Triglycerides in Human Serum with Roche c502

Detection of Triglycerides in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of triglycerides in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: This assay is based on the work by Wahlefeld using a lipoprotein lipase from microorganisms for the rapid and complete hydrolysis of triglycerides to glycerol followed by oxidation to dihydroxyacetone phosphate and hydrogen peroxide. The hydrogen peroxide produced then reacts with 4-aminophenazone and 4-chlorophenol under the catalytic action of peroxidase to form a red dyestuff (Trinder endpoint reaction). The color intensity of the red dyestuff formed is directly proportional to the triglyceride concentration and can be measured photometrically.
Results: Technical Range: 8.83-885 mg/dL
Reportable Range: 9.2-885 mg/dL
Reference Ranges: Normal Fasting: 20 – 150 mg/dL
Borderline High Fasting 150 – 199 mg/dL
High Fasting 200 – 499 mg/dL
Very high: ≥500 mg/dL
    Clinical Significance: Triglycerides are esters of the trihydric alcohol glycerol with 3 long chain fatty acids. They are partly synthesized in the liver and partly ingested in food.

The determination of triglycerides is utilized in the diagnosis and treatment of patients having diabetes mellitus, nephrosis, liver obstruction, lipid metabolism disorders and numerous other endocrine diseases.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li-heparin and K2-EDTA plasma

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:    Serum
3 months at -20°C
10 days at 4°C
2 days at 20-25°C
Plasma
3 months at -20°C
15 days at 4°C
2 days at 20-25°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.