2020
DOI: 10.1101/2020.12.22.20248614
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Real-world clinical performance of commercial SARS-CoV-2 rapid antigen tests in suspected COVID-19: A systematic meta-analysis of available data as per November 20, 2020

Abstract: BackgroundImmunochromatographic rapid antigen tests (RATs) emerged onto the COVID-19 pandemic testing landscape to aid in the rapid diagnosis of people with suspected SARS-CoV-2 infection. RATs are particularly useful where RT-PCR is not immediately available and symptoms suggestive of a high viral load and infectiousness are assumed. Several lateral flow immunoassays have been authorized for use under EUA and/or the CE mark, presenting varying overall clinical performance data generated by the manufacturer or… Show more

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Cited by 17 publications
(27 citation statements)
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“…Although rapid point‐of‐care antigen tests for detection of SARS‐CoV‐2 have been criticized because of their lower clinical sensitivity than NAATs, these assays may help detect the most infectious cases 13 . These rapid point‐of‐care antigen tests usually have a relatively high sensitivity in respiratory specimens with high viral loads (typically >80% in specimens with Ct values <25), while their positive rate in samples with a low viral load (eg, Ct values >25/30) is usually <80% 4,15,16 . These data support the use of rapid point‐of‐care antigen tests for the detection of SARS‐CoV‐2 in high‐viral‐load individuals.…”
Section: Discussionmentioning
confidence: 79%
See 1 more Smart Citation
“…Although rapid point‐of‐care antigen tests for detection of SARS‐CoV‐2 have been criticized because of their lower clinical sensitivity than NAATs, these assays may help detect the most infectious cases 13 . These rapid point‐of‐care antigen tests usually have a relatively high sensitivity in respiratory specimens with high viral loads (typically >80% in specimens with Ct values <25), while their positive rate in samples with a low viral load (eg, Ct values >25/30) is usually <80% 4,15,16 . These data support the use of rapid point‐of‐care antigen tests for the detection of SARS‐CoV‐2 in high‐viral‐load individuals.…”
Section: Discussionmentioning
confidence: 79%
“…A diverse range of rapid point‐of‐care antigen tests for the detection of SARS‐CoV‐2 from nasopharyngeal swabs and oropharyngeal swabs are currently available in the market. Some excellent publications have described the evaluation results for these rapid point‐of‐care assays, 17‐23 and meta‐analyses on this topic have also been published 15,16 . A summary of the published data suggests that the sensitivity of these rapid point‐of‐care antigen assays is generally low, ranging from 20% to 95% depending on the assay and the virus load.…”
Section: Discussionmentioning
confidence: 99%
“…The RT-PCR positivity rates in staff and residents were more variable than the antigen positivity rates, which apart from being generally lower by one order of magnitude also showed a lower variance. This reflects the higher sensitivity of the RT-PCR assay, able to pick up low viral RNA levels in the pre-infectious and post-infectious phases of asymptomatic infections, whereas antigen tests have been shown to score positive in the infectious phase with high viral RNA levels only [ 49 , 50 ]. Proper adherence to hygiene measures is therefore imperative to compensate for the lower diagnostic sensitivity of antigen tests, in particular among asymptomatic populations.…”
Section: Discussionmentioning
confidence: 99%
“…Diagnostic performances in low prevalence populations still needs to be determined and larger populations need to be tested. In addition, it is clear that antigen assay for SARS-CoV-2 need to be performed in the first week after symptoms onset [6,12]. Finally, here we used frozen nasopharyngeal swab specimens and the test was performed in a laboratory environment; we may expect different results in real-life at patients' bed and using fresh nasopharyngeal swab.…”
Section: Discussionmentioning
confidence: 99%
“…For the Standard Q (SD Biosensor, Roche Diagnostics), the overall sensitivity is 85% and specificity 99% (n=2892). Finally, the BD Veritor (Beckton & Dickinson) has an overall sensitivity of 91% and a specificity of 99% (n=964) [6][7][8][9]. It has been noted that the sensitivity increases with high viral load (RT-PCR Cycle threshold < 30).…”
Section: Introductionmentioning
confidence: 99%