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Diagnostic value of BinaxNOW antigen card for Severe Acute Respiratory Syndrome Coronavirus 2
Yue-Xue Mai1,2, Jia-Hao Zhang1,2, Xi-Feng Qian1,2
1Department of Clinical Laboratory Medicine, the Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Insights
The BinaxNOW antigen test shows high accuracy for detecting SARS-CoV-2, with 77% sensitivity and 99% specificity. This COVID-19 diagnostic tool is effective for symptomatic patients within 7 days of onset.
Area of Science:
- Medical Diagnostics
- Infectious Diseases
- Public Health
Background:
- Rapid laboratory detection of COVID-19 is critical for pandemic control.
- The BinaxNOW antigen test offers a simple, cost-effective method for SARS-CoV-2 detection.
Approach:
- A meta-analysis evaluated the diagnostic performance of the BinaxNOW assay for SARS-CoV-2.
- Seven studies, encompassing 59 data sets, were included after independent database retrieval and quality assessment.
- Statistical analysis was performed using Stata 16.0, Meta-DiSc 1.4, and Review Manager 5.3.
Key Points:
- Pooled sensitivity was 0.77 and specificity was 0.99 for the BinaxNOW assay.
- The test is most beneficial for symptomatic patients within 7 days of symptom onset.
- CT value and testing site may influence BinaxNOW accuracy, indicating potential sources of heterogeneity.
Conclusions:
- BinaxNOW demonstrates efficient performance in diagnosing COVID-19, particularly in patients with high viral loads.
- The test is a practical tool for large-scale screening and at-home use, even in the post-pandemic era.
Abstract:
Rapid laboratory detection is remarkably crucial to diagnosing coronavirus disease 2019 (COVID-19) infection, due to whose outbreak causes to the world pandemic. The BinaxNOW antigen card (BinaxNOW) is a simple, effective, and cheap tool to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The meta-analysis in this study was conducted to evaluate the diagnostic performance of BinaxNOW for SARS-CoV-2. The researchers independently retrieved the related databases (PubMed, Embase, Web of Science, Cochrane Library) before May 1st, 2021, and extracted the relevant data based on the early inclusion/exclusion criterion. Quality Assessment of Diagnostic Accuracy Study-2 was used to evaluate the quality of the enrolled studies. Stata 16.0, Meta-DiSc 1.4, and Review Manager 5.3 were used to generate analytical data for the statistical analysis. 59 sets of data were identified from the seven studies included in this meta-analysis. The combined sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, and their 95% confidence intervals were 0.77 (0.76 to 0.79), 0.99 (0.99 to 0.99), 65.72 (48.23 to 89.56), 0.23 (0.19 to 0.28), and 461.10 (281.55 to 755.13), respectively. The area under curve was 0.9910 in the summary receiver operating characteristic curve. BinaxNOW is beneficial for symptomatic patients' onset within 7 days. CT value and testing site may be the heterogeneity source of BinaxNOW accuracy. Moreover, this technology has an efficient performance for diagnosing COVID-19, especially in patients with heavy viral load. BinaxNOW may become a practical tool for large-scale or at-home use for COVID-19 in the post-pandemic era.Highlights● Pooled sensitivity with 0.77 and specificity with 0.99 in the BinaxNOW assay.● CT value and testing site may be the heterogeneity source of BinaxNOW accuracy.● BinaxNOW is beneficial for symptomatic patients' onset within 7 days.● BinaxNOW may become a practical tool for large-scale or at-home use for COVID-19.
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