Covid-19 IgG/IgM Test Cassettes

Fast and Accurate Results in as little as 3 Minutes

COVID 19 Image

Clarity Covid-19 IgG/IgM Test Cassettes

 

  • Sensitivity 100% *
  • Specificity 93%*
  • 95% Overall Accuracy*
  • Use Whole Blood, Plasma or Serum
  • Fast & Easy (with positive results as fast as 3 minutes)
  • No Age Restriction
  • Room Temperature Storage

*For fingerstick whole blood samples

Product Codes

  • CLA-COV19 (20/bx)
    • Contents: Covid19 Test Cassettes. Developer Solution. Disposable Pipettes. Package Insert
  • CD-SL21100 (100/bx)
    • Contents: Pre Cocked 21G Safety Lancets. Procedure Card
  • CLA-ALSWB100 (100/bx)
    • Contents: Individually Wrapped Sterile Alcohol Prep Pads

Important Information

  • The Clarity COVID-19 IgG/IgM Antibody Test is an in vitro, rapid, qualitative immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies of COVID-19 in human serum, plasma or whole blood.
  • The Clarity COVID-19 IgG/IgM Antibody Test Is currently classified as CLIA Highly Complex and should only be used sold to and used by CLIA Highly complex facilities.
  • This test is only provided for use in laboratories or by healthcare workers at the point-of-care.
  • 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.
  • The Clarity COVID19 IgG/IgM Antibody Test cannot be sold or purchased online.
  • The Clarity COVID19 IgG/IgM Antibody Test  is currently under Section IV.D of the FDA’s Policy for Coronavirus Disease-2019 Tests.
  • Pending EUA approval through Pathway C of the FDA.

Clarity

Test Results Interpretation

Product

Documents

We are happy to announce the release of our NEW COVID19 Test! Learn more by clicking here