COVID-19 & Flu A/Flu B RAPID TESTS

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

(Box of 25)

COVID-19 & Flu A/Flu B Rapid Test

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: 10-20 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.
      • Manufacturer: Salofa Oy (Finland)

Clinical Details

      • SARS-CoV-2: 93.8% Sensitivity, 99.2% Specificity

      • Specificity: No cross-reaction with species tested

      • Interference: No interfering factors tested

      • CPT Codes: Covid-19 87811QW

Box components

      • Nasopharyngeal swabs (25)
      • Test cassettes (25)
      • Extraction reagent capsules (25)
      • Workstation for mass testing (1)
      • Instructions for use (1)
Status™ COVID-19/Flu A&B Rapid Antigen Test

Manuals + Instructions

Storage and Handling

Test kits should be stored at 2-30°C (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.

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.

CONTACT

Direct Connect

15 + 12 =

Phone

(310) 957-9891