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    Lipase: Calib. Conc. Check Vial Label

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    Dinesh Sreedharan
    This document describes a kit for quantitatively determining lipase levels in human serum and plasma. Lipase is an enzyme produced in the pancreas that helps digest fats. Elevated lipase levels can indicate pancreatic disorders. The kit uses a synthetic lipase substrate that is specifically cleaved by lipase to produce a red dye, allowing for the photometric measurement of lipase activity in a sample. The kit provides optimized reagents and a simple procedure to accurately measure lipase levels as an indicator of pancreatic function or disorders.

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    Lipase: Calib. Conc. Check Vial Label

    Uploaded by

    Dinesh Sreedharan
    42 views2 pages
    This document describes a kit for quantitatively determining lipase levels in human serum and plasma. Lipase is an enzyme produced in the pancreas that helps digest fats. Elevated lipase levels can indicate pancreatic disorders. The kit uses a synthetic lipase substrate that is specifically cleaved by lipase to produce a red dye, allowing for the photometric measurement of lipase activity in a sample. The kit provides optimized reagents and a simple procedure to accurately measure lipase levels as an indicator of pancreatic function or disorders.

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    Lipase

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    This document describes a kit for quantitatively determining lipase levels in human serum and plasma. Lipase is an enzyme produced in the pancreas that helps digest fats. Elevated lipase levels can indicate pancreatic disorders. The kit uses a synthetic lipase substrate that is specifically cleaved by lipase to produce a red dye, allowing for the photometric measurement of lipase activity in a sample. The kit provides optimized reagents and a simple procedure to accurately measure lipase levels as an indicator of pancreatic function or disorders.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    42 views2 pages

    Lipase: Calib. Conc. Check Vial Label

    Uploaded by

    Dinesh Sreedharan
    This document describes a kit for quantitatively determining lipase levels in human serum and plasma. Lipase is an enzyme produced in the pancreas that helps digest fats. Elevated lipase levels can indicate pancreatic disorders. The kit uses a synthetic lipase substrate that is specifically cleaved by lipase to produce a red dye, allowing for the photometric measurement of lipase activity in a sample. The kit provides optimized reagents and a simple procedure to accurately measure lipase levels as an indicator of pancreatic function or disorders.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    LIPASE

    (Enzymatic/Colorimetric Method)
    Kit for the quantitative determination of Lipase in human Serum and Plasma.
    _______________________________________________________________________________________________
    SUMMARY: REAGENTS
    Lipases are enzymes which hydrolyze glycerol esters of A1: BUFFER (REAGENT 1)
    long fatty acids. The enzyme and its cofactor Goods Buffer (pH 8.0) : 55mmol/L
    colipase are produced in the pancreas, lipase being also Taurodesoxycholate : 4.4mmol/L
    secreted in small amounts by the salivaryglands as well Desoxycholate : 8.1mmol/L
    as by gastric, pulmonary and intestinal mucosa. Bile Calcium chloride : 16mmol/L
    acids and colipase form micellar Colipase : 2.1 mg/L
    complexes with the lipids and bind lipase on the Detergent&Preservative
    substrate / water interface. Determination of lipase is
    used for investigation of pancreatic disorders. In acute A2: SUBSTRATE (REAGENT 2)
    pancreatitis the lipase concentrations rise to Tartrate Buffer : (pH 4.0) 7.6mmol/L
    2-50 fold the upper reference limit within 4-8 hours Taurodesoxycholate : 17.5mmol/L
    after the beginning of abdominal pain peaking at Lipase Substrate : 0.6 mmol/L
    24 hours and decrease within 8 to 14 days. Elevated Stabilizer&Preservatives
    lipase values can also be observed in chronic STORAGE INSTRUCTIONS AND REAGENT STABILITY
    pancreatitis and obstruction of the pancreatic duct. The reagents are stable up to the end of the indicated
    expiry date if stored at 2 – 8 °C and when the
    METHOD: contamination isavoided. Do not freeze the reagents!
    A synthetically produced lipase substrate (1,2-o- REAGENT PREPARATION
    dilaurylrac-glycero-3-glutaric acid-(6- The reagents are ready to use. Do not shake.
    methylresorufin) ester) is added to a micro-emulsion SPECIMEN:
    which is specifically split by lipase in the Serum or Heparin Plasma
    presence of colipase and bile acids. The combination of Stability : 7 days at 20 - 25 °C
    lipase and bile acids make this specific and 7 days at 4 - 8 °C
    reliable for pancreatic lipase without any reaction due 1 Month at -20 °C
    to lipolytic enzymes or esterases. The reagent Discard contaminated specimens.
    composition has been thoroughly optimized so there
    are no serum matrix effects.The generated SYSTEM PARAMETERS
    methylresorufin-ester is spontaneously degraded to
    Reaction Type (Mode) : Kinetic
    methylresorufin. The absorbance by this red dye
    is directly proportional to the lipase activity in the Reaction Direction : Increasing
    sample. Wave Length : 578 nm
    Flow Cell Temp. : 37°C
    Zero Setting with : Distilled Water
    Delay Time : 120 Seconds (2 Mins)
    Measuring Time : 120 Seconds (2 Mins)
    Reagent Volume : 1.0 ml (R1) + 200 μl(R2)
    Sample Volume : 20 μl
    Calibrator : Calib. Conc. Check Vial Label
    Linearity : 220
    Units : U/L
    High Normal : 64 U/L
    LIPASE
    (Enzymatic/Colorimetric Method)
    Kit for the quantitative determination of Lipase in human Serum and Plasma.
    _______________________________________________________________________________________________

