Open AccessArticle Diagnostic Performance and Clinical Utility of Automated Plasma Amyloid-β 1-42/1-40 Assay by Seseung Kim Seseung Kim SciProfiles Scilit Preprints.org Google Scholar 1,†, Seok Ryun Kwon Seok Ryun Kwon SciProfiles Scilit Preprints.org Google Scholar 2,3, Joon Hee Lee Joon Hee Lee SciProfiles Scilit Preprints.org Google Scholar Joon Hee Lee received his MD (Doctor of Medicine) from Seoul National University College of Medicine [...] Read more 1,2,*,†, Kyunghoon Lee Kyunghoon Lee SciProfiles Scilit Preprints.org Google Scholar 1,2,*,†, Sang Hoon Song Sang Hoon Song SciProfiles Scilit Preprints.org Google Scholar 2,3 and Junghan Song Junghan Song SciProfiles Scilit Preprints.org Google Scholar 1,2 1 Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Republic of Korea 2 Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul 03080, Republic of Korea 3 Department of Laboratory Medicine, Seoul National University Hospital, Seoul 03080, Republic of Korea * Authors to whom correspondence should be addressed. † These authors contributed equally to this work. Diagnostics 2026, 16(12), 1767; https://doi.org/10.3390/diagnostics16121767 (registering DOI) Submission received: 30 April 2026 / Revised: 27 May 2026 / Accepted: 29 May 2026 / Published: 8 June 2026 Abstract Background: Blood-based biomarkers offer an accessible alternative to cerebrospinal fluid or positron emission tomography (PET) imaging for Alzheimer’s disease (AD) screening and diagnosis. This study evaluated the diagnostic performance of the fully automated HISCL plasma Aβ42/40 assay in a real-world clinical setting. Methods: We retrospectively enrolled 127 participants, stratified into cognitively normal (CN), mild cognitive impairment (MCI), AD, and Non-AD subgroups. Plasma Aβ42/40 levels were quantified using the HISCL and Simoa platforms. Additionally, plasma oligomerized Aβ (OAβ), glial fibrillary acidic protein (GFAP), and neurofilament light chain (NfL) were measured. Results: The HISCL plasma Aβ42/40 ratio was significantly lower in the AD continuum (MCI + AD) compared to the CN subgroup ( p 90 7 (5.5%) Sex Female 72 (56.7%) Male 55 (43.3%) Clinical Diagnosis CN 39 (30.7%) MCI 46 (36.2%) AD 18 (14.2%) Non-AD 24 (18.9%) APOE Genotype E4 non-carrier 73 (57.5%) E4 carrier (heterozygote) 46 (36.2%) E4 carrier (homozygote) 4 (3.1%) Unknown 4 (3.1%) MMSE Score 24–30 61 (48.0%) 19–23 25 (19.7%) ≤18 28 (22.0%) Unknown 13 (10.2%) Abbreviations: CN, cognitive normal; MCI, mild cognitive impairment; AD, Alzheimer’s disease; Non-AD, non-Alzheimer’s disease; MMSE, Mini-Mental State Examination. Table 2. Diagnostic classification of discordant cases between HISCL and Simoa assays. Table 2. Diagnostic classification of discordant cases between HISCL and Simoa assays. Simoa Total HISCL Positive Risk group Negative Positive 66 (52.0%) 6 (4.7%) 3 (2.4%) 75 (59.1%) Risk group 19 (15.0%) 3 (2.4%) 2 (1.6%) 24 (18.9%) Negative 23 (18.1%) 1 (0.8%) 4 (3.1%) 28 (22%) Total 108 (85%) 10 (7.9%) 9 (7.1%) 127 (100%) Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. © 2026 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license. Share and Cite MDPI and ACS Style Kim, S.; Kwon, S.R.; Lee, J.H.; Lee, K.; Song, S.H.; Song, J. Diagnostic Performance and Clinical Utility of Automated Plasma Amyloid-β 1-42/1-40 Assay. Diagnostics 2026, 16, 1767. https://doi.org/10.3390/diagnostics16121767 AMA Style Kim S, Kwon SR, Lee JH, Lee K, Song SH, Song J. Diagnostic Performance and Clinical Utility of Automated Plasma Amyloid-β 1-42/1-40 Assay. Diagnostics. 2026; 16(12):1767. https://doi.org/10.3390/diagnostics16121767 Chicago/Turabian Style Kim, Seseung, Seok Ryun Kwon, Joon Hee Lee, Kyunghoon Lee, Sang Hoon Song, and Junghan Song. 2026. "Diagnostic Performance and Clinical Utility of Automated Plasma Amyloid-β 1-42/1-40 Assay" Diagnostics 16, no. 12: 1767. https://doi.org/10.3390/diagnostics16121767 APA Style Kim, S., Kwon, S. R., Lee, J. H., Lee, K., Song, S. H., & Song, J. (2026). Diagnostic Performance and Clinical Utility of Automated Plasma Amyloid-β 1-42/1-40 Assay. Diagnostics, 16(12), 1767. https://doi.org/10.3390/diagnostics16121767 Note that from the first issue of 2016, this journal uses article numbers instead of page numbers. See further details here. Article Metrics Article metric data becomes available approximately 24 hours after publication online.
Diagnostic Performance and Clinical Utility of Automated Plasma Amyloid-β 1-42/1-40 Assay
