Automat ic Analyzer Reagents Clinical Chemistry آ  2019-09-26JSCC (Japan Society Clinical...

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Transcript of Automat ic Analyzer Reagents Clinical Chemistry آ  2019-09-26JSCC (Japan Society Clinical...

  • Automatic Analyzer Reagents

    Clinical Chemistry

    Contents 02 NanopiaTM CRP 04 PureautoTM S AST-L 06 PureautoTM S ALT-L 08 PureautoTM S ALP 10 PureautoTM S AMY-G2 12 PureautoTM S CK 14 PureautoTM S γ-GT 16 PureautoTM S LD 18 ClinimateTM MG

  • 2

    3. Components and Ingredients ⃝ Reagent 1 ⃝ Reagent 2  Anti-human CRP mouse monoclonal antibody coated latex

    NanopiaTM CRP C reactive protein kit

    2. Features

    For measuring CRP in serum or plasma C reactive protein (CRP), an abnormal protein resultin from various reactions againt inflammations or tissue necrosis, and reacts with C polysaccharides in the presence of calcium ion to form precipitates. CRP is useful for finding inflammation and cardiac infarct. In addition, CRP is measured for clinical follow-up or deciding on course of treatments.

    1. Wide assay range (0.01-42mg/dL). 2. No prozone effect up to appro. 100mg/dL. 3. Does not contaminate reaction cell 4. .Can be used on various types of automated analyzers

    1. Purpose of use1. Purpose of use

    4. Measurement principle (Latex-enhanced immunoturbidimetric assay) CRP in serum agglutinates with ani-human CRP mouse monoclonal antibody latex. CRP can be obtained by measuring agglutination as a change in absorbance.

    agglutination by antigen-antibody complex reactionanti-humanCRP mouse monoclonal antibody coated latexCRP +

  • 3

    ■ Within-run reproducibility

    NanopiaTM CRP

    Sample1 Sample2 Sample3

    n 20 20 20 Mean 0.452 3.739 0.139 S.D. 0.004 0.035 0.002 C.V.(%) 0.94 0.93 1.54 Max. 0.46 3.83 0.14 Min. 0.45 3.68 0.14 Range 0.02 0.15 0.01

    (mg/dL)

    5. Data

    0/10 2/10 4/10 6/10 8/10 10/10

    55.0

    49.5

    44.0

    38.5

    33.0

    27.5

    22.0

    16.5

    11.0

    5.5

    0.0

    10.0

    9.0

    8.0

    7.0

    6.0

    5.0

    4.0

    3.0

    2.0

    1.0

    0.0

    Dilution

    (mg/dL) ( 1 ) ( 2 )

    ■ Linearity

    0.045

    0.040

    0.035

    0.030

    0.025

    0.020

    0.015

    0.010

    0.005

    0.000

    -0.005 0/6 1/6 2/6 3/6 4/6 5/6 6/6

    (mg/dL)

    0.014 mg/dL

    ■ Detection limit(±2.6SD method)

    0 7 14 21 28 35

    5.00

    4.00

    3.00

    2.00

    1.00

    0.00

    On board day *Calibration was made at day0. Always open reagent cap, without invert reagent.

    ( m

    g/ dL )

    Sample1 Sample2 Sample3 ■ Stability

    Tr ac

    ea bi

    lit y

    secondary standard within the company

    ERM-DA472/IFCC(IRMM)

    daily samples

    result

    daily method

    SEKISUI MEDICAL

    IFCC

    SEKISUI MEDICAL

    each laboratory

    6. Traceability C Reactive Protein

    materials method

    standard method within the company

    standard method within the company

    Nanopia CRP calibrator

    operator

    ■ Interference (mg/dL) addition

    concentration

    measurement value

    Base serum Including interferingsubstance

    F-BIL 20 mg/dL 0.234 0.235

    C-BIL 20 mg/dL 0.232 0.235

    Hb 500 mg/dL 0.237 0.233

    Chyle 3000

    formazin turbidity

    0.238 0.235

    Ascorbic acid 50 mg/dL 0.242 0.236

    Rheumatoid factor 500 U/mL 0.264 0.267

    Calibration value assignment

  • 4

    3. Components and Ingredients ⃝ AST-L enzyme reagent 1   Malate dehydrogenase, reduced nicotinamide adenine dinucleotid, L-asparagine acid. ⃝ AST-L substrate Reagent 2  L-asparagine acid, α-ketoglutaric acid

    PureautoTM S AST-L Aspartate aminotransferase kit

    2. Features

    For measuring Aspartate aminotransferase in serum or plasma. Aspartate aminotransferase (AST), a type of enzyme found in various tissues in the body including cardiac muscle, liver, brain and red blood cell, catalyzes the transfer reaction of amino group between amino acid and α-keto acid. AST activity increases in patients with liver disease, biliary disease, cardiac infarct, and especially acute hepatitis.

    1. Reagent is based on JSCC (Japan Society of Clinical Chemistry) standardization. 2. Ready-to-use liquid reagent. 3. Can be used on various types of automated analyzers

    1. Purpose of use1. Purpose of use

    4. Measurement principle (JSCC standarization corresponding method) AST catalyzes the reaction that produces oxaloacetate and glutamate from L-asparagine acid and α-ketoglutaric acid, and NADH is converted to NAD in this process. AST activity is calculated by measuring the rate at NADH decreases.

