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Automatic Analyzer Reagents Clinical Chemistry Contents 02 Nanopia TM CRP 04 Pureauto TM S AST-L 06 Pureauto TM S ALT-L 08 Pureauto TM S ALP 10 Pureauto TM S AMY-G2 12 Pureauto TM S CK 14 Pureauto TM S γ -GT 16 Pureauto TM S LD 18 Clinimate TM MG

Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

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Page 1: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

Automatic Analyzer Reagents

ClinicalChemistry

Contents02 NanopiaTM CRP04 PureautoTM S AST-L06 PureautoTM S ALT-L08 PureautoTM S ALP10 PureautoTM S AMY-G212 PureautoTM S CK14 PureautoTM S γ-GT16 PureautoTM S LD18 ClinimateTM MG

Page 2: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

2

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

NanopiaTM CRPC reactive protein kit

2. Features

For measuring CRP in serum or plasmaC 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 cell4. .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 +

Page 3: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

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

-0.0050/6 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

Trac

eabi

lity

secondary standard within the company

ERM-DA472/IFCC(IRMM)

daily samples

result

daily method

SEKISUI MEDICAL

IFCC

SEKISUI MEDICAL

each laboratory

6. TraceabilityC Reactive Protein

materials method

standard methodwithin the company

standard methodwithin the company

Nanopia CRPcalibrator

operator

■ Interference (mg/dL)

additionconcentration

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

Chyle3000

formazin turbidity

0.238 0.235

Ascorbic acid 50 mg/dL 0.242 0.236

Rheumatoid factor 500 U/mL 0.264 0.267

Calibrationvalue assignment

Page 4: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

4

3. Components and Ingredients⃝ 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-LAspartate 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

Page 5: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

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

Trac

eabi

lity

JSCC enzymeJCCLS CRM-001

daily samples

result

daily method

JSCC/JCCLS

SEKISUI MEDICAL

each laboratory

6. TraceabilityAST

materials method

standard methodwithin the company

JSCC/JCCLS standard methodJSCC/JCCLS auto method

Enzyme calibratorplus 「daiichi」

operator

■ Interference (U/L)

additionconcentration

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

Chyle3000

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

Calibrationvalue assignment

Page 6: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

6

3. Components and Ingredients⃝ 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-LAlanine 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

Page 7: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

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

Trac

eabi

lity

JSCC enzymeJCCLS CRM-001

daily samples

result

daily method

JSCC/JCCLS

SEKISUI MEDICAL

each laboratory

6. TraceabilityALT

materials method

standard methodwithin the company

JSCC/JCCLS standard methodJSCC/JCCLS auto method

Enzyme calibratorplus 「daiichi」

operator

■ Interference (U/L)

additionconcentration

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

Chyle3000

formazin turbidity

18.0 17.5

Ascorbic acid 50 mg/dL 19.5 21.0

Rheumatoid factor 500 U/mL 20.0 20.0

■ 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

Calibrationvalue assignment

Page 8: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

8

3. Components and Ingredients⃝ ALP buffer reagent 1  Magnesium chloride

⃝ ALP substrate reagent 2  4-nitrophenyl phosphate disodium

PureautoTM S ALPAlkaline phosphatase kit

2. Features

For Measuring alkaline phosphatase in serum or plasma.Alkaline phosphatase (ALP) is an enzyme that hydrolyzes phosphate compounds at optimum pH.Tissues with high ALP activity include kidney (proximal kidney tubule), intestine (mucosal epithelia), osteoblast, placenta, liver, and milk gland.ALP activity increases with bone disease, liver/biliary disease, pregnancy, and cancer.

1. Final concentration of main component is the same as that recommended by the JSCC (Japan Society Clinical Chemistry) method.

