Field performance evaluation of the PanBio rapid SARS-CoV-2 antigen assay in an epidemic driven by 501Y.v2 (lineage B.1.351) in the Eastern Cape, South Africa

Ol, Akingba; Sprong, Kaitlin; Hardie, Diana Ruth

doi:10.1101/2021.02.03.21251057

Cited by 8 publications

(13 citation statements)

References 4 publications

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“…Multiple dilutions were detected with m2000, Alinity m, ID NOW, BinaxNOW, and Panbio Ag assays in the expected ranges previously observed with other strains (Tables 1-3) [14, 15]. These results confirm the in silico predictions and are consistent with recent Panbio Ag evaluations of the B.1.1.7 and B.1.351lineages[16,17].…”

supporting

confidence: 89%

Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests

Rodgers

Batra

Snell

et al. 2021

Preprint

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Background: Viral diversity presents an ongoing challenge for diagnostic tests, which need to accurately detect all circulating variants. The Abbott Global Surveillance program monitors severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants and their impact on diagnostic test performance. Objectives: To evaluate the capacity of Abbott molecular, antigen, and serologic assays to detect the SARS-CoV-2 B.1.1.7, B.1.351 and the P.1 variants. Study design: Virus variant culture stock dilutions (B.1.1.7, BEI NR-54011; B.1.351, BEI NR-54008 and 54009; P.1, BEI NR-54982) and clinical samples from patients with confirmed B.1.1.7 variant infection were run on the Abbott ID NOW COVID-19, m2000 RealTime SARS-CoV-2, Alinity m SARS-CoV-2, and Alinity m Resp-4-Plex molecular assays; the BinaxNOW COVID-19 Ag Card and Panbio COVID-19 Ag Rapid Test Device; and the ARCHITECT/Alinity i SARS-CoV-2 IgG and AdviseDx IgM assays, Panbio COVID-19 IgG assay, and ARCHITECT/Alinity i AdviseDx SARS-CoV-2 IgG II assay. Results: Cultured virus stocks and B.1.1.7 clinical samples were detected with molecular, antigen, and serologic assays in the expected ranges, confirming in silico predictions. The ratio between genome equivalents (GE) and calculated median tissue culture infectious dose (TCID50) were 31- to 83-fold higher for B.1.1.7 cultures compared to B.1.351 and P.1 cultures, demonstrating that GE are more consistent units between cultures than TCID50. Conclusions: Abbott molecular and antigen assays effectively detect B.1.1.7, B.1.351, and P.1 variant infections and Abbott serologic assays detect B.1.1.7 antibodies in patient sera. Future studies with SARS-CoV-2 virus cultures should use quantitative viral load values to compare detection of variants.

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supporting

confidence: 89%

Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests

Rodgers

Batra

Snell

et al. 2021

Preprint

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“…In 4 cases [49,60,65,66], authors reported that the required number of individuals who tested positive or negative by the reference standard was not reached, and in 1 case [56] no data on age were recorded. Eventually, author queries led to the inclusion of 8 further studies [48,50,51,54,61,63,64,67] resulting in a total of 17 relevant studies for this review (12 peer-reviewed journal articles and 5 preprints). The full list of included studies is reported in Table 3 .…”

Section: Resultsmentioning

confidence: 99%

“…CC-BY 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) 1 1 queries led to the inclusion of 8 further studies [48,50,51,54,61,63,64,67] resulting in a total of 17 relevant studies for this review (12 peer-reviewed journal articles and 5 preprints). The full list of included studies is reported in Table 3.…”

