Product Details:
|
Product |
Catalog Number |
Format |
|
Kit |
DZ098A-KY1 |
R1: 1 x 60 mL R2: 1 x 20 mL |
|
Calibrator |
DZ098A-CAL |
Cal: 5 x 1 mL |
|
Control |
DZ098A-CON |
Con: 2 x 1 mL |
Product Features:
- Apo(a) isoform–independent molar assay standardized in nmol/L against CDC/IFCC reference materials, enabling accurate, comparable Lp(a) results across patient populations.
- Latex-enhanced immunoturbidimetric method optimized for high-throughput automated analyzers (validated on Beckman Coulter AU680) for efficient routine testing.
- Broad measuring range of 4.85 – 240 nmol/L with an LOQ of 4.85 nmol/Land extended measuring range validated up to 720 nmol/L using a 1:3 dilution , supporting reliable assessment from low to very high Lp(a) levels.
- Excellent precision with total CV typically ≤2.1% across the measuring range, delivering consistent, reproducible results for clinical decision support.
- Clinically aligned with current National Lipid Association and international guideline recommendations for Lp(a) testing to aid in atherosclerotic cardiovascular disease risk assessment.
Downloads:
Assay Principle:
The Lipoprotein Assay is based on a latex particle enhanced immunoturbidimetric assay. Lipoprotein (a) in the sample binds to specific anti-Lipoprotein (a) antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lipoprotein (a) in the sample. The instrument calculates the Lipoprotein (a) concentration by interpolation of obtained signal of a calibration curve prepared from calibrators of known concentrations.
Intended Use:
The Lipoprotein (a) Molarity Assay is intended as an in vitro test for quantitative determination of Lipoprotein(a) [Lp(a)] concentrations in human serum and plasma on validated automated analyzers. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.
Regulatory Status:
Health Canada Registered