One Step POCT Covid-19 2019-NCoV Antigen Rapid Test Kit Self Test Home Use
Register in Thailand Thai FDA (Food & Drug Administration)
Colloidal Gold Assay
² Fast: in 15 Minutes
² Easy: One Step
² Convenient: Self Test Home Used
² Cheap: Lower cost with high efficiency
MAIN COMPONENTS
• Covid-19 Rapid Test Cassette.
• Extraction Tube.
• Extraction Reagent.
• Nasal/Oral Swab.
STORAGE & STABILITY
• Store at 2 ~ 30 º C in the sealed pouch up to the expiration date.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
HOW TO PERFORM COVID-19 ANTIGEN RAPID TEST?
1. Remove a Test Device from the foil pouch by tearing at the notch and place it on a level surface.
2. Holding Extraction Reagent bottle vertically, add 10 drops (400μL) to the Extraction tube.
3. Insert the nasopharyngeal (and oropharyngeal) swab sample(s) into the extraction solution, then, mix the swab 10 times.
4. Remove the swabs while pressing against the solution tube in order to extract most of the specimen
5. Place the dropper cap and drop 3 drops into the sample well.
6. Read the result in 10-15 minutes. Do not read results after more than 20 minutes.
Something you need to learn about:
1) What is the difference between an antigen test and a molecular test?
An antigen test detects specific proteins on the surface of the virus. These tests are quicker and less expensive, but have a higher chance of missing an active infection, according to the FDA.
A molecular (PCR or polymerase chain reaction) test detects the virus’s genetic material. These tests require a more complex technology to get results, and it usually takes a day or two to get those results (depending on lab capacity, results may take up to a week).
If an antigen test shows a negative result and you have reason to believe you may have the virus (because of symptoms or exposure), your doctor may order a molecular test to confirm the results.
2) If antigen tests are less accurate, why would we use them?
Experts say the value in the rapid antigen tests is in the frequency of the testing rather than the accuracy, with repeated testing recommended. According to Science, getting a false negative in an antigen test two or three times in a row is rare. This strategy lines up with the NPR report mentioned above, which would employ daily testing of those in high-risk areas.
3) When should you perform Dewei COVID-19 Ag Rapid Test?
The COVID-19 Ag Rapid test should NOT be used for diagnosis of COVID-19 infection. Any individual who is symptomatic or a contact of a confirmed case should be directed to their healthcare provider, an assessment centre, or participating licensed community lab to seek PCR testing.
4) Do long-term care homes have to conduct the rapid antigen tests themselves?
The ministry is exploring developing a Vendor of Record to connect LTC homes wishing to contract with providers to conduct surveillance screening clinics on their behalf in the LTC home. The ministry would look to developing and providing the necessary templates and service agreements to support licensees in making decisions regarding entering into contracts with providers and the terms and conditions on which services are provided. The Vendor of Record would be optional and would not prevent homes from contracting with a qualified vendor that is not on this roster.
Thai FDA List:
Home Use No. 217
Professional Use No.164
Product Tags:
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One Step Antigen POCT Test Kit Covid 19 Rapid Ag Test Kit Self Test Home Use Thai-FDA Images
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