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.
Highlights
The “Severe Acute Respiratory Syndrome coronavirus type 2” (SARS-CoV-2) is an enveloped, single-stranded, positive-sense RNA virus, responsible for a highly contagious infection, known as “coronavirus disease 19” (COVID-19)
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 reverse-transcription polymerase chain reaction (RT-PCR) in respiratory samples as gold standard for the COVID-19 diagnosis [4–6]
Articles (a) dealing with commercially available point-of-care diagnostic tests for SARS-CoV-2 antibodies (IgM/IgG); (b) including COVID-19 cases diagnosed by means of RT-PCR; (c) reporting the raw number of true positive/true negative, and false positive/false negative results were eligible for the full review
Summary
The “Severe Acute Respiratory Syndrome coronavirus type 2” (SARS-CoV-2) is an enveloped, single-stranded, positive-sense RNA virus, responsible for a highly contagious infection, known as “coronavirus disease 19” (COVID-19). RT-PCR is affected by several practical limitations, including a relatively invasive sampling, a time-consuming procedure to process and generate results, the need for specialized operators and certified laboratories [7] This makes the use of the RT-PCR challenging in resource-limited settings. From other molecular tests, they can be deployed at the site of the triage, and outside hospitals and other healthcare facilities They do not require specialized, time-consuming training and can be, conducted by low trained staff personnel, round-the-clock and on samples that do not need to be processed. By definition, they provide test results in a short amount of time (from a few minutes to hours), enabling a swift patient management. The present systematic review and meta-analysis was undertaken to explore the reliability of rapid diagnostic tests for SARS-CoV-2 antibodies in the management of the COVID-19 outbreak
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