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COVID-19 Ag Nasopharyngeal Swab Test
COVID-19 Ag Nasopharyngeal Swab Test
CorDx’s COVID-19 Ag Nasopharyngeal Swab Test is a chromatographic immunoassay test for the qualitative detection of the COVID-19 antigen in human nasopharyngeal swab specimens. The COVID-19 Ag Test provides a fast and straightforward method to gain qualitative results for the diagnosis of COVID-19, allowing clinicians and medical staff to contain the spread of the infection quickly and effectively.
The target antigen detected by the COVID-19 Ag Test is N protein. The spike protein is the primary mutation site of the UK mutant strain (B.1.1.7), South African mutant (501.V2), and Brazil mutant (P.1). Therefore, the COVID-19 Ag Nasopharyngeal Swab Test can detect the virus antigens of these three mutants.
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产品参数
Accessories:
Test cassette
Nasopharyngeal swab
Buffer bottle
Collection tube
Collection tube holder box

Principle of Test:
Immunochromatographic assay

Intended Use:
The COVID-19 Ag Nasopharyngeal Swab Test is a chromatographic immunoassay test used for the qualitative detection of the COVID-19 antigen in human nasopharyngeal swab specimens.

Instructions for Use:
Sample Preparation:
Insert the sample collection tube into the hole of the provided box. Make sure that the tube is standing firm and reaches the bottom of the workstation.
Unscrew the top of the sample processing solution bottle.
Add 0.3 mL (all solutions in the buffer bottle) of the sample processing solution into the collection tube.
Insert the swab in the collection tube to the bottom, rotate, and squeeze the swab 10 times while pressing the head against the bottom and side of the collection tube.
Leave the swab in the collection tube for 1 minute.
Rotate and squeeze the tube several times with fingers from the outside of the tube to unwater the swab. Remove the swab.
Screw the cap of the collection tube.
Shake and mix the retained solution well. The retained solution will be tested with the COVID-19 Ag test.

Note:
Use a swab for specimen collection.
To avoid contamination, collect the specimen while wearing a pair of safety gloves.
Do not touch the tip (specimen collection area) of the swab.
Collect samples as soon as after the onset of symptoms.
It is recommended to treat the sample immediately after collection. The sample can be stored at 2–8oC for 72 hours, and it needs to be frozen at -20℃ for long-term storage. Avoid repeated freezing and thawing.

Test Procedure:
Read the instructions before testing.
Bring the pouched test to room temperature before testing.
Do not open the pouch until ready to begin testing.
Remove the test from the sealed pouch. Lay it on a flat, clean, and dry surface.
Reverse the sample collection tube and add 2–3 drops (about 75–100 μl) of the test sample by squeezing the collection solution tube into the sample well.
Read results within 10–15 minutes.

Interpreting the Results:
Positive: Control line and T line appear in the show window.
Negative: Only one line appears in the control area, and no line appears in the T area.
Invalid: If no line appears in the control area, the test results are invalid regardless of the presence or absence of a line in the test area. The direction may not have been followed correctly or the test may have deteriorated. It is recommended that repeat the test using a new device. Stop using the product and contact your local distributor if the problem persists.
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