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The LDL-Cholesterol Gen. 3 assay is an in-vitro test for the quantitative determination of LDL-cholesterol in human serum and plasma on Roche/Hitachi cobas c systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Device Description

The LDL-Cholesterol Gen. 3 assay is a homogeneous enzyme colorimetric assay which provides the quantitative measurement of LDL-cholesterol in human serum and plasma. Reagents are packaged in a cassette labeled with their instrument positioning R1 (Reagent 1) and R2 (Reagent 2).

R1 contains Bis-trisb) buffer: 20.1 mmol/L, pH 7.0; 4-aminoantipyrine:0.98 mmol/L; ascorbic oxidase (AOD, Acremonium spec.): ≥ 66.7 µkat/L; peroxidase (recombinant from Basidiomycetes): ≥ 166.7 µkat/L; BSA: 4.0 g/L; preservative R2 contains MOPSC) buffer: 20.1 mmol/L, pH 7.0; EMSE: 2.16 mmol/L, cholesterol esterase (Pseudomonas spec.): ≥ 33.3 µkat/L; cholesterol oxidase (recombinant from E.coli)): ≥ 31.7 µkat/L; peroxidase (recombinant from Basidiomycetes): ≥ 333.3 µkat/L; BSA: 4.0 g/L; detergents; preservative

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the LDLC3 LDL-Cholesterol Gen.3 device, organized as requested:

Acceptance Criteria and Device Performance Summary

Performance Metric	Acceptance Criteria	Reported Device Performance
Limit of Blank (LoB)	Claim: 3.87 mg/dL	Result: 0.406 mg/dL (Meets acceptance criteria as it's below the claim)
Limit of Detection (LoD)	Claim: 3.87 mg/dL	Result: 0.99 mg/dL (Meets acceptance criteria as it's below the claim)
Limit of Quantitation (LoQ)	Claim: 3.87 mg/dL	Result: 2.28 mg/dL (Meets acceptance criteria as it's below the claim)
Drug Interference	Difference in recovery to the reference sample: ≤ ± 10%	All data passed the acceptance criteria for various common drugs, Simvastatin, Bezafibrate, and Nicotinic Acid. Specific highest concentrations shown not to interfere were reported for each drug (e.g., Acetylcysteine: 553 mg/L, Simvastatin: 16 mg/L).
Interference from VLDL, HDL, Chylomicrons	≤ ± 10% in recovery for VLDL-Cholesterol: ≤ 140 mg/dL, HDL-Cholesterol: ≤ 75 mg/dL, Chylomicrons: ≤ 2000 mg/dL triglycerides	All data passed the acceptance criteria for VLDL, HDL, and Chylomicrons within their specified concentration limits. The testing methodology confirmed the device's ability to selectively measure LDL-cholesterol.
Endogenous Substances Interference	≤ 10%	No significant interference was observed up to a Lipemia L index of 1000, Hemolysis H index of 1000, and Bilirubin I index of 60 (both conjugated and unconjugated). All data passed the ≤ 10% acceptance criteria.
Matrix Comparison	Comparisons with plasma vs. serum passed specification (details on specific regression equations and correlation coefficients are provided in the document).	Serum vs. Gel Separation P/B: y = 1.004x + 0.091, r = 1.000; Serum vs. Li-heparin P/B: y = 0.99x - 1.50, r = 0.999; Serum vs. K2-EDTA P/B: y = 0.98x - 0.248, r = 1.000; Serum vs. K3-EDTA P/B: y = 0.95x - 0.246, r = 0.999. All passed specification.
Linearity	3.87 mg/dL - 549 mg/dL: ≤ ± 10%	For both plasma and serum: Range tested: Plasma 3.66 - 584 mg/dL, Serum 3.53 - 565 mg/dL. Range found: Plasma 3.66 - 584 mg/dL, Serum 3.53 - 565 mg/dL. Recommended measuring range: 3.87 - 549 mg/dL. Linear regression equations and r-squared values indicate good linearity (e.g., Plasma: y = 1x + 0, r2 = 0.9995). Data passed the ≤ ± 10% acceptance criteria within the recommended range.
Precision	Not explicitly stated as a single acceptance criterion value in the provided text, but the data indicates typical precision study results, which are generally evaluated based on CV% limits for various concentrations. The reported CVs for both repeatability and intermediate precision are low (mostly

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