LifeSign Status™ COVID-19 Flu A&B Combo Test
A Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from anterior nasal and nasopharyngeal swab specimens.
***PLEASE NOTE - Unless you possess a verifiable CLIA number or NPI number requested and submitted during checkout process, you cannot order this product. All orders placed without one will be canceled and refunded.***
As an intended point-of-care (POC) designated test performed by medical professionals. Lifesign COVID-19/Flu A&B test helps provide critical answers about active infections to patients and healthcare workers alike.
A Rapid Point Of Care Test
- 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% - FDA Emergency Use Authorization (EUA)
- Visually read in 15 minutes
- Flocked nasopharyngeal swab for superior specimen collection and patient comfort
Kit Components
- 25 Test devices
- 1 Instruction for Use
Test type: Lateral flow immunoassay
Specimen type: Anterior nasal or nasopharyngeal swab specimens
Turnaround time: 15-20 minutes
FDA status: Emergency Use Authorization (EUA) Granted
CLIA complexity: Waived
Specimen type: Anterior nasal or nasopharyngeal swab specimens
Turnaround time: 15-20 minutes
FDA status: Emergency Use Authorization (EUA) Granted
CLIA complexity: Waived
- Status™ COVID-19/FLU A&B is an antigen test for use with nasopharyngeal swab specimens.
- Status™ COVID-19/FLU A&B test has been granted emergency use authorization (EUA) by the FDA for use at the point-of-care setting. During the duration of the emergency this test can be performed in a patient care setting that is operating under a CUA Waiver, Certificate of Compliance or Certificate of Accreditation
Product Resources
- Expiration Dating Memo 06-10-22
- Status™ COVID-19/Flu Package Insert
- Status™ COVID-19/Flu Provider Fact Sheet
- Status™ COVID-19/Flu Patient Fact Sheet
- Status™ COVID-19/Flu Procedure Card
- Status™ COVID-19/Flu Sell Sheet
- Status Flu A&B Annual Reactivity Report
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