Clungene COVID-19 antigen rapid self test (5 pcs/box)
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Unit price: €0,26/test
Clungene antigen rapid self test introduction
The Clungene COVID-19 antigen saliva test kit remains capable of detecting the mutated omicron coronavirus variant (download manufacturer’s certificate). The COVID-19 antigen rapid test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab from individuals with symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is intended for self-use by individuals aged 15 years or older and, as applicable for an adult lay user testing another person under 15 years of age. Individuals over 65 years of age should seek assistance in performing test.
Product name: COVID-19 antigen rapid test for self-testing
Specimen type: nasal (2,5 cm)
Kit size: 5 tests/box
Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Expiration date: 2023.03.
Clungene COVID-19 antigen rapid self test kit main components
- 5 pcs test cassettes
- 5 pcs extraction reagent tubes
- 5 pcs extraction buffers
- 5 pcs swabs
- Instructions for use
Clungene COVID-19 antigen rapid self test performance
The clinical performance of COVID-19 Antigen Rapid Test for professional testing was established in prospective studies with nasal swabs collected from 560 individuals. For comparison, to each of the subjects, an RT-PCR testing was performed by professional sampling with nasopharyngeal swab.
- The test correctly identified 95.5% (105 out of 110) SARS-CoV-2 positive samples with a confidence interval of 89.8% to 98.0% (known as sensitivity). The test correctly identified >99% (450 out of 450) of SARS-CoV-2 negative samples with a confidence interval of 99.2% to 100% (known as specificity).
- In a non-supervised clinical evaluation with 90 self-test users, the COVID-19 Antigen Rapid Test correctly identified 93.3% (28 out of 30) of SARS-CoV-2 positive samples with a confidence interval of 78.7% to 98.2%, and >99% (60 out of 60) of SARS-CoV-2 negative samples with a confidence interval of 94.0% to 100%.