Description
The test is intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human saliva.
It provides only an initial screening result. More specific alternative methods (molecular diagnostics and/or CT) should be used for confirmation of SARS-CoV-2 infection.
It is based on immunochromatographic technology. Each test device is equipped with a SARS-CoV-2 monoclonal antibody detection line (T line) and a anti-human rat IgG monoclonal antibody band on the quality control line (C line).
When the extracted sample is added to the sample well, it reacts with the labeled antibody to form a complex, then the mixture passes through the membrane by capillarity and interacts with the anti-SARS-CoV-2 monoclonal antibody on the detection line.
If the sample contains the SARS-CoV-2 antigen, the purple-red detection line will appear, indicating SARS-CoV-2 antigen positivity.
Otherwise, the test result will be negative.
The test device contains a C quality control line which should appear in purple-red for all valid tests. If the C quality control line does not appear, the test result is invalid, even if the detection line appears.
The test is for professional in vitro diagnostic use only. It is intended for clinical laboratories and healthcare professional use only for point-of-care testing. Not for home use.

Instructions for use
Test procedure
Before performing the test, wait for the test devices and solution to stabilise at room temperature (15-30 °C or 59-86 °F).
Do not place anything in the mouth (including food, chewing gum, drinks or tobacco) for 10 minutes before sample collection.

After returning the test card to room temperature, open the foil pouch and remove the test card.
Do not eat/drink/smoke/chew anything for 30 minutes before the test. Rinse your mouth before the test.
Cough deeply to transfer saliva from the deep throat and enrich the saliva in the mouth. Remove the cover and insert the swab into the oral cavity. Allow the swab to soak completely in saliva and wait 2 minutes to ensure the saliva reaches the test window.
Remove the kit and cover it. Read the test result at 15 minutes. Do not read the result after 20 minutes.
Rinse your mouth immediately after using the test kit.

Interpretation of results
Positive result: both the C quality control line and the T detection line appear. The test should be considered positive if the T line is present, regardless of its intensity.

Negative result: only the C quality control line appears, without any other lines.

Invalid result: the C quality control line does not appear, which means the test is invalid, regardless of whether the detection line appears or not. Collect a new sample and perform another test with a new test device.

Warnings
For professional in vitro diagnostic use only.
The results of the SARS-CoV-2 antigen test should not be used as the sole basis for diagnosing or excluding SARS-CoV-2 infection or for communicating infectious status.
Negative results do not rule out SARS-CoV-2 infection, especially in individuals who have been in contact with the virus. Follow-up tests with molecular diagnostics and/or CT should be considered to rule out infection in these individuals.
Positive results may be due to an existing infection caused by SARS coronavirus strains. Follow-up tests with molecular diagnostics and/or CT should be considered to confirm the test results.
Incorrect results may be due to a viscous or insufficient sample or bubble formation during application.
Do not use with UTM not verified/authorised by the manufacturer. May lead to false positive or false negative results.
Further testing with molecular diagnostics and/or CT is recommended to establish the actual physical situation.
Do not open the test device's foil pouch, exposing it to the surrounding environment, until the test device is ready for use.
Do not use damaged test devices or materials. Do not reuse the test device.
Do not use beyond the expiry date.
Specific training or guidance is recommended if operators are not experienced with sample collection and handling procedures.
Use only saliva as a sample. Follow the instructions on the package leaflet for accurate results.
Wear protective clothing such as lab coats, disposable gloves, and eye protection during sample collection and evaluation procedures.
All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after cleaning and disinfection. Follow appropriate precautions and all local regulations when disposing of used kits.
Wash hands thoroughly after handling.

Storage
Store the kit in a cool, dry place between 2-30 °C (36-86 °F). Keep away from light. Exposure to temperature and/or humidity outside the specified conditions may cause inaccurate results. Do not freeze or refrigerate.
Do not use the kit beyond the expiry date.
Shelf life unopened: 24 months.

Format
The kit contains the test devices and the package leaflet.

Bibliography
1. Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2 [J]. Nature Microbiology, 5, 536-544 (2020).
2. Perlman, S. Netland, J. Coronaviruses post-SARS: update on replication and pathogenesis. Nature Reviews Microbiology 7, 439-450, doi: 10.1038/nrmicro2147 (2009).
3. Lauer SA, Grantz KH, Bi Q, et al. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020; 172 (9): 577-582. doi: 10.7326/M20-0504.
4. McCarron, MM, et al. Detection of Phencyclidine Usage by Radioimmunoassay of Saliva. J Anal Tox.1984 Sep-Oct.; 8 (5), pp 197-201.
5. B. Korber et al. Tracking Changes in SARS-CoV-2 Spike: Evidence that D614G Increases Infectivity of the COVID-19 Virus. Cell, vol. 182, no. 4, pp. 812-827.e19, Aug. 2020, doi: 10.1016/j.cell.2020.06.043.
6. Investigation of novel SARS-CoV-2 variant: Variant of Concern 202012/01, GOV.UK.
7. New SARS-CoV-2 variant, GOV.UK.
8. D. C. Dinesh et al. Structural basis of RNA recognition by the SARS-CoV-2 nucleocapsid phosphoprotein. PLoS Pathog, vol. 16, no. 12, p. e1009100, Dec. 2020, doi: 10.1371/journal.ppat.1009100.
9. J. Mariën et al. Evaluating SARS-CoV-2 spike and nucleocapsid proteins as targets for antibody detection in severe and mild COVID-19 cases using a Luminex bead-based assay. Journal of Virological Methods, vol. 288, p. 114025, Feb. 2021, doi: 10.1016/j.jviromet.2020.114025.

Code. VCD17-01- 019