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

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.

The Wide Spectrum of COVID-19 Clinical Presentation in Children

“…To account for the potential lack of performance of the RT-PCR for SARS-CoV-2 due to sampling quality or kinetics (sensitivity <60%) [ 11 , 12 , 13 ], a body of evidence was used for a COVID-19 diagnosis in hospitalized children between 10th March and 10th May 2020: (i) a positive SARS-CoV-2 RT-PCR test in nasopharyngeal swabs and/or (ii) typical aspects of COVID-19 in HRCT or CTPA.…”

COVID-19 in the Rohingya refugee camps of Bangladesh: challenges and mitigation strategies

“…An alternative approach could be mass testing of Rohingya refugees using antigen based rapid diagnostic tests [22]. Epidemiological modelling has shown that large scale testing, even with lower sensitivity, is beneficial over testing with higher accuracy but limited number of samples [23].…”

Papel de las pruebas rápidas (POCT) en el diagnóstico del SARS-COV-2, agente causal de COVID-19

“…Estas pruebas detectan, en sangre, suero o plasma (2,3), los anticuerpos generados como respuesta a la infección por SARS-CoV-2 (4,5,6). En pacientes jóvenes y sanos, la IgM y la IgA aparecen entre el cuarto y el sexto día del inicio de los síntomas, con pico en el día 14 (7,8). En pacientes inmunodeprimidos y crónicos la respues-ta se da entre el séptimo y decimocuarto día.…”

“…En pacientes inmunodeprimidos y crónicos la respues-ta se da entre el séptimo y decimocuarto día. Por su parte, los anticuerpos IgG se retrasan en algunos casos y aparecen entre los días 15 y 21 (8,9,10,11), de modo que aparece su pico entre los días 17 y 19. Por ello, una POCT serológica realizada demasiado temprano puede no caracterizar adecuadamente el estado de los pacientes y generar falsos negativos (7,12,13,14,15).…”

“…Otros formatos, como el de inmunoflorescencia y búsqueda de anticuerpos neutralizantes, solo están disponibles en laboratorios de referencia o investigación (17). La sensibilidad de los productos comerciales varía entre el 40 % y 93 %, y la especificidad entre 93 % y 100 % (5,8,10,12,18), por lo que la tasa de casos falsos negativos puede ser sustancial (8). Asimismo, se ha reportado reactividad cruzada por la inmunidad adquirida contra otros coronavirus como el SARS-CoV (4,19,20).…”