Embed Size (px)
Citation preview
◆ RUO LZ TEST EIKEN SAA Calibration hierarchy 3）, 4）, 5）
◆ Contents・Storage・Shelf life
Reference1）Benditt,E.P. Eriksen,N.: Proc. Soc. Natl. Acad. Sci. USA., 74 : 4025-4028, 1977.2）Maury, C.P: Clin. Sci., 68 : 233-238, 1985.3）Qin Y, et al. The journal of clinical laboratory instruments and reagents 2020 ; 43（4）: 404-4094）Internal data5）ISO 17511 : 20206）Wilkins J, et al. Clin.Chem.1994 ; 40（7）: 1284-1290
RUO LZ TEST EIKEN SAA
Features
Research Use OnlyHuman Serum Amyloid A Kit
・ Latex agglutination turbidimetric immunoassay・ Applicable to various biochemistry analysers・ Traceable to WHO International Standard
Storage
2-8℃
Shelf life
12 Months
Product Name
RUO LZ TEST EIKEN SAA
Product Code
V-SZ11
Contents Storage Shelf lifeProduct Code
1 mL x 6（6 concentrations） 2-8℃ 12 MonthsV-SZ12
Product Name
RUO LZ-SAA Calibrator EIKEN
（Separately Sold : Calibrator）
Contents
R1 : 20 mL x 2R2 : 20 mL x 2
AKMK1231
For precautions and operation of this product, please refer to Instructions for Use and other related documents.
（Separately Sold : Control Serum）Contents Storage Shelf lifeProduct Code
2-8℃ 36 MonthsV-SZ13
V-SZ14
2 mL x 5
2 mL x 5
Product Name
RUO QC-SAA L EIKEN
RUO QC-SAA H EIKEN
August, 2021
manufacturer’sworking calibrator
manufacturer’s secondaryworking calibrator
RUO LZ-SAA Calibrator EIKEN
human sample with result
RUO LZ TEST EIKEN SAA
manufacturer’s standardoperating procedure
manufacturer’s standardoperating procedure
manufacturer’s standardoperating procedure
Wilkins J’s Method 6）
metrological traceability
WHO International Standard SERUM AMYLOID A（SAA）1st International Standard（NIBSC code : 92/680）
Corporate website (Product information)
◆ Intermediate precision◆ Repeatability
Serum amyloid A protein（SAA）, being synthesized in the liver and increases in blood levels in inflam-matory conditions such as infections, malignant tumors, autoimmune diseases, and tissue necrosis, was being discovered in serum components as a precursor of deposited protein（amyloid A protein）in persistent amyloidosis associated with chronic inflammatory diseases such as tuberculosis and rheu-matoid arthritis 1）. Same as C-reactive protein（CRP）, Serum amyloid A protein（SAA）is an acute phase protein which increases significantly during inflammation, but its amplification is greater than that of CRP, and SAA increases remarkably even in diseases such as viral infections and renal transplant rejection reactions, while CRP do not increase so much.Therefore, it has been stated at studies that measuring serum SAA holds different aspect from CRP 2）.
RUO LZ TEST EIKEN SAA, a latex agglutination turbidimetric immunoassay with high sensitivity, has a wide measurement range, prozone-adaptable, and is easily applicable to various automated biochemis-try analysers.
◆
Analyser : Hitachi 7180 Clinical Analyser
Mean
8.56
42.45
QC-SAA L
QC-SAA H
Days
19
19
C.V.
4.31%
4.00%
1.59%
1.66%
0.73%
1.49%
Variation factor
Total
Inter-day
Intra-day
Total
Inter-day
Intra-day
n
Mean
S.D.
C.V.（%）
MAX.
MIN.
Range
QC-SAA H
20
46.68
0.43
0.91%
47.6
46.0
1.6
QC-SAA L
20
9.58
0.13
1.39%
9.8
9.3
0.5
concentration in mg/L
350
300
250
200
150
100
50
00 600400 800200 1000 1200
Theoretical Value（mg/L）
Measured Value（mg/L）
5.0
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.00/10 2/10 4/10 6/10 8/10 10/10
Dilution Ratio
Measured Value（mg/L）
Measurement limit : 200 mg/L
450
400
350
300
250
200
150
100
50
00 150 40035030025020010050 450
n = 195y = 0.442x + 1.3r = 0.9992Sy/x = 1.73
5
4
3
2
1
00/10 10/108/106/104/102/10
Dilution Ratio
＜High concentration range＞
Measured Value（mg/L）
250
200
150
100
50
00/10 10/108/106/104/102/10
Dilution Ratio
＜Low concentration range＞
Measured Value（mg/L）
Conventional method : EIKEN SAA Japanese package（µg/mL）
RUO LZ TEST EIKEN SAA（mg/L）
1.0 mg/L
concentration in mg/L
No hook effect was seen up to 1200 mg/L SAA.
