COVID-19(SARS-CoV-2) Antigen Test Kit (Latex Microsphere Immunochromatographic Assay)

Warning: This product is not available for US market.

A.Intended Use

This kit is a lateral flow immunoassay intended for the in vitro qualitative detection of SARS-CoV-2 nucleocapsid protein antigen from human anterior nasal swabs specimens of individuals who are suspected of COVID-19 within the first 7 days of symptom onset. 

This kit is intended to be used manually by untrained lay users(self testing) in a private setting to aid in the diagnosis of an active SARS-CoV-2 infection. This product is suitable for users over 1 years old.

Children between 1-14 years should be supervised by an adult.

B. Advantage&Features

Although the development cycle of antigen detection is relatively long, its

1. Sensitivity and specificity are higher than antibody detection

2. The pathogen can be detected at the initial stage of infection

3. Short TAT and simple operation.

4. No professional technicians and equipment are required, and the test can be completed in 15 min.

5. Home use.

6. Personal test.

C. Storage Conditions and Shelf Life

The test card and sample diluent should be stored at 2C~30℃, valid for 24months. Test cards should be used as soon as possible within 1 hour after opening the foil pouch.

Date of manufacture and expiration: See package label for details.

D. Specification

1Test/Kit(REF#,TC1002ST1);

3Tests/Kit(REF#,TC1002ST3);

5Tests/Kit(REF#,TC1002ST5)

E.Precautions

This kit is suitable for the auxiliary diagnosis of COVID-19, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision.

1. This is a single-use in vitro diagnostic reagent, do not reuse, and do not use expired products.

2. Dispose of all specimens, reaction kits and potentially contaminated materials(i.e. Swab, Tube, Test card) in bag provided.

3. Do not use the aluminium foil bag if it is damaged.

4. Do not open the sealed foil pouch before use and use it as soon as possible after opening the aluminium foil bag.

5. Use fresh specimens for testing, do not use repeated freeze-thaw samples.6. Operate at room temperature. Test cards kept at low temperature should be restored to room temperature before opening to avoid moisture absorption.

7. Do not use reagent kits with obvious damage or test cards with damaged or expired packaging.

8. The aluminum foil bag contains desiccant and must not be taken orally.

9. Remove the swab by rotating against the sample tube while squeezing the sides of the tube is important, and improper progressing may lead to false negative results.

10. Improper sample collection or processing may result in false-negative results.

11. If the initial screen is a positive sample, contact your local public health agency.

12. As with the diagnostic reagents used, the final diagnosis should be made by a physician after combining the various test parameters and clinical symptoms.

13. If you have any questions or suggestions on the use of this kit, please contact the manufacturer.

14. Detergent, perfume and other substances may contain similar disinfectant ingredients. If exposed to samples collected, it may cause false negative results. Hands should be thoroughly cleaned before sampling.

15. Samples stored for a long time may lead to the decrease of virus content. It may cause false negative results. Please test immediately after sampling.

F. Product Qualification（by Jan.30th,2023）