FLU A+B Tests (BioSign) (Sold as Box of 25) - CLIA Waived

Draw nasal wash or nasopharyngeal aspirate sample to the first (lowest) mark of the graduated transfer pipette.

Dispense the entire sample in the transfer pipette into the Extraction Well of the test device.

Remove the cap from the Extraction Reagent bottle. Using a new transfer pipette--draw Extraction Reagent Solution to the first (lowest) mark.

Dispense all of the solution in the transfer pipette into the Extraction Well of the test device.

Incubate 1 minute.

Re-cap the Extraction Reagent bottle.

Raise the test device upright. Let it stand for 1-2 seconds.

Gently tap the device to ensure that the liquid flows into the hole. Lay the device back down onto the flat surface. Start timing.

Read test results at 10-15 minutes. Confirm negative results at 15 minutes.

FLU A&B

Positive: A reddish purple Control line (C position) and a reddish purple Test line (A or B position) indicate that Influenza A or B antigen has been detected. Lines at the A and C positions indicate the presence of Influenza type A viral antigen, and lines at the B and C positions indicate the presence of Influenza type B viral antigen in the specimen. A positive result does not rule out co-infections with other pathogens or identify any specific influenza A virus subtype. Determination of a positive result can be made as soon as both a visible Test line (either A or B) and Control line appear. Note: The Test line (reddish purple line) may vary in shade and intensity (light or dark, weak or strong) depending on the concentration of antigen detected. The intensity of the Control line should not be compared to that of the Test line for the interpretation of the test result. Even a light or faint Test line must be interpreted as a positive result.

Negative: Only a reddish purple Control line (C position), with no Test line at the A or B position, indicates that Influenza A or B antigen has not been detected. A negative result does not exclude infl uenza viral infection. Determination of negative results should not be made before 15 min.

Invalid: A reddish purple line should always appear at the Control line position (C). If a line does not form at the Control line position in 15 minutes, the test result is invalid and the test should be repeated with a new BioSign® Flu A+B test device.

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