COVID-19 FLOWFLEX RAPID ANTIGEN TEST SELF-DIAGNOSTIC QUALITATIVE DETERMINATION OF SARS-COV-2 ANTIGENS IN NASAL SWABS BY IMMUNOCHROMATOGRAPHY ALUMINUM TUBE PM2 SERVICES

Description
Lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab specimens directly from individuals suspected of having COVID-19 within the first 7 days of symptom onset.
The test can be used to analyze samples from asymptomatic subjects.
It does not distinguish between SARS-CoV and SARS-CoV-2.
The results concern the identification of the SARS-CoV-2 antigen. This antigen is generally found in samples taken from the upper respiratory tract during the acute phase of the infection.
Positive results indicate the presence of viral antigens, but to determine the infection status, the patient's medical history and other personal diagnostic data are needed. Positive results do not exclude the presence of bacterial infections or simultaneous infection with other viruses. The detected pathogen may not be the exact cause of the pathology.
Negative results obtained in subjects with symptoms appearing more than seven days before should be treated as probable negative. If necessary, seek confirmation through molecular analysis.
Negative results do not rule out SARS-CoV-2 infection.
The test results are read visually within the next 15-30 minutes, based on the presence or absence of the colored lines.
A colored procedural control line will always appear in the control line area, indicating that sufficient sample volume has been added and membrane adsorption has occurred.
The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infection.
The usability of self-testing by individuals under the age of 18 has not been determined. It is recommended that anyone under the age of 18 be tested by an adult.

How to use
Preparation
Wash or disinfect your hands. Make sure they are dry before starting the test. Read the instructions carefully before performing the test.
Check the expiration date printed on the foil pouch. Open the pouch and check the result window and sample well on the cassette.

Sample collection
The sample can be collected independently or by a caregiver.
Self-collection of the sample can be performed by anyone aged 18 or over.
Children under 18 must be sampled by a parent or legal guardian. Follow local guidelines for sample collection from children.

Procedure
Unscrew the dropper cap from the extraction solution tube without squeezing it. Insert the tube into the hole on the kit box (or place the tube in the tube holder). Open the swab package at the end of the stick.
Caution: Do not touch the absorbent tip of the swab with your hands.
Insert the entire absorbent tip of the swab into one nostril. Using a gentle rotation, push the swab within 1 inch of the edge of the nostril. Rotate the swab five times while lightly touching the inside of the nostril. Remove the swab and insert it into the other nostril, repeating the step. Remove the swab from the nostril and insert it into the tube, circling for 30 seconds. Rotate the swab 5 times, while squeezing the side of the tube. Remove the swab while squeezing the tube.
Firmly attach the dropper tip to the extraction buffer tube containing the sample. Mix thoroughly by swirling or tapping the bottom of the tube. Unscrew the small cap from the end of the dropper. Gently squeeze the tube and dispense 4 drops of solution into the sample well.
Read the result when the timer reaches 15-30 minutes. Do not read if 30 minutes have passed.

Interpretation of results
- NEGATIVE: Only the control line (C) appears and no test line (T). This means that no SARS-CoV-2 antigen has been detected. A negative test result means that it is unlikely that you currently have COVID-19. Continue to follow all applicable rules and protective measures when coming into contact with other people. Even if your test is negative, you may still have an infection. If you suspect this, repeat the test after 1-2 days, as the coronavirus cannot be accurately detected at all stages of infection.

- POSITIVE: Both the control line (C) and the test line (T) appear. This means that the SARS-CoV-2 antigen has been detected. A positive test result indicates a very high probability that you have COVID-19. Contact your doctor/GP or local health authority immediately. Follow local guidelines regarding self-isolation. A confirmatory PCR test should be performed.
Note: Any line, even a very faint one, present in the test line (T) area should be considered positive.

- INVALID: The control line (C) does not appear. The most likely reasons for an invalid result are insufficient sample volume or incorrect procedure. Reread the instructions and repeat the test with a new cassette. If the test results continue to be invalid, contact your healthcare provider or a COVID-19 testing center.

Warnings
Before performing the test, carefully read the package insert. Failure to follow the instructions may result in inaccurate test results.
Do not use the test after the expiration date printed on the pouch.
Do not eat, drink or smoke before and during the test.
Do not use the test if the pouch is damaged.
All used tests, specimens and potentially contaminated material must be disposed of in accordance with local regulations.
Humidity and temperature can negatively affect results.
The test line for a sample with a high viral load may appear within 15 minutes or even sooner, when the sample exceeds the test line area.
The test line for a sample with a low viral load may appear within 30 minutes.
Do not collect the nasal swab sample if you have a nosebleed.
Wash hands thoroughly after use.
If the extraction swab accidentally comes in contact with skin or eyes, rinse with large amounts of water and consult a doctor if necessary.
The SARS-CoV-2 Antigen Rapid Test is for self-testing only. The test should only be used for the detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal swab specimens. The intensity of the test line does not necessarily correlate with the SARS-CoV-2 viral load in the specimen.
A false negative test may occur if the antigen concentration in a sample is below the detection limit of the test or if the sample was collected incorrectly.
Test results should be viewed in conjunction with other clinical data sources available to the physician.
Positive results do not exclude the presence of joint infections caused by other pathogens. Positive results do not distinguish between SARS-CoV and SARS-CoV-2.
Negative test results do not rule out the presence of other viral or bacterial infections.
A negative result obtained in a subject with symptoms appearing more than seven days previously should be treated as probable negative and, if necessary, verified by molecular analysis.

Conservation
Store the kit at a temperature between 2°C and 30°C. Do not freeze.
The test must remain in the sealed pouch until use.
The test is stable until the expiration date printed on the sealed pouch. Do not use after the expiration date.
Validity with intact packaging: 24 months.

Format
The kit contains:
- test cassette;
- extraction swab tube;
- disposable swab;
- waste bag;
- package leaflet.

Bibliography
1. Shuo Su, Gary Wong, Weifeng Shi, et al. Epidemiology, Genetic recombination and pathogenesis of coronaviruses. Trends in Microbiology, June 2016, vol. 24, No. 6: 409-502
2. Susan R. Weiss, Julian L. Leibowitz, Coronavirus Pathogenesis, Advances in Virus Research, Volume 81: 85-164

Cod. L031-11855