Genedia W – COVID-19 Ag
Antigen rapid test · 20 tests per box
Single-use in vitro diagnostic test for the qualitative detection of the SARS-CoV-2 antigen in nasopharyngeal or oropharyngeal swab and sputum samples. Result in 5–10 minutes; sensitivity 90.1%, specificity 100% versus RT-PCR. Professional use and home testing.
In vitro diagnostic medical device — professional use and home testing
Description
Genedia W COVID-19 Ag is a single-use in vitro diagnostic test and a qualitative immunoassay for the detection of the SARS-CoV-2 antigen in nasopharyngeal swab and sputum samples. It is designed for laboratory staff, point-of-care testing and home testing, as an aid in identifying patients suspected of infection and asymptomatic patients. Manufacturer: GC Medical Science Corp., Korea.
- Result in 5–10 minutes
- Sensitivity 90.1%, specificity 100%, evaluated against RT-PCR
- Sample type: nasopharyngeal and oropharyngeal swab
- No additional reagents or further processing
- Shelf life 12 months; storage between 2 °C and 30 °C
Box contents. 20 individually sealed test cassettes, 20 sealed extraction buffer tubes, 20 filter caps, 20 sterile swabs for nasopharyngeal and oropharyngeal sampling, 1 tube holder and 1 package insert.
Intended use
- Medical practices, laboratories and point-of-care testing
- Home testing
- Identification of suspected and asymptomatic patients
Frequently asked questions
What is in the box?
20 sealed cassettes, 20 buffer tubes, 20 filter caps, 20 sterile swabs, 1 holder and 1 package insert.
How is it stored?
Between 2 °C and 30 °C; shelf life 12 months.
Who may perform the test?
The test is intended for professional use and for home testing, following the manufacturer's instructions for use. In professional settings, sampling and interpretation are carried out by qualified medical staff.
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