Healgen Covid-19 Test Kit

The Healgen Rapid COVID-19 Antigen Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.

Clinical Evaluation

Positive Percent Agreement (PPA): 95.7%

Negative Percent Agreement (NPA): 99.6%

Overall Percent Agreement (OPA): 98.9%

Specimen

Nasopharyngeal (NP) Swab

Time to Results

15 minutes

Shelf Life

24 months from the date of manufacture