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Review

Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data

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AUSL–IRCCS di Reggio Emilia, Servizio di Prevenzione e Sicurezza negli ambienti di Lavoro (SPSAL), I-42122 Reggio Emilia (RE), Italy
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ASL Foggia, Dipartimento di Prevenzione, Servizio Prevenzione e Sicurezza Ambienti Lavoro, Piazza Pavoncelli 11, I-41121 Foggia (FG), Italy
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Department of Medicine and Surgery, School of Medicine, University of Parma, 43123 Parma (PR), Italy
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Department of Medicine and Surgery, School of Occupational Medicine, University of Parma, I-43123 Parma (PR), Italy
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Cardiac Intensive Care Unit, The Heart Institute, Cincinnati Children’s Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229-3026, USA
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Department of Industrial Pharmacy, Sechenov First Moscow State Medical University (Sechenov University), 119991 Moscow, Russia
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Executive Director of the Union “National Pharmaceutical Chamber”, 125009 Moscow, Russia
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Laboratory for Industrial and Applied Mathematics (LIAM), Department of Mathematics and Statistics, York University, 4700 Keele Street, Toronto, ON M3J 1P3, Canada
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School of Medicine, Vita-Salute San Raffaele University, 20132 Milan (MI), Italy
*
Authors to whom correspondence should be addressed.
Equal contribution.
J. Clin. Med. 2020, 9(5), 1515; https://doi.org/10.3390/jcm9051515
Received: 17 April 2020 / Revised: 1 May 2020 / Accepted: 14 May 2020 / Published: 18 May 2020
SARS-CoV-2 is responsible for a highly contagious infection, known as COVID-19. SARS-CoV-2 was discovered in late December 2019 and, since then, has become a global pandemic. Timely and accurate COVID-19 laboratory testing is an essential step in the management of the COVID-19 outbreak. To date, assays based on the reverse-transcription polymerase chain reaction (RT-PCR) in respiratory samples are the gold standard for COVID-19 diagnosis. Unfortunately, RT-PCR has several practical limitations. Consequently, alternative diagnostic methods are urgently required, both for alleviating the pressure on laboratories and healthcare facilities and for expanding testing capacity to enable large-scale screening and ensure a timely therapeutic intervention. To date, few studies have been conducted concerning the potential utilization of rapid testing for COVID-19, with some conflicting results. Therefore, the present systematic review and meta-analysis was undertaken to explore the feasibility of rapid diagnostic tests in the management of the COVID-19 outbreak. Based on ten studies, we computed a pooled sensitivity of 64.8% (95%CI 54.5–74.0), and specificity of 98.0% (95%CI 95.8–99.0), with high heterogeneity and risk of reporting bias. We can conclude that: (1) rapid diagnostic tests for COVID-19 are necessary, but should be adequately sensitive and specific; (2) few studies have been carried out to date; (3) the studies included are characterized by low numbers and low sample power, and (4) in light of these results, the use of available tests is currently questionable for clinical purposes and cannot substitute other more reliable molecular tests, such as assays based on RT-PCR. View Full-Text
Keywords: SARS-CoV-2; COVID-19; point-of-care diagnostics; rapid testing; systematic review and meta-analysis; real-world data SARS-CoV-2; COVID-19; point-of-care diagnostics; rapid testing; systematic review and meta-analysis; real-world data
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MDPI and ACS Style

Riccò, M.; Ferraro, P.; Gualerzi, G.; Ranzieri, S.; Henry, B.M.; Said, Y.B.; Pyatigorskaya, N.V.; Nevolina, E.; Wu, J.; Bragazzi, N.L.; Signorelli, C. Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data. J. Clin. Med. 2020, 9, 1515. https://doi.org/10.3390/jcm9051515

AMA Style

Riccò M, Ferraro P, Gualerzi G, Ranzieri S, Henry BM, Said YB, Pyatigorskaya NV, Nevolina E, Wu J, Bragazzi NL, Signorelli C. Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data. Journal of Clinical Medicine. 2020; 9(5):1515. https://doi.org/10.3390/jcm9051515

Chicago/Turabian Style

Riccò, Matteo, Pietro Ferraro, Giovanni Gualerzi, Silvia Ranzieri, Brandon M. Henry, Younes B. Said, Natalia V. Pyatigorskaya, Elena Nevolina, Jianhong Wu, Nicola L. Bragazzi, and Carlo Signorelli. 2020. "Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data" Journal of Clinical Medicine 9, no. 5: 1515. https://doi.org/10.3390/jcm9051515

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