Genedia W – COVID-19 Ag (1/box)
Antigen rapid test · 1 test per box
Single-use qualitative immunoassay for SARS-CoV-2 antigen in nasopharyngeal / oropharyngeal swab or sputum. Result in 5–10 minutes; identifies the Delta variant.
In vitro diagnostic medical device — professional use and home testing
Description
Genedia W COVID-19 Ag is a single-use in-vitro diagnostic and qualitative immunoassay for the detection of SARS-CoV-2 antigen in human nasopharyngeal swab and sputum specimens. It is designed for professional laboratory and point-of-care staff as an aid in identifying suspected infected patients and asymptomatic patients.
- Rapid results: 5–10 minutes
- Sensitivity 90.1%, specificity 100% — evaluated against RT-PCR
- Sample type: nasopharyngeal and oropharyngeal exudate
- Simple, quick and inexpensive procedure that supports a fast clinical decision; no additional reagents or further processing
- Shelf life: 12 months; storage between 2°C and 30°C
- Identifies the Delta variant
Box contents (1 test): 1 test cassette sealed in protective foil, 1 sealed container with sample solvent, 1 filter cap for the container, 1 sterile swab for nasopharyngeal and oropharyngeal sampling, 1 container holder, 1 package insert.
Intended use
- Medical practices, laboratories and point-of-care testing
- Home testing
Frequently asked questions
How fast is the result?
In 5 to 10 minutes.
Does it work for asymptomatic people?
The test is designed as an aid in identifying both suspected infected patients and asymptomatic patients.
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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