Research Use Only
Human Serum Amyloid A Kit

RUO LZ TEST EIKEN SAAFeatures
・Latex agglutination turbidimetric immunoassay
・Applicable to various biochemistry analysers
・Traceable to WHO International Standard

Introduction
Serum amyloid A protein（SAA）, being synthesized in the liver and increases in blood levels in inﬂammatory conditions such as infections, malignant tumors, autoimmune diseases, and tissue necrosis, wasbeing 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 rheumatoid 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 awide measurement range, prozone-adaptable, and is easily applicable to various automated biochemistry analysers.

Principle of Measurement
This method is an optical measurement method by using the latex agglutination reaction and automated 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 concentration of SAA in the sample.
Measurement using RUO LZ TEST EIKEN SAA applies this principle to ﬁnd a calibration curve fromcalibrator of known antigen concentration. The amount of SAA in the sample is then found relative tothis calibrator.

Intended Use
For measurement of serum amyloid A（SAA）in serum or plasma

Assay Range
2 mg/L - 200 mg/L （or value of highest calibration point）

Analytical Performance Data 3）, 4）◆ RepeatabilityAnalyser : Hitachi 7180 Clinical Analyser◆ Intermediate precision
concentration in mg/L

（ ）QC-SAA L

QC-SAA H

2020

9.58

46.68

0.13

0.43

1.39%

0.91%

9.8

47.6

9.3

46.0

0.5

1.6

concentration in mg/L
Days

QC-SAA L

QC-SAA H

1919

Mean Variation factor

8.56

42.45

C.V.

Total

4.31%

Inter-day

4.00%

Intra-day

1.59%

Total

1.66%

Inter-day

0.73%

Intra-day

1.49%

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.

◆ Linearity＜Low concentration range＞＜High concentration range＞
250

Measured Value（mg/L）

Measured Value（mg/L）

5432
100/10

2/10

4/10

6/10

8/10

200
150
100
50
00/10

10/10

2/10

Dilution Ratio

6/10

8/10

10/10

Dilution Ratio◆ Prozone◆ Limit of Detection

No hook eﬀect was seen up to 1200 mg/L SAA.

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 wasmeasured at n=10, the mean of 1.0 mg/L SAA -2.6 SD does notoverlap with the mean of blank sample +2.6 SD.

350

5.0

300
250
200

Measurement limit : 200 mg/L

150

4.5

Measured Value（mg/L）

Measured Value（mg/L）

4/10

100

4.0
3.5
3.0
2.5
2.0

1.0 mg/L

1.5
1.0

50

0.5

00

200

400

600

800

1000

0.0
0/10

1200

2/10

Theoretical Value（mg/L）

6/10

8/10

10/10

Dilution Ratio

Almost no eﬀect on the measured value was observed from thefollowing co-existing substances at the indicated concentrations.

Conjugated Bilirubin

25 mg/dL

Unconjugated Bilirubin

25 mg/dL500 mg/dLChyle

2000 FTU

Rheumatoid Factor

1000 IU/mLSodium Fluoride

1000 mg/dL

Sodium Citrate

500 mg/dLHeparin Sodium

20 mg/dLDisodium EDTA

200 mg/dL
FTU : Formazin Turbidity UnitRUO LZ TEST EIKEN SAA（mg/L）◆ Correlation◆ Interfering substances

Haemoglobin

4/10

450= 195= 0.442 + 1.3= 0.9992= 1.73400350300
250200150100500050

100 150 200 250 300 350 400 450

Conventional method : EIKEN SAA Japanese package（µg/mL）metrological traceability◆ RUO LZ TEST EIKEN SAA Calibration hierarchy 3）, 4）, 5）
Wilkins J s Method 6）

WHO International Standard
SERUM AMYLOID A（SAA）
1st International Standard（NIBSC code : 92/680）

manufacturer s standard
operating procedure

manufacturer sworking calibrator

manufacturer s standard
operating procedure

manufacturer s secondary
working calibrator

manufacturer s standard
operating procedure

RUO LZ-SAA Calibrator EIKENRUO LZ TEST EIKEN SAA
human sample with result◆ Contents・Storage・Shelf life
Product Name

Contents

Product CodeStorage

Shelf life

RUO LZ TEST EIKEN SAA

R1 : 20 mL x 2
R2 : 20 mL x 2

V-SZ112- 8℃

12 Months

Contents

Product CodeStorage

Shelf life

V-SZ122- 8℃

12 Months

Storage

Shelf life

2- 8℃

36 Months（Separately Sold : Calibrator）
Product Name

1 mL x 6

RUO LZ-SAA Calibrator EIKEN （6 concentrations）（Separately Sold : Control Serum）
Product Name

Contents

Product CodeRUO QC-SAA L EIKEN

2 mL x 5

V-SZ13RUO QC-SAA H EIKEN

2 mL x 5

V-SZ14

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）: 404-409
4）Internal data5）ISO 17511 : 20206）Wilkins J, et al. Clin.Chem.1994 ; 40（7）: 1284-1290

For precautions and operation of this product, please refer to Instructions for Use and other related documents.

1231 AKMKCorporate website(Product information)

August, 2021