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Germaine™ Laboratories Healgen™ COVID-19/Flu A and B Ag Combo Rapid Test Cassette Box

Catalog No. 23900207
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Quantity:
25 Tests/Kit
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Catalog No. Quantity
23-900-207 25 Tests/Kit
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Catalog No. 23-900-207 Supplier Germaine™ Laboratories Supplier No. GCFC525SA
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Description

Lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigens. Box of 25 test cassettes.

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. Positive results do not rule out bacterial infection or co-infection with other viruses.

Detect Three Respiratory Viruses Simultaneously from a Single Sample: Faster diagnosis for improved patient care and cost-effectiveness

  • 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

Box of 25 test cassettes

Specifications

CE Marker No
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 Test
Quantity 25 Tests/Kit
Form Swab
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