The DZ-Lite OxPL Lipoprotein Assay is a magnetic particle based chemiluminescent immunoassay similar to the chemiluminescent ELISA assay as described by Tsimikas S. et al26-27 with modifications in Kiechl et al28 and Bertoia et al.4 In the assay
| REF: DZ565A-CLIA Reagent cartridge for 100 tests | |
|---|---|
| Magnetic particles coated with IgG MB47, a murine monoclonal antibody binding human apoB-100 | 2.5 mL |
| IgM E06, a murine monoclonal binding to phosphocholine-containing oxidized phospholipids, labeled with ABEI* | 12.0 mL |
| Sample Diluent | 10.0 mL |
| OxPL Lipoprotein Calibrator Low | 1.0 mL |
| OxPL Lipoprotein Calibrator High | 1.0 mL |
| OxPL Lipoprotein Control Low | 1.0 mL |
| OxPL Lipoprotein Control High | 1.0 mL |
Product Features
- Specific for oxidized phosphocholines on apoB-100 containing lipoproteins
- Assay is fully automated
- No manual sample pre-dilution required
- A substantial amount of clinical data strongly supports the link between OxPL-apoB level and risks of CVD
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Assay Principle
The DZ-Lite OxPL Lipoprotein Assay is a magnetic particle based chemiluminescent immunoassay similar to the chemiluminescent ELISA assay as described by Tsimikas S. et al26-27 with modifications in Kiechl et al28 and Bertoia et al.4 In the assay, magnetic particles coated with a monoclonal antibody MB47 that specifically binds to apoB-100 of all apoB-100-containing lipoproteins (VLDL, IDL, LDL, Lp(a)) are mixed with serum samples to capture the apoB containing lipoprotein molecules to a saturation condition per magnetic particle. After a washing step to remove unbound apoB-100 molecules, the detecting antibody, ABEI-labeled E06, is added to the reaction mixture to allow the E06 monoclonal antibody to react with OxPL on the captured apoB-100 molecules. After another wash to remove the unbound E06, the reaction mixture is added to a trigger reagent to generate a chemiluminescent signal (relative light units, RLU) measured by a photomultiplier. The amount of OxPL Lipoprotein is quantified by using a 10-point calibration curve. The results are reported as nM OxPL Lipoprotein. The assay is fully automated with a DZ-Lite chemiluminescent immunoanalyzer.
Intended use
The DZ-Lite OxPL Lipoprotein Assay kit is a chemiluminescent immunoassay, and the assay is intended to be used for the in vitro quantitative measurement of oxidized phospholipids of low-density lipoproteins in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The assay is FDA 510K exempt (see Code of Federal Regulations Title 21, Volume 8: 21CFR862.1475)
Regulatory Status
