INTENDED USE
A Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from anterior nasal and nasopharyngeal swab specimens. Status™ COVID-19/Flu A&B test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and/or 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.
PERFORMANCE
COVID-19
- Anterior nasal swab specimen − Sensitivity 93.8 %, Specificity 100%
- Nasopharyngeal − Sensitivity 93.1 %, Specificity 100%
Flu A/B
- Flu A - Sensitivity 91.4%, Specificity 95.7%
- Flu B - Sensitivity 87.6%, Specificity 95.9%
KEY BENEFITS
- FDA Emergency Use Authorization (EUA)
- Visually read in 15 minutes
- Flocked nasopharyngeal swab for superior specimen collection and patient comfort
Additional Information
The Status™ Covid-19/Flu A&B test has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under CLIA 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. This product has been authorized only for the detection of proteins from SARS-CoV-2 influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Status™ Covid-19/Flu A+B Rapid Test, QC Included
Item Status™ Covid-19/Flu A+B with QC Included Regulatory Authorized by the FDA under an EUA, pending FDA clearance / approval
CLIA-Waived & Approved for Point-of-Care TestingKit 25 tests/kit Controls Included Time to Result 15 minutes Sample Type anterior nasal or nasopharyngeal swab Performance COVID-19:
Anterior Nasal - 93.8% Sensitivity, 100% Specificity;
Nasopharyngeal - 93.1%, 100% Specificity
Flu A/B:
Flu A: 91.4% Sensitivity, 95.7% Specificity
Flu B: 87.6% Sensitivity, 95.9% SpecificityIntended Use For those who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms.