specificity (99.99%) and high negative predictive value (99.94%) [32]. Still, considerations about the performance of RDTs and drug resistance with undiagnosed HIV infection necessitate additional evidence on the safety and utility of HIVST in PrEP delivery.…”

Section: Discussionmentioning

confidence: 99%

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Uptake and impact of facility‐based HIV self‐testing on PrEP delivery: a pilot study among young women in Kisumu, Kenya

et al. 2020

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Introduction HIV testing is a required part of delivery of pre‐exposure prophylaxis (PrEP) for HIV prevention. However, repeat testing can be challenging in busy, under‐staffed clinical settings, which could negatively impact PrEP uptake and continuation. We prospectively evaluated optional facility‐based HIV self‐testing (HIVST) among young women using PrEP in an implementation programme. Methods Between February and November 2019, we collected data from young women receiving PrEP at two family planning facilities in Kisumu, Kenya. At each PrEP follow‐up visit, women were given the option to choose between provider‐initiated testing and HIVST. We assessed factors associated with HIVST uptake and compared satisfaction with HIV testing and clinic experience between acceptors and decliners of HIVST. Results A total of 172 women were offered HIVST at 202 PrEP follow‐up visits. The median age was 21 years, 27% had multiple partners and 15% reported previously using HIVST. HIVST was accepted at 34.7% (70/202) of visits. Age (adjusted relative risk (aRR) 1.09 per year, 95% CI (confidence interval) 1.01 to 1.18), never being married (aRR 1.81, 95% CI 1.11 to 2.95) and having more PrEP follow‐up visits (aRR 1.13 per visit, 95% CI 1.04 to 1.23) were associated with HIVST uptake. Compared to HIVST decliners, HIVST acceptors were more likely to be very happy with their overall testing experience (73% vs. 47% of visits, p = 0.003) and were more likely to say they would use HIVST in the future (96% vs. 76%, p < 0.001). Women who accepted HIVST had shorter visits than those choosing standard provider‐initiated HIV testing (median [IQR]: 33 [32, 38] vs. 54 [41.5, 81] minutes, p = 0.003). Conclusions In this pilot evaluation in Kenya, about one‐third of women using PrEP opted for HIVST over provider‐initiated testing, and those choosing HIVST spent less time in the clinic and were generally satisfied with their experience. HIVST in PrEP delivery is feasible and has the potential to simplify PrEP delivery and give clients testing autonomy. Additional studies are needed to explore optimal HIV retesting strategies in PrEP delivery, including the use of HIVST in PrEP at a larger scale and in different settings.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Uptake and impact of facility‐based HIV self‐testing on PrEP delivery: a pilot study among young women in Kisumu, Kenya

et al. 2020

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“…Field studies of the US Food and Drug Administration (FDA)‐approved rapid Alere Determine™ HIV‐1/2 Ag/Ab Combo have shown that antigen is rarely detected in whole blood specimens, with poor sensitivity for detection of AHI. The re‐formulated Alere TM HIV Combo has shown much improved sensitivity for detection of p24 antigen , however, further evaluation of its use in clinical practice is required. Other options include diagnostic platforms for RNA testing, such as the Alere™ q HIV‐1/2 Detect which has been validated for RNA detection among infants and children, the Cepheid GeneXpert ® , the technology for which already has an existing presence in sub‐Saharan Africa where it is predominantly used for tuberculosis testing , and SAMBA which is a dipstick‐based nucleic acid assay for the detection of HIV in whole blood developed for monitoring and diagnostic use in LMIC settings.…”

Section: Discussionmentioning

confidence: 99%

Challenges of HIV diagnosis and management in the context of pre‐exposure prophylaxis (PrEP), post‐exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review

et al. 2019

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Introduction Knowledge of HIV status relies on accurate HIV testing, and is the first step towards access to HIV treatment and prevention programmes. Globally, HIV‐status unawareness represents a significant challenge for achieving zero new HIV infections and deaths. In order to enhance knowledge of HIV status, the World Health Organisation (WHO) recommends a testing strategy that includes the use of HIV‐specific antibody point‐of‐care tests (POCT). These POCTs do not detect acute HIV infection, the stage of disease when viral load is highest but HIV antibodies are undetectable. Complicating things further, in the presence of antiretroviral therapy (ART) for pre‐exposure prophylaxis (PrEP) or post‐exposure prophylaxis (PEP), other currently available testing technologies, such as viral load detection for diagnosis of acute HIV infection, may yield false‐negative results. In this scoping review, we evaluate the evidence and discuss alternative HIV testing algorithms that may mitigate diagnostic dilemmas in the setting of increased utilization of ART for immediate treatment and prevention of HIV infection. Discussion Missed acute HIV infection prevents people living with HIV (PLHIV) from accessing early treatment, increases likelihood of onward transmission, and allows for inappropriate initiation or continuation of PrEP, which may result in HIV drug resistance. While immediate ART is recommended for all PLHIV, studies have shown that starting ART in the setting of acute HIV infection may result in a delayed or complete absence of development of HIV‐specific antibodies, posing a diagnostic challenge that is particularly pertinent to resource‐limited, high HIV burden settings where HIV‐antibody POCTs are standard of care. Similarly, ART used as PrEP or PEP may supress HIV RNA viral load, complicating current HIV testing algorithms in resource‐wealthy settings where viral detection is included. As rollout of PrEP continues, HIV testing algorithms may need to be modified. Conclusions With increasing use of PrEP and ART in acute infection we anticipate diagnostic challenges using currently available HIV testing strategies. Research and surveillance are needed to determine the most appropriate assays and optimal testing algorithms that are accurate, affordable and sustainable.

