The GENEDIANCOVID-19 Antigen Test Cassette is a lateral flow chromatographic immunoassayfor the qualitative detection of the nucleocapsid protein antigen fromSARS-CoV-2 in nasopharyngeal and anterior nasal swabspecimens directly from individuals suspected of COVID-19 by theirhealthcare provider within the first 7 days of the onset of symptoms. TheGENEDIAN COVID-19 Antigen Test Cassette can also test specimens fromasymptomatic individuals. Highlights n Nasopharyngeal swab specimens n Results to read at 15 min n Easier and faster compared to molecular methods n Room temperature storage n Easy use, no need of equipment Clinical Performance ClinicalSensitivity and specificity The COVID-19Antigen Test Cassette (nasopharyngeal swab specimen) has high sensitivity andspecificity when compared with PCR products on the market. Positive resultsbreak - down by days since symptom onset: Theclinical sensitivity is 97.6%:95%Cl（92.9%-99.5%） Days Post Symptom Onset Number of Samples PCR Positive COVID-19 Antigen Test Cassette 95% Confidence Interval 1 8 8 8（100%） 62.8%-100% 2 11 11 11（100%） 70.0%-100% 3 25 25 25（100%） 84.2%-100% 4 20 20 20（100%） 81.0%-100% 5 23 23 22（95.7%） 77.3%-99.9% 6 22 22 21（95.5%） 76.5%-99.9% 7 16 16 15（93.8%） 69.7%-99.9% 125 125 122（97.6%） 92.9%-99.5% Theclinical specificity is 99.6%:95%Cl（97.5%-99.9%） Number of Samples PCR PCR Negative Results COVID-19 Antigen Test Cassette 250 250 249/250=99.6% Total N/A 99.6%；95%Cl: (97.5%-99.9%) Test Procedure and Interpretation Ordering Information P/N Product Name Package G0400050* COVID-19 Antigen Test Cassette 25 tests/kit
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