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Evaluation of the diagnostic accuracy of COVID-19 antigen tests: A systematic review and meta-analysis
Yuan-Hung Wang1,2, Chia-Chang Wu3,4,5, Chyi-Huey Bai6
1Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan, ROC.
Insights
Antigen tests show moderate sensitivity and high specificity for detecting SARS-CoV-2, the virus causing COVID-19. These rapid tests may be more sensitive when used within seven days of symptom onset to identify infectious individuals.
Area of Science:
- Infectious Diseases
- Diagnostic Accuracy
- Public Health
Background:
- The COVID-19 pandemic necessitates effective nonpharmaceutical interventions.
- Antigen tests offer advantages of low cost and rapid results for identifying infectious individuals.
- Accurate diagnostic tools are crucial for controlling SARS-CoV-2 transmission.
Purpose of the Study:
- To evaluate the diagnostic accuracy of antigen tests for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
- To determine the pooled sensitivity and specificity of antigen tests in detecting SARS-CoV-2.
- To assess the potential role of antigen testing in controlling viral transmission.
Main Methods:
- A systematic literature search was conducted across major databases (PubMed, Embase, Cochrane Library, Biomed Central) up to January 2, 2021.
- Studies reporting diagnostic accuracy data for SARS-CoV-2 antigen tests against reference standards were included.
- A random-effects model was used to calculate pooled sensitivity and specificity from 14 included studies (8624 participants).
Main Results:
- The meta-analysis revealed a pooled sensitivity of 79% and a pooled specificity of 100% for antigen tests.
- Subgroup analysis indicated higher pooled sensitivity (95%) when tests were performed within 7 days of symptom onset.
- The included studies aligned with the review's focus on patient selection, index tests, and reference standards.
Conclusions:
- SARS-CoV-2 antigen tests demonstrate moderate sensitivity and high specificity.
- Antigen testing may be particularly effective for detecting the virus within the first week of symptom onset.
- These tests represent a valuable tool for identifying contagious individuals and mitigating SARS-CoV-2 spread.
Background:
The coronavirus disease 2019 (COVID-19) pandemic continues to affect countries worldwide. To inhibit the transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), testing of patients, contact tracing, and quarantine of their close contacts have been used as major nonpharmaceutical interventions. The advantages of antigen tests, such as low cost and rapid turnaround, may allow for the rapid identification of larger numbers of infectious persons. This meta-analysis aimed to evaluate the diagnostic accuracy of antigen tests for SARS-CoV-2.
Methods:
We searched PubMed, Embase, Cochrane Library, and Biomed Central databases from inception to January 2, 2021. Studies evaluating the diagnostic accuracy of antigen testing for SARS-CoV-2 with reference standards were included. We included studies that provided sufficient data to construct a 2 × 2 table on a per-patient basis. Only articles in English were reviewed. Summary sensitivity and specificity for antigen tests were generated using a random-effects model.
Results:
Fourteen studies with 8624 participants were included. The meta-analysis for antigen testing generated a pooled sensitivity of 79% (95% CI, 66%-88%; 14 studies, 8624 patients) and a pooled specificity of 100% (95% CI, 99%-100%; 14 studies, 8624 patients). The subgroup analysis of studies that reported specimen collection within 7 days after symptom onset showed a pooled sensitivity of 95% (95% CI, 78%-99%; four studies, 1342 patients) and pooled specificity of 100% (95% CI, 97%-100%; four studies, 1342 patients). Regarding the applicability, the patient selection, index tests, and reference standards of studies in our meta-analysis matched the review title.
Conclusion:
Antigen tests have moderate sensitivity and high specificity for the detection of SARS-CoV-2. Antigen tests might have a higher sensitivity in detecting SARS-CoV-2 within 7 days after symptom onset. Based on our findings, antigen testing might be an effective method for identifying contagious individuals to block SARS-CoV-2 transmission.
