Description
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This kit is designed for in vitro qualitative analysis of the SARS-CoV-2 nucleocapsid protein antigen from nasal swabs from individuals suspected of having COVID-19. The kit is intended for lay use and is intended for persons 7 years of age or older, children 7-14 years of age must be tested by an adult (over 18 years of age). People over 65 should ask for help to take the test. COVID-19 is an acute respiratory infectious disease. People are generally receptive. Based on current epidemiological investigation, the incubation period is 1-14 days, mostly 3-7 days. The main symptoms include fever, tiredness and a dry cough. In some cases, nasal congestion, runny nose, sore throat, muscle aches and diarrhoea may also occur.
CONTENTS OF THE TEST KIT
- Antigen test cassette
- R1 buffer solution
- Sampling swab
- Extraction tube (with dropper)
- Instructions for use
- Biohazardous waste collection bag
PRINCIPLES OF TESTING
This kit uses immunochromatography for detection. The sample advances through the test cassette by the phenomenon of capillarity. If the SARS-CoV-2 virus antigen is present, it binds to colloidal gold-labelled SARS-CoV-2 specific antibodies. The immunocomplex is captured by the coronavirus monoclonal antibody observed in the T (Test) line. If the specimen is SARS-CoV2 positive, both the T (test) and C (control) lines will be visible. If the sample is SARS-CoV-2 negative, the C (control) line will be visible but the T (test) line will be invisible. Line C should be visible if the test has been performed correctly.
TÁROLÁS ÉS STABILITÁS
1. can be stored at 2-30℃, shelf life up to 12 months. DO NOT FREEZE.
2. As soon as possible after opening the tinfoil packaging, the test cassette should be
to use.
PREPARATORY STEPS
1. Disinfect the surface where you will open the kit for testing. Remove and place the contents of the kit on a clean, flat surface.
2. Blow your nose and clear your nostrils before taking the test.
3. Wash your hands with soap and water. If soap and water are not available, use hand sanitiser. Before taking the test, dry your hands completely.
4. Prepare a timer or any device with a timing function.
TESTING METHODS
1. Push the box in along the dotted line to make a pipe rack. Place the extraction tube in the tube rack. Unscrew the end of the buffer solution container and place it upside down at the opening of the extraction tube so that it does not touch it. Carefully squeeze and empty the entire buffer solution into the extraction tube
A. Remove the tampon from the packaging. Do not touch the soft end (the head of the tampon) with your hand or anything else.
B. Insert the full, soft end of the swab into the nostril (about 1.5-2.0 cm). 5. Wash your hands or use hand sanitiser again after testing.
Slowly rotate the swab, pressing it against the inside of your nostril at least 5 times for a total of 15 seconds. Get as much nasal fluid as possible on the soft end of the swab. Carefully remove the swab.
Using the same swab, repeat steps B-D in the other nostril, using the same end of the swab.
3. Place the swab sample in the extraction tube, rotate the swab in the liquid for approx. for 10 seconds and press the head of the swab against the wall of the tube to release the sample inside the swab.
4. squeeze the swab over the head while removing the swab from the extraction tube to remove as much liquid as possible from the swab. After use, place the tampon in the biohazard waste collection bag.
5. Place the dropper head on the extraction tube, open the packaging and remove the antigen test cassette.
6. Add 2-3 drops to the collection port of the test cassette and start the timer. The drops should be liquid, not foam/bubble. If the drops are foamy/bubbly, add another drop.
7. Read the result in 15 minutes. A strong positive result is seen within 15 minutes, but a negative result can only be detected after 15 minutes. After 25 minutes the results are no longer valid.
8. The antigen test cassette, buffer solution, extraction tube (with dropper head) and sampling swab should be placed in the biohazardous waste collection bag after use and disposed of with household waste.
9. Wash your hands or reuse hand sanitiser after testing
INTERPRETATION OF THE RESULTS AND THE WAY FORWARD
Positive result: if both the C and T lines appear (as shown in the figure below), the new coronavirus antigen has been detected and the result is positive.
Take a very close look! The T line can be very faint. All pink/purple lines shown here indicate a positive result.
A positive result indicates that COVID-19 infection is currently suspected, if your result is positive, contact your doctor/physician or local health authority immediately and seek their professional opinion, follow local quarantine guidelines and have a COVID-19 PCR confirmatory test to confirm infection.
Negative result: if there is only a C line (as shown in the figure below), the T line is colourless, indicating that no new coronavirus antigen has been detected and the result is negative.
A negative result does not exclude the possibility of infection, and infection may still exist even if the result is negative. You must continue to comply with all applicable rules on contact with others and protective measures. In case of suspicion, please repeat the test after 1-2 days, as the new coronavirus may not be detected accurately at all stages of infection.
Invalid result: if the C-line is not observed, the result will be invalid regardless of whether there is a T-line (as shown in the figure below) and the test will have to be repeated.
An invalid test result is probably caused by the test not being executed correctly, please retake the test. If the test result is still invalid, contact your doctor or COVID19 test centre for a professional opinion and contact the manufacturer or local distributor immediately.
TESTING METHODS
1. Push the box in along the dotted line to make a pipe rack. Place the extraction tube in the tube rack. Unscrew the end of the buffer solution container and place it upside down at the opening of the extraction tube so that it does not touch it. Gently squeeze and empty the entire buffer solution into the extraction tube.
2. Sampling:
4. Read the result in 15 minutes. A strong positive result is seen within 15 minutes, but a negative result can only be detected after 15 minutes. After 25 minutes the results are no longer valid.
5. After use, the antigen test cassette, buffer solution, extraction tube (with dropper) and sampling swab should be placed in the biohazardous waste collection bag and disposed of with household waste.
ADVANTAGES AND DISADVANTAGES
Benefits:
1. This test kit can be transported and stored at room temperature and can be used for up to 12 months.
2. This test kit is user-friendly, requires no professional testing equipment, and
can be used by non-professionals on site or at home. The results are free
can be observed by eye in just 15 minutes.
3. The test results can help your healthcare provider to.
make informed recommendations about your treatment/care, and
can help limit the spread of COVID-19 to people in your family and in your environment
among.
Barriers:
1. This test kit is for in vitro use only.
2. This test kit is for use only with human anterior nasal cavity specimens. Results for other samples may be inaccurate.
3. This test kit can only be used for qualitative detection and cannot indicate the level of new coronavirus antigen in the sample.
4. This test kit is a clinical aid only. In the case of a positive result, other tests are recommended and the doctor’s diagnosis is the guide.
OGYÉI Registration number: OGYÉI/61561-3/2021
45/2014. (II. 26.) Korm. Regulation, the product cannot be returned after delivery for health or hygiene reasons; therefore, the 14-day right of return does not apply to this product.
29. § (1) The consumer may not exercise the rights under Article 20. § (consumer’s right of withdrawal) e) in respect of a product in a sealed package which cannot be returned after opening after delivery for health or hygiene reasons.
Imports and distributes:
A-Lab Pharma (Arvali Ltd.)
1054, Budapest, Szabadság tér 7. 1. em. (Bank Center)
www.alabpharma.hu
info@alabpharma.hu
Read our blog post on COVID snap-tests: http://rapidtest-lab.com/megjelentek-a-minosegi-nyaltesztek-europaban-es-magyarorszagon-is/
