The product uses the wrong flow immunoassay for the qualitative detection of novel coronavirus antigen in nasopharyngeal and nasopharyngeal swabs in suspected patients.
Extensive application: applicable for hospitals, centers for disease control, communities, airports, stations, customs, schools, enterprises, etc
[Sample Requirements]
It is recommended to use polyester sponge samples with polypropylene rods for sterile sample collection.
(1) Collection method of pharyngeal samples: the head is slightly tilted, mouth open, and both pharyngeal tonsils are exposed. Apply the swab across the tongue to the pharyngeal tonsils on both sides of the recipient at least 3 times, and then wipe the swab up and down the posterior pharyngeal wall at least 3 times.
(2) Nasyngeal sample collection method: The sampler gently supports the head with one hand and the swab in one hand, inserts the nostrils and slowly stabbing back along the bottom of the lower nasal canal. Because the nose canal is curved, do not force too hard, so as not to cause traumatic bleeding. When the tip of the swab reaches the posterior wall of the nasopharyngeal, gently rotate the swab once (with a reflex cough, pause for a moment) and slowly remove the swab.
(3) Sample Treatment: The collected samples shall be treated with sample buffer provided in this kit as soon as possible (if not immediately, in dried, sterilized, sealed plastic pipes) and at 2 more than 24 h-8 ℃ at-70 ℃, but repeated freezing and thawing shall be avoided
Test Method
[Test method]
Return all reagents to room temperature before testing. The test shall be conducted at room temperature
I. Specimen extraction (see Figure 1)
1. adds 400 μL(about 10 drops) sample buffer vertically to the sample extraction tube, then inserts the sample into the solution, rotating about 10 times near the inner wall, leaving the sample as dissolved in solution as possible.
2. presses the sample tip along the inner wall of the extraction tube to keep the liquid in the tube as much as possible, remove and discard the sample.
3. covers the transmitter.
Second. Test procedure (see Figure 2)
1.. Remove the test card from the sealing bag.
2. adds 2 drops (about 80 μl) treated sample extract to the addition hole of the test card and then activates the timer.
3. The placed the test card at room temperature for 15 minutes to read the results. Invalid results after 20 minutes.
Interpretation of test results
Judgment diagram of the test card results:
① Invalid result: the quality control line (C line) has no reaction line, the test is invalid. The experiment should be redone.
② negative results: a red ribbon, quality control line (C line) color.
③ positive results: two red bands with color display on the test line (T-line) and QC line (C-line).