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)

4-nitrophenol detaches when ALP reacts with 4-nitropheyl phspate in ethylamino ethanol buffer.ALP activity can be calculated y measuring the rate at which 4-nitrophenol is produced.

phosphate4-nitrophenol(yellow) +ALP Mg2++4-nitrophenyl phosphate α-ketoglutaric acid

Page 9: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

9

■ Within-run reproducibility

PureautoTM S ALP

Sample1 Sample2 Sample3

n 20 20 20 Mean 250.7 507.9 227.3 S.D. 2.06 3.52 2.57 C.V.(%) 0.82 0.69 1.13 Max. 255 515 234 Min. 247 502 223 Range 8 13 11

(U/L)

5. Data

0 7 14 21 28 35

600.0

500.0

400.0

300.0

200.0

100.0

0.0

On board day

(U

/L)

Sample1 Sample2 Sample3

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

■ Stability

Trac

eabi

lity

JSCC enzymeJCCLS CRM-001b

daily samples

result

daily method

JSCC/JCCLS

SEKISUI MEDICAL

each laboratory

6. TraceabilityALP

materials method

standard methodwithin the company

JSCC/JCCLS standard methodJSCC/JCCLS auto method

Enzyme calibratorplus 「daiichi」

operator

■ Interference (U/L)

additionconcentration

measurement value

Base serum Including interfering substance

F-BIL 20 mg/dL 205 203

C-BIL 20 mg/dL 200 204

Hb 500 mg/dL 205 202

Chyle3000

formazin turbidity

204 207

Ascorbic acid 50 mg/dL 208 208

Rheumatoid factor 500 U/mL 218 212

■ Linearity

Dilution

(U/L)( 1 ) ( 2 )

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

5,500

4,950

4,400

3,850

3,300

2,750

2,200

1,650

1,100

550

0

400

360

320

280

240

200

160

120

80

40

0

Calibrationvalue assignment

Page 10: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

10

3. Components and Ingredients⃝ AMY-G2 buffer reagent 1

Sodium chlorideCalcium chloride

⃝ AMY-G2 substrate reagent 2α-2-chloro−4−nitrophenil−galactopyranosylmaltosidesPotassium rhodanate

PureautoTM S AMY-G2Amylase kit

2. Features

For Measuring amylase in serum, plasma and urine.Amylase is a type of digestive enzyme found in pancreatic fluid, saliva, blood, and urine.Amylase in serum increases immediately with acute pancreatitis.Amylase assay is very important for the diagnosis of pancreatopathy.

1. Ready-to-use liquid reagent.2. Good reproducibility.3. Can be used on various types of automated analyzers

1. Purpose of use1. Purpose of use

*Gal-G2-CNP:α-2-chloro−4−nitrophenil−galactopyranosylmaltosides

CNP+

4. Measurement principleAMY activity is calculated by measuring the production rate of 2-chloro-4-nitriphenol (CNP), the end product of the reaction.

Gal-G2Gal-G2-CNP AMY

Page 11: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

11

■ Within-run reproducibility

PureautoTM S AMY-G2

Sample1 Sample2 Sample3

n 20 20 20 Mean 97.66 105.00 241.04 S.D. 0.74 0.82 1.49 C.V.(%) 0.76 0.78 0.62 Max. 98.8 106.6 243.5 Min. 96.2 103.2 237.9 Range 2.6 3.4 5.6

(U/L)

5. Data

Trac

eabi

lity

result

daily method

JSCC/JCCLS

SEKISUI MEDICAL

each laboratory

6. TraceabilityAMY

materials method

standard method within the company

JSCC/JCCLS standard methodJSCC/JCCLS auto method

operator

■ Interference (U/L)

additionconcentration

measurement value

Base serum Including interferingsubstance

F-BIL 40 mg/dL 81.8 83.1

C-BIL 40 mg/dL 81.4 79.7

Hb 500 mg/dL 82.0 81.0

Chyle5600

formazin turbidity

81.7 81.4

Ascorbic acid 300 mg/dL 81.8 82.3

JSCC enzymeJCCLS CRM-001c

daily samples

Enzyme calibrator plus 「daiichi」

■ Linearity

Dilution

(U/L)( 1 ) ( 2 )

