Flu A/Flu B Antigen
2 in 1 Combo Test

Key features and details:

Flu A/Flu B Antigen 2 in 1 Combo Test (Colloidal Gold) is a rapid immunoassay designed to qualitatively detect Influenza Virus type A and Influenza Virus type B antigen in nasopharyngeal swab specimens. It aids in diagnosing infections caused by these viruses.

Packaging Size:

25 Tests

SKU:

03FABA0025

FDA 510(k) Cleared:

K250398

Product Description:

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

Specifications:

SKU:

Disease Screened:

Influenza A, Influenza B

Analyte / Target:

Influenza A Virus, Influenza B Virus

Packaging Size

25 Tests

Sample Type:

Nasopharyngeal Swab

Diagnostic Platforms:

Rapid Test

Diagnostic Solutions:

Infectious Disease

Species Reactivity:

Human

03FABA0025

Compared with adults, children are more likely to spread the virus widely and for a long time, so the sensitivity to children's detection may be higher than that of adults.
This product is a one-time in vitro diagnostic reagent. Do not use expired products.
Results read after 30 minutes are considered invalid.
The temperature of the experiment environment should be avoided too high or too low; the test stored at low temperature needs to be restored to room temperature and then opened to avoid moisture absorption.
In case of long-term exposure to the environment, the product should be used within 1 hour of opening the pouch.
Use fresh specimens whenever possible, and do not use repeated freeze-thaw samples.
Please use the sample extract provided with this reagent, and do not mix different batches of the test and extraction diluent.
Sample collection should be accurate. Improper sample collection or processing may result in false negative results.
If a sample initially tests positive for Flu A, further confirmation is required. If necessary, consult your local public health prevention agency.
For testing Influenza A viruses or subtypes, small changes in epitopes due to small mutations in the nucleic acid sequence may result in negative results.
Follow standard biosafety guidelines for handling and disposal of potentially infectious material.
There is a desiccant in the aluminum foil pouch, which should not be taken.

The kit is for qualitative detection and auxiliary diagnosis only and cannot be used as the only basis for clinical diagnosis and treatment.
The kit is limited to the qualitative detection of Flu A/Flu B antigen in human nasopharyngeal secretion.
If the specimen is improperly collected, handled, or transported, the correct test results may not be obtained. Unreasonable sample collection, transportation, and processing and excessively low virus droplets in samples may also cause false-negative results.
Genetic variations in the virus may lead to changes in the epitope, which can lead to false negative results. This may happen with reagents using monoclonal antibodies.
For an emergent Influenza A virus, the most suitable type of sample to be tested and the best sampling time after infection (virus titer peak) may not be confirmed, so sampling multiple times in the same patient at multiple sites can reduce the likelihood of false negative results.
Samples were taken with certain medications, such as high concentrations of over-the-counter and prescription drugs (nasal sprays) that can interfere with results. If the results are suspicious, repeat the test.
Due to antigen detection reagent methodology limitations, its analytical sensitivity is generally lower than that of nucleic acid reagents. Therefore, laboratory personnel should pay more attention to the negative results and make a comprehensive judgment based on other testing results.
Further experimentation with positive results is recommended to confirm the subtype of influenza A virus and consult with the local public health prevention agency for consultation and treatment.

For more information on purchasing and further inquiries

Purchase Information:

CONTACT US: 800-678-6081 order@beb.bio