Yingke Innovation Influenza A/B Virus Antigen Test Cassette Colloidal Gold Method

Influenza A/B Virus Antigen Test Kit
(Colloidal Gold Method)
【Product Name】
Generic name: Influenza A/B Virus Antigen Test Kit (Colloidal Gold Method)
【Packaging Specification】

Cassette type: 1 test/box, 10 tests/box, 20 tests/box, 40 tests/box, 50 tests/box, 100 tests/box. Boxed.
【Intended Use】
This kit is used for the in vitro qualitative detection of influenza A and influenza B virus nucleoprotein antigens in human throat swab samples.
For influenza A virus, this kit has been evaluated and clinically validated only for the novel influenza A H1N1 and seasonal influenza A H3N2 subtypes. 
【Storage Conditions and Shelf Life】
1. Store sealed and dry at 2~30°C; shelf life 24 months.
2. After the aluminum foil pouch is opened, use it as soon as possible within 1 hour;
if it cannot be used immediately,
store it at a temperature between 2~30°C,
and under conditions of humidity less than 30%; after use, the sample extraction solution bottle should be capped immediately, and
kept in a cool place or refrigerator within the shelf life.
3. Manufacturing date and shelf life: see the label.
【Sample Requirements】
Use sterile swabs with a PP (polypropylene) shaft and a polyester sponge tip for sample collection.
1. Throat secretion collection: to collect throat secretions, insert the swab fully into the pharynx through the mouth, and, with the reddened areas of the pharyngeal wall and palatine tonsils
as the center, wipe both palatine tonsils and the posterior pharyngeal wall with moderate force, avoiding contact with the tongue,
then remove the swab.
2. After collection, specimens should be processed with the sample extraction solution provided in this kit as soon as possible. If they cannot be processed immediately,
the specimen should be placed in a dry, sterile, strictly sealed plastic tube for storage; it can be stored at 2°C–8°C for 24 hours, and at -70°C
for long-term storage; the number of freeze-thaw cycles should not exceed 4.
【Test Method】
The instructions must be read in full before performing any test. Before use, remove the reagents and test samples from their storage conditions
and allow them to equilibrate to room temperature
(18~25°C) and humidity less than 90%, and label them.
Sample extraction:
1. Add 300 μL (~10 drops) of sample extraction solution to the sample extraction tube. 2
. Insert the sampling swab into the solution in the sample extraction tube, and immediately rotate it about 10 times against the inner wall of the tube to dissolve the specimen as much as possible
in the solution. 3
, squeeze the swab tip against the inner wall of the extraction tube so that the liquid remains in the tube as much as possible, then remove and discard the swab. 4
, and cap the dropper tip.

Test card procedure:
1. Place the test card on a clean, flat bench top, lay it horizontally, and label it. 2
. Vertically add 100 μL (about 3 drops) of the processed sample extraction solution into the sample well (S) of the test card. 3
. Read the test result within 15-20 minutes; results read after 20 minutes are considered invalid.

【Interpretation of Test Results】
Negative: Only one purple-red band appears in the control region (C), with no purple-red band in either test region A or test region B. Because the influenza A and B virus nucleoprotein antigen content in the specimen does not reach the minimum detection limit of this test or the antigen is absent, the test result is negative.
A negative result indicates that the influenza A and B virus nucleoprotein antigen content in the specimen is below the minimum detection limit of this test
or absent.
Positive: If two purple-red bands appear in both test region B and control region (C), it indicates influenza B virus
positivity; if one purple-red band appears in both test region A and control region (C), it indicates influenza A virus positivity.
Invalid: If no purple-red band appears in the control region (C), the result is invalid, indicating improper operation
or reagent deterioration. In this case, carefully read the instructions again and repeat the test using new reagents
. If the problem persists,
stop using that batch immediately and contact your local supplier.