Abstract
Background: The global spread of COVID-19 created an explosion in rapid tests with results in < 1 hour, but their relative performance characteristics are not fully understood yet. Our aim was to determine the most sensitive and specific rapid test for the diagnosis of SARS-CoV-2.
Methods:
Design: Rapid review and diagnostic test accuracy network meta-analysis (DTA-NMA).
Eligibility criteria: Randomized controlled trials (RCTs) and observational studies assessing rapid antigen and/or rapid molecular test(s) to detect SARS-CoV-2 in participants of any age, suspected or not with SARS-CoV-2 infection.
Information sources: Embase, MEDLINE, and Cochrane Central Register of Controlled Trials, up to September 12, 2021.
Outcome measures: Sensitivity and specificity of rapid antigen and molecular tests suitable for detecting SARS-CoV-2.
Data extraction and risk of bias assessment: Screening of literature search results was conducted by one reviewer; data abstraction was completed by one reviewer and independently verified by a second reviewer. Risk of bias was not assessed in the included studies.
Data synthesis: Random-effects meta-analysis and DTA-NMA.
Results: We included 93 studies (reported in 88 articles) relating to 36 rapid antigen tests in 104,961 participants and 23 rapid molecular tests in 10,449 participants. Overall, rapid antigen tests had a sensitivity of 0.75 (95% confidence interval 0.70–0.79) and specificity of 0.99 (0.98–0.99). Rapid antigen test sensitivity was higher when nasal or combined samples (e.g., combinations of nose, throat, mouth, or saliva samples) were used, but lower when nasopharyngeal samples were used, and in those classified as asymptomatic at the time of testing. Rapid molecular tests may result in fewer false negatives than rapid antigen tests (sensitivity: 0.93, 0.88–0.96; specificity: 0.98, 0.97–0.99). The tests with the highest sensitivity and specificity estimates were the Xpert Xpress rapid molecular test by Cepheid (sensitivity: 0.99, 0.83–1.00; specificity: 0.97, 0.69–1.00) among the 23 commercial rapid molecular tests and the COVID-VIRO test by AAZ-LMB (sensitivity: 0.93, 0.48–0.99; specificity: 0.98, 0.44–1.00) among the 36 rapid antigen tests we examined.
Conclusions: Rapid molecular tests were associated with both high sensitivity and specificity, while rapid antigen tests were mainly associated with high specificity, according to the minimum performance requirements by WHO and Health Canada. Our rapid review was limited to English, peer-reviewed published results of commercial tests, and study risk of bias was not assessed. A full systematic review is required.
Review registration: PROSPERO CRD42021289712
Methods:
Design: Rapid review and diagnostic test accuracy network meta-analysis (DTA-NMA).
Eligibility criteria: Randomized controlled trials (RCTs) and observational studies assessing rapid antigen and/or rapid molecular test(s) to detect SARS-CoV-2 in participants of any age, suspected or not with SARS-CoV-2 infection.
Information sources: Embase, MEDLINE, and Cochrane Central Register of Controlled Trials, up to September 12, 2021.
Outcome measures: Sensitivity and specificity of rapid antigen and molecular tests suitable for detecting SARS-CoV-2.
Data extraction and risk of bias assessment: Screening of literature search results was conducted by one reviewer; data abstraction was completed by one reviewer and independently verified by a second reviewer. Risk of bias was not assessed in the included studies.
Data synthesis: Random-effects meta-analysis and DTA-NMA.
Results: We included 93 studies (reported in 88 articles) relating to 36 rapid antigen tests in 104,961 participants and 23 rapid molecular tests in 10,449 participants. Overall, rapid antigen tests had a sensitivity of 0.75 (95% confidence interval 0.70–0.79) and specificity of 0.99 (0.98–0.99). Rapid antigen test sensitivity was higher when nasal or combined samples (e.g., combinations of nose, throat, mouth, or saliva samples) were used, but lower when nasopharyngeal samples were used, and in those classified as asymptomatic at the time of testing. Rapid molecular tests may result in fewer false negatives than rapid antigen tests (sensitivity: 0.93, 0.88–0.96; specificity: 0.98, 0.97–0.99). The tests with the highest sensitivity and specificity estimates were the Xpert Xpress rapid molecular test by Cepheid (sensitivity: 0.99, 0.83–1.00; specificity: 0.97, 0.69–1.00) among the 23 commercial rapid molecular tests and the COVID-VIRO test by AAZ-LMB (sensitivity: 0.93, 0.48–0.99; specificity: 0.98, 0.44–1.00) among the 36 rapid antigen tests we examined.
Conclusions: Rapid molecular tests were associated with both high sensitivity and specificity, while rapid antigen tests were mainly associated with high specificity, according to the minimum performance requirements by WHO and Health Canada. Our rapid review was limited to English, peer-reviewed published results of commercial tests, and study risk of bias was not assessed. A full systematic review is required.
Review registration: PROSPERO CRD42021289712
| Original language | English |
|---|---|
| Article number | 110 |
| Number of pages | 11 |
| Journal | BMC Medicine |
| Volume | 21 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 29 Mar 2023 |
Keywords
- COVID-19
- Diagnostic test accuracy
- Network meta-analysis
- Rapid review
- Rapid tests
- Review
- SARS-CoV-2