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

3,500

3,000

2,500

2,000

1,500

1,000

500

0

200

180

160

140

120

100

80

60

40

20

0

Calibrationvalue assignment

Page 12: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

12

3. Components and Ingredients⃝ CK enzyme reagent 1

Nicotinamide adenine dinucleotide phosphate(oxidized form)Hexokinase Glucose-6-phosphate dehydrogenase Adenosine potassium diphosphate D(+)-glucoseN-acetylcysteine

⃝ CK substrate reagent 2Creatine phosphate disodium

PureautoTM S CKCreatine kinase kit

2. Features

For measuring Creatine Kinase (CK) in serum and plasma.CK is an enzyme that acts on creatine phosphate and ADP to produce creatine and ATP.CK is a useful marker for the diagnosis of myophathy and cardiac infarct as CK is abundant in skeletal and cardiac muscle.Recently, various recommended methods to measure CK in serum and plasma, such as GSCC, JSCC have been introduced. The method is expected to become standardized.

1. Final concentration of the main component is the same as that recommended by the JSCC method.2. No effect on hemolysis due to the use of doublekinetic method.3. Wide assay range.

1. Purpose of use1. Purpose of use

4. Measurement principleCK activity is calculated based on the production rate of NADPH, the end product of the reaction.

Creatine

Glucose-6-phosphoric acid

Glucose-6-phosphoric acid

Phosphoreatine

Glucose

6-phosphogluconate

ADP

ATP

NADP NADPH

ATP

ADP

+ +

*HK:Hexokinase*NADP:Nicotinamide adenine dinucleotide phosphate*G-6-PD:Glucose-6-phosphate dehydrogenase*NADPH:Reduced form of NADP

CK

HK

G-6-PD

Mg2+

Mg2+

Page 13: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

13

■ Within-run reproducibility

PureautoTM S CK

Sample1 Sample2 Sample3

n 50 50 50 Mean 133.5 221.4 665.0 S.D. 2.7 2.5 3.5 C.V.(%) 1.99 1.13 0.53 Range 13 11.0 18.0

(U/L)

5. Data

Trac

eabi

lity

6. TraceabilityCK

materials method operator

■ Interference (U/L)

additionconcentration

measurement value

Base serum Including interferingsubstance

F-BIL 20 mg/dL 113 117

C-BIL 20 mg/dL 120 128

Hb 500 mg/dL 117 129

Intralipos 2% 120 120

Ascorbic acid 50 mg/dL 118 120

result

daily method

JSCC/JCCLS

SEKISUI MEDICAL

each laboratory

standard method within the company

JSCC/JCCLS standard methodJSCC/JCCLS auto method

JSCC enzymeJCCLS CRM-001c

daily samples

Enzyme calibrator plus 「daiichi」

■ Linearity

Dilution

(U/L)( 2 )( 1 )

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

5,000

4,000

3,000

2,000

1,000

0

1000

900

800

700

600

500

400

300

200

100

0

Calibrationvalue assignment

Page 14: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

14

3. Components and Ingredients⃝ γ-GT buffer reagent 1⃝ γ-GT substrate reagent 2

L-γ-glutamyl-3-carboxy-4-nitroanilide・ammonium, glycylglycine

PureautoTM S γ-GTγ-glutamyltranspeptidase kit

2. Features

For measuring γ-glutamyltranspeptidase (γ-glutamyltransferase:γ-GT) in serum and plasma.γ-GT is an enzyme present in various tissues including kidney, pancreas, prostate, and liver.γ-GT hydrolyses γ-glutamylpeptide.γ-GT activity increases in partiens with obstructive jaundice, liver cancer, and alcoholic liver disease.Reaction rate measurement method with the use of synthetic substrate is widely used.

