Status™ COVID-19/Flu test is an in vitro rapid qualitative test that detects SARS-CoV-2 and influenza A and influenza B nucleoprotein antigens, directly from nasopharyngeal swab specimens obtained from patients with signs and symptoms of respiratory infection, who are suspected of COVID-19 and/or influenza by their healthcare provider, within the first five days of onset of symptoms. It is intended to aid in the rapid differential diagnosis of SARS-CoV-2, influenza A, and B viral infections.
| Country of Origin | United States |
| Application | Rapid Test Kit |
| Contents | (25) Test Devices, (25) Extraction Reagent Capsules, (25) Sterile Swabs, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instruction |
| Number of Tests | 25 Tests |
| Storage | USP Controlled Room Temperature |
| Test Format | Test Device |
| Test Method | Lateral Flow Immunochromatographic Assay |
| SKU | 33225 |
| Test Type | Rapid Antigen Detection |
| Time to Results | 15 Minute Results |
| Box Packing | 20 Tests |
| Case Packing | 32 Kits (800 Tests) |
| Application | Rapid Antigen Test |
| Pallet Packing | 10 Cases (8,000 Tests) |
- Status™ COVID-19 / FLU A and B test has been granted emergency use authorization (EUA) by the FDA for use at the point-of-care setting: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- During the duration of the emergency, this test can be performed in a patient care setting that is operating under a CLIA Waiver, Certificate of Compliance, or Certificate of Accreditation
- Results are for the simultaneous identification of nucleocapsid antigens of SARS-CoV-2, influenza A and influenza B, but does not differentiate between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens
- The Status™ COVID-19/Flu test is intended for use by medical professionals and laboratory personnel trained to perform the test
- Flocked nasopharyngeal swab for superior specimen collection and patient comfort
- COVID-19 – Sensitivity 93.9%, Specificity 100%
- Flu A – Sensitivity 91.4%, Specificity 95.7%
- Flu B – Sensitivity 87.6%, Specificity 95.9%
