JMIR Publications

Background:

Early detection of coronavirus disease (COVID-19) infection to improve disease management becomes the greatest challenge. Despite the high sensitivity of RT-PCR, it was reported that 20-67% of infected patients have false-negative results. Rapid diagnostic tests (RDTs) are widely used as a point-of-care test for SARS-CoV-2 detection.

Objective:

To assess the diagnostic accuracy of RDTs, compare the RT-PCR for COVID-19 diagnosis, the eligible studies for sensitivity and specificity of RDTs and explore the factors that influence the results investigated.

Methods:

We included diagnostic accuracy studies using cross-sectional and cohort studies using respiratory specimens to evaluate RDTs against the reference standard (RT-PCR). The electronic database, including Scopus, Medline/PubMed, EMBASE, Web of sciences, and Cochrane library, uses Mesh-standardized keywords: (((Rapid antigen detection test * OR RDT*) OR "Rapid Antigen Test" OR "point of care testing") AND ("Real-time PCR" OR "RT-PCR" OR ‎"Molecular diagnostic test" OR "RNA virus") AND ("2019 nCoV" OR 2019nCoV OR "2019 novel coronavirus" OR "COVID 19" OR COVID19 OR "new coronavirus" OR "novel coronavirus" OR "novel coronavirus" OR "SARS CoV-2" OR (Wuhan AND (coronavirus OR "corona virus") OR "COVID-19" OR "severe acute respiratory syndrome coronavirus 2")). Variability was assessed using test type and threshold applied as covariates by subgroup analyses and metaregression. According to the heterogeneity test results, either Der Simonian's and Laird's random‑effects method or Mantel‑Haenszel's fixed‑effects method were used to estimate the overall sensitivity and specificity and 95% confidence intervals.

Results:

Overall, 783 studies were initially collected. Finally17, Studies with eligible data were included for analysis, which imposes 33 different tests (including 26,056 patients, mean age ranging from 20.5 to 53.14 years). The overall sensitivity and specificity RDTs were 0.4 (0.38-0.42) 95% CI, and 0.84 (0.84-0.85) 95% CI, respectively. The pooled estimation demonstrated significant heterogeneity in sensitivity (P= 0.001, chi-square= 1212.1, I2 = 97.9%). For specificity, the significant heterogeneity was observed, too (P= 0.001, chi-square = 4629.3 I2 = 99.4%). The pooled DOR was 20.71 (95% CI, 7.98-53.73), with significant heterogeneity (P =0.001, chi-square =340.94, I2= 92.4%). Further analysis has demonstrated that the sensitivity and specificity in the nasopharyngeal swabs were 0.4 with (0.38-0.42) 95% CI and 84% (0.84-0.85) with 95% CI, respectively. Additionally, the throat washing and bronchoalveolar were assessed and were accompanied with considerable diagnostic accuracy (sensitivity 0.54 (0.22-45) and 0.85 specificity (0.8-0.89)). Our findings have shown that the highest sensitivity (0.94 (0.9-0.97) 95%CI) and highest specificity (0.93(0.89-0.96) 95% CI) belonged to the finger-stick whole-blood; it is necessary to note that just one author investigated this specimen

Conclusions:

We observed substantial variation in sensitivity and specificity of all tests, which was likely attributable to the type of specimen, the timing of sampling, type of assay, and viral load with considering them, RDTs could be used for identifying suspected patients in the early stage of disease with desirable sensitivity and specificity and help to control COVID-19 pandemic.