Point-of-Care Diagnostic of SARS-CoV-2: a Systematic Review and Meta-Analysis of Real-World Data
SARS-CoV-2 is an enveloped, single-stranded, positive-sense RNA virus, responsible for a highly contagious infection, known as COVID-19. SARS-CoV-2 was discovered in late December 2019 and, since then, has spread out from China into neighboring countries, becoming a global pandemic. Timely and accurate COVID-19 laboratory testing is an essential step in the management of the COVID-19 outbreak. To date, both the “European Centre for Disease Prevention and Control” (ECDC) and the “World Health Organization” (WHO) have recommended the use of an assay based on the real-time polymerase chain reaction (RT-PCR) in respiratory samples as 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 so far concerning the potential utilization of rapid testing for COVID-19. However, some conflicting results have been reported and there is a need for an updated synthesis of the literature to better inform health policies and guidelines. 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 four studies, we computed a pooled sensitivity of 70.5% (95%CI 47.5–86.3), and specificity of 99.1% (95%CI 88.8–99.9). 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 on commercially available tests; 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.