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SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) are increasingly being integrated in testing strategies around the world. Studies of the Ag-RDTs have shown variable performance. In this systematic review and meta-analysis, we assessed the clinical accuracy (sensitivity and specificity) of commercially available Ag-RDTs.
The remaining 35 Ag-RDTs did not present sufficient data for univariate or bivariate meta-analysis. However, 9/35 had results presented in more than 1 dataset, and these are summarized in Table 2. Herein, the widest ranges of sensitivity were found for the ESPLINE SARS-CoV-2 by Fujirebio (Japan), with sensitivity reported between 8.1% and 80.7%, and the RIDA QUICK SARS-CoV-2 Antigen by R-Biopharm (Germany), with sensitivity between 39.2% and 77.6%, both with 3 datasets each. In contrast, 2 other tests with 2 datasets each showed the least variability in sensitivity: The Zhuhai Encode Medical Engineering SARS-CoV-2 Antigen Rapid Test (China) reported sensitivity between 74.0% and 74.4%, and the COVID-19 Rapid Antigen Fluorescent by SureScreen Diagnostics (UK) reported sensitivity between 60.3% and 69.0%. However, for both tests, both datasets originated from the same studies. Overall, the lowest sensitivity range was reported for the SARS-CoV-2 Antigen Rapid Test by MEDsan (Germany): 36.5% to 45.2% across 2 datasets. The specificity ranges were above 96% for most of the tests. A notable outlier was the 2019-nCov Antigen Rapid Test Kit by Shenzhen Bioeasy Biotechnology (China; henceforth called Bioeasy), reporting the worst, with a specificity as low as 85.6% in 1 study. Forest plots for the datasets for each Ag-RDT are provided in S3 Fig. The remaining 26 Ag-RDTs that were evaluated in 1 dataset only are included in Table 1 S3 Fig.
Most datasets evaluated NP or combined NP/OP swabs (122 datasets and 59,810 samples) as the sample type for the Ag-RDT. NP or combined NP/OP swabs achieved a pooled sensitivity of 71.6% (95% CI 68.1% to 74.9%). Datasets that used AN/MT swabs for Ag-RDTs (32 datasets and 25,814 samples) showed a summary estimate for sensitivity of 75.5% (95% CI 70.4% to 79.9%). This was confirmed by 2 studies that reported direct head-to-head comparison of NP and MT samples from the same participants using the same Ag-RDT (Standard Q), where the 2 sample types showed equivalent performance [271,272]. Analysis of performance with an OP swab (7 datasets, 5,165 samples) showed a pooled sensitivity of only 53.1% (95% CI 40.9% to 65.0%). Saliva swabs (4 datasets, 1,088 samples) showed the lowest pooled sensitivity, at only 37.9% (95% CI 11.8% to 73.5%) (Fig 8).
Median sensitivity was 72.4% (range 46.9% to 100%) in samples with viral load > 5 log10 copies/mL, 97.8% (range 71.4% to 100%) for >6 log10 copies/mL, and 100% (range 93.8% to 100%) for >7 log10 copies/mL, showing that the sensitivity increases with increasing viral load.
The result of the Deeks test (p = 0.001) shows significant asymmetry in the funnel plot for all datasets with complete results. This indicates there may be publication bias from studies with small sample sizes. The funnel plot is presented in S10 Fig.
Overall, the reported analytical sensitivity (limit of detection [LOD]) in the studies resembled the results of the meta-analysis presented above. Rapigen (LOD, in log10 copies per swab: 10.2) and Coris (LOD 7.46) were found to perform worse than Panbio (LOD 6.6 to 6.1) and Standard Q (LOD 6.8 to 6.0), whereas Clinitest (LOD 6.0) and BinaxNOW by Abbott (LOD 4.6 to 4.9) performed better [191,256,282]. Similar results were found in another study, where Standard Q showed the lowest LOD (detecting virus up to what is an equivalent Ct value of 26.3 to 28.7), compared to that of Rapigen and Coris (detecting virus up to what is an equivalent Ct value of only 18.4 for both) [208,274,275]. However, another study found Panbio, Standard Q, Coris, and BinaxNOW to have a similar LOD values of 5.0 × 103 plaque forming units (PFU)/mL, but the ESPLINE SARS-CoV-2 by Fujirebio (Japan), the COVID-19 Rapid Antigen Test by Mologic (UK), and the Sure Status COVID-19 Antigen Card Test by Premier Medical Corporation (India) performed markedly better (LOD 2.5 × 102 to 5.0 × 102 PFU/mL) . An overview of all LOD values reported in the studies can be found in S3 Table.
The 2 Ag-RDTs that have been approved through the WHO emergency use listing procedure, Abbott Panbio and SD Biosensor Standard Q (distributed by Roche in Europe), have not only drawn the largest research interest, but also perform at or above average when their pooled accuracy is compared to that of all Ag-RDTs (sensitivity of 71.8% for Panbio and 74.9% for Standard Q). Standard Q nasal demonstrated an even higher pooled sensitivity (80.2% compared to the NP test), although this is likely due to variability in the populations tested, as head-to-head performance showed a comparable sensitivity. Three other Ag-RDTs showed an even higher accuracy, with sensitivities ranging from 77.4% to 88.2% (namely Sofia, Lumipulse G, and LumiraDx), but were only assessed on relatively small samples sizes (ranging from 1,373 to 3,532), and all required an instrument/reader.
Our analysis also found that the accuracy of Ag-RDTs is substantially higher in symptomatic patients than in asymptomatic patients (pooled sensitivity 76.7% versus 52.5%). This is not surprising as studies that enrolled symptomatic patients showed a lower range of median Ct values (i.e., higher viral load) than studies enrolling asymptomatic patients. Given that other studies found symptomatic and asymptomatic patients to have comparable viral loads [299,300], the differences found in our analysis are likely explained by the varied time in the course of the disease at which testing is performed in asymptomatic patients presenting for one-time screening testing. Because symptoms start in the early phase of the disease, when viral load is still high, studies testing only symptomatic patients have a higher chance of including patients with high viral loads. In contrast, study populations drawn from only asymptomatic patients have a higher chance of including patients at any point of disease (i.e., including late in disease, when PCR is still positive, but viable virus is rapidly decreasing) .
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