The SARS-CoV-2 rapid antigen test 2019-nCoV antigen test (lay test method)
From Guangzhou Wondfo Biotech Co., Ltd. Wondfo. It is a test kit (immunochromatographic) for the quick and easy qualitative detection of the novel coronavirus 2 (SARS-CoV-2) antigen. The test is intended for use as an aid in diagnosing SARS-CoV-2-induced coronavirus disease (COVID-19). Extraction of nasopharyngeal or oropharyngeal swab specimens (nose and throat swab), see instructions for use. Positive results already after 3-4 minutes, according to the manufacturer, however, only after 15-20 minutes.n.
Facts at a glance
- Box with 42 packaging units
- 20 tests per packaging unit including all consumables
- Result in 15 to 20 minutes
- Easy to use
- no additional materials required
- Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
- Sensitivity: 96.18% (95% CI: 96.43% ~ 98.49%)
- Specificity: 99.72% (95% CI: 98.45% ~ 99.95%)
- The test also detects the mutation from Great Britain VOC-202012/01, alias 20I / 501Y.V1 or B.1.1.7 or B117 as well as the mutation from South Africa 501.V2 alias N501Y.V2 or B.1.351
- CE, MDD 98/79 / EG
- EN ISO 13485, EN ISO 15223-1: 2016, EN ISO 23640: 2015, EN ISO14971: 2012, EN ISO 18113-1: 2011, EN 13641: 2002, EN 13612: 2002, EN ISO 18113-2: 2011, EN 62366: 2008
- Fulfills the minimum criteria for antigen tests set by the Paul Ehrlich Institute (PEI) in coordination with the Robert Koch Institute (RKI) and is available at BfArM (Federal Institute for Drugs and Medical Devices) as an antigen test for direct detection of the pathogen of the coronavirus SARS -CoV-2 listed.
- BfArM listed, test ID: AT125 / 20List of antigen tests (bfarm.de)
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