STATUS™ COVID-19/Flu A&B Rapid Antigen Test

Status™ COVID-19/Flu A&B

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.

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.

Specification:

• Sample Type: nasopharyngeal swab specimens
• Detection Method: Colloidal Gold
• Detection Time: 15 minutes
• COVID-19 – Anterior Nasal – Sensitivity 93.8%,  Specificity 100%
  Nasopharyngeal – Sensitivity 93.1%,    Specificity 100%
  • Flu A – Sensitivity 91.4%,  Specificity 95.7%
  • Flu B – Sensitivity 87.6%,  Specificity 95.9%
• Interim order: IO#326827
• All necessary reagents provided and no equipment is needed

Each Box Contains:

• 25 individually packed test strips the test strips contain mouse monoclonal antibodies to nucleocapsid protein of influenza A, influenza B and SARS-CoV
• 25 Extraction Reagent capsules
• 25 individually packed sterile Swabs
• 1 Positive Control Swab: Influenza A, B, and SARS-CoV-2 antigen
• 1 Negative Control Swab
• 1 Package Insert /Instructions for use
• 1 Quick Reference Instructions

Interpretation of Results

Positive: A reddish purple Control line (C position) and a reddish purple Test line (Flu A, Flu B or CoV19 position) indicate that Influenza A, B and/or SARS-CoV-2 antigen has been detected.
Lines at the A and C positions indicate the presence of Influenza type A viral antigen, lines at the B and C positions indicate the presence of Influenza type B viral antigen, and
lines at the CoV19 and C positions indicate the presence of SARS-CoV-2 viral antigen in the specimen.

A positive result does not rule out co-infections with other pathogens or identify any specific influenza A virus subtype.

Negative: A reddish purple Control line (C position) only, with no Test line at the A, B, CoV19 positions.

Invalid: A reddish purple line should always appear at the Control line position (C position). If a line does not form at the Control line position in 15 minutes, the test result
is invalid and the test should be repeated with a new Status™ COVID-19/Flu test device.

Limitations

The performance of this test has not been evaluated for immunocompromised individuals.

The performance of the Status™ COVID-19/Flu test was not evaluated for SARS-CoV-2 detection with samples collected in viral transport media and should not be used with this test.

Individuals who received nasally administered influenza A vaccine may produce positive test results for up to three days after vaccination.

The Status™ COVID-19/Flu test can distinguish among influenza A, B and SARS-CoV-2 viruses, but it cannot differentiate influenza subtypes.

Performance of the Status™ COVID-19/Flu test has not been established for novel variants of SARS-CoV-2.

Extra Information

Product Insert

Factsheet for Healthcare Professionals

Factsheet for Patient