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

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

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

Form

Swab