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ACCUCARE

LDL CHOLESTROL
Direct Enzymatic colorimetric, Liquid

ORDER INFORMATION SAFETY PRECAUTIONS AND WARNINGS

REF: DLDL 20 Cont. 1x20 ml HDL/LDL CAL
DLDL 40 1x40 ml Components from human origin have been tested and found to be
negative for the presence of HBsAg, HCV and antibody to HIV
CLINICAL SIGNIFICANCE (1/2).
However handle cautiously as potentially infectious.
The LDL particles are lipoproteins that transport cholesterol to the SAMPLE COLLECTION AND PRESERVATION
cells. Often called “bad cholesterol” because high levels are risk
factor for coronary heart disease and are associated with obesity, Serum : After Serum separation, the test should be performed
diabetes and nephrosis. without delay. Repeated freezing and thawing should be avoided.
Clinical diagnosis should not be made on a single test result; it Stability of the sample : 7days at 2-8°C
should integrate with clinical and other laboratory data.
REAGENT PREPARATION AND STORAGE
PRINCIPLE
Direct determination of serum LDL (low-density lipoprotein - R1 and R2 : Are ready to use.
cholesterol) levels without the need for any pre-treatment or - HDL/LDL CAL : Dissolve the contents with 0.5 mL of distilled
centrifugation steps. water. Cap vial and mix gently to dissolve contents.
The assay takes place in two steps.
-1o Elimination of lipoprotein non-LDL REAGENT STABILITY
CHE All the components of the kit are stable until the expiration date on
Cholesterol esters ⎯⎯⎯⎯→Cholesterol + Fatty acids the label when stored tightly closed at 2-8°C and contaminations
CHOD are prevented during their use. Do not freeze the reagents.
Cholesterol + O2 ⎯⎯⎯⎯→4-Cholestenone + H2O2
Catalase LINEARITY
2H2O2 ⎯⎯⎯⎯→2H2O+O2
-2O Measurement of LDLc 1000 mg/dl
CHE
Cholesterol esters ⎯⎯⎯⎯→Cholesterol + Fatty acids ASSAY PROCEDURE
CHOD
Cholesterol + O2 ⎯⎯⎯⎯→ 4-Cholestenone + H2O2 1. Assay conditions :
POD Wavelength : .................................600 nm
2H2O2 + TOOS + 4-AA ⎯⎯⎯⎯→2H2O+O2 Cuvette:..........................................1cm light path
Temperature : .............................................37°C
The Intensity of the color formed is proportional to the LDL 2. Adjust the instrument to zero with distilled water.
concentration in the sample. 3. Pipette into a cuvette:

REAGENT COMPOSITION Blank Standard Sample

GOOD pH 7.0 50 mmol/L R1 (μL) 300 300 300
Cholesterol esterase (CHE) 380U/L Standard(μL) - 4 -
Sample (μL) - - 4
R1 Cholesterol oxidase (CHOD) 380U/L
Catalase 400 U/mL 4. Mix and Incubate for 5 min at 37°C.
N-(2hydroxy-3-sulfopropyl)-3,5- 0.45 mmol/L
5. Add:
dimethoxyaniline (TOOS)
GOOD pH 7.0 50mmol/L R2(μL) 100 100 100
R2 4- Amino antipyrine (4-AA) 1.00mmol/L
Enzymes Peroxidase (POD) 1000u/L 6. Mix and Incubate for 5 min at 37oC.
HDLc/LDLc CAL Standard, Lyophilized human serum 7. Read the absorbance (A), against the Blank.

996.5 0. (x). Masby Co. If control values are found outside the defined automatic analyzers.. 1996. = mg/dL of LDLc in the sample hemoglobin up to 500 mg/dL or bilirubin up to 30 mg/dL. Clin. 3rd ed AACC 1995. St REFERENCE INTERVAL Louis.com W ebsite : www. Tests 4th ad High >160mg/mL AACC 2001. Medium 4.7 0.7 1. Each laboratory should establish its own Quality Control scheme and corrective actions if controls do not meet the acceptable tolerances. Tietz N W et al. Lipoprotein Clin Chem The C.8 0. Tests. Shed No.labcarediagnostics. Teitz Texbook of Clinical Chemistry.7 mg/dL to linearity limit of 1000 mg/dL.7 1. request.3 1. Desirable <100 mg/dL 3. PERFORMANCE CHARACTERISTICS Measuring range : From detection limit of 3.density lipoprotein can be chemically Levels of the risk measured J. Okada M. SARIGAM . LAB-CARE DIAGNOSTICS (INDIA) PVT. Young DS. Kaplan A et al.8 101. dilute the sample 1/2 with NaCl 9 g/L and multiply the result by 2.9 50. LAb. V. A Calibrator A list of drugs and other interfering substances with LDL cholesterol determination has been reported by Young et al 8.940x. The results of the performance characteriatics depend on the analyzer used. Precision: Intra -assay Inter . Chemical Zone. Burlis A et al. Instructions for many of them are available on range. LTD. Mad.com . BIBLIOGRAPHY 1. If the results obtained were greater than linearity limit. 4th ad AACC Press.4 QUALITY CONTROL NOTES Control sera are recommended to monitor the performance of ACCUCARE has Instrument application sheets for several assay procedures.0 100. INDIA Tel : 91-22-2554 2109 / 2554 1558 ●Fax : 2554 3541 Email : accucare@labcarediagnostics. Clinical Guide to Laboratory Tests. 6. Effects of diseases on Clinical Lab. Young DS. Valsad).assay Mean (mg/dL) 32. each laboratory should AACC 1999.3 0.5 1.8 50. 195-201. 2. 3rd ed These values are for orientation purpose. et al Low.6+0.4 32.1 Senstivity : 1mg/dL = 0. Effects of Drugs on Clinical Lab.396 155 (Dist.1 SD 0. Accuracy : Results obtained using ACCUCARE reagents (y) did not show systematic differences when compared with other commercial reagents. 5.4 0. ⎯⎯⎯⎯⎯⎯x Calibrator conc. 1995. C1 Type. Correction coefficient (r) : 0.2 0. establish its own reference range. Regression equation : y =4.1 CV 0. 132.0012 A. 3225. GIDC Sarigam. check the instrument reagents and calibrator for problems. The results obtained using 92 samples were the following. ACCUCARE CALCULATION INTERFERENCES A Sample No Interferences were observed with ascorbic acid up to 50 mg/dL.