Description
Test for rapid and qualitative detection of nucleocapside protein antigen from SARS-CoV-2 in nasal swabs or human pharynants or nasopharynx buffers.
The Verino Pro SARS-CoV-2 rapid test Ag is based on immunochromatic technology. Each test has an antibody line anti-SARS-CoV-2 on the detection line (T line) and an antibody line IgG anti-tope on the quality control line (C line).
When the sample extract is added to the sample well, it will react with the marked antibody to form a complex, the mixture then migrates through the membrane for capillary action and interacts with the antibody anti-SARS-CoV-2 coated on the detection line.
If the sample contains the SARS-CoV-2 antigen, the detection line will appear red, to indicate that the SARS-CoV-2 antigen is positive.
Otherwise, the test result will be negative.
The test also contains a C quality control line that should appear red for all valid tests. If the C quality control line is not displayed, the test result will not be valid even if the detection line is displayed.
The test is only for in vitro diagnostic use. For professional use only.
It is intended for clinical laboratories and medical professional use only for test point of care.
The product provides only a preliminary result of the screening test. You must propose more specific alternative diagnosis methods (molecular diagnostics and/or TC) to confirm SARS-CoV-2 infection. Not for home use.

Mode of use
Sample collection
Nasal leg: it is important to get as much secretion as possible. Insert the sterile tampon into a nostril. The tip of the pad must be inserted up to 2.5 cm (1 inch) from the edge of the nostril. Rotate the swab 5 times along the mucosa inside the nostril to ensure that both the mucus and the cells are collected. Repeat this process for the other nostril to make sure to collect a proper sample from both nasal cavities (use the same swab).

Oropharynx: it is important to get as much secretion as possible. Insert the sterile swab into the throat area that presents the most secretion from the red area of the throat wall and the maxillary tonsils to collect the sample of the pharyngeal tampon. Gently rub the tonsils and the wall of the throat to get the sample. Please do not touch the tongue when removing the tampon.

Nasopharynx: it is important to get as much secretion as possible. Insert the sterile swab into the nostril that presents the most secretion on the basis of visual inspection. Keep the swab close to the base of the nasal septum while gently pushing the tampon into the rear renofaring. Rotate the swab 5 times, then remove it from the nasopharynx.

The samples you just collected must be tested as soon as possible. It is essential to follow the correct collection and preparation methods.

Test procedure
Before testing, wait for testing devices and extraction solution to reach a uniform temperature, including in the range of 15-30 °C.
Open the extraction solution (in the sealed tube). Insert the swab with sample collected in the pipe filled with the extraction solution. Rotate the swab 5 times by pressing the head against the bottom and side of the tube. Extract the swab while simultaneously crushing the sides of the tube to extract the liquid from the buffer. Try to let out as much liquid as possible. Dispose of the buffer used in biologically hazardous waste.
Put the tip of the test tube.
Extract a test from a sealed aluminum bag and place it on a clean and flat surface.
Apply 3 drops of sample extracted on the sample well. Please avoid bubble formation during extraction.
Read the test result after 15 minutes. Do not read the result after 20 minutes.

Do not exchange or mix extraction solutions from different batches.
Handle the extraction solution carefully, avoid contact with eyes or skin. In case of pouring on eyes or skin, wash thoroughly with water.
To comply with local regulations to manage the materials used.

Interpretation of results
Positive result: both the quality control line (C) and the detection line (T) appear.

Negative result: only the quality control line (C) is displayed without other lines.

Result not valid: the quality control line (C) does not appear, which means that the test is not valid, regardless of whether the detection line appears or not. Collect a new sample and run another test with a new test device.

Warnings
SARS-CoV-2 antigen test results should not be used as the sole basis for diagnosing or excluding SARS-CoV-2 infection or informing about the state of the infection.
Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. Follow-up tests with molecular diagnostics and/or TC must be taken into consideration to exclude infection in these individuals.
The positive results can be caused by the current SARS-coronavirus strain infection. To confirm the result of the test, it is necessary to consider follow-up tests with molecular diagnostic and/or TC.
The results of false negativity or positivity can be due to a sticky sample, insufficient sample volume or bubble formation during application.
Please take a new sterile packaging to take the sample if it is damaged or it is impossible to use.
Do not use unchecked UTMs or sterile pads, which could lead to false positivity or false negativity results.
For use only in vitro diagnostics. Not suitable for home testing.
It is recommended to perform additional molecular and/or TC diagnostic tests to identify the actual physical situation.
Do not open the foil pouch of the test by exposing it to its surroundings until the test is ready for use.
Do not use any damaged device or test material.
Do not reuse the test.
Handle the extraction solution carefully, avoid contact with eyes or skin. In case of pouring on eyes or skin, wash thoroughly with water.
Do not use the test beyond the expiry date.
Specific training or guidance is recommended if operators have no experience with sample collection and handling procedures.
Use only nasal swabs, oropharynx swabs or nasopharynx swabs as samples. Follow the leaflet to get accurate results.
Wear protective clothing such as lab coats, disposable gloves and eye protection during sample collection and evaluation procedures.
Wash your hands thoroughly after handling.
All parts of the kit are considered at biological risk and can potentially cause disease infectious from pathogens, even after cleaning and disinfection. Follow the appropriate precautions and all local regulations when you dispose of the used kits.

Conservation
Store the kit in a cool and dry place between 2-30 °C. Keep away from the light. Don't freeze.
Use the test between 10 and 90% humidity. Exposure at temperature and/or humidity outside the specified conditions can cause unexpected results.
Do not use the test over the expiry date (printed on the aluminum envelope and the box).
Validity of whole packaging: 24 months.

Format
The kit contains:
- 25 test boxes;
- 25 sterile swabs;
- 25 tubes containing the extraction solution;
- 25 caps for the extraction solution;
- 1 test support;
- 1 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.
4. 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.
5. Investigation of novel SARS-CoV-2 variant: Variant of Concern 202012/01, GOV.UK.
6. New SARS-CoV-2 variant, GOV.UK.
7. 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.
8. 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.