ccd021 - colesterolo hdl peg 6000 4x50 m _eng_ rev.03

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ccd021 - colesterolo hdl peg 6000 4x50 m _eng_ rev.03 Powered By Docstoc
					                                                                                               REAGENTS- INITIAL CONCENTRATION                                                               Pipette into labelled centrifuge tubes :
                                                                                                                                                                                                                                          SAMPLE          STANDARD
Via Acuto 30, – 00131 – Rome – ITALY                                                           Reagent 1        Good buffer, pH 10                                 100 mmol/L                Standard                                        -                               L
Tel: +39-(0)6-4190735                                                                                           Polyethylenglycol-6000 (PEG6000)                   30 %                      Sample                                         500                -             L
Fax: +39-(0)6-4190735 - +39-(0)6-233223561                                                                      Sodium azide                                       0,05 - 0.1%               Reagent 1                                                        300            L
Ordini                                                                Reagent 2        Cholesterol HDL standard                           50 mg/dL                  Mix thoroughly and after 10’ at +15-25°C centrifuge at 3000 rpm for 10’.
                                                                                                                                                                                             Measure the HDL cholesterol HDL on the clear supernatant with the reagent of the
   HDL CHOLESTEROL PEG 6000                                                                    REAGENTS – STORAGE AND STABILITY                                                              cholesterol CHOD-PAP (COD.CCD016-CCD017).
               Method with precipitanting reagent PEG 6000.
    Kit for measurement of HDL cholesterol concentration in serum and in                       Kit:                           Store Reagent 1 at +15-25°C.                                   ANALYTICAL PROCEDURE CHOLESTEROL CHOD-PAP (COD.CCD016-CCD017)
                                 plasma.                                                                                      Store Reagent 2 at +2-8°C. Do not refrigerate.
                                                                                                                              Stable until the expiry date shown on the label.               Wavelenght                                 520 (500 o 546)nm
                                                                                               Opened reagents:               Reagents are stable after opening until the expiry date        Lightpath                                  1 cm
                                                    CCD021                       4x50 mL                                      shown on the bottle if it's closed immediately after the       Temperature                                37°C
                                                                                                                              take of the sample and protected from direct light and         Measurement                                Against reagent blank
                                                                                                                              stored at the reported temperature.                            Reaction                                   End point (increase)

PRINCIPLE OF THE METHOD                                                                                                                                                                                                       BLANK           STANDARD            SAMPLE
                                                                                               REAGENTS - PREPARATION
Lipoproteins of fractions VLDL (very low density lipoproteins) and LDL (low density                                                                                                          Working Reagent                    1000             1000                1000       L
                                                                                               The reagent s are stable liquid ready to use.
lipoproteins) and the chylomicrons are quantitative precipitated at buffered pH by                                                                                                           Distilled water                     50                 -                  -        L
addition of polyethylenglycol-6000 (PEG6000). After centrifuge, is determinated the                                                                                                          Sample                               -                 -                 50        L
                                                                                               REAGENTS - PRECAUTION AND WARNING                                                             Standard                             -                50                  -        L
HDL cholesterol concentration with the enzimatic colorimetric CHOD-PAP method.
                                                                                                                                                                                             Mix thoroughly and incubate for 5 minutes at 37°C.
                                                                                               -      The present method descrives the manual use of this kit.                               Measure the absorbance of the Sample (E Sample) and the Standard (E Standard)
METROLOGICAL CHARACTERISTICS CHOLESTEROL CHOD-PAP                                              -      Quality control data sheet of the reagent are available upon request. Refer to the     against the blank Reagent.
(COD.CCD016-CCD017)                                                                                   batch number on the label.                                                             The colour is stable at least 60 minutes at +15-25°C, protected from direct light.

