Wondfo one step Influenza AB rapid test kit

Wondfo is a globally recognized fast growing POCT company devoted to R&D, manufacture and sales of rapid diagnostic reagents and medical devices in IVD field. Apart from the Guangzhou headquarters, Wondfo also owns one overseas lab in San Diego, one branch in Chicago and several overseas offices.“Quality is life!” is paramount in everything we do. Wondfo has won good reputation worldwide by providing premium products and professional services. We aim at serving the public, and hence people will trust Wondfo.
1. Quick and easy operation and 99% accuracy.
2. Wondfo has 27 years history, and has won good reputation around the world for good quality products and professional services..
3. Wondfo have got CE certificates, FSC certificates, ISO 9001:2008 and ISO 13485:2012 quality system certification.
4. For in vitro diagnostic use only.
Intended use
Wondfo One Step Influenza A&B Test is a rapid qualitative assay that detects influenza type A (including the subtype H1N1) and B
nucleoprotein antigens extracted from the nasal swab specimen.These device is used to aid in the differential diagnosis of influenza type A and B infection.
Materia
Material provided:
1.5 Individual sealed pouch, each containing:
Test device Desiccant pouch
2. 5 Extraction tube.
3. 5 Nasal swabs.
4. 5 bottles of extraction buffer (0.5mL/bottle).
5. Leaflet with instructions for use.

Interpretation of results
Positive (+)
A colored band is visible in the control region and one or two bands in the appropriate test region. It indicates a positive result for the influenza type A / B of that specific test zone.
1. Type A positive: One color band presents in test region “2” close to control region and one band in control region indicates influenza type A positive.
2. Type B positive: One color band presents in test region “1” away from control region and one band in control region indicates influenza type B positive.
3. Type A and type B positive: both two test bands present in the two test regions (“1”+”2”) and one band in control region indicate influenza type A and B positive.
Negative (-)
A colored band is visible in the control region. No colored band appears in the appropriate test region. It indicates that the
concentration of the influenza type A/B antigen of that specific test zone is zero or below the detection limit of the test.
Invalid:
No visible band at all, or there is a visible band only in the test region but not in the control region. Another test should be run to re-evaluate the specimen. If test still fails, please contact Wondfo or the distributor for technical assistance.
Note: There is no meaning attributed to line color intensity or width.
Test procedure
Allow the test device, specimen, and extraction buffer to equilibrate to room temperature (10°C ~30°C) prior to testing.
1. Use an extraction tube (provided) for each specimen to be tested, and label each tube appropriately.
2. Transfer all of the extraction buffer (about 400 l) to the extraction tube.
3. Place the specimen swab in the tube and swirl the swab for 10 times while pressing the
swab head against the inside of the tube to release the specimen in the swab.
4. Remove the swab while squeezing the swab head against the inside of the collection tube as you remove it to expunge as much liquid as possible from the swab. Discard the swab. Cap the tube and mix contents by gently swirling. The extraction specimen must be tested immediately.
5. Remove the test device from its sealed foil pouch by tearing at the notch. Dispense 3~4 drops (80 l~100 l) of extraction specimen from the extraction tube into the sample well of the test device by inverting and squeezing the tube as shown.
6. Read the test results at 15~20 minutes. DO not read test results after 30 minutes.