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Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

Author

Listed:
  • Lukas E Brümmer
  • Stephan Katzenschlager
  • Mary Gaeddert
  • Christian Erdmann
  • Stephani Schmitz
  • Marc Bota
  • Maurizio Grilli
  • Jan Larmann
  • Markus A Weigand
  • Nira R Pollock
  • Aurélien Macé
  • Sergio Carmona
  • Stefano Ongarello
  • Jilian A Sacks
  • Claudia M Denkinger

Abstract

Background: SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) are increasingly being integrated in testing strategies around the world. Studies of the Ag-RDTs have shown variable performance. In this systematic review and meta-analysis, we assessed the clinical accuracy (sensitivity and specificity) of commercially available Ag-RDTs. Methods and findings: We registered the review on PROSPERO (registration number: CRD42020225140). We systematically searched multiple databases (PubMed, Web of Science Core Collection, medRvix, bioRvix, and FIND) for publications evaluating the accuracy of Ag-RDTs for SARS-CoV-2 up until 30 April 2021. Descriptive analyses of all studies were performed, and when more than 4 studies were available, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity in comparison to reverse transcription polymerase chain reaction (RT-PCR) testing. We assessed heterogeneity by subgroup analyses, and rated study quality and risk of bias using the QUADAS-2 assessment tool. From a total of 14,254 articles, we included 133 analytical and clinical studies resulting in 214 clinical accuracy datasets with 112,323 samples. Across all meta-analyzed samples, the pooled Ag-RDT sensitivity and specificity were 71.2% (95% CI 68.2% to 74.0%) and 98.9% (95% CI 98.6% to 99.1%), respectively. Sensitivity increased to 76.3% (95% CI 73.1% to 79.2%) if analysis was restricted to studies that followed the Ag-RDT manufacturers’ instructions. LumiraDx showed the highest sensitivity, with 88.2% (95% CI 59.0% to 97.5%). Of instrument-free Ag-RDTs, Standard Q nasal performed best, with 80.2% sensitivity (95% CI 70.3% to 87.4%). Across all Ag-RDTs, sensitivity was markedly better on samples with lower RT-PCR cycle threshold (Ct) values, i.e.,

Suggested Citation

  • Lukas E Brümmer & Stephan Katzenschlager & Mary Gaeddert & Christian Erdmann & Stephani Schmitz & Marc Bota & Maurizio Grilli & Jan Larmann & Markus A Weigand & Nira R Pollock & Aurélien Macé & Sergio, 2021. "Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis," PLOS Medicine, Public Library of Science, vol. 18(8), pages 1-41, August.
  • Handle: RePEc:plo:pmed00:1003735
    DOI: 10.1371/journal.pmed.1003735
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    Cited by:

    1. Viet Tran & Giles Barrington & Zach Aandahl & Amelia Lawrence & Senudi Wijewardena & Brian Doyle & Louise Cooley, 2023. "Evaluation of the Abbott Panbio™ COVID-19 Ag Rapid Antigen Test for Asymptomatic Patients during the Omicron Wave," J, MDPI, vol. 6(1), pages 1-9, March.
    2. Silvia Cocchio & Michele Nicoletti & Francesco Paolo De Siena & Gaia Lattavo & Patrizia Furlan & Marco Fonzo & Michele Tonon & Federico Zabeo & Francesca Russo & Vincenzo Baldo, 2021. "Prevalence of Asymptomatic SARS-CoV-2 Infection in the General Population of the Veneto Region: Results of a Screening Campaign with Third-Generation Rapid Antigen Tests in the Pre-Vaccine Era," IJERPH, MDPI, vol. 18(20), pages 1-8, October.
    3. Anna Maria Cattelan & Lolita Sasset & Federico Zabeo & Anna Ferrari & Lucia Rossi & Maria Mazzitelli & Silvia Cocchio & Vincenzo Baldo, 2022. "Rapid Antigen Test LumiraDx TM vs. Real Time Polymerase Chain Reaction for the Diagnosis of SARS-CoV-2 Infection: A Retrospective Cohort Study," IJERPH, MDPI, vol. 19(7), pages 1-12, March.

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