Description
The LifeSign Status COVID-19/Flu A&B Rapid Immunoassay (#33225) comes with 25 tests per box. Each box includes 25 test devices, 25 extraction reagent capsules, 25 sterile nasopharyngeal swabs, a positive control swab, a negative control swab, a package insert, and a procedure card. With results in as little as 15 minutes, these top-of-the-line devices allow you to test in the privacy of your own home before any event giving you the peace of mind you need to enjoy yourself. The LifeSign Status COVID-19/Flu A&B Rapid Immunoassay has been Health Canada approved and received FDA Emergency Use Authorization (EUA).
Warranty: Until Use/Expiration.
Note: Physician’s licensing required. This is NOT an at-home test and should only be completed in a lab facility. The CLIA number MUST be provided before this item is ordered.
Features
LifeSign Status COVID-19/Flu A&B Rapid Immunoassay Features
- Flocked nasopharyngeal swab provides superior specimen collection and patient comfort.
- Visually read results in just 15 minutes.
- Sensitivity and Specificity:
- COVID-19: Sensitivity 93.9%, Specificity 100%.
- Flu A: Sensitivity 91.4%, Specificity 95.7%.
- Flu B: Sensitivity 87.6%, Specificity 95.9%.
- Health Canada approved.
- Approved under FDA Emergency Use Authorization (EUA).
Specifications
LifeSign Status COVID-19/Flu A&B Rapid Immunoassay Specifications
| Specimen Positivity Breakdown Based on Days Post Onset (COVID-19 positive = 46) | |||
|---|---|---|---|
| Days Posts Symptom Onset | # Specimens Tested | # Positive Specimens | %Positive |
| 01. | 27 | 16 | 59.3% |
| 1 | 43 | 13 | 30.2% |
| 2 | 25 | 6 | 24.0% |
| 3 | 14 | 6 | 42.9% |
| 4 | 10 | 5 | 50.0% |
| 52. | 6 | 0 | 0.0% |
- Two specimens were Status COVID-19/Flu negative and Positive by reference extracted RT-PCR.
- One specimen was Status COVID-19/Flu negative and Positive by reference extracted RT-PCR.
Literature
LifeSign Status COVID-19/Flu A&B Rapid Immunoassay Literature
LifeSign Status COVID-19/Flu A&B Rapid Immunoassay Package Insert
LifeSign Status COVID-19/Flu A&B Rapid Immunoassay Patient Fact Sheet
LifeSign Status COVID-19/Flu A&B Rapid Immunoassay Procedure Card
LifeSign Status COVID-19/Flu A&B Rapid Immunoassay Provider Fact Sheet
LifeSign Status COVID-19/Flu A&B Rapid Immunoassay SDS
LifeSign Status COVID-19/Flu A&B Rapid Immunoassay Sell Sheet