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
[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).