Intended Use
The CLINITEST Rapid COVID-19 Antigen Self-Test is a lateral flow immunoassay device for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
It is intended for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older.
Explanation of the Test
COVID-19 is a disease caused by a type of novel coronavirus called SARS-CoV-2.
The test is a rapid, qualitative immunochromatographic assay for the determination of the presence of SARS-CoV-2 antigens in direct human anterior nasal swab specimens.
Materials Provided
The test kit includes a test device, sterile swab, extraction tube with buffer and tip, and tube holder with instructions for use.
Quality Control
Each test has a built-in internal procedural control, indicated by a reddish-purple line at the “C” position.
A distinct visible pink/red Control line should always appear if the test has been performed correctly.
Test Procedures
The test involves placing the tube in a tube holder, opening the tube and swab, swabbing both nostrils, placing the swab in the tube, and waiting for 1 minute before removing the swab and adding a tube tip.
Manual:
Download: CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST Health Care Provider Instructions for Use (IFU)
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