Diagnostic accuracy
How accurate is a 15-minute COVID antigen strip?
Open access · cc by · source: Europe PMC
COVID-19 Ag Respi-Strip was highly specific (99.5%) but only moderately sensitive (57.6%) vs PCR, best when viral load was high (CT <22).
Key findings
Between-observer disagreement 1.7%, robustness 98%, no cross-reactivity with other virus-infected samples. Overall sensitivity 57.6%, specificity 99.5%, accuracy 82.6%; ICT cut-off around CT <22. Authors propose first-line use complementary to molecular tests.
Methodology
Developed a colloidal-gold ICT targeting conserved SARS-CoV nucleoprotein, then measured analytical reproducibility/cross-reactivity and clinical performance on 328 nasopharyngeal aliquots against qRT-PCR.
Limitations
Moderate sensitivity means many PCR-positive cases are missed, especially at higher CT; evaluation was during an ascending epidemic curve and does not replace PCR confirmation.
How this study connects
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