1. Final concentration of the main component is same as that recommended by the JSCC method.2. Ready-to-use reagent.3. Can be used on various types of automated analyzers.

1. Purpose of use1. Purpose of use

4. Measurement principleγ-GT activity can be calculated based on the production rate of -amino-2-nitrobenzoic acid, the end product of the reaction.

5-amino-2-nitrobenzoic acid(Yellow)+L-γ-glutamyglycylglycine

glycylglycine+L-γ-glutamyl-3-carboxy-4-nitroanilide

γGT

Page 15: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

15

■ Within-run reproducibility

PureautoTM S γ-GT

Sample1 Sample2 Sample3

n 20 20 20 Mean 24.9 86.9 38.0 S.D. 0.3 0.6 0.2 C.V.(%) 1.24 0.68 0.59 Max. 25 88 38 Min. 24 86 37 Range 1 2 1

(U/L)

5. Data

0 7 14 21 28 35

120.0

100.0

80.0

60.0

40.0

20.0

0.0

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

(U

/L)

Sample1 Sample2 Sample3■ Stability

Trac

eabi

lity

result

daily method

JSCC/JCCLS

SEKISUI MEDICAL

each laboratory

6. Traceabilityγ-GT

materials method

standard method within the company

JSCC/JCCLS standard methodJSCC/JCCLS auto method

operator

■ Interference (U/L)

additionconcentration

measurement value

Base serum Including interferingsubstance

F-BIL 20 mg/dL 34.0 32.5

C-BIL 20 mg/dL 34.0 34.0

Hb 500 mg/dL 35.0 32.5

Chyle3000

formazin turbidity

34.5 34.5

Ascorbic acid 50 mg/dL 35.0 35.0

JSCC enzymeJCCLS CRM-001c

daily samples

Enzyme calibrator plus 「daiichi」

■ Linearity

Dilution

( 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

150

135

120

105

90

75

60

45

30

15

0

(U/L)

Calibrationvalue assignment

Page 16: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

16

3. Components and Ingredients⃝ LD substrate reagent 1

L-lactic acid litium

⃝ LD coenzyme reagent 2Nicotinamide adenine dinucleotide(oxidized form)

PureautoTM S LDLactase dehydrogenase kit

2. Features

For measuring lactase dehydrogenase (LD) in serum and plasma.LD is an enzyme found in various parts of the body that catalyzes lactic acid and pyruvic acid.LD increases in patients with cancer, leukemia, anemia, pernicious anemia, and diseases of the heart, liver, and kidney.Therefore, the measurement of LD is very important for the diagnosis and clinical follow-up of these diseases.

1. Final concentration of the main component is the same as that recommended by the JSCC method.2. Ready-to-use reagent.3. Can be used on various types of automated analyzers

1. Purpose of use1. Purpose of use

NAD NADH+ +

4. Measurement principleLD activity can be calculated based on the rate at which NAD is converted to NADH.

Pyruvic acidLactic acid LD

Page 17: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

17

■ Within-run reproducibility

PureautoTM S LD

Sample1 Sample2 Sample3

n 20 20 20 Mean 160.0 396.4 159.6 S.D. 1.2 2.9 0.8 C.V.(%) 0.73 0.72 0.52 Max. 163 402 161 Min. 157 389 158 Range 6 13 3

(U/L)

5. Data

0 7 14 21 28 35

500.0

400.0

300.0

200.0

100.0

0.0

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

(U

/L)

