Status™ COVID-19/Flu A&B Rapid Combination Test
- 25 Tests per Box
- Test type: Lateral flow immunoassay
- Specimen type: Anterior nasal or nasopharyngeal swab specimens
- Turnaround time: 15-20 minutes
- FDA status: Emergency Use Authorization (EUA) Granted
- CLIA complexity: Waived
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 product 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.
- COVID-19 - Anterior nasal swab specimen − Sensitivity 93.8 %, Specificity 100%
- COVID-19 - Nasopharyngeal − Sensitivity 93.1 %, Specificity 100%
- Flu A - Sensitivity 91.4%, Specificity 95.7%
- Flu B - Sensitivity 87.6%, Specificity 95.9%
- Flocked nasopharyngeal swab for superior specimen collection and patient comfort
- Status COVID-19/Flu A&B test devices (25): The test strip in each device contains mouse monoclonal antibodies to nucleocapsid protein of influenza A, influenza B and SARS-CoV-2. The device is individually pouched.
- Extraction Reagent in capsules (25): For use with swab specimens; 300 µL of Phosphate buffer with detergents and preservative
- Sterile Swabs (25): For swab specimen collection
- Positive Control Swab (1): Influenza A, B, and SARS-CoV-2 antigen (non-infective recombinant nucleocapsid protein)
- Negative Control Swab (1): Inactivated Group B Streptococcus antigen (non-infective)
- Package Insert /Instructions for use (1)
- Quick Reference Instructions (1)
- Status™ COVID-19/Flu Provider Fact Sheet
- Status™ COVID-19/Flu Patient Fact Sheet
- Status™ COVID-19/Flu SDS
- Status™ COVID-19/Flu Sell Sheet
- Status™ COVID-19/CLSI
- Status Flu A&B Annual Reactivity Report
- Status™ COVID-19/Flu Package Insert
- Status™ COVID-19/Flu Provider Fact Sheet
- Status™ COVID-19/Flu Procedure Card
- Download PDF
- Download PDF
FAQs
This test can detect the presence of COVID-19, influenza A, and influenza B.
A negative result could be due to an antigen level below the test's detection limit, or if the sample was collected or transported incorrectly.
A positive result doesn't rule out co-infections with other pathogens. It also doesn't identify specific influenza A subtypes or differentiate between SARS-CoV and SARS-CoV-2.
If you need to differentiate between specific strains of influenza A or SARS, you should consult with your local or state public health department.
