高密度脂蛋白胆固醇检测试剂盒直接法

Low -density lipoprotein cholesterol (LDL-C) Test Kit (Direct)

【NAME 】

Low-density lipoprotein cholesterol (LDL-C) Test Kit (Direct)

【PACKAGE 】

R1:60mL×2 R2:20mL×2 R1:18mL×4 R2:6mL×4 R1:18mL×1 R2:6mL×1 R1:60mL×1 R2:20mL×1 R1:40mL×3 R2:20mL×2 R1:48mL×2 R2:16mL×2 R1:45mL×2 R2:15mL×2 R1:90mL×1 R2:30mL×1 2×200Tests

【INTEND USE 】

The reagent is used to test Low-density lipoprotein cholesterol (LDL-C) content in human serum or plasma.

【METHODOLOGY 】

Polyanion and LDL combine into complex and shelter LDL - C, in serum HDL, VLDL and CM under the effect of surfactants with enzymes reagent have incomplete Trinder reaction, the reaction H2O2 in the absence of coupling agent is consumed without color. When add R2, surfactant containing have a specific effect on LDL can hydrolyze LDL, release the cholesterol, participate in the complete Trinder reaction, determine the

absorbance at 546 nm was positively ratio with LDL-C.

【REAGENT COMPOSITION 】

Reagent 1（R1）：

polyanionic compound 0.5mmo1/L 4-amino-antipyrine 0.5mmo1/L cholesterol esterase 800U/L cholesterol oxidase 500U/L

surfactant appropriate volume Reagent 2（R2）：

peroxidase appropriate volume surfactant appropriate volume

【STABILITY AND STORAGE 】

Unopened, avoid light preservation in 2 ~ 8 ℃, valid for 12 months; Opened, avoid light preservation in 2 ~ 8 ℃, valid for 1 month. Reagent is not allowed frozen.

【SAMPLE REQUEST 】

Fresh serum or heparin anticoagulant blood plasma.

Stability of sample: 2～8℃ for 3days, -20℃ for two weeks

【APPLICABLE INSTRUMENT 】

BIOBASE 、HITACHI 、OLYMPUS 、BECKMAN 、GLAMOUR 、ABBOTT 、TOSHIBA, etc. fully automatic biochemical analyzer.

【TESTING SPECIFICATION 】

Wavelength/ Sub-wavelength 546nm/700nm Cuvette light path 1.0cm Temperature 37℃ Assay Type End-point

【OPERATION STEPS 】

R1: reagent 1 R2: reagent 2 S: calibrator U: sample

Incubation time 5min

Reaction time 5min

【CALCULATION 】

Sample △A

Sample LDL-C concentration = —————— ×Calibrator concentration Calibrator △A

【REFERENCE RANGE 】

1.27～4.13mmol/L （80～120mg/dl ）

By clinical trials, choose no less than 100 women or men blood specimens,

tested by automatic biochemical analyzer, and then processing the testing value with statistical method, calculating out the reference range. Recommendation: The laboratory set up its own reference range!

【THE LIMITATION OF TEST RESULTS 】

LDL-C testing from serum or plasma is just one of the standard that clinicist diagnose the patient. Clinical physicians should according to patients' bodies, history and other diagnostic program, to get comprehensive judgment.

【THE INTERPRETATION OF TEST RESULTS 】

Human error, the processing of specimen, analysis instrument deviation, etc. all can affect the measurement result ；When one sample deviates from the expected value too far, need to be tested again.

【PERFORMANCE INDEX 】

1.Reagent blank absorbance ≤0.4,(546nm,lcm optical path).

2.Precision: repeatability CV≤5％;batch variations R ≤5％.

3.Accuracy: relative deviation ≤10％.

4.Linearity range: 0～11.6mmol/L, r≥0.990.

5.Sensitivity for analysis: When test reagent HDL-C, the absorbance change with the concentration of 1 unit as not less than 0.102∆A (equivalent to1.0mmol/L LDL-C concentration).

6.Stability: All package reagent, unopened and avoid light, preservation in 2~8 ℃, stable 12 months, once opened, avoid light, preservation in 2~8 ℃,stable 30 days.

【ATTENTION 】

1.Reagent contains sodium azide (toxic) preservatives, avoid to touch with skin and mucous membrane. If necessary preventive measures should be taken use of reagents, reagent touch with skin and mucous membrane, please rinse with water, please go to a doctor if necessary

2.This method linearity up limit is 11.6mmol/L. If sample value is more than limit, pls test again by use 0.9% sodium chloride solution to dilute, the result is multiplied the dilution ratio.

3.Application of double reagent method, should not be operated of single reagent method.

4.This reagent is potentially polluting, so should be treated carefully same as the patient samples.

5.Different batches reagents cannot mix, replacing reagents batch number, please calibrator again.

Biobase Biodustry

Record absorbance

value A2

Distilled water 、U or S: 3μl;R1:225μl Record absorbance value A1,

and then add R2: 75µl