Flu A/Flu B Antigen 2 in 1 Combo Test

$0.00

The Famwell Flu A/B Antigen Rapid Test is intended for the qualitative detection of Influenza Virus type A and Influenza Virus type B antigen directly from nasopharyngeal swab specimen of symptomatic patients.

The test is intended for use as an aid in the rapid differential diagnosis of Influenza type A and type B infection. The test is not intended to detect influenza C antigens.

Negative results should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

FDA 510(k) Number: K250398

The Famwell Flu A/B Antigen Rapid Test is intended for the qualitative detection of Influenza Virus type A and Influenza Virus type B antigen directly from nasopharyngeal swab specimen of symptomatic patients.

The test is intended for use as an aid in the rapid differential diagnosis of Influenza type A and type B infection. The test is not intended to detect influenza C antigens.

Negative results should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

FDA 510(k) Number: K250398

SPECIFICATION:

Method: Double antibody sandwich immunoassay-based test

Time to Result: 15–30 minutes

Storage Condition: Store at 4–30℃ (39–86℉). DO NOT FREEZE.

Shelf Life: 18 months

Sample Type: Nasopharyngeal swab

Cut-Off Level: Qualitative detection

Kit Sizes: 25 tests/box

Kit Contents:

  • Test Cassette

  • Extraction Diluent (500μL/Tube)

  • Dropper Tip

  • Swab

  • Instruction for Use (IFU)

Sensitivity / Specificity:

  • Influenza A: PPA: 85.7%, NPA: 99.5%

  • Influenza B: PPA: 85.7%, NPA: 100%

HOW TO USE:

Step 1: Allow the test device, specimen, and extraction diluent to reach room temperature (15–30°C / 59–86°F) before use.

Step 2: Remove the test device from the sealed aluminum foil pouch.

Step 3: Add 3 drops of the diluted specimen into the specimen well.

Step 4: Wait for 15–30 minutes for the results to appear.

Caution: Do not interpret the results after 30 minutes.