LITUO nasal-swab COVID-19 Box antigen rapid tests for home CE 1434
Manufacturer: Joinstar Biomedical Technology Co. LTD
Country of origin: CN/0720
Customs tariff number: 38220000
Weight per piece: 20 g
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Joinstar COVID-19 Rapid Antigen Test for Home, Applications, Nasal SamplingThe COVID-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of double antibody sandwich technology. The SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated with colored microparticles is used as a detector and sprayed onto the conjugation pad. During the test, the SARS-CoV-2 antigen in the sample interacts with the SARS-CoV-2 antibody, which is conjugated with colored microparticles, creating an antigen-antibody-labeled complex. This complex migrates via capillary action on the membrane to the
test line, where it is captured by the pre-coated monoclonal SARS-CoV-2 nucleocapsid protein antibody. A colored test line (T) would be visible in the result window if SARS-CoV-2 antigens are present in the sample. The absence of the T-line indicates a negative result. The control line (C) is used as a procedural control and should always be displayed when the test procedure is being carried out properly.
- Sensitivity: 94.53 %
- Specificity: >99 %
- Accuracy: 98.02%
- On the list of the BfArM (Federal Institute for Drugs and Medical Devices)
- Test for the qualitative detection of the SARS-CoV-2 antigen
- Tools for diagnosing an acute SARS-CoV-2 infection
- Sampling with a nasopharynx swab
- The test result is available in 15 minutes
- CE 1434
Set consisting of
- 1 test cassette
- 1 swab
- 1 extraction tube
- 1 buffer ampoule
- 1 instruction manual
No files available for download
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