Description
In vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human nasopharyngeal swabs and oropharyngeal swabs, using the rapid immunochromatographic method.
Identification is based on specific monoclonal antibodies to the novel coronavirus antigen. It will provide information to clinicians to prescribe correct medications.
It is a membrane immunochromatographic test that uses highly sensitive monoclonal antibodies against the novel coronavirus.
The test strip consists of a sample pad, reagent pad and reaction membrane. The reagent membrane contains colloidal gold conjugated with monoclonal antibodies against the novel coronavirus; the reaction membrane contains secondary antibodies for the novel coronavirus and polyclonal antibodies against mouse globulin, which are pre-immobilized on the membrane.
When the sample is added to the device, the dried conjugates in the reagent pad dissolve and migrate along with the sample.
If coronavirus is present in the sample, a complex formed between the anti-coronavirus conjugate and the virus will be captured by the specific anti-coronavirus monoclonal antibody coated on the T region.
Regardless of whether the sample contains the virus or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) which binds to the remaining conjugates, thus producing a red line on the C region.
The test is intended for use by healthcare professionals or trained operators who are familiar with performing rapid antigen tests.

How to use
Sample collection and preparation
The sample must be collected using the collection tools provided with the kit. Follow the instructions for use. No other collection tools should be used for this test.

Nasopharyngeal swab: Insert the swab into the nasal cavity, slowly and gently. Do not overdo it to avoid traumatic bleeding. When the tip of the swab touches the posterior parts of the nasopharyngeal cavity, leave the swab in place for a few seconds (about 3 seconds) and gently rotate it. Then remove the swab.

Oropharyngeal swab: Do not put anything in your mouth, including food, drinks, gum, tobacco, water and mouth cleaning products for at least 10 minutes before sample collection. Have the patient tilt their head back and open their mouth, thus exposing the tonsils from both sides. Swab the root of the tongue. Clean the pharyngeal tonsils on both sides, applying some force for at least three times.

Test procedure
Allow the test device, sample and extraction tube to reach room temperature (15-30 °C) before testing.
Remove the aluminum seal from the sample extraction tube. Immerse the swab containing the sample in the tube, rotate it and press it 5 times. Remove the swab and dispose of it. Insert the cap on the extraction tube.
Gently shake the extraction tube for about 5 seconds to ensure the sample mixes well with the extraction solution.
Transfer 2-3 drops of solution vertically into the test card and start the timer.
Read the result at 15 minutes. Do not interpret the result after 20 minutes.

Interpretation of results
POSITIVE: two red lines appear. A red line appears in the control region (C) and a red line in the test region (T). The result should be considered positive regardless of the shade of color of the line in the test region (T).

NEGATIVE: only one red line appears in the control region (C), while no line appears in the test region (T). A negative result indicates that there are no novel coronavirus particles in the sample or that the number of viral particles is below the detection limit of the test.

INVALID: no red line appears in the control region (C). The test is invalid even if a line is present in the test region (T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the failure of the control line to appear. Review the test procedure and repeat the test using a new device. If the problem persists, stop using the kit and contact the local distributor.

Warnings
For in vitro diagnostic use only.
Do not use after the expiration date.
Ensure that the aluminum pouch containing the test device is not damaged before opening for use.
Wear gloves when handling samples. Avoid touching the reagent membrane and the sample window on the test card.
All samples and used components must be treated as infectious agents and disposed of according to local regulations.
Do not use bloody samples.
The kit is an acute phase screening test for qualitative detection. The collected sample may contain an antigen concentration below the detection limit of the reagent, so a negative test result does not rule out novel coronavirus infection.
The kit detects vital and non-vital novel coronavirus antigen. Test performance depends on the antigen load in the sample and may not correlate with cell culture performed on the same sample.
A positive result does not rule out the possibility that other pathogens may be present. Results must, therefore, be compared with all available clinical and laboratory information to make an accurate diagnosis.
If the level of extracted antigen in a sample is below the detection limit of the test or if the sample is collected inaccurately, a negative test result may be generated.
Positive results do not exclude co-infections with other pathogens.
Negative results do not exclude the possibility of other coronavirus infections (non-SARS-CoV-2).

Storage
Store at room temperature or in the refrigerator (4-30 °C). Do not freeze.
Validity with intact packaging: 24 months.

Format
The kit contains:
- test card;
- sterile swab;
- extraction tube;
- instructions for use;
- extraction tube cap.

Cod. RNS92048B