Xandr Universal Pixel

Status™ COVID-19 and Flu A/B Rapid Test (Rx only)

Lifesign Medical
SKU: Status1-c

$450.00 per package (25 tests per package)

The Status™ COVID-19 and Flu A/B test allows for healthcare providers to test patients with COVID-19 or flu-like symptoms by a rapid point of care solution. It provides three test results from one sample within 15 minutes.

The Status™ COVID-19 and Flu A/B test allows for healthcare providers to test patients with COVID-19 or flu-like symptoms by a rapid point of care solution. It provides three test results from one sample within 15 minutes.

The Fine Print

Purpose: The Status™ COVID-19 and Flu A/B test allows for healthcare providers to test patients with COVID-19 or flu-like symptoms by a rapid point of care solution. It provides three test results from one sample within 15 minutes.

Benefits: The test is read visually at the point-of-care in 15 minutes.

Sample type: Flocked nasopharyngeal swab for anterior nasal or nasopharyngeal specimen collection.

Technology: Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A, and Type B Antigens.

  • COVID-19 — Sensitivity 93.9%, Specificity 100%o
  • Flu A — Sensitivity 91.4%, Specificity 95.7%o
  • Flu B — Sensitivity 87.6%, Specificity 95.9%

When to test? Within first five days of symptom onset.

Limitation: Does not differentiate between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens.

In the USA, the Status™ COVID-19 and Flu A/B Rapid Test has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories; use by 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. The Status™ COVID-19 and Flu A/B Rapid 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.

  • No products in the cart.