The Rapid Response COVID-19 Test Cassette is a rapid, qualitative test for the detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasm samples, to aid in the diagnosis of COVID-19. Interpretation of test results are COVID-19 virus positive (two lines or three lines) and COVID-19 virus negative (one line). Available for research use only. CE mark and Health Canada approval pending for diagnostic use.

Notes for Clinical use in the United States:

On March 16, 2020 the FDA updated its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. The updated policy can be viewed by clicking here.

This test is for professional in vitro diagnostic use only. Read the product insert prior to use. Directions should be read and followed carefully.

Laboratories and healthcare providers must include this information in their patient test report as specified in FDA guidance:

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • Not for the screening of donated blood.

For more information, please contact orders@lochnessmedical.com.

Product Information
  • Product Code: COV-13C25
  • Sample: Whole Blood / Serum / Plasma
  • Format: Cassette
  • Sensitivity: IgM: 93.7%, IgG: 98.8%
  • Specificity: COVID-19 virus IgG and IgM antibody
  • Time-to-Result: 15 minutes
  • Storage Condition: 36-86°F/2-30°C
  • Test Principle: Lateral Flow Immunoassay
Contents
  • 25 Test Cassettes
  • Disposable Pipettes
  • Buffer
  • Product Insert
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