Antigen Detection Tests for SARS-CoV-2: a systematic review and meta-analysis on real world data

Antigen Detection Tests for SARS-CoV-2: a systematic review and meta-analysis on real world data


  • Matteo Riccò Azienda USL-IRCCS di Reggio Emilia; V.le Amendola n.2 - 42122 RE; Servizio di Prevenzione e Sicurezza negli Ambienti di Lavoro (SPSAL)Dip. di Prevenzione
  • Silvia Ranzieri University of Parma, Department of Medicine and Surgery, School of Occupational Medicine, I-43123 Parma (PR), Italy
  • Simona Peruzzi AUSL–IRCCS di Reggio Emilia, Laboratorio Analisi Chimico Cliniche e Microbiologiche, Ospedale Civile di Guastalla, I-42016 Guastalla
  • Marina Valente University of Parma, Department of Medicine and Surgery, Unit of Clinical Surgery, I-43123 Parma (PR), Italy
  • Federico Marchesi University of Parma, Department of Medicine and Surgery, Unit of Clinical Surgery, I-43123 Parma (PR), Italy
  • Nicola Luigi Bragazzi Laboratory for Industrial and Applied Mathematics (LIAM), Department of Mathematics and Statistics, University of York, Toronto (ON), Canada
  • Davide Donelli AUSL-IRCCS di Reggio Emilia, Department of Primary Care, I-42122, Reggio Emilia RE, Italy
  • Federica Balzarini ATS Bergamo, Dipartimento P.A.A.P.S.S., Servizio Autorizzazione e Accreditamento, Via Galliccioli, 4, Bergamo
  • Pietro Ferraro ASL di Foggia, Occupational Health and Safety Service of Local Health Unit of Foggia, Piazza Pavoncelli 11, I-41121 Foggia
  • Vincenza Gianfredi University “Vita e Salute”, San Raffaele Hospital; Via Olgettina n. 58, I-20132; Milan (MI), Italy
  • Carlo Signorelli University “Vita e Salute”, San Raffaele Hospital; Via Olgettina n. 58, I-20132; Milan (MI), Italy


COVID-19, SARS-CoV-2, point-of-care diagnostics, rapid testing, real-world data, systematic review and meta-analysis


Background and aim Rapid antigen detection (RAD) tests on nasopharyngeal specimens have been recently made available for SARS-CoV-2 infections, and early studies suggested their potential utilization as rapid screening and diagnostic testing. The present systematic review and meta-analysis was aimed to assess available evidence and to explore the reliability of antigenic tests in the management of the SARS-CoV-2 pandemic.

Materials and Methods. We reported our meta-analysis according to the PRISMA statement. We searched Pubmed, Embase, and pre-print archive medRxiv.og for eligible studies published up to November 5th, 2020. Raw data included true/false positive and negative tests, and the total number of tests. Sensitivity and specificity data were calculated for every study, and then pooled in a random-effects model. Heterogeneity was assessed using the I2 measure. Reporting bias was assessed by means of funnel plots and regression analysis.

Results. Based on 25 studies, we computed a pooled sensitivity of 72.8% (95%CI 62.4–81.3), a specificity of 99.4% (95%CI 99.0–99.7), with high heterogeneity and risk of reporting bias. More precisely, RAD tests exhibited higher sensitivity on samples with high viral load (i.e. <25 Cycle Threshold; 97.6%; 95%CI 94.1–99.0), compared to those with low viral load (≥25 Cycle Threshold; 43.6%; 95% 27.6-61.1).

Discussion. As the majority of collected reports were either cohort or case-control studies, deprived of preventive power analysis and often oversampling positive tests, overall performances may have been overestimated. Therefore, the massive referral to antigenic tests in place of RT-qPCR is currently questionable, and also their deployment as mass screening test may lead to intolerable share of missing diagnoses. On the other hand, RAD tests may find a significant role in primary care and in front-line settings (e.g. Emergency Departments). (

Author Biography

Matteo Riccò, Azienda USL-IRCCS di Reggio Emilia; V.le Amendola n.2 - 42122 RE; Servizio di Prevenzione e Sicurezza negli Ambienti di Lavoro (SPSAL)Dip. di Prevenzione

Dipartimento di Sanità Pubblica

Dirigente Medico di Medicina del Lavoro


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How to Cite

Riccò M, Ranzieri S, Peruzzi S, Valente M, Marchesi F, Bragazzi NL, et al. Antigen Detection Tests for SARS-CoV-2: a systematic review and meta-analysis on real world data. Acta Biomed [Internet]. 2022 May 11 [cited 2024 Jul. 25];93(2):e2022036. Available from: