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 HDL-C
HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD） ◆ Procedure
1. Reagent Preparation: Both reagent 1 and reagent 2 are liquid reagents and can be used directly.
◆ Product Name 2. Test condition (parameters)
HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD） Temperature 37℃ Reagent 1 300 μL
◆ Intended Use Main wavelength 540~570nm Reagent 2 100μL
This reagent is applied to the invitro quantitive measurement of high density lipoprotein-cholesterol (HDL-C) concentration Sub wavelength 660nm Sample volume 4 μL
contained in human serum. Test mode 2 point end assay Optical path 1.0 cm
The fall of HDL-C content is the dangerous factor of anemic heart disease and reflected in coronary artery disease, Absorbance range 0 ~2A Test time 300 s
hyperlipidemia, smoking, adiposity, diabetes, liver disease etc. Alcohol absorption and proper exercise can lead to the rise of 3. Testing procedure
HDL-C. Sample volume: 4μL Record absorbance A1 Temperature:37℃
Reagent R1volume: 300μL Reagent R2 volume: 100μL Main wavelength: 546nm
◆ Principle
Sub wavelength: 660nm
High-density lipoprotein cholesterol in the sample, under the existence of surfactant in the reagent, is selectively catalyzed and
hydrolyzed by cholesterol esterase into cholesterol and free fatty acid. The generated cholesterol oxidized by cholesterol Record absorbance A2
oxidase to produce cholest - 4 - ene - 3 - ketone and hydrogen peroxide. Under the existence of peroxidase, hydrogen peroxide
react with aniline color of the original material and 4 - amino-antipyrine to produce H2O and quinone imine pigment, the
300s 300s
generated quinone imine pigment volume generate is proportional to high density lipoprotein cholesterol content in the sample,
by measuring the final pigment volume at specific wavelength, high-density lipoprotein cholesterol concentration in the 4. Calibration
sample can be calculated.
It is suggested to use supplementary calibrator as instructed. 2-point calibration: conduct 2-point calibration with purified
Cholesterol esterase
water and calibrator according to the instruction of calibrator. Calibration curve will be formed after tests.When lot number is
High-density lipoprotein cholesterol＋ H2O Cholesterol ＋ Free fatty acid
changed or QC is invalid, calibration shall be conducted again.
Cholesterol oxidase 5. QC
Cholesterol + O2 Cholest -4 - ene -3 - ketone ＋ H2O2 It is suggested to use QC products produced by Dirui. The laboratory shall establish its own QC area and limit. If QC value is
Peroxidas out of control, correction measures shall be taken.
H2O2 + 4-Aminoantipyrine+ Aniline color of the original material Quinone imine pigment + H2O 6. Calculation
Sample tube △A
◆ Reagent Composition Sample concentration(mg/dL) = ×Calibrator Concentration(mg/dL)
Reagent 1 4-aminoantipyrine 1mmol/L Calibration tube △A
Cholesterol oxidase 1 kU/L ◆ Reference Range
Cholesterol esterase 1 kU/L Male 41.409mg/dL ~ 66.951mg/dL（1.07mmol/L ~ 1.73mmol/L）
Peroxidase 4 kU/L Female 48.762mg/dL ~ 73.143mg/dL（1.26mmol/L ~ 1.89mmol/L）
Non-ionic Surfactant 0.5 % The reference range applied is the expected value for this method, which is for reference only. It is recommended for all
Polymer compound Appropriate amount laboratories to do relevant tests to validate such range or establish their own reference range.
MOPS Buffer 100mmol/L
◆ Explanation of Results
Reagent 2 DSBmT 1.2%
1. Sample can be diluted by physiological saline if HDL-C concentration exceeds the range, and retest and multiply diluting
Non-ionic Surfactant 0.5%
times to calculate the result.
MOPS Buffer 100 mmol/L
2. HDL-C concentration measurement is only one of the indicators of clinical diagnosis for patients, and clinicians also
Each component in different lot kits can not be exchanged.
conduct a comprehensive diagnosis including body,history diagnosis, as well as other items and diagnostic methods.
◆ Storage Conditions and Shelf Life
◆ Limit
1. When stored at 2℃~8℃ and protected from light, the reagent is stable for 12 months. 1. The accuracy of results relies on the calibration of instrument control of testing temperature and time.
2. The used reagent is stable for 1 month at 2℃~8℃.
2. When hemoglobin is ＞5g/L, triglyceride is ＞9mmol/L, ascorbic acid＞0.17mmol/L the test result will be affected.
◆ Suitable Device ◆ Specifications
Any kind of semi-auto and auto-chemistry analyzers; all kinds of parameters of auto-chemistry analyzers are prepared for 1. The linear range of this reagent: up to 150 mg/dL
reference. 2. Blank absorbance: A≤0.200
◆ Sample Requirements 3. Limit of detection: test normal saline 20 times repeatedly, and the minimum test limit is determined as 0.16 mg/dL by
1. Serum sample should not be hemolyzed. average +2 times SD.
2. The sample is stable for 7 days at 2℃~8℃, and 1 month at -20℃. Avoid repeated freezing and thawing sample. 4. Precision: test two samples with different concentration on the same test system within 20 work days.
 Precision of the same lot number n=20 Precision between days n=20 Photometric
13~31 13~31 13~31 13~41 11~31 17~41 17~47 9~31 9~31 11~33
QC serum point
X ( mg/dL) SD CV% X ( mg/dL) SD CV%
Main
546 546 546 546 546 546 546 546 546 546
Sample 1 43.3 0.60 1.38 43.6 1.29 2.96 wavelength

