Rapid salivary antigenic test for self-diagnosis. Intended for the qualitative detection of nCoV-2019 nucleocapsid protein antigen in saliva samples collected from patients with suspected COVID-19 infection within the first 7 days of symptom onset.

Description
V-Check Single Rapid Salivating Test
The V-Check 2019-NCOV Ag Rapid Antigenic 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 who show or do not show symptoms or there are other epidemiological reasons to suspect COVID-19 infections.

Suitable for self-diagnosis
A positive result indicates 2019-nCoV infection, and a doctor should be contacted. Additional tests are needed. However, positive results do not exclude bacterial infections or co-infections due to other viruses. A negative result should be considered presumptive. It does not exclude being infected with 2019-nCoV. Negative results should be considered in the context of the patient’s recent exposure, 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)

Test principle

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

kit-V-Check-2019-NCOV-Ag-Test-Salivary-Antigenic-Card-Immunochromatography—test-single

Conservation and stability

Store the test card as packed at temperatures between 2 and 30°C
Avoid exposure to sunlight, moisture and localised heat sources.
The Test Card is stable until the expiry date printed on the outside of the package.
Do not use the products after their expiry date.
Do not freeze any of the test contents.
The test card should be used within 1 hour after removal of the foil from the bag.
Test procedure

Please read the instructions carefully before carrying out the test.
1. Remove the Test Card to equilibrate it to the 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 bulge at the end of the saliva swab should be in the hole of the Test Sheet holder.
4. When the test begins, the red colour will move to the results window in the centre 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
Detection of variants