Tina-quant Cardiac high sensitivity CRP III

The Tina-quant Cardiac high sensitivity CRP III is an in vitro test that quantitatively measures C-reactive protein (CRP) in human serum and plasma using automated cobas c systems. It is used to assess cardiovascular disease risk and, when combined with other clinical evaluations, to help predict recurrent cardiac events in patients with stable or acute coronary syndromes.

Both the candidate and predicate devices use particle-enhanced immunoturbidimetric assay methodology with turbidimetric detection and the same calibration method and sample types (human serum and plasma). The candidate has an improved measuring range of 0.150–10.0 mg/L versus the predicate's 0–20 mg/L, extended reagent stability on-board (24 weeks versus 12 weeks), and updated standardization to ERM-DA474/IFCC reference material.

CLSI guideline EP05-A3 (precision), CLSI EP17-A2 (limit of blank, detection, and quantitation), and CLSI EP06-A-Ed2 (linearity). The method is standardized against IRMM certified reference material ERM-DA474/IFCC, directly traceable to ERM-DA470.

The analytical performance data demonstrate substantial equivalence through identical assay and detection methods, same sample matrices and calibration approach, excellent method comparison results (correlation r = 0.999, Passing-Bablok regression y = 1.068x – 0.0302), and all acceptance criteria met for precision, analytical sensitivity, linearity, interferences, and stability. The candidate maintains the same indications for use and clinical performance as the predicate device.