Cholesterol in Human Serum with Roche c502

Detection of Cholesterol in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of cholesterol in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: Colorimetric method that measures the consecutive reactions of cholesterol to form a red quinone-imine dye. The color intensity of the dye is directly proportional to the cholesterol concentration. It is determined by measuring the increase in absorbance.
Results: Technical Range: 3.86 – 800 mg/dL Reportable Range: 4.5-742.1 mg/dL
Reference Ranges: Cholesterol Level 2-17 years ≥18 years
Desirable cholesterol level < 170 mg/dL < 200 mg/dL Borderline high cholesterol 170-199 mg/dL 200 239 mg/dL High cholesterol   ≥ 200 mg/dL ≥ 240 mg/dL
  Clinical Significance: Cholesterol is a steroid with a secondary hydroxyl group in the C3 position. It is synthesized in many types of tissue, but particularly in the liver and intestinal wall. Approximately three quarters of cholesterol is newly synthesized, and a quarter originates from dietary intake. Cholesterol assays are used for screening for atherosclerotic risk and in the diagnosis and treatment of disorders involving elevated cholesterol levels as well as lipid and lipoprotein metabolic disorders.
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 and K2-EDTA plasma
Do not use citrate, oxalate or fluoride.
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:     7 days at 15 – 25 °C
7 days at 2 – 8 °C
90 days at (-15°C) – (-25°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.