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

Mak, Gannon C.K.; Au, Shermen S M; Yeung, Mick C W; Lau, Dominic M W; Lau, Karen; Ng, Ken H.L.; Lam, Edmund Wing Wo; Chan, RW; Fan, Cecilia Y M

doi:10.1002/jmv.27369

Cited by 5 publications

(8 citation statements)

References 6 publications

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“…The sampling process was observed in 17 of the self-sampling studies (22 datasets), totaling 19,280 samples (60.6%) 12 , 13 , 37 – 41 , 43 , 46 , 48 , 49 , 51 , 52 , 54 , 58 , 61 , whereas sampling was not observed in four studies (4 datasets; 10.8%) 35 , 36 , 47 , 59 . For the remaining ten studies (10 datasets; 27.0%), it was unclear whether the sampling was observed or not 42 , 44 , 45 , 50 , 53 , 55 – 57 , 60 , 62 . Overall, 78.6% of the self-testing studies were carried out at a testing site, and the testing procedure was observed (without providing instructions) by the study team in three studies (1083 samples; 2.9%) 11 , 28 , 32 .…”

Section: Resultsmentioning

confidence: 99%

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Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis

Katzenschlager,

Brümmer,

Schmitz

et al. 2023

Sci Rep

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Self-testing is an effective tool to bridge the testing gap for several infectious diseases; however, its performance in detecting SARS-CoV-2 using antigen-detection rapid diagnostic tests (Ag-RDTs) has not been systematically reviewed. This study aimed to inform WHO guidelines by evaluating the accuracy of COVID-19 self-testing and self-sampling coupled with professional Ag-RDT conduct and interpretation. Articles on this topic were searched until November 7th, 2022. Concordance between self-testing/self-sampling and fully professional-use Ag-RDTs was assessed using Cohen’s kappa. Bivariate meta-analysis yielded pooled performance estimates. Quality and certainty of evidence were evaluated using QUADAS-2 and GRADE tools. Among 43 studies included, twelve reported on self-testing, and 31 assessed self-sampling only. Around 49.6% showed low risk of bias. Overall concordance with professional-use Ag-RDTs was high (kappa 0.91 [95% confidence interval (CI) 0.88–0.94]). Comparing self-testing/self-sampling to molecular testing, the pooled sensitivity and specificity were 70.5% (95% CI 64.3–76.0) and 99.4% (95% CI 99.1–99.6), respectively. Higher sensitivity (i.e., 93.6% [95% CI 90.4–96.8] for Ct < 25) was estimated in subgroups with higher viral loads using Ct values as a proxy. Despite high heterogeneity among studies, COVID-19 self-testing/self-sampling exhibits high concordance with professional-use Ag-RDTs. This suggests that self-testing/self-sampling can be offered as part of COVID-19 testing strategies.Trial registration: PROSPERO: CRD42021250706.

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Section: Resultsmentioning

confidence: 99%

“…Two self-testing and one self-sampling studies provided additional instructional videos 24 , 29 , 45 . Regarding self-testing studies, four studies provided study-specific test instructions since no manufacturer instructions for self-testing were available at the time 11 , 24 , 25 , 29 .…”

Section: Resultsmentioning

confidence: 99%

Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis

Katzenschlager,

Brümmer,

Schmitz

et al. 2023

Sci Rep

View full text Add to dashboard Cite

show abstract

“…Finally, due to the role of PHLSB in this study, we confirmed preliminary SARS-CoV-2 positive CNTS specimens, sensitivity and specificity of using CNTS for diagnosis of SARS-CoV-2 could not be obtained. However, we performed a small study to show the usefulness of CNTS for diagnosis of SARS-CoV-2 with the use of RT-PCR and antigen techniques [ Mak et al, 2021b ].…”

Section: Discussionmentioning

confidence: 99%

Assessment of SARS-CoV-2 viral loads in combined nasal-and-throat swabs collected from COVID-19 individuals under the Universal Community Testing Programme in Hong Kong

Mak

Lam

et al. 2022

Journal of Virological Methods

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“…Across 36 datasets from 31 self-sampling studies, sensitivity again ranged widely from 20.0% [33] to 100% [35] with wide CIs. Speci city for selfsampling studies ranged from 96.4% [58] to 100% [12]…”

Section: Performance Of Self-testing and Self-sampling In Comparison ...mentioning

confidence: 99%

Performance of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing and self-sampling in comparison to molecular and professional-use antigen tests: A systematic review and meta-analysis

Katzenschlager,

Brümmer,

Schmitz

et al. 2023

Preprint

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Purpose Self-testing is an effective tool to bridge the testing gap for several infectious diseases; however, its performance in detecting SARS-CoV-2 using antigen-detection rapid diagnostic tests (Ag-RDTs) has not been systematically reviewed. To inform WHO guideline development, we evaluated the accuracy of COVID-19 self-testing and/or self-sampling using Ag-RDTs. Methods: We searched multiple databases for articles evaluating the accuracy of COVID-19 self-testing or self-sampling through November 7th, 2022. Cohen’s kappa was estimated to assess concordance between self-testing/self-sampling and fully professional-use Ag-RDT results. Bivariate meta-analysis was performed to obtain pooled performance estimates compared to molecular testing. The QUADAS-2 and GRADE tools were used to evaluate quality and certainty of evidence. Results: Among 43 studies included in the review, twelve reported on self-testing, while 31 studies assessed self-sampling only. The risk of bias was low in 49.6% of the studies. Overall concordance with professional-use Ag-RDTs (n = 7 datasets) was high (kappa 0.92 [95% confidence interval (CI) 0.89 to 0.95]). Overall pooled sensitivity and specificity of Ag-RDT testing using self-testing/self-sampling (n = 54 datasets) was 70.5% (95% CI 64.3 to 76.0) and 99.4% (95% CI 99.1–99.6), respectively. Conclusion: Despite high heterogeneity among studies, COVID-19 self-testing/self-sampling exhibits high concordance with professional-use Ag-RDTs. This suggest that self-testing/self-sampling can be offered as part of COVID-19 testing strategies. Trial registration PROSPERO: CRD42021250706

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

Abstract: We read with interest the recent article by Cassuto et al. 1 about selftesting of rapid antigen detection (RAD) test from coronavirus disease 2019 (COVID-19) individuals. For the 100 participants with valid results,

Cited by 5 publications

References 6 publications

Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis

Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis

Assessment of SARS-CoV-2 viral loads in combined nasal-and-throat swabs collected from COVID-19 individuals under the Universal Community Testing Programme in Hong Kong

Performance of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing and self-sampling in comparison to molecular and professional-use antigen tests: A systematic review and meta-analysis

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