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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 2-8C
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 2-8C 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 : .............................................37C
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 (L) 300 300 300


Cholesterol esterase (CHE) 380U/L Standard(L) - 4 -
Sample (L) - - 4
R1 Cholesterol oxidase (CHOD) 380U/L
Catalase 400 U/mL 4. Mix and Incubate for 5 min at 37C.
N-(2hydroxy-3-sulfopropyl)-3,5- 0.45 mmol/L
5. Add:
dimethoxyaniline (TOOS)
GOOD pH 7.0 50mmol/L R2(L) 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.
ACCUCARE

CALCULATION INTERFERENCES

A Sample No Interferences were observed with ascorbic acid up to 50 mg/dL,


x Calibrator conc. = mg/dL of LDLc in the sample hemoglobin up to 500 mg/dL or bilirubin up to 30 mg/dL.
A Calibrator A list of drugs and other interfering substances with LDL cholesterol
determination has been reported by Young et al 8.4
QUALITY CONTROL
NOTES
Control sera are recommended to monitor the performance of
ACCUCARE has Instrument application sheets for several
assay procedures. If control values are found outside the defined
automatic analyzers. Instructions for many of them are available on
range, check the instrument reagents and calibrator for problems.
request.
Each laboratory should establish its own Quality Control scheme
and corrective actions if controls do not meet the acceptable
tolerances.
BIBLIOGRAPHY

1. Kaplan A et al. Lipoprotein Clin Chem The C. V. Masby Co. St


REFERENCE INTERVAL
Louis.
2. Okada M. et al Low- density lipoprotein can be chemically
Levels of the risk measured J. LAb, Clin. Mad., 1996; 132, 195-201.
Desirable <100 mg/dL 3. Young DS. Effects of Drugs on Clinical Lab. Tests, 4th ad
AACC Press, 1995.
Medium 4. Young DS. Effects of diseases on Clinical Lab. Tests 4th ad
High >160mg/mL AACC 2001.
5. Burlis A et al. Teitz Texbook of Clinical Chemistry, 3rd ed
These values are for orientation purpose; each laboratory should AACC 1999.
establish its own reference range. 6. Tietz N W et al, Clinical Guide to Laboratory Tests, 3rd ed
AACC 1995.
PERFORMANCE CHARACTERISTICS

Measuring range : From detection limit of 3.7 mg/dL to linearity limit


of 1000 mg/dL.
If the results obtained were greater than linearity limit, dilute the
sample 1/2 with NaCl 9 g/L and multiply the result by 2.

Precision:

Intra -assay Inter - assay


Mean
(mg/dL) 32.9 50.8 101.4 32.8 50.0 100.1
SD 0.3 0.2 0.7 0.4 0.7 1.1
CV 0.8 0.5 0.7 1.3 1.5 1.1

Senstivity :
1mg/dL = 0.0012 A.
Accuracy : Results obtained using ACCUCARE reagents (y) did not
show systematic differences when compared with other commercial
reagents. (x).
The results obtained using 92 samples were the following.
Correction coefficient (r) : 0.996.
Regression equation : y =4.6+0.940x.
The results of the performance characteriatics depend on the
analyzer
used.

LAB-CARE DIAGNOSTICS (INDIA) PVT. LTD.


C1 Type, Shed No. 3225, Chemical Zone, GIDC Sarigam,
SARIGAM - 396 155 (Dist. Valsad). INDIA
Tel : 91-22-2554 2109 / 2554 1558 Fax : 2554 3541
Email : accucare@labcarediagnostics.com
W ebsite : www.labcarediagnostics.com