1. Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data
- Author
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Carlo Signorelli, Elena Nevolina, Younes Ben Said, Pietro Ferraro, Giovanni Gualerzi, Brandon Michael Henry, Nicola Luigi Bragazzi, Jianhong Wu, Silvia Ranzieri, Matteo Riccò, N.V. Pyatigorskaya, Riccò, M., Ferraro, P., Gualerzi, G., Ranzieri, S., Henry, B. M., Said, Y. B., Pyatigorskaya, N. V., Nevolina, E., Wu, J., Bragazzi, N. L., and Signorelli, C.
- Subjects
medicine.medical_specialty ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Point-of-care testing ,lcsh:Medicine ,systematic review and meta-analysis ,03 medical and health sciences ,0302 clinical medicine ,Pandemic ,Health care ,medicine ,030212 general & internal medicine ,Intensive care medicine ,030304 developmental biology ,Point of care ,0303 health sciences ,real-world data ,business.industry ,SARS-CoV-2 ,lcsh:R ,COVID-19 ,General Medicine ,Gold standard (test) ,rapid testing ,Reporting bias ,Meta-analysis ,business ,point-of-care diagnostics - Abstract
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.
- Published
- 2020