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.

Bioengineered
|July 25, 2023
PubMed

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.