COVID-19 Ag Rapid Test CE – OnSite

Description

AKL 20303120548

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.

Spesifikasi

Reagents and Materials Provided:

  1. Individually sealed foil pouches containing:
    1. One cassette device
    2. 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

Feature

  • 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

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