Flu A/Flu B Antigen 2 in 1 Combo Test
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
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.