For the in vitro quantitative determination of Total Cholesterol in serum
METHODOLOGY
Alain and Roeschlau began using cholesterol esterase and oxidase,in a single reagent to determine total cholesterol in serum. Trinder’s color system of peroxidase / phenol/4-aminoatipyrine has been used successfully for some time now. The system’ s only drawback was the corrosive properties of phenol. The present method utilizes a phenol substitute that performs like phenol but without being corrosive.
The intensity of the red color produced is directly proportional to the total cholesterol in the sample when read at 500nm.
PRECAUTIONS
1. This reagent is for in vitro diagnostic use only.
2. Reagent contains sodium azide. Poison. Do not ingest .
REAGENT PREPARATION
Reagent is supplied ready to use.
REAGENT DETERIORATION
The reagent should not be used if:
1. The reagent is turbid.
2. The working reagent does not meet stated performance parameters.
INTERFERENCES
Studies to determine the level of interference for hemoglobin, bilirubin, and lipemia were carried out, the following results were obtained:
Hemoglobin: No significant interference ( 10%) from hemoglobin up to 200 mg/dL.
Bilirubin: No significant interference ( 10%) from bilirubin up to 19.8 mg/dL.
Lipemia : No significant interference( 10%)from lipemia up to 1093 mg/dl measured as triglycerides.
ADDITIONAL EQUIPMENT REQUIRED BUT NOT PROVIDED:
1. A clinical chemistry analyzer capable maintaining constant temperature (37°C), and measuring absorbance at 500±20 nm.
2. Iron-free deionized water and related equipment, e.g.: pipettes