CareStart Covid-19 Antigen Test Kits-Rapid Test Kits
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Lateral flow assay
Detect SARS-CoV-2 nucleocapsid protein antigen
Rapid results within 10-15 minutes
Intended at POC setting (i.e., inpatient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic use only
For prescription use only
For use with direct anterior nasal and nasopharyngeal swab specimens
Clinical Performance
93.75% PPAa and 99.32% NPAb when used with a nasopharyngeal swab
87.18% PPAa and 100% NPAb when used with anterior nasal swab
aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement.