The Verify® Self Test Covid-19 is a single-use rapid test for in vitro self-diagnosis of Sars-Cov-2 through oral fluid, providing a preliminary result.
Indications
The Covid-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the novel Sars-Cov-2 coronavirus that causes Covid-19 in human oral fluid. The test is designed for home use1 with self-collection of oral fluid samples. The test is Intended for use in symptomatic individuals who meet the case definition for COVID-19 as well as in asymptomatic individuals, limited to contacts of confirmed or probable cases of COVID-19 and healthcare workers at risk.
The COVID-19 Rapid Antigen Test (Oral Fluid) provides only a preliminary result; final confirmation must be based on clinical diagnostic results.
The novel coronavirus belongs to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, patients infected with the new coronavirus are the main source of infection; asymptomatic infected people can also be a source of infection. Based on current epidemiological investigations, the incubation period ranges from 1 to 14 days, in most cases from 3 to 7 days. The main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are present in a limited number of cases.
Composition
Active ingredients
The Covid-19 Antigen Rapid Test (Oral Fluid) is a membrane-based qualitative immunoassay for the detection of Sars-Cov-2 antigens in human oral fluid samples.
The test device contains anti-Sars-Cov-2 antibodies.
How to use Instructions for Use and Dosage
Before Testing
Do not put anything in your mouth, including food, drinks, chewing gum, or tobacco products, for at least 10 minutes before testing.
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.
Step 1: Specimen Collection
Remove the funnel and plastic tube from the packaging and insert the funnel over the tube.
Cough deeply 3-5 times.
Note: Wear a face mask or cover your mouth and nose with a cloth while coughing and maintain distance from bystanders.
Gently spit the oral fluid into the funnel.
The oral fluid (without bubbles) should reach the height indicated by the reference line.
Note:
If the fluid collected is not sufficient, repeat the sample collection steps above.
Insert the used funnel into the biosafety bag.
Step 2: Sample Preparation
Pull open the buffer solution and pour the entire solution into the oral fluid tube. Replace the cap on the tube. Gently squeeze the tube 10-15 times to mix well.
Step 3: Performing the Test
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.
Invert the tube and add 2 drops of solution into the well (S) of the test device, 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 the biosafety bag and dispose of it according to local regulations. Do not reuse any used kit components.
Wash your hands thoroughly after disposing of the test.
Inform your healthcare provider of the results and carefully follow local instructions/regulations for COVID-19 cases.
Positive:* Two colored lines appear. One colored line should appear in the control line (C) and another colored line should appear in the test line (T).
*Note: The intensity of the color in the test line (T) region varies 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 very likely infected with COVID-19; positive samples must be confirmed. Immediately self-isolate as prescribed by local regulations and contact your doctor or district health care as directed by local authorities. The test will be Your blood test has been verified by a confirmatory molecular test (PCR) and you will be given instructions on the next steps.
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 may have COVID-19 even if the test gave a negative result.
Also, you can repeat the test with a new kit. If suspected, repeat the test after 1-2 days, as the coronavirus cannot be detected at all stages of infection.
Even with a negative result, 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.
An insufficient sample volume or an 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 or a Covid-19 testing center.
Warnings
Read the package insert carefully before performing the test.
The test is intended for in vitro self-diagnosis only.
This test is single-use; do not reuse. Do not use after the expiration date.
Do not eat, drink, or smoke in the area where specimens or kits are handled.
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.
Do not use the test if the package is damaged. damaged.
Wash your hands thoroughly before and after handling.
If the preliminary result is positive, inform your doctor of the result and carefully follow the local instructions/regulations for COVID-19 cases.
Tests performed on children and adolescents must be performed in the presence of adults.
The used test must be disposed of according to local regulations.
Storage
Store the test at temperatures between 35.6-86°F (2-30°C). Do not open the package until you are ready to perform the test. Do not freeze
Format
1 Test
Product Code:FRCM228548
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