Sub
Sample 2 59.8 0.78 1.31 59.1 1.13 1.91 660 660 660 660 660 660 660 660 660 660
wavelength
5.Method comparison: Conduct tests upon 200 samples with reagent y of the company and the on the market reagent x, the
Reagent R1/T1 300 300 300 300 300 300 300 300 300 300
relevance between our reagent (y) and approved market reagent (x) is: y=0.9894x-6.0337，r=0.977.
R2/T2 100 100 0 100 0 100 100 100 100 0
◆ Standardization Traceability
R3/T3 —— —— 100 —— 100 —— —— —— —— 100
The constant value of calibrator can be traced to international reference SRM1951b.
R4/T4 —— —— 0 —— 0 —— —— —— —— 0
◆ Matters Need Attention
Normal volume
1. Cautions for operation of serum 4 4 4 4 4 4 4 4 4 4
1.1 The product is only for in vitro diagnosis. sample
1.2 Do not add additive during the test. Avoid direct sunlight. Absorbance
3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3
1.3 Volume of reagent and sample can be changed proportionally in accordance with the requirements of instrument. limit

1.4 Do not save it at below 0℃. Reaction type

Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive
1.5 Unit conversion: mmol/L×38.7=mg/dL reaction reaction reaction reaction reaction reaction reaction reaction reaction reaction

2. Cautions for safety -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower
Prozone check
2.1 Consider the product as dangerous materials that may cause HIV, HBV, HCV and other infections. To avoid the risk, use limit limit limit limit limit limit limit limit limit limit
disposable single-use gloves. Calibration 2-point 2-point 2-point 2-point 2-point 2-point 2-point 2-point 2-point 2-point
2.2 Avoid contact with skin, clothes, and eyes. Once in contact with skin or clothes, rinse the contact part with plenty of water, method linearity linearity linearity linearity linearity linearity linearity linearity linearity linearity
and go to see a doctor. Deflection
3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3
2.3 The samples and waste liquid have potential infectious risk, and the user should manage them according to the laboratory check
safety operation rule, local laws and regulations. Discreteness
0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1
check
◆ Reference
1. Young DS. Effects of Drugs on Clinical Laboratory Tests. AACC Press, 1990. Sensitivity
0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02
check
2. G. Russell Warnick etc.，Comparison of Improved Precipitation Methods for Quantification of High-Density Lipoprotein
Cholesterol，CLIN. CHEM. 31/2，217-222 (1985). Blank
horizontal -0.01~0.2 -0.01~0.2 -0.01~0.2 -0.01~0.2 -0.01~0.2 -0.01~0.2 -0.01~0.2 -0.01~0.2 -0.01~0.2 -0.01~0.2
3. Miyauchi etc.，Method for Determining the Amount of Cholesterol in a High-Density Lipoprotein，U.S. Pat.5,736,406.
check
4. Kerscher etc.，Process and Reagent for the Specific Determination of HDL Cholesterol in Serum or Plasma，U.S.
Linearity range 0.2~150 0.2~150 0.2~150 0.2~150 0.2~150 0.2~150 0.2~150 0.2~150 0.2~150 0.2~150
Pat.4,851,335.
5. NCCLS.Interference Testing in Clinical Chemistry;Approved Guideline,2005.
◆ Date of Approval and Revision: 02/2014

◆ Packaging Specification
No. Specifications Type
232012702007 R1:3×50mL R2:2×25mL Standard：0.8mL Dirui CS-400/600/800/1200/1300/1600/6400 Package
232012702001 R1:4×60mL R2:4×20mL Standard：0.8mL Dirui CS-240/300 Package
232012702012 R1:2×60mL R2:2×20mL Standard：0.8mL Dirui CS-T Series Package
232012702013 R1:4×30mL R2:4×10mL Standard：0.8mL Dirui CS-T Series Package
232012702014 R1:3×150mL R2:1×150mL Standard：0.8mL Dirui CS-1600/6400 Package

◆ P.S.：CS Series Auto-Chemistry analyzer parameters

Model CS-240 CS-300 CS-400 CS-600 CS-1200 T240 T300 CS-6400 CS-1600 CS-1300

Item HDL-C HDL-C HDL-C HDL-C HDL-C HDL-C HDL-C HDL-C HDL-C HDL-C

Unit mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL
2 point 2 point 2 point 2 point 2 point 2 point 2 point 2 point 2 point 2 point
Method
end end end end end end end end end end
Time 20 20 10 10 10 13 10 9 12 9