Status™ Rapid COVID-19 / FLU Combo POC – 25 Tests / Kit

$575.00

Rapid Immunoassay POC Covid-19 Test for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigens.

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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%

Additional information

Weight 23 lbs
Dimensions 20 × 24 × 14 in
Product Packaging

1 Kit – 25 tests, Case, Pallet