    ASSAY PROCEDURE: Between day precision Mean SD CV


    n = 40 [U/L] [U/L] [%]
    A1 Buffer (Reagent 1) 1000 μL Sample 1 13.4 0.24 1.81
    Sample 2 58.9 0.49 0.80
    20 μL Sample 3 103 0.65 0.63
    Serum/ Plasma
    METHOD COMPARISON:
    A comparison between ASRITHALIPASE (y) and a
    Mix and incubate for 5 min at 37 °C in an Incubator commercially available colorimetric test (x) using 67
    samplesgave following results:
    200 μL y = 0.96 x – 1.15 U/L; r= 0.999.
    A2 Substrate (Reagent 2) INTERFERENCE:
    Mix well and after 120Sec incubation, measure the The following concentrations were not found to affect
    change of optical density per 60 seconds during 120 the assay:
    seconds against distilled water at 578 nm as follows: Conjugated Bilirubin 40 mg/dl, Free Bilirubin 70 mg/dl,
    A0 - Exactly after 2 minutes. Haemoglobin 1000mg/dl ,Intralipid 800 mg/dl,
    A 1, A 2 - Exactly after every 60 seconds for 120 Triglycerides1000 mg/dl
    seconds. Reference Range : 0-64 U/L
    It is strongly recommended that each laboratory
    CALCULATION: establish its own normal range.
    Lipase Activity (IU/L) = Δ Abs / Min X Conc. Of Calib. LITERATURE
    PERFORMANCE CHARACTERISTICS: 1. Lorentz K. Lipase. In: Thomas L, editor. Clinical laboratory
    diagnostics. 1st ed. Frankfurt: TH-Books
    Measuring range
    Verlagsgesellschaft; 1998. p. 95-7.
    The test has been developed to determine lipase 2. Moss DW, Henderson AR. Digestive enzymes of pancreatic origin.
    concentrations up to 220 U/L. In: Burtis CA, Ashwood ER, editors.Tietz
    When values exceed this range samples Textbook of Clinical Chemistry. 3rd ed.Philadelphia: W.B Saunders
    should be diluted 1 + 1 with NaCl solution (9 g/L) and Company; 1999.p. 689-708.
    3. Tietz N, Shuey DF. Lipase in serum – the elusive enzyme: an
    the result should be multiplied by 2. overview. ClinChem 1993; 39: 746-56.
    SPECIFICITY/INTERFERENCES 4. Lott J, Patel ST, Sawhney AK, Kazmierczak SC, Love JE. Assays of
    No interference was observed by ascorbic acid up to 30 serum lipase: analytical and clinical
    mg/dL, free and conjugated bilirubin up to 60 mg/dL, considerations. ClinChem 1986; 32: 1290-1302.
    hemoglobin
    LIPASE PRODUCT FEATURES
    up to 500 mg/dL and lipemia up to 1000 mg/dL
    triglycerides. • Liquid (2R) (5 parts R1+ 1 part R2) System
    SENSITIVITY / LIMIT OF DETECTION • Uses 1,2-O-dilauryl-rac-glycero-3-glutaric acid (6'-
    The lower limit of detection is 3 U/L. methylresorufin)-ester asLipase Specfic Substrate.
    Precision: • Linearity: 220 U/L
    According to protocol EP-5 of the NCCLS (National • Measuring wavelength 578 nm.
    Committee of Clinical Laboratory Standards) • Two Step Kinetic Assay : 5 Minutes Incubation in
    Within run precision Mean SD CV the Incubator and 4 Minutes Incubation in the
    n = 40 [U/L] [U/L] [%] Analyzer120 Sec Delay+ 120 Sec Measuring. (4
    Sample 1 13.4 0.24 1.81 Minutes).
    • No interference from Bilirubinupto 40 mg/dl,
    Sample 2 58.9 0.60 1.01
    Haemoglobin 1000mg/dl , Triglycerides
    Sample 3 103 1.50 1.45
    1000mg/dl,Ascorbic Acid 40 mg/dl

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