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1133010I Rev. 02
1133010I Rev. 02
1133010I Rev. 02
REF 1133010
2 x 40 mL HDL-CHOLESTEROL
CONTENTS
DIFFERENTIAL PRECIPITATION
Enzymatic colorimetric test
R1. Reagent 2 x 40 mL
CAL. Standard 1 x 3 mL ENDPOINT
For in vitro diagnostic use only
PRINCIPLE INTERFERENCES
This technique1 uses a separation method based on the selective Lipemia (triglycerides 10 g/L) does not interfere.
precipitation of apoliprotein B-containing lipoproteins (VLDL, LDL Bilirubin (10 mg/dL), hemoglobin (5 g/L), may affect the results.
and (a)Lpa) by phosphotungstic acid/MgCl2, sedimentation of the
precipitant by centrifugation, and subsequent enzymatic analysis of Other drugs and substances may interfere3.
high density lipoproteins (HDL) as residual cholesterol remaining in
the clear supernatant.
MATERIALS REQUIRED
The Reagents and Standard are ready-to-use. Store the vials tightly
Sample 1
closed, protected from light and prevented contaminations during Sample or Standard 0.2 mL Ratio =
the use. Reagent 2
Serum .EDTA or heparinized plasma, free of hemolysis. Obtained 3. Vortex and allow to stand for 10 minutes at room temperature.
from the patient after an overnight fast. Remove from cells within 3 4. Centrifuge for 10 minutes at 4000 r.p.m., or 2 minutes at 12000
hours of venipuncture. Samples may be kept at 4-8ºC for 2 weeks, r.p.m.
and at –20ºC for 3 months with no alteration of HDL cholesterol. 5. Separate off the clear supernatant within 2 hours.
The supernate containing the HDL fraction is conveniently
prepared on the day of sample collection and may be analysed In case of turbid supernatants caused by elevated triglycerides
after 2 weeks at 4-8ºC or 3 months at –20ºC in a non-selfdefrosting (350 g/dL) the sample should be diluted 1:2 with saline and steps
freezer.2 2,3,4 and 5 repeated. Multiply the result of the colorimetry by 2.
QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS, S.L.U. Joaquim Costa 18 2ª planta. 08390 Montgat (Barcelona) SPAIN
ISO 9001 ISO 13485 Telf. (+34) 934 694 990; E-mail: info@linear.es ; website: www.linear.es NIF-VAT:B60485687
CLINICAL SIGNIFICANCE
II. Colorimetry
1. Bring the Cholesterol MR Monoreagent and the cholesterol Low HDL-cholesterol is a strong independent predictor of coronary
standard (50 mg/dL) of the kit to room temperature heart disease. In ATP III4, low HDL cholesterol is defined
2. Pipette into labelled tubes: categorically as a level 40 mg/dL (1.04 mmol/L), a change from
the level of 35 mg/dL in ATPII (1993).
Low HDL cholesterol is used as a risk factor to estimate 10-year
Sample Standard risk for coronary heart disease, having several causes: elevated
TUBES Blank
Supernat Supernat triglycerides, overweigh and obesity, physical inactivity, and type 2
diabetes. Other causes are, cigarrete smoking, very high
Monoreagent 1.0 mL 1.0 mL 1.0 mL carbohydrate intakes ( 60% of calories), and certain drugs as
anabolic steroids and progestional agents.
Supernate 50 L
Standard 50 L
ANALYTICAL PERFORMANCE
3. Mix and let the tubes stand for 10 minutes at room temperature - Detection limit: 1.2 mg/dL
or 5 minutes at 37ºC.
4. Read the absorbance (A) of the supernatant and the standard - Linearity: Up to 200 mg/dL
at 500 nm against the reagent blank. - Precision:
mg/dL Within-run Between-run
The color is stable for at least 30 minutes protected from light. Mean 42.1 45.8 54.6 42.1 45.8 54.6
SD 0.23 0.23 0.2 0.27 0.28 0.31
REFERENCE VALUES4
NOTES
Clinical values of HDL-Cholesterol used to classify risk groups. 1. This method may be used with different instruments. Any
application to an instrument should be validated to demonstrate
Cholesterol from lipoproteins of high density RISK that results meets the performance characteristics of the
method. It is recommended to validate periodically the
55 mg/dL ( 1.42 mmol/L) Low instrument. Contact to the distributor for any question on the
Men 35-55 mg/dL (0.90-1.42 mmol/L) Moderate application method.
40 mg/dL ( 1.04 mmol/L) High 2. Clinical diagnosis should not be made on findings of a single test
result, but should integrate both clinical and laboratory data.
65 mg/dL ( 1.68 mmol/L) Low
Women 45-65 mg/dL (1.16-1.68 mmol/L) Moderate
REFERENCES
45 mg/dL ( 1.16 mmol/L) High
B1133-2/0901
R1.ing
QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS, S.L.U. Joaquim Costa 18 2ª planta. 08390 Montgat (Barcelona) SPAIN
ISO 9001 ISO 13485 Telf. (+34) 934 694 990; E-mail: info@linear.es ; website: www.linear.es NIF-VAT:B60485687