Status™ COVID-19/Flu A&B Rapid Antigen Test
1 swab, 1 sample, 3 results.
The Status™ Covid/Flu A&B rapid antigen combo test is authorized for professional use by the FDA (EUA) in point-of-care settings by organizations with CLIA certification. With visual results in 15 minutes, Status™ is the fastest and easiest way to differentiate between Covid, Flu A, and Flu B.
General Details
Test type: Antigen
Run time: 15-20 minutes
Collection type: Nasopharyngeal swab
Authorization: FDA EUA for professional use. CLIA required.
Intended Use: Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein and Influenza A & B strains.
Manufacturer: Princeton BioMeditech (USA)
CPT Codes: Covid-19 87811QW, Flu A 87804QW, Flu B 87804QW-59
Clinical Details
SARS-CoV-2: 93.9% Sensitivity, 100.0% Specificity
Flu A: Sensitivity 91.4%, Specificity 95.7%
Flu B: Sensitivity 87.6%, Specificity 95.9%
Specificity: No cross-reaction with species tested
Interference: No interfering factors tested
*See Instructions for Use for detailed clinical data.
Box Components
Nasopharyngeal swabs (25)
Test cassettes (25)
Extraction reagent capsules (25)
Positive control swab (1)
Negative control swab (1)
Instructions for use (1)
Quick reference guide (1)
Storage & Handling
Test kits should be stored at 35-86°F. Reagents and materials are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use. Do not freeze any contents of the kit.
Manuals and Instructions
Product Images
Intended Use
Status™ COVID-19/Flu test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.