    *MD:Malate dehydrogenase *NADH:Dihydronicotinamide adenine dinucleotide

    *NAD:Nicotinamide adenine dinucleotide

    oxaloacetate

    NADH NAD

    L-asparagine acid α-ketoglutaric acid glutamic acid

    oxaloacetate malic acid

    ++

    + +

    AST

    MD

  • 5

    ■ Within-run reproducibility

    PureautoTM S AST-L

    Sample1 Sample2 Sample3

    n 20 20 20 Mean 36.9 106.7 21.8 S.D. 0.31 0.59 0.44 C.V.(%) 0.83 0.55 2.04 Max. 37 108 22 Min. 36 106 21 Range 1 2 1

    (U/L)

    5. Data

    0 7 14 21 28 35

    150.0

    125.0

    100.0

    75.0

    50.0

    25.0

    0.0

    On board day

    ( U

    /L )

    Sample1 Sample2 Sample3

    *Calibration was made at day0. Always open reagent cap, without invert reagent.

    ■ Stability

    Tr ac

    ea bi

    lit y

    JSCC enzyme JCCLS CRM-001

    daily samples

    result

    daily method

    JSCC/JCCLS

    SEKISUI MEDICAL

    each laboratory

    6. Traceability AST

    materials method

    standard method within the company

    JSCC/JCCLS standard method JSCC/JCCLS auto method

    Enzyme calibrator plus 「daiichi」

    operator

    ■ Interference (U/L) addition

    concentration

    measurement value

    Base serum Including interferingsubstance

    F-BIL 20 mg/dL 19.0 19.0

    C-BIL 20 mg/dL 19.0 19.5

    Hb 500 mg/dL 19.0 53.5

    Chyle 3000

    formazin turbidity

    19.0 20.5

    Ascorbic acid 50 mg/dL 19.5 21.0

    Rheumatoid factor 500 U/mL 21.0 21.0

    ■ Linearity

    Dilution

    (U/L) ( 1 ) ( 2 )

    0/10 2/10 4/10 6/10 8/10 10/10

    2,500

    2,250

    2,000

    1,750

    1,500

    1,250

    1,000

    750

    500

    250

    0

    200

    180

    160

    140

    120

    100

    80

    60

    40

    20

    0

    Calibration value assignment

  • 6

    3. Components and Ingredients ⃝ ALT-L enzyme reagent 1   Lactase dehydrogenase, reduced nicotinamide adenine dinucleotid, L-alanine. ⃝ ALT-L substrate Reagent 2  L-alanine, α-ketoglutaric acid

    PureautoTM S ALT-L Alanine aminotransferase kit

    2. Features

    For Measuring alanine aminotransferase in serum or plasma. Alanine aminotransferase (ALT), a type of enzyme found in various tissues in the body including cardiac muscle, liver , and brain, catalyzes the transfer reaction of amino group between amino acid and α-keto acid. ALT activity increases in patients with liver disease, biliary disease, cardiac infarct, and especially acute hepatitis.

    1. Reagent is based on JSCC (Japan Society of Clinical Chemistry) standardization. 2. Ready-to-use liquid reagent. 3. Can be used on various types of automated analyzers

    1. Purpose of use1. Purpose of use

    4. Measurement principle (JSCC standarization corresponding method) ALT catalyzes the reaction that produces pyrvic acid and glutamate from L-alanine and α -ketoglutaric acid, and NADH is converted to NAD in this process. ALT activity is calculated by measuring the rate at which NADH decreases.

    NADH NAD

    L-alanine α-ketoglutaric acid glutamic acidpyrvic acid

    pyrvic acid Lactase

    ++

    + +LD

    ALT

    *MD:Malate dehydrogenase *NADH:Dihydronicotinamide adenine dinucleotide

    *NAD:Nicotinamide adenine dinucleotide

  • 7

    ■ Within-run reproducibility

    PureautoTM S ALT-L

    Sample1 Sample2 Sample3

    n 20 20 20 Mean 31.0 95.8 18.8 S.D. 0.22 0.72 0.41 C.V.(%) 0.72 0.75 2.18 Max. 31 97 19 Min. 30 94 18 Range 1 3 1

    (U/L)

    5. Data

    0 7 14 21 28 35

    150.0

    125.0

    100.0

    75.0

    50.0

    25.0

    0.0

    On board day

    ( U

    /L )

    Sample1 Sample2 Sample3

    *Calibration was made at day0. Always open reagent cap, without invert reagent.

    ■ Stability

    Tr ac

    ea bi

    lit y

    JSCC enzyme JCCLS CRM-001

    daily samples

    result

    daily method

    JSCC/JCCLS

    SEKISUI MEDICAL

    each laboratory

    6. Traceability ALT

    materials method

    standard method within the company

    JSCC/JCCLS standard method JSCC/JCCLS auto method

    Enzyme calibrator plus 「daiichi」

    operator

    ■ Interference (U/L) addition

    concentration

    measurement value

    Base serum Including interferingsubstance

    F-BIL 20 mg/dL 18.0 18.0

    C-BIL 20 mg/dL 17.5 18.0

    Hb 500 mg/dL 18.0 20.5

    Chyle 3000

    formazin turbidity

    18.0 17.5

    Ascorbic acid 50 mg/dL 19.5 21.0

    Rheumat