Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study

Area of Science:

• Clinical diagnostics
• Infectious disease testing
• Point-of-care diagnostics

Background:

• Antigen point-of-care tests (AgPOCTs) offer rapid SARS-CoV-2 detection.
• Growing interest in the performance of available AgPOCTs necessitates comparative evaluations.

Purpose of the Study:

• To compare the analytical sensitivity and specificity of seven commercially available AgPOCT devices for SARS-CoV-2 detection.

Main Methods:

• Laboratory evaluation of seven AgPOCT products using recombinant nucleoprotein, various coronaviruses, and clinical samples.
• Determination of analytical sensitivity by quantifying viral load (RT-PCR) yielding positive results.
• Assessment of specificity by evaluating cross-reactivity and false-positive rates in non-SARS-CoV-2 samples.

Main Results:

• Six of seven AgPOCTs had a 95% limit of detection between 2.07×10^6 and 2.86×10^7 copies/swab.
• High specificities were observed (98.5%-100%) for five products, with two outliers.
• No significant cross-reactivity with endemic human coronaviruses, but SARS-CoV was cross-detected by all assays.

Conclusions:

• Most AgPOCTs demonstrate sensitivity overlapping with the infectious period of SARS-CoV-2.
• AgPOCTs with appropriate detection limits can facilitate rapid clinical and public health decision-making.
• Performance variations exist, highlighting the importance of device-specific evaluation.