COVID-19 Ag Rapid Test CE | CTK-R0182C

The OnSite COVID-19 Ag Rapid Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal (NP), or nasal swab specimens from individuals who are suspected of COVID-19, within the first seven days of the onset of symptoms.

Currently, the laboratory method for detecting COVID-19 is RT-PCR. However, this method requires sophisticated equipment and highly trained laboratory technicians. The OnSite COVID-19 Ag Rapid Test is easy to use, cost-efficient and can be done at the point of care.

The test is intended for use by healthcare providers or personnel trained in rapid test procedure.

Product Features:

• The OnSite COVID-19 Ag Rapid Test has 94.7% sensitivity and 100% specificity, aiding in early diagnosis by detecting viral components.

• The OnSite COVID-19 Ag Rapid Test is a qualitative antigen detection test that provides results in 15 minutes.

• Pre-filled extraction tubes simplify test procedure.

• This test is easy to use and does not require the use of laboratory equipment.

• Compatible with CTK Rapid Test Reader (RTR-1)

• 200 tests per hour in batch mode

• Capable of connecting to Laboratory Information System (LIS)

• Built-in barcode reader provides faster test setup

• Stores up to 1,000 results, presented on-screen, via printout, or uploaded to a database

Product Specification:

Reagents and Materials Provided: 1. Individually sealed foil pouches containing:

• One cassette device

• One desiccant 2. Sealed pouch containing pre-filled extraction tubes 3. Sample extraction tube rack 4. Nozzles 5. Sterile swabs, each sealed in a plastic-paper pouch 6. Instructions for Use Materials Required but Not Provided: • Clock or timer Materials May be Required but Not Provided: • Positive control • Negative control • Nasal swab