Tina-quant Lipoprotein(a) Gen.2 Molarity

The Tina-quant Lipoprotein(a) Gen.2 Molarity is an in vitro immunoassay that quantitatively measures lipoprotein(a) [Lp(a)] in human serum and plasma using cobas c systems. It reports results in nmol/L with calibration traceable to WHO/IFCC SRM2B reference material and is used to evaluate lipid metabolism disorders and atherosclerotic cardiovascular disease risk in conjunction with clinical evaluation and other lipoprotein tests.

The candidate device uses the same particle-enhanced immunoturbidimetric assay method, cobas c instrument platform, sample types, calibrator, and control as the predicate. The key difference is traceability: the candidate is standardized to WHO/IFCC SRM2B reference material for nmol/L reporting, whereas the predicate used in-house reference material and reported in mg/dL. The candidate's measuring range is 7–240 nmol/L versus the predicate's 6.0–80 mg/dL.

CLSI EP05-A3 (precision/repeatability and intermediate precision), CLSI EP17-A2 (limit of blank, detection, and quantitation), CLSI EP06-A-Ed2 (linearity assessment).

The device is substantially equivalent because it uses the identical assay methodology, instrument platform, sample matrices, calibrator, and control materials as the predicate. Although the candidate reports results in a different unit system (nmol/L versus mg/dL) with standardization to an internationally recognized reference material rather than in-house material, analytical performance data demonstrate equivalent or superior accuracy (Deming regression r = 0.992), precision (CV ≤2.6%), and sensitivity. Method comparison to an Lp(a) ELISA reference standard (n=126) shows excellent correlation, and all performance acceptance criteria were met. The change to WHO/IFCC standardization represents a technological improvement—enabling harmonization with international standards—without altering the fundamental device function or clinical utility.