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COVIBLOCK COVID-19 IgG/IGM ANTIBODY TEST, Cassettes, 20/ Box # CD-COV19

COVIBLOCK COVID-19 IgG/IGM ANTIBODY TEST, Cassettes, 20/ Box # CD-COV19FACT SHEETINSTRUCTIONS - ENGLISHINSTRUCTIONS - SPANISHCONTROLS PACKAGE INSERT SDSCPT CODES

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COVIBLOCK COVID-19 IgG/IGM ANTIBODY TEST, CASSETTES, 20/ Box

Use w/ Venous Whole Blood, Plasma or Serum
# CD-COV19
NON-RETURNABLE

Clarity Coviblock™ Covid-19 Rapid Test Cassettes

Features:
Sensitivity 91.5%
Specificity 100%
95% Overall Accuracy
Use Whole Blood, Plasma or Serum
Fast & Easy (with positive results as fast as 10 minutes)
No Age Restriction
Room Temperature Storage
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 is currently under Section IV.D of the FDA™’s Policy for Coronavirus Disease-2019 Tests.
EUA approval through Pathway C of the FDA.

Test Results Interpretation