Description
The product is intended for the qualitative detection of SARS-CoV-2 antigens in clinical samples (nasal swab).
The current test card is based on the specific antibody-antigen reaction and immunoassay technology. The test card contains SARS-CoV-2 N protein monoclonal antibody labeled with colloidal gold, which is pre-coated on the combination pad, SARS-CoV-2 N protein monoclonal antibody immobilized on the test area (T), and the corresponding antibody in the quality control area (C). During the test, the N protein in the sample combines with the colloidal gold-labeled SARS-CoV-2 N protein monoclonal antibody, which is pre-coated on the combination pad. The conjugates migrate upwards under capillary action and are then captured by the N protein monoclonal antibody immobilized in the test area (T). The higher the N protein content in the sample, the higher the capture of conjugates and the darker the color in the test area. If there is no virus in the sample or if the virus content is below the detection limit, no color will appear in the test area (T). Regardless of the presence or absence of the virus in the sample, a purple stripe appears in the quality control area (C). The purple stripe in the quality control area (C) is a criterion for judging whether there is a sufficient sample and whether the chromatographic procedure is normal.
Diagnostic sensitivity: 92.00% (95%CI: 83.63%-96.28%)
Diagnostic specificity: 99.26% (95%CI: 95.92%-99.87%)

Instructions for use
Sample collection
During sample collection procedures, be careful to adequately protect yourself and avoid direct contact with the sample. In case of accidental contact, disinfection treatment must be carried out promptly and necessary measures must be taken.
Nasal swab sample: During sample collection, the swab head must be fully inserted into the nasal cavity and gently rotated 5 times. Once removed, the nasal swab head must be tested in the other nasal cavity in the same way to ensure there is enough sample.
Sample storage: After sample collection, complete the test within 1 hour. The sample should reach room temperature before testing.
Each test card must be used within 1 hour after removing the seals.
Test method
Please read the instructions for use carefully before performing the test. Before testing, bring reagents and sample to room temperature.
1. During sample collection, the swab head must be fully inserted into the nasal cavity and gently rotated 5 times. After removal, the swab head must be tested in the other nasal cavity in the same way to ensure there is enough sample.
2. Before testing, the double-sided adhesive protective layer must be removed in advance to avoid liquid splashing. If the double-sided adhesive protective layer is removed after adding the diluent, it is easy for liquid to splash.
3. Thread the swab sample through the bottom of well B into well A. Add 6 drops of diluent into well A. Do not pour the diluent into the other wells. Rotate the barrel twice in each direction.
4. During testing, the test card must be placed on a horizontal surface. The test card must be fixed and not removed.
5. After covering the left side, gently apply pressure to the adhesive position to completely match the sides and start timing. Wait until the purple stripe appears. The test result must be read within 15-20 minutes.
Interpretation of results
Positive (+): There are purple stripes in both the quality control area (C) and the test area (T).
Negative (-): There is only one purple stripe in the quality control area (C), and no purple stripe in the test area (T).
Invalid: There is no purple stripe in the quality control area (C), or there is a blue stripe in the quality control area (C), indicating incorrect operating procedures or that the test card has already deteriorated. In this condition, the instructions for use must be read again carefully, and then a new test card must be used to perform a new test. If the problem persists, stop using products with the same lot number and contact local suppliers immediately.

Warnings
The test results of this product must be judged comprehensively by the physician in combination with other clinical information, and should not be used as the sole criterion. The product is used to test the SARS-COV-2 antigen of the clinical sample.
The test is only suitable for professionals for in vitro auxiliary diagnosis. Do not use expired products. Do not freeze or use after the expiration date (see packaging for expiration date). Avoid excessive temperatures and humidity in the laboratory environment. The reaction temperature should be 15-30°C and humidity should be below 70%. The test card pouch contains desiccant and should not be taken orally. During the testing phase, wear protective clothing, a medical mask, gloves, and glasses. Do not use test cards with a broken single package, unclear markings, or after the expiration date. Dispose of used samples, test cards, and other waste according to local regulations and laws. The test card must be used within 1 hour after being removed from the aluminum pouch. Users must collect samples according to the Instructions for Use. Before testing, the double-sided adhesive protective layer must be removed in advance to avoid liquid splashing. If the double-sided adhesive protective layer is removed after adding the diluent, it is easy to cause liquid splashing. Do not pour the diluent into the wrong well. During testing, the test card must be placed on a horizontal surface. The test card must be fixed and not removed.
Cross-reactivity
This test has no cross-reactivity with endemic human coronavirus OC43, influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus, EB virus, measles, cytomegalovirus, rotavirus, Norovirus, mumps virus, varicella zoster, mycoplasma pneumoniae, human metapneumovirus.

Storage
Store at a temperature between 4°C and 30°C, in a dry place and away from sunlight.
Shelf life of unopened packaging: 12 months.

Format
Contains:
25 tests/kit;
1 instruction manual;
2 sample treatment solutions of 3 ml.

Code. TEST0007