Clarity COVIBLOCK Rapid Test Cassettes

Clarity Diagnostics > Clarity COVIBLOCK Rapid Test Cassettes

We are happy to announce

WE ARE NOW CLIA WAIVED AND POCT APPROVED!

Clarity COVIBLOCK COVID-19 Rapid Test Cassettes

  • Combined Sensitivity 93.3%
  • Combined Specificity 98.8%
  • 95% Overall Accuracy
  • Use Whole Blood, Plasma or Serum
  • Fast & Easy (with positive results as fast as 10 minutes)
  • Room Temperature Storage

Product Codes

  • CD-COV300 (300/case, 20/box)
    • Contents: Covid19 Test Cassettes. Buffer Solution. Disposable Pipettes. Lancets. Alcohol Swabs. Package Insert.
  • CD-COV19-GMCTL
    • Contents: 1 Positive Control and 1 Negative Control

Important Information

  • The Clarity COVIBLOCK COVID-19 Rapid Test Cassettes is an in vitro, rapid, qualitative immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies of COVID-19 in Whole blood ( Fingerstick and Venous) , Plasma or Serum.
  • The Clarity COVIBLOCK COVID-19 Rapid Test Cassette used with fingerstick whole blood specimen is currently classified as CLIA Waived, and authorized for use at Point of Care (POC) settings under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
  • 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 test 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 COVIBLOCK COVID-19 Rapid Test Cassettes are not OTC approved and cannot be purchased online or used at home.
  • The Clarity COVIBLOCK COVID-19 Rapid Test Cassettes CLIA Waiver can be found at: https://www.fda.gov/media/140079/download
  • CLIA waived and POCT approved.

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