LDL-Cholesterol in Human Serum with Roche c502

Detection of LDL-Cholesterol in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of LDL-cholesterol in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: Homogeneous enzymatic colorimetric assay.
Results: Technical Range: 3.87-549 mg/dL
Reportable Range: 3.8-449.5m g/dL
Reference Ranges: Reference Ranges taken from Mayo Clinic.

The National Lipid Association and the National Cholesterol Education Program (NCEP) have set the following guidelines for LDL-C in adults (ages 18 years and up):

Desirable: <100 mg/dL Above Desirable: 100-129 mg/dL Borderline high: 130-159 mg/dL High: 160-189 mg/dL Very high: ≥190 mg/dL The Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents has set the following guidelines for LDL-C in children and adolescents (ages 2-17 years) Acceptable: <110 mg/dL Borderline high: 110-129 mg/dL High: ≥130 mg/dL

Clinical Significance: Low Density Lipoproteins (LDL) play a key role in causing and influencing the progression of atherosclerosis and, in particular, coronary sclerosis.

The LDLs are derived from VLDLs (Very Low Density Lipoproteins) rich in triglycerides by the action of various lipolytic enzymes and are synthesized in the liver. The elimination of LDL from plasma takes place mainly by liver parenchymal cells via specific LDL receptors. Elevated LDL concentrations in blood and an increase in their residence time coupled with an increase in the biological modification rate results in the destruction of the endothelial function and a higher LDL‑cholesterol uptake in the monocyte/macrophage system as well as by smooth muscle cells in vessel walls. The majority of cholesterol stored in atherosclerotic plaques originates from LDL. The LDL‑cholesterol value is the most powerful clinical predictor among all of the single parameters with respect to coronary atherosclerosis. Therefore, therapies focusing on lipid reduction primarily target the reduction of LDL‑cholesterol which is then expressed in an improvement of the endothelial function, prevention of atherosclerosis and reducing its progression as well as preventing plaque rupture.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Plasma: Li-heparin, K2 and K3-EDTA plasma
Fasting and non-fasting samples can be used.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases.  When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
Storage and Stability:    365 days at -70°C
365 days at -20°C
7 days at 2-8°C

Rejection Criteria: Rejection criteria include but are not limited to:
1. Specimens containing fibrin or clots.
2. Excessive platelet clumping
3. Leaking specimens
4. Substandard mixing or collection
5. Expired or improperly stored collection tubes.
6. Improperly filled tubes based on collection tube manufacturer’s guidelines.
7. Contaminated specimens (IV fluid, foreign particles, etc.)
8. Specimens not analyzed within the appropriate time frame.
9. Samples not shipped at appropriate temperature.
10. Samples without 2 proper identifiers or samples having identifiers that do not match the electronic or paper lab requisition.
Authorization: Diagnostic testing can only be performed with approval from an authorized provider/agency.
Turn Around Time: 1 day.