Healgen Rapid Check SARS-CoV-2/Flu A+B Rapid Antigen Point-of-Care Test is a lateral flow immunoassay intended for in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from anterior nasal swab specimens obtained from patients who are suspected of COVID-19 by their healthcare provider, within the first five days of onset of symptoms.
Features and Benefits:
- SARS-CoV-2/Flu A+B Rapid POC Combo Antigen Test
- Simultaneous testing for acute respiratory infections caused by COVID-19, Flu A, Flu B
- Lateral flow immunoassay
- Covid-19: Sensitivity 92.0%; Specificity 99.0%
- Flu A: Sensitivity 92.5%; Specificity 99.9%
- Flu B: Sensitivity 90.5%; Specificity 99.9%
- Nasal swab samples
- Delivers results within 15 minutes
- No equipment necessary
- CLIA Waived Test
Authorized Laboratories:
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. This product 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.
Disclaimer:
"For Emergency Use Authorization (EUA) only*. For in vitro diagnostic use. For Prescription Use Only.
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens,
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner."
