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Healgen® COVID-19/Flu A&B Ag Combo Rapid Test
Regular price
$150.00
Sale price
$150.00
Regular price
Unit price
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Detect three respiratory viruses simultaneously from a single sample.
- 25 tests per box
- Rapid Detection: Results available in 15 minutes.
- Excellent Test Performance (comparator method RT-PCR).
- Simple and Effective: CLIA Waived testing at the point-of-care for use with minimally trained healthcare professionals.
- External Quality Controls Available: Facilitates routine quality procedures.
- Shelf Life that Spans Viral Seasonality: 16 months from date of manufacture at room temperature storage.
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Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for the 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 by their healthcare provider within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
- Items Per Box: 25
- Clia Complexity: Waived (EUA)
- Detectable Analytes: Influenza A and Influenza B Nucleoprotein Antigens, SARS-CoV-2 Nucleocapsid Antigen
- Detection Method: Qualitative Detection
- DoA Calibrators: No
- Format Test: Cassette
- Sample Type: Single Nasal Swab Sample
- Sensitivity: Test: SARS-CoV-2 Positive Percent Agreement: 90.2% Negative Percent Agreement: 99.1% Test: Flu A Positive Percent Agreement: 90.0% Negative Percent Agreement: 99.9% Test: Flu B Positive Percent Agreement: 91.2% Negative Percent Agreement: 100.0%
- Type: Rapid Test
- Disposable: Single-use For Use With (Application) Covid and Flu A+B Rapid
- 25 Sealed Test Cassettes
- 25 Sterile Nasal Swabs
- 25 Pre-filled Extraction Tubes
- 25 Extraction Tube Tips
- 2 Tube Holders
- 1 Instructions for Use
- 1 Healthcare Provider Fact Sheet
- 1 Patient Fact Sheet
- 1 Quick Reference Guide (QRG)
Pro-Tip
Detect 3 viruses at once (SARS-CoV-2, Flu A&B)
Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for the 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 by their healthcare provider within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests.
Frequently asked questions
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It is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of the SARS-CoV-2 nucleocapsid antigen and influenza A & B virus nucleoprotein antigens from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19, within the first five days of symptom onset.
It is authorized under Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) that meet the requirements to perform moderate, high, or waived complexity tests, and is for in-vitro diagnostic use only.
It detects three viruses at once (SARS-CoV-2, Flu A & B), uses shallow nasal swab sample collection, and is suitable for individuals aged 2 years and older (with adult swabbing for ages 2–13).
Results are available in about 15 minutes after specimen collection. A negative result is presumptive only and should not be used as the sole basis for treatment or management—clinical context, exposures and symptoms must also be considered.
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About Healgen
Innovation at the Core
Healgen is a leading global in-vitro diagnostics (IVD) developer and manufacturer, dedicated to improving healthcare worldwide through high-quality, reliable, and cutting-edge testing technologies.
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