Detailed Product Description

One Step Influenza A Test

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.

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.

(1) Sensitivity of One Step Influenza A Test is:  91.3

(2) Specificity of One Step Influenza A Test is:  95.7

1.          20 Individual sealed pouches, each containing:

    Test device

   Desiccant pouch

2.          20 Extraction tubes.

3.          20 Nasal swabs.

4.          One extraction buffer in a dropper bottle (6mL): 0.1M phosphate buffer saline (PBS).

5.          Leaflet with instructions for use.

OEM service available.

CE IVD certificate

KIT CONTENTS

1. Colloidal gold strips (10)

2. Sample buffer (10)

3. Sterile swabs (10)

4. Disposable Droppers (10)

5. Operation instruction (1)

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.

TESTING METHOD

 1. All reagents should be warmed to room temperature before use.

3. Open aluminum foil bags, take out the test kit, put on a horizontal plane, suck three to four drops of nasal swab sample with the dropper, then add it to the Sample Port.

4. Record the result at 10 to 15 minutes, after 15 minutes record the result to be invalid or not.

 RESULT EXPLANATION

Positive: a red Test Line (T) along with a red Control Line (C) appears.

Negative: only a red Control Line (C) appears.

If no red line appears or only a red Test Line (T) appears in the examination area, you should check the product expiration date, and test again according to requirement of instruction with the product in validation.

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

PACKING SPECIFACATION

10 strips /Kit

STORAGE

 The test kit should be reserved at the room temperature4-25 recommended

 TERM OF VALIDITY

10 months