OSOM® Flu SARS-CoV-2 Combo Home Test

The OSOM® Flu SARS-CoV-2 Combo Test and components should be stored between 15-30°C (59-86°F). Ensure all kit components are at room temperature before use.

Nasal Swab

In a clinical study to establish the performance characteristics of the OSOM® Flu SARS-CoV-2 Combo Test, samples were compared to PCR and the following positive percent agreements were determined per virus:

· SARS-CoV-2: 87.0% (determined by a controlled analysis, data shown is inclusion of 10% low positive samples by PCR)

· Influenza A: 99.3%

· Influenza B: 89.1%

In a clinical study to establish the performance characteristics of the OSOM Flu SARS-CoV-2 Combo Test, samples were compared to PCR and the following negative percent agreements were determined per virus:

· SARS-CoV-2: 99.1%

· Influenza A: 99.5%

· Influenza B: 99.7%

10 minutes

Each OSOM® Flu SARS-CoV-2 Combo Home Test has a built-in internal procedural control. The pink/purple line appearing at the “CONT” position verifies proper assembly and capillary flow of the test strip. A distinct pink/purple Control Line should always appear if the test has been performed correctly. If the Control Line does not appear, the test result is invalid, and a new test should be performed using a new swab and new test kit.