COVID-19 Ag Rapid Test CE

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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.

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Product Features

  • The OnSite COVID-19 Ag Rapid Test has 92.3% 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.
  • 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 specifications

  • Reagents and Materials Provided:
    1. Individually sealed foil pouches containing:
      1. One cassette device
      2. One desiccant
    2. Sample extraction tubes
    3. Sample extraction tube rack
    4. Sample extraction buffer
    5. Nozzles
    6. Sterile swabs, each sealed in a plastic-paper pouch
    7. Instructions for Use

    Materials Required but Not Provided:

    • Clock or timer

    Materials May be Required but Not Provided:

    • Positive control
    • Negative control
    • Nasal swab

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COVID-19 Ag Rapid Test CE