Clungene – COVID-19 Ag, nasal (1/box)
Antigen rapid test · nasal swab · 1 test per box
Lateral-flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab samples from individuals aged 7 years or older. Result in 10–15 minutes, individually packed single test.
In vitro diagnostic medical device — professional use and home testing
Description
The Clungene COVID-19 Antigen Rapid Test is a lateral-flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab samples from individuals aged 7 years or older. The test is supplied as an individually packed single test.
- Evaluated against RT-PCR
- Rapid results: 10–15 minutes
- Simple, quick procedure; no additional reagents or further processing; visual reading of the result
- Shelf life: 24 months; storage between 4°C and 30°C
Box contents (1 test, individually packed): 1 sealed test cassette, 1 sample solvent container, 1 extraction tube with cap, 1 sterile nasal swab, 1 package insert.
Manufacturer: Hangzhou Clongene Biotech Co., Ltd. (China). EC representative: Shanghai International Holding Corp. GmbH (Europe), Hamburg, Germany.
Intended use
- Medical practices, laboratories and point-of-care testing
- Home testing
Frequently asked questions
Which sample does it use?
A nasal swab, from individuals aged 7 years or older.
Who may perform the test?
The test is intended for professional use and for home testing, following the manufacturer's instructions for use.
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