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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
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 +
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
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
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
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
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
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
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
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
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
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+
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
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
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
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
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
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)
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
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