Description
Lateral flow immunoassay method for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal swabs from subjects with symptoms or other epidemiological reasons to suspect COVID-19 infection.
The test is intended for use by non-professionals aged 15 and over, and, where appropriate, by adults to test another subject under 15 years of age. Subjects over 65 years of age must request assistance in performing the test.
The test only provides a preliminary screening result for the SARS-CoV-2 virus. Positive results must be confirmed by a laboratory-performed PCR test.
People with a negative test result who continue to experience COVID-19-like symptoms should consult a doctor.

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

Performing the test
Open the tube containing the extraction reagent by carefully removing the film. Insert the tube into the tube holder (hole on the packaging).
Remove the swab from the pouch: open the packaging from the stick end. Do not touch the swab tip. Extract the swab and gently insert the entire swab tip into the nostril, to a depth of about 2.5 cm. Rotate the swab against the nostril wall at least 5 times. Remove the swab, insert it into the other nostril and repeat the same operation. Perform this operation carefully: false negative results may 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 swab tip 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 squeeze 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 pressing 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 extra drops of sample are added, provided that 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 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 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 to be interpreted as positive. A positive test result indicates that you are likely carrying the COVID-19 disease. You should undergo a laboratory PCR test as soon as possible to confirm the COVID-19 diagnosis and follow local isolation guidelines to avoid transmitting the virus to others.

- NEGATIVE: only one colored line appears, the control line (C). The test line (T) does not appear. A negative test result indicates that you are probably not carrying the COVID-19 disease. Even if you get a negative result, you must still follow all guidelines to limit the spread of COVID-19. If symptoms develop or persist, undergo a laboratory PCR test. If infection is suspected, 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 professional at any time if symptoms persist or worsen, or if you are concerned about your health.
Negative results may occur if the test is not performed within the first 7 days of symptom onset.
Testing of a subject under 15 years of age must be performed by an adult.
Keep out of reach of children to reduce the risk of accidental drinking of the reagent or swallowing small parts.
Do not use after the expiry date.
The test is single-use and to be used only with the provided components.
Do not perform the test in direct sunlight.
Avoid contact with the extraction reagent. In cases 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 a sample to be taken from the nasal cavity. When performing the test, pay particular attention to the instructions on how to perform the swab. Incorrect sampling may result in an incorrect result. This is particularly important in the absence of symptoms.
The test cassette must remain in the sealed pouch until use.
Wash hands thoroughly before and after the test.
The test should only be used for the qualitative detection of SARS-CoV-2 antigens in samples collected with a nasal swab.
The intensity of the test line is not necessarily related to the viral titer of SARS-CoV-2 present in the sample.
Failure to comply with the "Instructions for use" may adversely affect test performance and/or invalidate the test result.
This is an exclusively presumptive test. In case of a positive result, immediate laboratory PCR testing and clinical follow-up are required.
Negative results may occur if the antigen level in a sample is below the test's limit of detection. It is recommended to repeat the test after 1-2 days if an ongoing infection is suspected, if you are in a high-risk environment or where there is occupational risk, or have known exposure to COVID-19.
Negative results do not rule out SARS-CoV-2 infection. If COVID-19-like symptoms appear, immediate further laboratory PCR testing is required.
Positive test results do not rule out co-infections with other pathogens.
A positive result cannot determine if a person is contagious.

Storage
Store in the sealed pouch at a temperature of 4-30 °C.
Validity in unopened packaging: 24 months.

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

Code ISCOVU002-B00