Sample1 Sample2 Sample3■ Stability

Trac

eabi

lity

JSCC enzymeJCCLS CRM-001c

daily samples

result

daily method

JSCC/JCCLS

SEKISUI MEDICAL

each laboratory

6. TraceabilityLD

materials method

standard method within the company

JSCC/JCCLS standard methodJSCC/JCCLS auto method

Enzyme calibrator plus 「daiichi」

operator

■ Interference (U/L)

additionconcentration

measurement value

Base serum Including interferingsubstance

F-BIL 20 mg/dL 142.5 143.0

C-BIL 20 mg/dL 141.5 144.0

Hb 500 mg/dL 143.0 774.0

Chyle3000

formazin turbidity

143.0 144.5

Ascorbic acid 50 mg/dL 144.0 139.5

■ Linearity

Dilution

( 1 ) ( 2 )

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

2,000

1,800

1,600

1,400

1,200

1,000

800

600

400

200

0

300

270

240

210

180

150

120

90

60

30

0

(U/L)

Calibrationvalue assignment

Page 18: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

18

3. Components and Ingredients⃝ MG coloring solution

Xylylazo VioletⅠ

ClinimateTM MGMagnesium kit

2. Features

For measuring magnesium (MG) in serum and urine.MG is abundant in body fluid as structural component of electrolytes and has important physiological functions such as in glycolysis and activation of enzymes in the urea cycle.Because MG concentration in body fluid is regulated within a narrow range, measurement of MG is important for the diagnosis of various diseases.

1. Ready-to-use reagent.2. Reacts specifically with MG3. Can be used on various types of automated analyzers

1. Purpose of use1. Purpose of use

MG2 +

4. Measurement principleMG produces a red complex when combined with xylylazo violet I (xylidyl blue).MG concentration is calculated by measuring the absorbance of the red color.

xylylazo violetⅠ Complex(red)

Page 19: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

19

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

12.0

10.8

9.6

8.4

7.2

6.0

4.8

3.6

2.4

1.2

0.0

4.0

3.6

3.2

2.8

2.4

2.0

1.6

1.2

0.8

0.4

0.0

Dilution

(mg/dL)( 1 ) ( 2 )

■ Within-run reproducibility

ClinimateTM MG

Sample1 Sample2 Sample3

n 20 20 20 Mean 2.22 4.56 2.32 S.D. 0.04 0.06 0.04 C.V.(%) 1.85 1.33 1.77 Max. 2.3 4.7 2.4 Min. 2.2 4.5 2.3 Range 0.1 0.2 0.1

(mg/dL)

5. Data

0 7 14 21 28 35

6.0

5.0

4.0

3.0

2.0

1.0

0.0

On board day

*Calibration was made at day0. Always open reagent cap, without invert reagent. 【Change factor and recommendation】"Reagent pH will decrease due to absorbing carbon dioxide.In case of using for a few days with opening cap, we recommend several ideas.1)Re-calibration on each measurement.2)Prepare reagent in small quantity for each measurements."

(U

/L)

Sample1 Sample2 Sample3(mg/dL)■ Stability

Trac

eabi

lity NIST SRM929

daily samples

result

SI unit

daily method

NIST

SEKISUI MEDICAL

each laboratory

6. TraceabilityMg

materials method

standard method within the company

mass spectrometry(MS)

SERONORUM・Multi calibrator

operator

■ Interference (mg/dL)

additionconcentration

measurement value

Base serum Including interferingsubstance

F-BIL 20 mg/dL 2.0 2.0

C-BIL 20 mg/dL 2.0 2.0

Hb 500 mg/dL 2.0 2.1

Chyle3000

formazin turbidity

2.0 2.0

Ascorbic acid 50 mg/dL 2.3 2.2

■ Linearity

Calibrationvalue assignment

Page 20: Automat ic Analyzer Reagents Clinical Chemistry ·  · 2019-09-26JSCC (Japan Society Clinical Chemistry) method. 2. Ready-to-use liquid reagent. 3. Can be used on various types of

For more information contact:

International Business Department Diagnostics Division

13-5, Nihonbashi 3-chome, Chuo-ku, Tokyo 103-0027 JAPANTel: +81-3-3272-0828, Fax: +81-3-3272-0907E-mail: [email protected]: www.sekisuimedical.jp/english