Diazyme's PLAC® Test is the only blood test cleared by the FDA to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
| Product | Catalog Number | Format |
|---|---|---|
| Kit | 10-0148 | R1/R2 (Dual Vial Liquid Stable, Enzymatic) |
| Calibrator | 100148B-CAL | Cal: 5 Level (Lyophilized) |
| Control | 100148B-CON | Con: 2 Level (Lyophilized) |
Product Features
Diazyme's PLAC® Test is the only blood test cleared by the FDA to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events. The PLAC test's linearity was demonstrated from 10 - 382 nmol/min/mL with a deviation from linearity of ≤10%. Total precision CV's for each reagent lot and sample were <3%. The test is analytically robust with performance that has been validated on multiple automated chemistry analyzers.
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Assay Principle
The PLAC Test for Lp-PLA2 Activity is an enzyme assay. Lp-PLA2, in plasma or serum, hydrolyzes the sn-2 position of the substrate, 1-myristoyl-2-(4-nitrophenylsuccinyl) phosphatidylcholine, producing a colored reaction product, 4-nitrophenol. The rate of formation of 4-nitrophenol is measured spectrophotometrically and the Lp-PLA2 activity is calculated from the rate of change in absorbance. A set of five Lp-PLA2 calibrators is used to generate a standard curve fit of change in absorbance versus Lp-PLA2 activity level in nmol/min/mL from which the sample Lp-PLA2 activity is derived.
Intended use
The PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
Regulatory Status
Health Canada Registered