Diagnostic Accuracy of Rapid Antigen Tests for COVID-19 Detection: A Systematic Review With Meta-analysis

Abstract

IntroductionReverse transcription-polymerase chain reaction (RT-PCR) to detect SARS-CoV-2 is time-consuming and sometimes not feasible in developing nations. Rapid antigen test (RAT) could decrease the load of diagnosis. However, the efficacy of RAT is yet to be investigated comprehensively. Thus, the current systematic review and meta-analysis were conducted to evaluate the diagnostic accuracy of RAT against RT-PCR methods as the reference standard.MethodsWe searched the MEDLINE/Pubmed and Embase databases for the relevant records. The QUADAS-2 tool was used to assess the quality of the studies. Diagnostic accuracy measures [i.e., sensitivity, specificity, diagnostic odds ratio (DOR), positive likelihood ratios (PLR), negative likelihood ratios (NLR), and the area under the curve (AUC)] were pooled with a random-effects model. All statistical analyses were performed with Meta-DiSc (Version 1.4, Cochrane Colloquium, Barcelona, Spain).ResultsAfter reviewing retrieved records, we identified 60 studies that met the inclusion criteria. The pooled sensitivity and specificity of the rapid antigen tests against the reference test (the real-time PCR) were 69% (95% CI: 68–70) and 99% (95% CI: 99–99). The PLR, NLR, DOR and the AUC estimates were found to be 72 (95% CI: 44–119), 0.30 (95% CI: 0.26–0.36), 316 (95% CI: 167–590) and 97%, respectively.ConclusionThe present study indicated that using RAT kits is primarily recommended for the early detection of patients suspected of having COVID-19, particularly in countries with limited resources and laboratory equipment. However, the negative RAT samples may need to be confirmed using molecular tests, mainly when the symptoms of COVID-19 are present.

Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

“…Our pooled sensitivity for variants exhibited a relatively low value (69.7%) when compared with those of previous articles for wild type SARS-CoV-2. However, it was within the 95% CI of pooled sensitivities in most of the previously published meta-analyses [ 16 , 24 , 32 , 34 , 35 , 36 , 37 ], evidencing the continuous use of RATs without extra interventions in the COVID-19 pandemic caused by SARS-CoV-2 variants. In terms of specificity, the pooled specificities were consistently high (98% to 100%), which was similar to those in our study (100.0%).…”

“…There have been several systematic reviews for the diagnostic accuracy of RATs for detecting wild type SARS-CoV-2. The pooled sensitivities of these meta-analyses ranged from 56.2% (95% CI = 29.5% to 79.8%) to 82% (95% CI = 71% to 89%) [ 16 , 24 , 32 , 33 , 34 , 35 , 36 , 37 ]. The advancement of developed RATs, the target study population, types of RATs, and search timing could influence the pooled diagnostic sensitivity values.…”

Sensitivity and Specificity of the Assays in the Covid-19 Pandemic

“…One of them reported the pooled sensitivity of the 68.4% (95% CI: 60.8-75.9; I 2 = 98%) and RATs' specificity of 99.4% (95% CI: 99.1-99.8; I 2 = 90%) [7]. Similar findings were from the metaanalysis performed on 60 studies with real time PCR as a reference test [9]. The pooled sensitivity was 69% (95% CI: 68-70) and specificity was 99% (95%CI: 99-99) [9].…”

“…Even so, the RATs (rapid antigen tests) and PCR (polymerase chain reaction) were the most common and often complementary diagnostic approaches used during the Covid-19 pandemic. Several systematic reviews and meta-analysis explored their accuracy measuring their sensitivity and specificity [5][6][7][8][9]. The "sensitivity" refers to the accurate identification of the patients that have the disease.…”

Microbiological screening tests for SARS-CoV-2 in the first hour since the hospital admission: A reliable tool for enhancing the safety of pediatric care

“…From a methodological point of view, RT-PCR is very accurate (Allplex TM SARS-CoV-2 Assay Seegene: Sensitivity 95.2%–Specificity 98.9%) ( 19 ) but the results are not available for several hours with the consequent risk of increased transmission ( 20 – 22 ). As an alternative screening method, SARS-CoV-2 antigen-based tests can significantly reduce this time, especially in crowded settings such as a full emergency room where SARS-CoV-2 infection must be confirmed as soon as possible ( 23 – 25 ).…”