Evaluation of a SARS‐CoV‐2 antigen‐detecting rapid diagnostic test as a self‐test: Diagnostic performance and usability

Cassuto, Nino Guy; Gravier, Anne; Colin, Mathilda; Theillay, Aurélie; Pires‐Roteira, Daniela; Pallay, Sandra; Serreau, R.; Hocqueloux, Laurent; Prazuck, Thiérry

doi:10.1002/jmv.27249

Cited by 26 publications

(31 citation statements)

References 14 publications

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“…Although there is reduced sensitivity compared to using NP swabs in our evaluation, the NA swab offers several advantages. It is less invasive, which is more acceptable by people compared to NP swabs ( 26 , 27 ), and the ease of use facilitates volunteer training and self-testing at home or workplace ( 28 , 29 ). These factors, combined with rapid turnaround time, low cost, and ease of use afforded by Ag-RDTs ( 30 – 32 ), can help facilitate repeat testing over time and may compensate for reduced sensitivity ( 5 , 9 , 33 ).…”

Section: Discussionmentioning

confidence: 99%

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

et al. 2022

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Section: Discussionmentioning

confidence: 99%

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

et al. 2022

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“…This quite likely results from the on average low viral load in 1 study [49], and the asymptomatic study population in the other [175]. On the contrary, compared to the other studies unusual high sensitivity was found in studies where average viral load was high [45, 84, 144, 145] or participants were mainly within the first week of symptom onset [42, 54, 135].…”

Section: Discussionmentioning

confidence: 99%

Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: an updated systematic review and meta-analysis with meta regression analyzing influencing factors

Brümmer

Katzenschlager

McGrath

et al. 2022

Preprint

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Background Comprehensive information about the accuracy of antigen rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 is essential to guide public health decision makers in choosing the best tests and testing policies. In August 2021, we published a systematic review and meta-analysis about the accuracy of Ag-RDTs. We now update this work and analyze the factors influencing test sensitivity in further detail. Methods and findings We registered the review on PROSPERO (registration number: CRD42020225140). We systematically searched multiple databases (PubMed, Web of Science Core Collection, medRvix, bioRvix, and FIND) for publications evaluating the accuracy of Ag-RDTs for SARS-CoV-2 until August 31, 2021. Descriptive analyses of all studies were performed, and when more than 4 studies were available, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity with reverse transcription polymerase chain reaction (RT-PCR) testing as a reference. To evaluate factors influencing test sensitivity, we performed 3 different analyses using multivariate mixed-effects meta-regression models. We included 194 studies with 221,878 Ag-RDTs performed. Overall, the pooled estimates of Ag-RDT sensitivity and specificity were 72.0% (95% confidence interval [CI] 69.8 to 74.2) and 98.9% (95% CI 98.6 to 99.1), respectively. When manufacturer instructions were followed, sensitivity increased to 76.4% (95%CI 73.8 to 78.8). Sensitivity was markedly better on samples with lower RT-PCR cycle threshold (Ct) values (sensitivity of 97.9% [95% CI 96.9 to 98.9] and 90.6% [95% CI 88.3 to 93.0] for Ct-values <20 and <25, compared to 54.4% [95% CI 47.3 to 61.5] and 18.7% [95% CI 13.9 to 23.4] for Ct-values ≥25 and ≥30) and was estimated to increase by 2.9 percentage points (95% CI 1.7 to 4.0) for every unit decrease in mean Ct-value when adjusting for testing procedure and patients symptom status. Concordantly, we found the mean Ct-value to be lower for true positive (22.2 [95% CI 21.5 to 22.8]) compared to false negative (30.4 [95% CI 29.7 to 31.1]) results. Testing in the first week from symptom onset resulted in substantially higher sensitivity (81.9% [95% CI 77.7 to 85.5]) compared to testing after 1 week (51.8%, 95% CI 41.5 to 61.9). Similarly, sensitivity was higher in symptomatic (76.2% [95% CI 73.3 to 78.9]) compared to asymptomatic (56.8% [95% CI 50.9 to 62.4]) persons. However, both effects were mainly driven by the Ct-value of the sample. With regards to sample type, highest sensitivity was found for nasopharyngeal (NP) and combined NP/oropharyngeal samples (70.8% [95% CI 68.3 to 73.2]), as well as in anterior nasal/mid-turbinate samples (77.3% [95% CI 73.0 to 81.0]). Conclusion Ag-RDTs detect most of the individuals infected with SARS-CoV-2, and almost all when high viral loads are present (>90%). With viral load, as estimated by Ct-value, being the most influential factor on their sensitivity, they are especially useful to detect persons with high viral load who are most likely to transmit the virus. To further quantify the effects of other factors influencing test sensitivity, standardization of clinical accuracy studies and access to patient level Ct-values and duration of symptoms are needed.

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“…6 and 94 reported positive and negative results respectively. 1 This study is appealing and we had a similar study performed in Hong Kong.…”

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confidence: 99%

Evaluation of rapid antigen detection test for individuals at risk of SARS‐CoV‐2 under quarantine

Mak

Yeung

et al. 2021

Journal of Medical Virology

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Evaluation of a SARS‐CoV‐2 antigen‐detecting rapid diagnostic test as a self‐test: Diagnostic performance and usability

Cited by 26 publications

References 14 publications

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: an updated systematic review and meta-analysis with meta regression analyzing influencing factors

Evaluation of rapid antigen detection test for individuals at risk of SARS‐CoV‐2 under quarantine

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