Certum appears once on this page of Tests that have been approved for diagnostic use in the United States (about 1/2 way down the page (search for the word Certum)
Country of development - Mexico
Type of Serological Test - RDT
Authors/Company Kabla Clinical Diagnostics
Description - Colloidal gold lateral flow assay for the detection of IgM and IgG antibodies in human serum, plasma or whole blood. In collaboration with Certum Diagnostics.
Sensitivity - 99.9% (IgG) 85% (IgM)
Specificity - 98% (IgG) 96% (IgM)
Phase of development Received CE/IVD, emergency use authorized in Mexico, Brazil, and other countries
Proposed release - Current
Type of test - Rapid diagnostic test (RDT)
Time to results - 10-30 minutes
What it tells us - The presence or absence (qualitative) of antibodies against the virus present in patient serum.
What it cannot tell us - The amount of antibodies in the patient serum, or if these antibodies are able to inhibit virus growth
Most hits are in Spanish.
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