WIZ Biotech COVID-19 / SARS-COV-2 Antigen Rapid Nasal Test, Approval for Private Use / Self-administration by Lay Persons, File Number Special Approval 5640-S-164/21 BfArM Listing (reimbursable), PEI evaluated (5 tests per box)12. November 2021
Profitest – Clungene® 3in1 COVID-19 Antigen Rapid Test – BfArM Listing (reimbursable) – AT079/20 – PEI evaluated (25 tests per box)14. November 2021
Wantai COVID-19 / SARS-COV-2 Antigen Rapid Saliva / Nasal / Lollipop Test, Approval Private Use / Self-administration by Lay Persons, CE2854, BfArM Listing (reimbursable) – AT1265/21 – (5 tests per box)
Wantai SARS-CoV-2 Antigen Lay Test Saliva/Nasal/Lollipop (Pack of 1)
The Wantai Covid-19 test is approved for use from 0 years of age and for this reason is recommended for kindergartens and schools.
- Colloidal gold immunoassay self-test
- Sensitivity: 95.4%
- Specificity: 99.6%
- Sample material: saliva or swab from the anterior nasal region
- Pack size: 5 tests
- Storage: 2…30°C
- Durability: 18 months
- Special approval for lay persons by the BfArM
- BfArM approval (AT1265/21)
- EU-RAT Listing No. 1484
Independent on vaccination coverage and incidence, corona self-tests are a practical means of infection control. On the one hand, they can be used in groups of people who are unvaccinated for a wide variety of reasons. On the other, they help enable increasingly regular daily routines and preventive action in the event of a new wave of infection.
The Wantai SARS-CoV-2 antigen lay test saliva/nasal/Lollipop is particularly suitable for sensitive groups of people, because: It can be applied to children as young as 0 years. In addition, it offers 2 variants of sample collection. This makes testing less complicated and the appropriate test procedure can be used depending on the patient.
Minimally invasive test procedure already for babies
The BfArM has already approved the Wantai SARS-CoV-2 Antigen Lay Test Saliva/Nasal/Lollipop Corona Self-Test for newborns as a lay test. This means that should it be necessary, it is possible to test babies for Corona infection using this test. The swab is taken either in the anterior nasal cavity or as a saliva sample. Thus, the test is also ideally suitable for daycare centers and schools. This is because older children, under the guidance of an adult, are easily able to perform a saliva test independently.
Corona self-test: Here’s how
The sample collection is conceivably simple in each variant. If the nasal swab is performed, the sterile swab must be inserted into both nostrils respectively. By turning it slowly, the sample material collects on it. When taking an oral swab, it is important to ensure that no food or drink is consumed for approximately 30 minutes prior to testing. The persons to be tested should also refrain from smoking during this period. To obtain the sample, the swab is inserted into the mouth. The sample material is collected from the upper palate and the inside of the cheeks. Care should be taken to ensure that the swab is well saturated.
The swab is then placed in the buffer liquid and carefully stirred several times. The swab must be squeezed out in the liquid to make all sample material available. After the user opens the dropper of the tube, he/she adds a few drops of the sample liquid to the test cassette. After about 15 minutes, the result is displayed on the test strip. If the test is positive, it is essential to contact a physician or the health department. In addition, a PCR test is required.
Reliable test results in minutes
The Wantai SARS-CoV-2 Antigen Lay Test Saliva/Nasal/Lollipop meets all RKI requirements and is highly reliable with a sensitivity of 95.4% and a specificity of 99.6%. When stored between 2 and 30° Celsius, the test can be used for 18 months. When using the test, hygienic conditions must be observed. This includes disinfecting hands and placing the test cassette on a clean surface. The sterile swab should never be touched.
One test kit contains:
- 5x individually wrapped test cassettes
- 5x sterile swabs
- 5x test tubes with extraction buffer
- 5x plastic bags for disposal
- 1x Instructions for use
- 1x quick reference guide
Whether babies from 0 years, school children or other sensitive groups of people: The Wantai SARS-CoV-2 antigen lay test saliva/nasal/Lollipop uncomplicated ensures more safety for all – especially in kindergartens and schools.
Notes on sales by PSA partners
Thanks to the special approval, sales through PSA partners can also be made to private individuals. In addition to purchasing smaller quantities of 10 or more, we also accept wholesale inquiries. Accordingly, we supply a large customer base who pass on these tests for laymen to the respective end customers.
You have further questions about our offer? Contact us and we will be happy to help you. Order the BfArM-approved rapid test and other high-quality protective equipment now from PSA-Partner.
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