V-CHEK 2019-NCOV AG SALIVA RAPID TEST

V-CHEK 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatographic)

V-Check Rapid Salivary Test single

The V-Check 2019-NCOV Ag Antigenic Rapid Saliva Test is a lateral flow immunoassay intended for the in vitro qualitative detection of 2019-nCoV N-protein antigen in human saliva samples. The Test Card can be used for individuals with or without symptoms or other epidemiological reasons for suspecting COVID-19 infections.

Suitable for self-diagnosis

A positive result indicates 2019-nCoV infection, and a doctor should be contacted. Additional tests are required. However, positive results do not exclude bacterial infections or co-infections due to other viruses. A negative result should be considered presumptive. He does not rule out being infected with 2019-nCoV. Negative results should be considered in the context of the patient's recent exposures, medical history, and the presence of clinical signs and symptoms consistent with COVID-19. Ideal for Covid self-testing.

Clinical Performance

Sensitivity 92.14%, 95% CI (88.39; 94.75)
Specificity 98.83%, 95% CI (97.47; 99.46)
Accuracy 96.47%, 95% CI (94.94, 97.55)

Principle of the test

This salivary test uses a pair of double antibodies to legally detect the new coronavirus (2019-nCoV) antigen in saliva samples. During detection the 2019-nCoV gold-labeled monoclonal antibody in the labeling pad binds to the anti-2019-nCoV antigen in the sample to form a complex and the reaction complex that runs along the nitrocellulose membrane below the action of chromatography, is captured by the monoclonal antibody of the anti-2019-nCoV pre-coated from the Test area (T) on the nitrocellulose membrane, and finally a red reaction line is formed in the Test area (T ). In case the sample does not contain the 2019-nCoV antigen, no red reaction line will be formed in the test area (T). Regardless of whether the sample to be tested contains a 2019-nCoV antigen or not, a red reaction line will always form in the Quality Control area (C) if the test was performed correctly.

Conservation and stability

Store the test card as packaged at temperatures between 2 and 30 ° C

Avoid exposure to sunlight, humidity and localized heat sources.

The Test Card is stable until the expiration date printed on the outside of the package.

Do not use the products after the expiration date.

Do not freeze any test contents.

The test card should be used within 1 hour of removing the foil from the pouch.

Test procedure

Before testing, please read the instructions carefully.
1. Remove the Test Card to allow it to equilibrate to ambient temperature.
2. Unpack by removing the foil from the envelope, placing the Test Card horizontally on the table.
3. Insert the saliva swab with the collected sample into the Test Card holder and push the saliva swab down. The bump at the end of the saliva pad should be in the hole in the Test Card holder.
4. When the test begins, the red color moves to the result window in the center of the test device.
5. Wait 10 minutes and read the results. Do not read the results after 15 minutes.

Documentation

• EC Certificate IVDD 21 042 0106
• IFU-V check self test- Saliva2019-nCoV Ag saliva rapid Test Card Ver1.4
• Declaration of conformity
• Variant detection

Format

Single test - 1 test / 1 kit