Selling unit: per 100ml
Common name: Total cholesterol (TC) assay kit (enzyme method)
English name: TC Reagent Kit (Enzymic Method)
Single, 3:1, 4:1 (common ratio), other ratios need to be customized
This kit is used to determine the amount of TC in human serum.
TC measurement can be used as a diagnostic indicator of liver function, biliary function, intestinal absorption and coronary artery disease. It is also important in the diagnosis and classification of hyperlipoproteinemia (primary hyperlipoproteinemia, secondary hyperlipoproteinemia such as diabetes, nephrotic syndrome). elevated TC concentration can be caused by primary hyperlipoproteinemia or secondary hyperlipoproteinemia such as: diabetes, nephrotic syndrome and hypothyroidism. clinical diagnostic methods for TC determination kits include enzymatic assay, Cholesterol oxidase method, endpoint method, COD-PAP method, etc.
Cholesterol esterase and cholesterol oxidase coupled with Trinder reaction were used. About 1/3 of the cholesterol in serum is free cholesterol and 2/3 is cholesterol esters bound to fatty acids. Cholesteryl esters are hydrolyzed by cholesteryl esterase (CHE) to fatty acids and free cholesterol, which is oxidized by cholesteryl oxidase (COD) to cholesterol enzymes and produces hydrogen peroxide, which is then combined with 4-aminoantipyrine and TOOS to form a red quinoneimine compound by the action of POD (Trinder reaction). The maximum light absorption of quinoneimine is around 572 (550-590) nm and within a certain range, the absorbance A is proportional to the CHOL content of the sample.
Reagent components included in the product.
*The components of the kits are not interchangeable between batches.
*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.
Storage Conditions And Expiration Date
The kit is stored at 2-8°C away from light and is valid for one year.
Reagents that have been opened are taken care not to be contaminated and the reagents are stabilized in the instrument compartment (2-8°C) for one month.
The reagents must not be frozen.
Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.
Blood was collected on an empty stomach and specimens were separated as soon as possible. Serum specimens were stored at 4°C for one week and frozen at -20°C for 3 months.
- Reagent preparation: liquid reagents are ready to use out of the bottle.
- test conditions: (different test instruments can be requested according to the different parameters on the machine)
Single reagent operation procedure.
Dual reagent operation procedure.
*Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers as appropriate.
- Calibration procedure.
Randox calibration sera are recommended. the Randox calibration sera are selected for cholesterol oxidase.
- QC control procedures.
It is recommended that each laboratory establish its own quality control system and select appropriate quality control products for quality control. The measured values of QC products should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.
TC content in the sample (mmol/L) =(ΔAsample – ΔAblank ) × Cstandard / (ΔAstandard – ΔAblank )
Positive judgment value or reference interval.
Suitable range for serum or plasma: 0 to 5.2 mmol/L
Hazardous margin threshold: 5.2 to 6.2 mmol/L
It is recommended that each laboratory establish its own reference range of normal values.
Interpretation of test results.
The measurement of TC in serum is only one of the indicators used by clinicians to diagnose patients. Clinicians must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, as well as other diagnostic items and diagnostic tools.
Limitations of the test method.
Ascorbic acid ≤ 10 mg/dL, bilirubin ≤ 20 mg/dL, hemoglobin ≤ 200 mg/dL, and celiac disease ≤ 500 mg/dL did not interfere with the determination.
Product Performance Index
Absorbance of reagent blank: wavelength 572 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 0.080.
Analytical sensitivity: the kit tests 0.5 mmol/L of the test substance, the absorbance change value ΔA ≥ 0.002.
Linearity interval: test serum samples, reagent linearity in the interval of 0.5 to 12.9 mmol/L, linear correlation coefficient|r| should not be less than 0.990; in the interval of 0.5 to 5.2 mmol/L, the absolute deviation of linearity should not exceed 0.52 mmol/L; in the interval of (5.2 to 12.9 mmol/L, the relative deviation of linearity should not exceed ±10% .
Precision: repeatability CV≤ 4.0%; relative extreme difference between batches≤ 6.0%.
Accuracy: Relative deviation ≤ 10.0%.
- This product is used for in vitro diagnosis only.
- Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
- Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
- Do not mix R1 and R2 into a single reagent, or exchange reagents with different lot numbers.
- When changing the reagent lot number, please recalibrate.
1.SCHETTLER G., NUSSEL E., ARBEITSMED. SOZIALMED.
PRAVENTIVMED 1975; 10: 25