                                       INTERFERENCES                                           ADDITIONAL EQUIPMENT                                                                          CALCULATIONS
                                  Doesn't interfere until the concentration of:
Bilirubin                                             20                           mg/dL
Hemoglobin                                            600                          mg/dL       Pipettes                                                                                      Serum:
Triglycerides                                        1000
                                 INTRA-ASSAY PRECISION
                                                                                   mg/dL       Centrifuge
                                                                                                                                                                                                           Cholestero l HDL(mg/dL) (mmol/L) 
                                                                                                                                                                                                                                                    E Sample
                                                                                                                                                                                                                                                                  STD   
                                                                                                                                                                                                                                                   E Standard
             Control:                    Low                    High                           Cuvette (Lightpath = 1cm).                                                                    Where:
                n:                        20                     20                            Thermostatic water at 37°C                                                                    [STD] = concentration of standard cholesterol HDL (50mg/dL)
              MEAN:                     177,50                 194,25              mg/dL
               D.S.:                     1,53                   1,76
             C.V.(%):                    0,86                   0,90                           SAFETY PRECAUTIONS                                                                            QUALITY CONTROL
                                 INTER-ASSAY PRECISION
             Control:                    Low                    High                           Reagent 1        Refering to european law this product is not classified as a dangerous       Each laboratory should estabilish its own internal Quality Control scheme and procedures
                n:                        20                     20                                             substance. The reagents contain inactive components such as detergent        for corrective action if controls do not recover within the acceptable tolerances.
              MEAN:                     176,77                 196,68              mg/dL
                                                                                                                and preservatives. The total concentration of these components is lower
               D.S.:                     3,51                   4,39
             C.V.(%):                    1,99                   2,22                                            than the limits reported by 67/548/CEE and 88/379/CEE directives and         BIBLIOGRAPHY
                                        CORRELATION                                                             next modifications about classification, packaging and labelling of
Results obtained on the same samples with an equivalent method have done the following data:                    dangerous substances.
                                                                                                                                                                                             Burstein, M., Scholnick, H.R., and Morgin, R.: Rapid method for the isolation of
                               y = 0,9462x + 2,8499                                                             However, the reagents should be handled with caution, avoiding
                                                                                                                                                                                             lipoproteins from human serum by precipitation with polyanions, J. Lipid Res. 11:583-595,
                                      2 = 0,9912                                                                swallowing and contact with skin, eyes and mucous membranes.
                                      n = 20                                                                    The use of laboratory reagents according to good laboratory pratice is
                                                                                                                                                                                             Wiebe, P.A., and Smith, S.J., Clin. Chem. 31:746-750, 1985.
LINEARITY:                                            800                          mg/dL                        recommended (*).
                                                                                                                                                                                             Vilkari, J., Scand. J. Clin. Lab. Invest. 36:265-268, 1976.
SENSITIVITY:                                           2                           mg/dL                                                                                                     Castelli, W.P., Doyle, J.T., Gordon, T., et al., Circulation 55:767-772, 1977.
MEASURED RANGE:                                     2 - 800                        mg/dL       Reagent 2        Harmful
                                                                                                                                                                                             Tietz, NW., Clinical Guide To Laboratory Tests, W.B. Saunders Co., Philadelphia, 1986.
SAMPLE                                                                                                          -Isooctylphenoxypolyethoxyethanol                                            SYMBOLS
                                                                                                                Risk phrases
Serum, plasma.                                                                                                  - Risk of serious damage to eyes (R 41)
                                                                                                                Safety phrases                                                                         Read use istruction                                      Manufactured by
Note:                                                                                                           - In case of contact with eyes, rinse immediately with plenty of water and
-     Avoid use of hemolyzed samples.                                                                           seek medical advise (S 26)
-     After the collection of the sample , separate as soon as possible serum or plasma                         - Wear eye/face protection (S 39)                                                                                                               In Vitro Diagnostic
                                                                                                                                                                                                        Size/number of tests
      from red cells.                                                                                                                                                                                                                                           Medical Device
-     Avoid use of anticoagulants such as heparin, citrate, fluoride and oxalate.              * EU-Dir 1999/11 Commission Directive of March 1999 adapting to technical progress the
-     Cholesterol HDL in the sample is stable for 14 hours at room temperature (+15-           principles of good laboratory pratice as specified in Council Directive 87/18/EEC.                       CE mark declaring compliance with                       Catalogue number
      30°C), 1 week at +2-8°C.                                                                                                                                                                          the In Vitro Diagnostics Medical
                                                                                                                                                                                                        Device Directive, 98/79/EC
                                                                                               WASTE MANAGEMENT                                                                                                                                                 Batch number
                                                                                                                                                                                                        Store at +15-25°C
                                                                                               Please refer to local legal requirements.
    MAN                     41 – 58,7       mg/dL           (1.06 – 1.52    mmol/L)            ANALYTICAL PROCEDURE                                                                                                                                             Vial content
    WOMAN                    45 - 65        mg/dL           (1.26 – 1.94    mmol/L)                                                                                                                     Store at +2-8°C
                                                                                               Allow reagents to reach working temperature +15-25°C before using.
Every laboratory is advised to establish the refernce interval in relation to its own
geographic area.
Cod.CCD021 Rev.03