Linearity was tested at the low and high concentration range.RUO LZ TEST EIKEN SAA has a linear range of 2 mg/L ‒ 200 mg/L.
The Limit of Detection is 1.0 mg/L. This means that when SAA samples were diluted in 10 steps with saline and each sample was measured at n=10, the mean of 1.0 mg/L SAA -2.6 SD does not overlap with the mean of blank sample +2.6 SD.
Almost no effect on the measured value was observed from the following co-existing substances at the indicated concentrations.
Conjugated Bilirubin
Unconjugated Bilirubin
Haemoglobin
Chyle
Rheumatoid Factor
Sodium Fluoride
Sodium Citrate
Heparin Sodium
Disodium EDTA
25
25
500
2000
1000
1000
500
20
200
mg/dL
mg/dL
mg/dL
FTU
IU/mL
mg/dL
mg/dL
mg/dL
mg/dL
FTU : Formazin Turbidity Unit
Introduction
Linearity
◆ Prozone
◆ Correlation◆ Interfering substances
◆ Limit of Detection
This method is an optical measurement method by using the latex agglutination reaction and automat-ed analyser.The latex reagent is prepared by binding anti-SAA antibodies to the surface of the latex particles. When this reagent is mixed in a cell to react with the sample, anti-SAA antibodies which are bound to the latex particles react with SAA in the sample, and cause agglutination.This reaction is then measured as a change in the turbidity, which increases in proportion to concen-tration of SAA in the sample.Measurement using RUO LZ TEST EIKEN SAA applies this principle to find a calibration curve from calibrator of known antigen concentration. The amount of SAA in the sample is then found relative to this calibrator.
Principle of Measurement
For measurement of serum amyloid A（SAA）in serum or plasma
Intended Use
2 mg/L - 200 mg/L （or value of highest calibration point）
Assay Range
Analytical Performance Data 3）, 4）
◆ Intermediate precision◆ Repeatability
Serum amyloid A protein（SAA）, being synthesized in the liver and increases in blood levels in inflam-matory conditions such as infections, malignant tumors, autoimmune diseases, and tissue necrosis, was being discovered in serum components as a precursor of deposited protein（amyloid A protein）in persistent amyloidosis associated with chronic inflammatory diseases such as tuberculosis and rheu-matoid arthritis 1）. Same as C-reactive protein（CRP）, Serum amyloid A protein（SAA）is an acute phase protein which increases significantly during inflammation, but its amplification is greater than that of CRP, and SAA increases remarkably even in diseases such as viral infections and renal transplant rejection reactions, while CRP do not increase so much.Therefore, it has been stated at studies that measuring serum SAA holds different aspect from CRP 2）.
RUO LZ TEST EIKEN SAA, a latex agglutination turbidimetric immunoassay with high sensitivity, has a wide measurement range, prozone-adaptable, and is easily applicable to various automated biochemis-try analysers.
◆
Analyser : Hitachi 7180 Clinical Analyser
Mean
8.56
42.45
QC-SAA L
QC-SAA H
Days
19
19
C.V.
4.31%
4.00%
1.59%
1.66%
0.73%
1.49%
Variation factor
Total
Inter-day
Intra-day
Total
Inter-day
Intra-day
n
Mean
S.D.
C.V.（%）
MAX.
MIN.
Range
QC-SAA H
20
46.68
0.43
0.91%
47.6
46.0
1.6
QC-SAA L
20
9.58
0.13
1.39%
9.8
9.3
0.5
concentration in mg/L
350
300
250
200
150
100
50
00 600400 800200 1000 1200
Theoretical Value（mg/L）
Measured Value（mg/L）
5.0
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.00/10 2/10 4/10 6/10 8/10 10/10
Dilution Ratio
Measured Value（mg/L）
Measurement limit : 200 mg/L
450
400
350
300
250
200
150
100
50
00 150 40035030025020010050 450
n = 195y = 0.442x + 1.3r = 0.9992Sy/x = 1.73
5
4
3
2
1
00/10 10/108/106/104/102/10
Dilution Ratio
＜High concentration range＞
Measured Value（mg/L）
250
200
150
100
50
00/10 10/108/106/104/102/10
Dilution Ratio
＜Low concentration range＞
Measured Value（mg/L）
Conventional method : EIKEN SAA Japanese package（µg/mL）
RUO LZ TEST EIKEN SAA（mg/L）
1.0 mg/L
concentration in mg/L
No hook effect was seen up to 1200 mg/L SAA.