Section: Diagnostic Accuracy Measures and Data Synthesismentioning

confidence: 99%

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis

Fujita-Rohwerder

Beckmann

Zens

et al. 2021

Preprint

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Objective: To systematically assess the diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children under real-life conditions. Study design: Multiple bibliographic databases including MEDLINE and Embase, clinical trial registries and further information sources were systematically searched for literature (last bibliographic search: May 7, 2021). Diagnostic cross-sectional or cohort studies that included paediatric study participants and evaluated rapid point-of care tests for diagnosing current SARS-CoV-2 infections against RT-PCR as the reference standard were eligible for inclusion. QUADAS-2 was used to assess the risk of bias and the applicability of the included studies. Bivariate meta-analyses with random effects were performed. Variability was assessed by subgroup analyses. Results: We included 17 studies with a total of 6355 paediatric study participants. All included studies compared antigen tests against RT-PCR. Only one study was at low risk of bias. The pooled overall diagnostic sensitivity and specificity in paediatric populations was 64.2% (95% CI: 57.4%-70.5%) and 99.1% (95% CI: 98.2%-99.5%), respectively. In symptomatic children, the pooled diagnostic sensitivity was 71.8% (95% CI: 63.6%-78.8%) and the pooled diagnostic specificity was 98.7% (95% CI: 96.6%-99.5%). The pooled diagnostic sensitivity in asymptomatic children was 56.2% (95% CI: 47.6%-64.4%) and the pooled diagnostic specificity was 98.6% (95% CI: 97.3%-99.3%). Conclusions: Performance of current antigen tests under real-life conditions varies broadly. Policymakers should especially be aware of the low diagnostic sensitivity of current antigen tests. Results should be interpreted with caution since risk of bias was predominantly judged as unclear due to poor reporting. Study Registration: CRD42021236313 (PROSPERO).

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“…We identified 10 studies which contributed data relevant to modifying infection-control procedures which are summarized in Table 4. Of these 10 studies, 8 were modeling, 50, 59–62 lab-based 63, 64 or grey literature 65 and thus not critically appraised. Of the two that were appraised, one was high quality, 27 and the other was medium quality.…”

Section: Resultsmentioning

confidence: 99%

“…Between November 17 and 20, 2020, Akingba et al tested the field performance of the PanBio SARS-CoV-2 Rapid Antigen Test (RTD) with 677 patients attending one of 6 mobile clinics in Nelson Mandela Bay, South Africa. 64 This rapid test is available and validated for use in Canada. At this time, South Africa was experiencing their second wave of the pandemic and B.1.351 was responsible for 84% of infections in Nelson Mandela Bay.…”

Section: Resultsmentioning

confidence: 99%

Public Health and Health Systems Impacts of SARS-CoV-2 Variants of Concern: A Rapid Scoping Review

Curran

Dol

Boulos

et al. 2021

Preprint

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Background: As of April 2021, three SARS-CoV-2 variants of concern (VOC: B.1.1.7, B.1.351 and P.1) have been detected in over 132 countries. Increased transmissibility of VOC has implications for public health measures and health system arrangements. This rapid scoping review aims to provide a synthesis of current evidence related to public health measures and health system arrangements associated with VOC. Methods: Rapid scoping review. Seven databases were searched up to April 7, 2021 for terms related to VOC, transmission, public health and health systems. A grey literature search was conducted up to April 14, 2021. Title, abstracts and full text were screened independently by two reviewers. Data were double extracted using a standardized form. Studies were included if they reported on at least one of the VOC and public health or health system outcomes. Results: Of the 2487 articles and 59 grey literature sources retrieved, 37 studies and 21 guidance documents were included. Included studies used a wide range of designs and methods. Most of the studies and guidance documents reported on B.1.1.7, and 18 studies and 4 reports provided data for consideration in relation to public health measures. Public health measures, including lockdowns, physical distancing, testing and contact tracing, were identified as critical adjuncts to a comprehensive vaccination campaign. No studies reported on handwashing or masking procedures related to VOC. For health system arrangements, 17 studies were identified. Some studies found an increase in hospitalization due to B.1.1.7 but no difference in length of stay or ICU admission. Six studies found an increased risk of death ranging from 15-67% with B.1.1.7 compared non-B.1.1.7, but three studies reported no change. One study reported on the effectiveness of personal protective equipment in reducing VOC transmission in the hospital. No studies reported on screening staff and visitors, adjusting service provisions, or adjusting patient accommodations and shared spaces, which is a significant gap in the literature. Guidance documents did not tend to cite any evidence and were thus assumed to be based on expert opinion. Conclusion: While the findings should be interpreted with caution as most of the sources identified were preprints, findings suggest a combination of non-pharmaceutical interventions (e.g., masking, physical distancing, lockdowns, testing) should be employed alongside a vaccine strategy to improve population and health system outcomes. While the findings are mixed on the impact of VOC on health system arrangements, the evidence is trending towards increased hospitalization and death.

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Field performance evaluation of the PanBio rapid SARS-CoV-2 antigen assay in an epidemic driven by 501Y.v2 (lineage B.1.351) in the Eastern Cape, South Africa

Cited by 8 publications

References 4 publications

Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests

Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests

Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis

Public Health and Health Systems Impacts of SARS-CoV-2 Variants of Concern: A Rapid Scoping Review

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