Healgen Covid & Flu Antigen Test

Specifications

• CLIA Waived

• Test type: Rapid Antigen

• Run time: 15 minutes

• Collection type: Lower nasal swab

• SARS-CoV-2: 92.0% PPA, 99.0% NPA

• Flu A: 92.5% PPA, 99.9% NPA

• Flu B: 90.5% PPA, 99.9% NPA

• CPT Codes: Covid-19 87811QW, Flu A/B 87804QW-59

• Manufacturer: Healgen

Storage & Expiration

• Store at 2-30°C (35-86°F)

• Do not freeze any contents of the kit.

• Reagents and materials are stable until expiration date printed on outer packaging.

• Test device must remain in the sealed pouch until use.

Box Components

• Lower nasall swabs (25)

• Test cassettes (25)

• Extraction reagent tubes (25)

• Instructions for use (1)

• Quick reference guide

Manuals & Documents

• Healgen Brochure

• Instructions for Use

• Quick Reference Guide

• Provider Fact Sheet

• Patient Fact Sheet

Intended Use

The Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptoms onset when tested at least twice over three days with at least 48 hours between tests. Clinical sign and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to 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 test is a 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.