CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Gold Standard Diagnostics announced FDA 510(k) clearance of its 25-OH vitamin D, total ELISA. This assay correlates with established liquid chromatography/mass spectrometry, enzyme immunoassay, and chemiluminescence methods, and offers high sensitivity and specificity over a wide dynamic range. The assay can be automated on a variety of instruments, providing a cost-effective vitamin D testing option even at lower volumes.
The Gold Standard vitamin D assay features a pretreatment step that allows for complete automation on virtually any open ELISA processor. All assay protocol steps are completed in a standard microtiter plate without the need for labor-intensive, time-consuming, and complicated pretreatment done manually outside of the analyzer.
Gold Standard Diagnostics, 530-759-8000