Verify® Self Test Covid-19
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Verify® Self Test Covid-19
【 INTENDED USE 】
The COVID-19 Rapid Antigen Test (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2, which causes COVID-19, in human oral fluid. The test is intended for home use [1] with self-collection of oral fluid samples. The test is intended for use in symptomatic individuals who meet the COVID-19 case definition, as well as in asymptomatic individuals, limited to contacts of confirmed or probable COVID-19 cases and at-risk healthcare workers.
The COVID-19 Rapid Antigen Test (Oral Fluid) provides only a preliminary result; final confirmation must be based on clinical diagnostic results. 【 SUMMARY 】
The new coronavirus belongs to the β genus . COVID-19 is an acute respiratory infectious disease. Humans are generally susceptible. Currently, patients infected with the new coronavirus are the main source of infection; even asymptomatic infected individuals can be a source of infection. Based on current epidemiological investigations, the incubation period ranges from 1 to 14 days, with 3 to 7 days in most cases. The main symptoms include fever, fatigue, and a dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are present in a limited number of cases.
【 PRINCIPLE 】
The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative, membrane-based immunoassay for the detection of SARS-CoV-2 antigens in human oral fluid specimens.
【 REAGENTS 】
The test device contains anti-SARS-CoV-2 antibodies.
【 ATTENTION 】
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Read the package leaflet carefully before performing the test.
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The test is intended for in vitro self -diagnosis only.
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This test is for single use only; do not reuse. Do not use after the expiration date.
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Do not eat, drink, or smoke in the area where specimens or kits are handled.
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Do not drink the buffer solution in the kit. Handle the buffer solution.
with care and avoid contact with skin and eyes, in case of contact
rinse immediately with plenty of running water.
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Do not use the test if the package is damaged.
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Wash your hands thoroughly before and after handling.
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If the preliminary result is positive, inform your doctor of the result.
attending physician and carefully follow local instructions/regulations for cases of
COVID.
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Tests performed on children and adolescents must be carried out in the presence of adults.
10.The used test must be disposed of according to local regulations.
【 CONSERVATION 】
Store the test at temperatures between 35.6-86°F (2-30°C). Do not open the pouch until you are ready to perform the test. DO NOT FREEZE.
【 MATERIALS PROVIDED 】
Test cassette
Swab
Collection device (funnel, tube and tube tip)
Information leaflet
Biosecurity bag
【 MATERIALS NOT PROVIDED 】
Timer
【 TEST 】
Before taking the test
Do not put anything in your mouth, including food, drinks, chewing gum, or tobacco products, for at least 10 minutes before taking the test.
Wash your hands with soap and water for at least 20 seconds before testing. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
ace 1: Sample collection
Remove the funnel and plastic tube from the package, insert the funnel onto the tube.
Cough deeply 3-5 times.
Note: Wear a face mask or cover your mouth and nose with a cloth when coughing and maintain social distancing.
Gently spit the oral fluid into the funnel.
Oral fluid (without bubbles) should reach the height indicated by the reference line.
Note:
If the collected fluid is not sufficient, repeat the sample collection steps previously described.
Insert the used funnel into the bio -safety bag.
Step 2: Sample preparation
Pull to open the buffer solution and pour the entire solution into the tube with the oral fluid. Replace the cap on the tube. Gently squeeze the tube 10-15 times to mix well.
ace 3: Test execution
Remove the test device from the sealed pouch and use it within one hour. Best results are obtained if the test is performed immediately after opening the foil pouch.
Place the test cassette on a flat surface.
Turn the tube upside down and pour 2 drops of solution into the well (S) of the test device and then start the timer.
Do not move the test cassette while performing the test.
Step 4:
Read the results after 15 minutes. Do not interpret the results after 20 minutes.
After completing the test, place all test kit components in a biosafety bag and dispose of them according to local regulations. Do not reuse any used kit components.
Wash your hands thoroughly after disposing of the test.
【 READING THE RESULTS 】
Please inform your healthcare provider of your results and carefully follow local COVID guidelines/regulations.
POSITIVE:* Two colored lines appear. One colored line should appear in the control region (C) and another colored line should appear in the test region (T).
*NOTE: The color intensity in the test line region (T) varies with
depending on the number of SARS-CoV-2 antigens present in the sample. Therefore, the presence of any shade of color in the test region (T) should be interpreted as a POSITIVE result.
A positive result means that the person is highly likely infected with COVID-19; positive samples must be confirmed. Immediately self-isolate as required by local regulations and contact your doctor or local health authority as directed by local authorities. The test will be verified with a confirmatory molecular (PCR) test, and instructions on the next steps will be provided.
NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test line region (T).
It is unlikely that you have COVID- 19. However, it is possible that this test may give an incorrect result (a false negative) in some people with COVID-19.
This means that you could have COVID-19 even if your test came back negative.
Additionally, you can repeat the test with a new kit. If you suspect the virus, repeat the test after 1-2 days, as coronavirus cannot be detected at all stages of infection.
Even with a negative test result, social distancing and hygiene rules must continue to be observed. Migration/travel, participation in events, and so on should follow local COVID guidelines/requirements.
INVALID: The control line does not appear.
Insufficient sample volume or incorrect procedure are the most likely causes of a missing control line. Review the procedure and repeat the test with a new kit or contact your doctor.
doctor or a COVID-19 diagnostic center.
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