Item No.: DPC-9012
Item Name:Influeza A+B Antigen Test Kit

INTENDED USE: One Step Influenza A Test is a rapid qualitative assay that detects influenza type A (including the subtype H1N1) nucleoprotein antigen extracted from the nasal swab specimen. The device is used to aid in the diagnosis of influenza type A infection.

Features:

1.You don't need to collect blood make it much more safer,easier and appealing to consumers;
2.Very sensitive,it's more than 99.9% .
3.Time will be shorter than Blood Test method,you should read results within 3-5 minutes.

Contents: 1 Influenza A+B Test Cassette + 1 desiccant bag,both of them are packed in a foil pouch;
                 1 pc of Sterile  Nasal swab
                 1 Extraction tube packed in a sealed plastic bag;
                 1 Extraction buffer in a dropper bottle (6mL): 0.1M phosphate buffer saline (PBS);
                 1 pc of Leaflet with instructions for use.
                 All the components are packed in the self-sealed bag or individual box.

Sensitivity of One Step Influenza A Test is:  91.3
Specificity of One Step Influenza A Test is:  95.7

Long shelf life: 24 months at room temperature.

ASSAY 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.Hold the extraction buffer bottle upside down vertically, then add 6 drops of extraction buffer 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 80μl~100μl) of extraction specimen from the extraction tube into the sample well of the test device by inverting and squeezing the tube as shown.
6.Record the result at 10 to 15 minutes, after 15 minutes record the result to be invalid or not.

SPECIMEN COLLECTION:
For proper test performance, use the swabs supplied in the kit.To collect a nasal swab sample, insert the sterile swab into the nostril that presents the most secretion under visual inspection. Rotating gently, then push the swab, until the resistance met the level of the turbinates (less than one inch into the nostril). Rotate the swab a few times against the nasal wall.
Place patients swab sample into the sample buffer. Roll the swab at least three times.

LIMITATION: The result only takes as the assistance diagnostic tool, doctors should unify the laboratory inspection according to patient's clinical symptom to make the correct diagnosis.

PRECISION:
The Flu A lowest determine precision should not be higher than 5×104TCID50/ 0.1mL
The Flu B lowest determine precision should not be higher than 2×105TCID50/ 0.1mL

ATTENTION:
 1. This test strip only to be used in external diagnosing
2. Expired or the expiration product cannot use

STORAGE: The test kit should be reserved at the room temperature4-25 recommended
TERM OF VALIDITY: 10 months