March 22, 2022
Sysmex Corporation

Sysmex Presents Academic Report in Effort to Create a Simple Blood
Test to Diagnose Alzheimer’s Disease
The Content Presented at the International Conference on Alzheimer's & Parkinson's Diseases:(AD/PDTM 2022)

Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu; hereafter, “Sysmex”)
are aiming to leverage their individual technologies and knowhow in the creation of next generation
diagnostic agents that enable early diagnosis of dementia as well as treatment selection and regularconfirmation of treatment efficacy.
Sysmex Corporation announced today that a poster presentation on the basic evaluation of plasma
Aβ1-40 and Aβ1-42 using an HISCL fully automated immunoassay system had been given at theInternational Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD TM 2022) held from March
15 to 20 2022 in Barcelona, Spain.
Presentation The Evaluation of Plasma Aβ1-40 and Aβ1-42 Immunoassays on the Fully AutomatedtitleAuthors

Immunoassay Platform (HISCLTM series)
Shunsuke Watanabe1, Kazuto Yamashita1, Kengo Ishiki1, Masahiro Miura1, YasuhiroIrino1, Toshiko Kubo2, Jun Matsui3, Kei Hagino3, Shigeki Iwanaga1, Toshiyuki Sato 1,Tomokazu Yoshida4
1Central Research Laboratories, Sysmex Corporation, Kobe, Japan; 2Sysmex R&D

Center Americas, Inc., Mundelein, Illinois, USA; 3Business Incubation, Sysmex
Corporation, Kobe, Japan; 4 Sysmex Corporation, Kobe, Japan
Type ofPoster

presentation
Overview of Accumulation of β-amyloid peptide (Aβ) (amyloid pathology) in the brain is a hallmark
presentation pathology in the diagnosis of Alzheimer’s disease (AD). In recent years, progress has
been made in the development of various diagnostic tests and demand for simple
tests such as those based on blood biomarkers is expected to increase in the future.
In the present study, we evaluated the analytical performance of plasma Aβ1-40 andAβ1-42 assays using an HISCL automated immunoassay system (Sysmex).
(Results)✓

The quantification limits were 2.46 pg/mL for Aβ1-40 and 0.16 pg/mL for Aβ1-42.

✓

The repeatability (within-run) coefficients of variation (CVs) were less than
3.7% (Aβ1-40) and 2.0% (Aβ1-42).

✓The intermediate precision (within-laboratory) CVs were less than 4.6%
(Aβ1-40) and 5.3% (Aβ1-42).

✓The cross-reactivity with various lengths of Aβ peptide was less than 0.5%.

✓The interference from blood components was less than 10% for both assays.

✓For commercially available plasma samples from 20 patients, there weresignificant correlations between our assays and immunoprecipitation mass
spectrometry (IP-MS) assays with correlation coefficients of Pearson’sr = 0.91 (Aβ1-40) and 0.82 (Aβ1-42).

The assays for Aβ1-40 and Aβ1-42 evaluated in the present study were robust and there
were no cross reactions with blood components or other Aβ peptides. With highsensitivity and specificity, analytical performance was high. The measurement ofAβ1-40 and Aβ1-42 in blood using an HISCL fully automated immunoassay system is
low in invasiveness and could be useful in routine screening in the clinical setting.
References(1) K. Yamashita et. al. Biochemical and Biophysical Research Communications, 576, 2021, 22-26(2) T. Iino et. al.The Journal of Applied Laboratory Medicine, 6, 2021, 834–845,