Description
The product is aimed at the qualitative detection of antigens against SARS-COV-2 in clinical specimens (nasal swab). Rapid test kit (colloidal gold immunochromatography) intended for the qualitative detection of antigens against SARSCoV-2 in clinical samples (nasal swab). - Non-invasive, simple to use;
- practical, does not require any device;
- fast, provides results in 15 minutes;
- stable and very accurate;
- economical and convenient.
The current test sheet is based on the specific antibody-antigen reaction and immunoassay technology. The test card contains colloidal gold-labeled SARS-CoV-2 N protein monoclonal antibody, which is pre-coated on the combination pad, the matched SARS-CoV-2 protein N monoclonal antibody immobilized on the test area (T) and the corresponding antibody in the quality control area (C). During testing, the N protein in the sample combines with the gold-labeled SARS-CoV-2 N colloidal protein monoclonal antibody, which is pre-coated on the combination pad. Conjugates migrate upward under capillary effect, and are subsequently captured by the immobilized N-protein monoclonal antibody in the test area (T). The higher the protein N content in the sample, the higher the conjugate captures 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 is shown in the test area (T). Regardless of the presence or absence of 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 or not there is sufficient sample and whether the chromatographic procedure is normal or not.
Clinical performance
Diagnostic sensitivity: 92.00% (95%CI: 83.63%-96, 28%)
Diagnostic specificity: 99.26% (95%CI: 95.92%-99, 87%)

How to use
Sample requirements
The product is used to test human nasal swab samples. Specimen Collection: During specimen collection procedures, care should be taken to adequately protect and avoid direct contact with the specimen. In case of accidental contact, the disinfection treatment must be carried out in time and the necessary measures must be taken. Nasal Swab Specimen: During specimen collection the swab head should be fully inserted into the nasal cavity and gently rotated 5 times. Once removed, the nasal swab head must be tried in the other nasal cavity in the same way to ensure that there is enough sample. Sample Storage: After sample collection, complete the test within 1 hour. The sample should come to room temperature before testing.
Test method
Please read the instructions for use carefully before performing the test. Before testing, bring the reagents and sample back to room temperature.
1. During specimen collection the swab head should be fully inserted into the nasal cavity and gently rotated 5 times. After removal, the swab head should be tried in the other nasal cavity in the same way to ensure that there is enough sample.
2. Before testing the double-sided adhesive protection layer must be removed in advance to avoid liquid splashes. If the double-sided adhesive protection layer is removed after adding the diluent, the liquid can easily splash.
3. Thread the swab sample through the bottom of well B into well A. Add 6 drops of diluent to well A. Do not pour the diluent into the other wells. Rotate the barrel twice in each direction.
4. During the test the test card must be placed on the horizontal plane. The test card must be fixed and must not be removed.
5. After covering the left side, press gently on the adhesive position to make the sides mate completely and start timing. Wait until the purple stripe appears. The test result should be read within 15-20 minutes.
Interpretation of the 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).
- Null: There is no purple stripe in the quality control area (C), or there is a blue stripe in the quality control area (C), thereby indicating incorrect operating procedures or that the proof has already deteriorated. In this condition, the instructions for use must be read carefully again, and then the new test card must be used to carry out a new test. If the problem persists, stop using products with the same lot number and contact your local suppliers immediately.

Warnings
The test plate must be used within 1 hour of opening. Read the instruction manual carefully. Do not use in case of damaged or opened package. The test results of this product should be evaluated by healthcare professionals in conjunction with other clinical information, and should not be used as the sole criterion for evaluation; This product is used to test for antibodies to SARS-CoV-2 of the sample.
The test is only suitable for professionals for an auxiliary in vitro diagnosis. Do not use expired products. Do not freeze or use after the expiration date (see package for expiration date. Avoid excessive temperatures and humidity in the laboratory environment. The reaction temperature should be 15 ° C-30 ° C and the humidity should be below 70%. Test card pouch contains desiccant and should not be taken orally. Wear protective clothing, medical mask, gloves and goggles during testing. Do not use test cards with single package broken, unclear markings , nor 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 taken out of the foil pouch. Users must take samples according to the Instructions for Use. Before testing the double-sided adhesive protection layer must be removed in advance to avoid liquid splashing. facial is removed after adding the diluent, it is easy to cause liquid splash. Do not pour the diluent into the wrong well. During the test the test card must be placed on the horizontal plane. The test card must be fixed and must not be removed.
Cross-reactivity
This test has no cross-reactivity with human coronavirus OC43 endemicity, influenza virus type A, influenza virus type B, respiratory syncytial virus, adenovirus, EB virus, measles, cytomegalovirus, rotavirus, norovirus, mumps virus, chicken pox zoster, mycoplasma pneumoniae, human metapneumovirus.

storage
Store at a temperature between 4 ° C and 30 ° C, in a dry place and away from sunlight.
Validity for intact packaging: 12 months.

Format
Contains:
20 test cards;
1 instruction manual for use;
2 3 ml diluted sample.

Cod.24585