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“…These results indicate an increased sensitivity of the new version of the RDT for detecting early HIV-1 infection prior to seroconversion. Several studies that have recently investigated the performance of the new RDT to detect infection in p24CA-positive, immunoblot-negative serum samples showed lower reactivity rates (< 30%) [30,33], while other groups demonstrated higher reactivity rates of more than 85% in similar specimens [29,31,32].…”

Section: Discussionmentioning

confidence: 99%

“…However, its reported sensitivity for the detection of HIV p24CA antigen, the critical determinant for identifying acute HIV-1 infection, varied considerably: some studies found relatively high rates of p24CA detection (> 85%) in samples from infected individuals prior to seroconversion [29,31,32]. In contrast, other studies reported considerably lower p24CA detection rates (< 30%) in similar patient cohorts [30,33]. Not surprisingly, the detection rates of the HIV antigen were particularly poor in samples from patients infected with the closely related HIV-2 [30].…”

Section: Introductionmentioning

confidence: 99%

Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection

Wratil

Rabenau

Eberle³

et al. 2020

Med Microbiol Immunol

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In resource-limited or point-of-care settings, rapid diagnostic tests (RDTs), that aim to simultaneously detect HIV antibodies and p24 capsid (p24CA) antigen with high sensitivity, can pose important alternatives to screen for early infections. We evaluated the performance of the antibody and antigen components of the old and novel version of the Determine™ HIV-1/2 Ag/Ab Combo RDTs in parallel to quantifications in a fourth-generation antigen/antibody immunoassay (4G-EIA), p24CA antigen immunoassay (p24CA-EIA), immunoblots, and nucleic acid quantification. We included plasma samples of acute, treatment-naïve HIV-1 infections (Fiebig stages I-VI, subtypes A1, B, C, F, CRF02_AG, CRF02_AE, URF) or chronic HIV-1 and HIV-2 infections. The tests' antigen component was evaluated also for a panel of subtype B HIV-1 transmitted/ founder (T/F) viruses, HIV-2 strains and HIV-2 primary isolates. Furthermore, we assessed the analytical sensitivity of the RDTs to detect p24CA using a highly purified HIV-1 NL4-3 p24CA standard. We found that 77% of plasma samples from acutely infected, immunoblot-negative HIV-1 patients in Fiebig stages II-III were identified by the new RDT, while only 25% scored positive in the old RDT. Both RDTs reacted to all samples from chronically HIV-1-infected and acutely HIV-1-infected patients with positive immunoblots. All specimens from chronically infected HIV-2 patients scored positive in the new RDT. Of note, the sensitivity of the RDTs to detect recombinant p24CA from a subtype B virus ranged between 50 and 200 pg/mL, mirrored also by the detection of HIV-1 T/F viruses only at antigen concentrations tenfold higher than suggested by the manufacturer. The RTD failed to recognize any of the HIV-2 viruses tested. Our results indicate that the new version of the Determine™ HIV-1/2 Ag/Ab Combo displays an increased sensitivity to detect HIV-1 p24CA-positive, immunoblotnegative plasma samples compared to the precursor version. The sensitivity of 4G-EIA and p24CA-EIA to detect the major structural HIV antigen, and thus to diagnose acute infections prior to seroconversion, is still superior.

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The fourth generation Alere TM HIV Combo rapid test improves detection of acute infection in MTN-003 (VOICE) samples

Cited by 25 publications

References 15 publications

Uptake and impact of facility‐based HIV self‐testing on PrEP delivery: a pilot study among young women in Kisumu, Kenya

Uptake and impact of facility‐based HIV self‐testing on PrEP delivery: a pilot study among young women in Kisumu, Kenya

Challenges of HIV diagnosis and management in the context of pre‐exposure prophylaxis (PrEP), post‐exposure prophylaxis (PEP), test and start and acute HIV infection: a scoping review

Comparative multi-assay evaluation of Determine™ HIV-1/2 Ag/Ab Combo rapid diagnostic tests in acute and chronic HIV infection

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