Rapid test intended for the qualitative detection of SARS-CoV-2 antigen found in nasal cavity (anterior nasal) specimens from individuals with suspected COVID-19 infection. The kit is intended for self-testing.
Indications
Single-use test kit intended to detect SARS-CoV-2 that causes COVID-19 in self-collected nasal swab specimens.
The test is intended for use in symptomatic individuals who meet the case definition for COVID-19 as well as in individuals with suspected COVID-19 infection. in asymptomatic individuals, limited to contacts of confirmed or probable COVID-19 cases and at-risk healthcare workers.
Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens.
An antigen is generally detectable in upper respiratory tract specimens during the acute phase of infection.
Positive results indicate the presence of viral antigens, but clinical correlation with the patient's history and other diagnostic information is necessary to determine the infection status. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek further care from a healthcare provider. Positive results do not rule out bacterial infection or coinfection with other viruses.
Negative results do not rule out SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should contact their healthcare provider.
How to Use
Procedure
Wash your hands with soap and water for at least 20 seconds before and after the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
Remove the lid from the tube containing the swab extraction solution and place the tube in the tube holder on the box.
Sample Collection
Remove the sterile swab from the pouch.
Insert the swab into your nostril until you feel slight resistance (about 2 cm up your nose). Slowly rotate the swab, rubbing it along the inside of your nostril 5-10 times. This may be uncomfortable. Do not insert the swab further than this. Insert the swab thoroughly if you experience severe resistance or pain. If the nasal mucosa is damaged or bleeding, collecting a nasal swab is not recommended.
If you are collecting swabs from others, please wear a face mask.
With children, it may not be necessary to insert the swab as far into the nostril.
For very young children, another person may be needed to hold the child's head while collecting the sample.
Gently remove the swab. Using the same swab, repeat the process in the other nostril.
Remove the swab.
Sample Preparation
Place the swab in the extraction tube, make sure it touches the bottom, and shake the swab to mix well. Press the swab head against the tube and rotate the swab for 10-15 seconds.
Remove the swab by pressing the swab head against the inside of the extraction tube. Place the swab in the biosafety bag.
Close the cap of the extraction tube.
Test Procedure
Remove the test cassette from the sealed foil 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.
Open the small cap and invert the sample extraction tube and add 3 drops of the extracted sample to the well (S) of the test cassette and start the timer. Do not move the test cassette during the test.
Read the result at 15 minutes. Do not read the result after 20 minutes.
After completing the test, place all components in the plastic biosafety bag and dispose of according to local regulations.
Reading the Results
Please share the test result with your healthcare provider and carefully follow local COVID guidelines/requirements.
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). The intensity of the color in the test region (T) 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 to have COVID-19.
Positive samples must be confirmed. Immediately self-isolate as required by local regulations and contact your doctor or district health care provider as directed by local authorities. Your test result 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 been infected with COVID-19, however, this test may give an incorrect result (a false negative) in some people with COVID-19. This means that you may have contracted COVID-19 even if the test was negative.
You can repeat the test with a new kit. If you suspect COVID-19, repeat the test after 1-2 days, as the coronavirus cannot be detected at all stages of infection. Even with a negative result, social distancing and hygiene rules must continue to be observed.
INVALID: The control line does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely causes of the missing control line.
Review the procedure and repeat the test with a new kit or contact your healthcare provider or a COVID-19 testing center.
Warnings
Please read all information in the package insert before performing the test.
For in vitro self-diagnostic use only. 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 swab extraction solution contained in the kit.
Handle the swab with care and avoid contact with skin or eyes. Rinse immediately with plenty of running water if contact occurs.
Please do not use if the foil pouch is damaged or has been opened.
This test kit should only be used as a preliminary test, and repeatedly abnormal results should be discussed with a doctor or healthcare professional.
Strictly follow the indicated times.
Use the test only once.
Do not disassemble or touch the test window of the test cassette.
The kit should not be frozen or used after the expiration date printed on the package.
Keep out of reach of children.
Testing for children and adolescents should be performed in the presence of an adult. Young children should be swabbed with the help of a second adult.
Wash your hands thoroughly before and after handling.
Please ensure that an adequate amount of specimen is used for testing. Too much or too little specimen may lead to inaccurate results.
Performance has been evaluated only with nasal swab specimens, using the procedures described in the package insert.
The test will only indicate the presence of SARS-CoV-2 antigens in the specimen.
If the test result is negative or nonreactive and clinical symptoms persist, it is because the infection virus is very early and may not be detected. It is recommended to retest with a new kit or a molecular diagnostic device to rule out infection in these individuals.
Negative results do not rule out SARS-CoV-2 infection, especially in those who have been in contact with the virus. Molecular diagnostic screening tests should be considered to rule out infection in these individuals.
Positive COVID-19 results may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors.
Failure to follow test procedures may alter test performance.
False-negative results may occur if a specimen is improperly collected or handled, or if insufficient levels of virus are present in the specimen.
Storage
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). Do not freeze.
The test is stable until the expiration date printed on the sealed pouch. Do not use beyond the expiration date.
The test must remain in the sealed pouch until use.
Shelf life if packaged intact: 24 months.
Format
The kit contains:
- 1 test cassette;
- 1 sterile swab;
- 1 swab extraction solution;
- 1 biosafety bag;
- 1 package insert.
Product Code:FRCM172368
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