NEW YORK ─ Veravas said this week that it has received CE marking for its suite of in vitro diagnostic interference detection and mitigation products, enabling clinical use in research, laboratories, hospitals, and other healthcare settings in Europe and other geographies that accept such designation.
The Oakdale, Minnesota-based company said its suite of products consists of VeraTest Biotin, a competitive binding lateral flow assay that uses a True Diagnostics Digital Reader to rapidly detect exogenous biotin levels greater than 15 ng/mL in five minutes; VeraPrep Biotin, a sample pretreatment system that uses streptavidin-coated magnetic particle technology and VeraMag magnetic separation to remove free biotin from an aliquot of plasma or serum; and VeraMag, a magnetic particle separation device that uses neodymium magnets to separate different biomolecules for further analysis.
Biotin is often found in multivitamins and over-the-counter health and beauty supplements. Undetected high levels of biotin in patient samples can cause false-positive or false-negative results in certain clinical tests and especially those that employ streptavidin-biotin binding mechanisms.
Veravas, True Diagnostics, and Infectolab Americas announced in April that they are collaborating to develop a rapid, point-of-care immunoassay for SARS-CoV-2.