Linearity was tested at the low and high concentration range.RUO LZ TEST EIKEN SAA has a linear range of 2 mg/L ‒ 200 mg/L.
The Limit of Detection is 1.0 mg/L. This means that when SAA samples were diluted in 10 steps with saline and each sample was measured at n=10, the mean of 1.0 mg/L SAA -2.6 SD does not overlap with the mean of blank sample +2.6 SD.
Almost no effect on the measured value was observed from the following co-existing substances at the indicated concentrations.
Conjugated Bilirubin
Unconjugated Bilirubin
Haemoglobin
Chyle
Rheumatoid Factor
Sodium Fluoride
Sodium Citrate
Heparin Sodium
Disodium EDTA
25
25
500
2000
1000
1000
500
20
200
mg/dL
mg/dL
mg/dL
FTU
IU/mL
mg/dL
mg/dL
mg/dL
mg/dL
FTU : Formazin Turbidity Unit
Introduction
Linearity
◆ Prozone
◆ Correlation◆ Interfering substances
◆ Limit of Detection
This method is an optical measurement method by using the latex agglutination reaction and automat-ed analyser.The latex reagent is prepared by binding anti-SAA antibodies to the surface of the latex particles. When this reagent is mixed in a cell to react with the sample, anti-SAA antibodies which are bound to the latex particles react with SAA in the sample, and cause agglutination.This reaction is then measured as a change in the turbidity, which increases in proportion to concen-tration of SAA in the sample.Measurement using RUO LZ TEST EIKEN SAA applies this principle to find a calibration curve from calibrator of known antigen concentration. The amount of SAA in the sample is then found relative to this calibrator.
Principle of Measurement
For measurement of serum amyloid A（SAA）in serum or plasma
Intended Use
2 mg/L - 200 mg/L （or value of highest calibration point）
Assay Range
Analytical Performance Data 3）, 4）
◆ RUO LZ TEST EIKEN SAA Calibration hierarchy 3）, 4）, 5）
◆ Contents・Storage・Shelf life
Reference1）Benditt,E.P. Eriksen,N.: Proc. Soc. Natl. Acad. Sci. USA., 74 : 4025-4028, 1977.2）Maury, C.P: Clin. Sci., 68 : 233-238, 1985.3）Qin Y, et al. The journal of clinical laboratory instruments and reagents 2020 ; 43（4）: 404-4094）Internal data5）ISO 17511 : 20206）Wilkins J, et al. Clin.Chem.1994 ; 40（7）: 1284-1290
RUO LZ TEST EIKEN SAA
Features
Research Use OnlyHuman Serum Amyloid A Kit
・ Latex agglutination turbidimetric immunoassay・ Applicable to various biochemistry analysers・ Traceable to WHO International Standard
Storage
2-8℃
Shelf life
12 Months
Product Name
RUO LZ TEST EIKEN SAA
Product Code
V-SZ11
Contents Storage Shelf lifeProduct Code
1 mL x 6（6 concentrations） 2-8℃ 12 MonthsV-SZ12
Product Name
RUO LZ-SAA Calibrator EIKEN
（Separately Sold : Calibrator）
Contents
R1 : 20 mL x 2R2 : 20 mL x 2
AKMK1231
For precautions and operation of this product, please refer to Instructions for Use and other related documents.
（Separately Sold : Control Serum）Contents Storage Shelf lifeProduct Code
2-8℃ 36 MonthsV-SZ13
V-SZ14
2 mL x 5
2 mL x 5
Product Name
RUO QC-SAA L EIKEN
RUO QC-SAA H EIKEN
August, 2021
manufacturer’sworking calibrator
manufacturer’s secondaryworking calibrator
RUO LZ-SAA Calibrator EIKEN
human sample with result
RUO LZ TEST EIKEN SAA
manufacturer’s standardoperating procedure
manufacturer’s standardoperating procedure
manufacturer’s standardoperating procedure
Wilkins J’s Method 6）
metrological traceability
WHO International Standard SERUM AMYLOID A（SAA）1st International Standard（NIBSC code : 92/680）
Corporate website (Product information)
