RAPID ANTIGEN TEST COVID-19 CLUNGENE SELF-DIAGNOSTIC QUALITATIVE DETERMINATION OF SARS-COV-2 ANTAGENS IN NASAL SWABS BY IMMUNOCHROMATOGRAPHY

Description
Lateral flow immunoassay method for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal swabs of subjects with symptoms or other epidemiological reasons suggesting COVID-19 infection.
The test is intended for use by lay persons aged 15 years and older and, as appropriate, by adults to test another person under the age of 15. Persons over the age of 65 should seek assistance in performing the test.
The test provides only a preliminary screening result for the SARS-CoV-2 virus. Positive results must be confirmed by a PCR test performed in a laboratory.
People with a negative test result who continue to experience COVID-19-like symptoms should seek medical attention.

How to use
Test preparation
Make sure all test components are at room temperature (15-30°C).
Keep a clock, timer, or stopwatch handy.
Check that the package is intact. Do not use the test if the package is visibly damaged.
Do not open the test cassette package until you are ready to use it. Use the test cassette within one hour of opening the package.
Wash your hands with soap and water and dry them thoroughly.

Running the test
Open the tube containing the extraction reagent by carefully removing the film. Insert the tube into the tube holder (hole on the package).
Remove the swab from the pouch: open the package at the end of the stick. Do not touch the head of the swab. Remove the swab and gently insert the entire head of the swab into the nostril, to a depth of about 2.5 cm. Rotate the swab against the wall of the nostril at least 5 times. Remove the swab, insert it into the other nostril and repeat the same operation. Do this carefully: false negative results can occur if the nasal swab is not performed correctly.
Insert the swab into the tube containing the extraction reagent. Rotate the swab 5 times inside the reagent, pressing the head of the swab against the bottom and side of the tube. Leave the swab in the reagent for 1 minute. Remove the swab by pressing the sides of the tube to release the liquid from the swab. Close the tube tightly with the cap.
Open the sealed pouch containing the test cassette and remove it. Place the test cassette on a flat surface.
Hold the tube vertically over the sample well and add 3 drops to the well, gently squeezing the sides of the tube. A false negative result may occur if less than 3 drops of sample are added to the well. The result will not be affected if 1-2 more drops of sample are added, as long as the control line (C) can be read.
Start the clock/stopwatch or timer. Read the test result after 15-20 minutes, do not read the result if more than 20 minutes have passed. Incorrect results may occur if the test results are read before 15 minutes or after 20 minutes.
Once the test is performed, collect the used kit parts and swab samples in a disposal bag and dispose of them with household waste. Wash your hands thoroughly after handling.

Interpretation of results
- POSITIVE: Two lines appear, the control line (C) and the test line (T). The color intensity of the test line (T) may be very faint, but the result is still positive. A positive test result indicates that you are likely to be a carrier of COVID-19. You should undergo a laboratory PCR test as soon as possible to confirm the diagnosis of COVID-19 and follow local isolation guidelines to avoid transmitting the virus to others.

- NEGATIVE: Only one colored line, the control line (C), appears. The test line (T) does not appear. A negative test result means that you are probably not carrying COVID-19. Even if you get a negative result, you should still follow all guidelines to limit the spread of COVID-19. If you develop symptoms or if symptoms persist, get a laboratory PCR test. If you suspect an infection, it is recommended to repeat the test after 1–2 days, as the virus cannot be accurately detected at all stages of infection.

- INVALID: The control line (C) does not appear. The test result is invalid regardless of whether the test line (T) appears or not. Repeat the test with a new cassette or contact your doctor.

Warnings
For in vitro diagnostics only.
Do not use this test as the sole basis for managing COVID-19 infection. Please consult a healthcare provider at any time if symptoms persist or worsen, or if you are concerned about your health.
Negative results may occur if testing is not performed within the first 7 days of symptoms appearing.
Testing on a subject under 15 years of age must be performed by an adult.
Keep out of reach of children to reduce the risk of accidentally drinking the reagent or swallowing small parts.
Do not use after expiration date.
The test is for single use only and should be used with the components provided.
Do not perform the test in direct sunlight.
Avoid contact with the extraction reagent. In case of inhalation, ingestion or skin or eye exposure to the extraction reagent, immediately take first aid measures in accordance with the safety data sheet (SDS).
The test requires taking a sample from the nasal cavity. When performing the test, pay close attention to the instructions on how to perform the swab. Performing the sampling incorrectly may result in an incorrect result. This is especially important if you have no symptoms.
The test cassette must remain in the sealed pouch until ready for use.
Wash your hands thoroughly before and after testing.
The test is to be used only for the qualitative detection of SARS-CoV-2 antigens in nasal swab samples.
The intensity of the test line does not necessarily correlate with the SARS-CoV-2 viral titer present in the sample.
Failure to follow the "Instructions for Use" may adversely affect the performance of the test and/or invalidate the test result.
This is a presumptive test only. If the result is positive, you should immediately undergo a laboratory PCR test and clinical follow-up.
Negative results may occur if the antigen level in a sample is below the detection limit of the test. It is recommended to repeat the test after 1-2 days if you suspect an ongoing infection, are in a high-risk environment or where there is an occupational hazard, or have a known exposure to COVID-19.
Negative results do not rule out SARS-CoV-2 infection. If you experience symptoms similar to COVID-19, you should immediately undergo an additional laboratory PCR test.
Positive test results do not exclude co-infections with other pathogens.
A positive result cannot determine whether a person is contagious.

Conservation
Store in the sealed bag at a temperature of 4-30 °C.
Validity with intact packaging: 24 months.

Format
The kit contains:
- 1 test cassette;
- 1 test tube containing extraction reagent;
- 1 swab;
- 1 disposal bag;
- 1 instructions for use.

Code ISCOVU002-B00