Academic Journal
Serum as an alternative to plasma for determining the ApoE4 phenotype using Pan-ApoE and ApoE4 chemiluminescent enzyme immunoassays.
| Title: | Serum as an alternative to plasma for determining the ApoE4 phenotype using Pan-ApoE and ApoE4 chemiluminescent enzyme immunoassays. |
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| Authors: | Kortmann, Eric, Steinacker, Petra, Guthknecht, Arthur, Weise, Christopher M., Otto, Markus |
| Source: | Clinical Chemistry & Laboratory Medicine; Aug2026, Vol. 64 Issue 9, p1997-2006, 10p |
| Subject Terms: | Apolipoprotein E4, Blood plasma, Chemiluminescence immunoassay, Genotypes, Biomarkers, Blood sampling, Alzheimer's disease |
| Abstract: | Since apolipoprotein E4 (ApoE4) is associated with therapy-related adverse effects of anti-amyloid-β monoclonal antibodies in Alzheimer's disease, such as amyloid-related imaging abnormalities, methods for determining the ApoE4 status are needed. The Lumipulse® ApoE4 and Pan-ApoE assays provide a practical approach, but they have so far been validated only in plasma. Plasma and serum obtained from a single blood draw from 157 patients were analyzed using ApoE4 and Pan-ApoE chemiluminescent enzyme immunoassays. The APOE genotype was determined by allele-specific quantitative polymerase chain reaction. Additional experiments assessed assay repeatability, intermediate precision, and sample stability under various storage conditions. ApoE4, Pan-ApoE, and the resulting ApoE4/Pan-ApoE ratio showed minimal bias, strong positive correlation and linearity between plasma and serum. Using matrix-specific thresholds, plasma- and serum-derived ApoE4/Pan-ApoE ratios accurately classified the ApoE4 phenotypes in concordance with APOE ε4 genotypes. The assay demonstrated repeatability of <15 % and <5 % (day 1 and 2), with intermediate precision <10 % for both Pan-ApoE and ApoE4. Plasma and serum showed both comparable stability after multiple freeze-thaw-cycles and up to 120 h at 4 °C, while serum showed deterioration after 120 h storage at 20 °C. Using matrix-specific thresholds, the ApoE4/Pan-ApoE ratio in plasma and serum accurately classified the ApoE4 phenotype in concordance with APOE ε4 genotypes. Serum and plasma showed comparable stability and precision. Thus, serum is a reliable alternative to plasma for measuring Pan-ApoE and ApoE4 with the Lumipulse assays. The use of serum expands sample availability, particularly in retrospective studies or when collected alongside cerebrospinal fluid. [ABSTRACT FROM AUTHOR] |
| Copyright of Clinical Chemistry & Laboratory Medicine is the property of De Gruyter and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Complementary Index |
| FullText | Text: Availability: 0 |
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| Header | DbId: edb DbLabel: Complementary Index An: 195834842 RelevancyScore: 1082 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 1082.42456054688 |
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| Items | – Name: Title Label: Title Group: Ti Data: Serum as an alternative to plasma for determining the ApoE4 phenotype using Pan-ApoE and ApoE4 chemiluminescent enzyme immunoassays. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Kortmann%2C+Eric%22">Kortmann, Eric</searchLink><br /><searchLink fieldCode="AR" term="%22Steinacker%2C+Petra%22">Steinacker, Petra</searchLink><br /><searchLink fieldCode="AR" term="%22Guthknecht%2C+Arthur%22">Guthknecht, Arthur</searchLink><br /><searchLink fieldCode="AR" term="%22Weise%2C+Christopher+M%2E%22">Weise, Christopher M.</searchLink><br /><searchLink fieldCode="AR" term="%22Otto%2C+Markus%22">Otto, Markus</searchLink> – Name: TitleSource Label: Source Group: Src Data: Clinical Chemistry & Laboratory Medicine; Aug2026, Vol. 64 Issue 9, p1997-2006, 10p – Name: Subject Label: Subject Terms Group: Su Data: <searchLink fieldCode="DE" term="%22Apolipoprotein+E4%22">Apolipoprotein E4</searchLink><br /><searchLink fieldCode="DE" term="%22Blood+plasma%22">Blood plasma</searchLink><br /><searchLink fieldCode="DE" term="%22Chemiluminescence+immunoassay%22">Chemiluminescence immunoassay</searchLink><br /><searchLink fieldCode="DE" term="%22Genotypes%22">Genotypes</searchLink><br /><searchLink fieldCode="DE" term="%22Biomarkers%22">Biomarkers</searchLink><br /><searchLink fieldCode="DE" term="%22Blood+sampling%22">Blood sampling</searchLink><br /><searchLink fieldCode="DE" term="%22Alzheimer's+disease%22">Alzheimer's disease</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Since apolipoprotein E4 (ApoE4) is associated with therapy-related adverse effects of anti-amyloid-β monoclonal antibodies in Alzheimer's disease, such as amyloid-related imaging abnormalities, methods for determining the ApoE4 status are needed. The Lumipulse<superscript>®</superscript> ApoE4 and Pan-ApoE assays provide a practical approach, but they have so far been validated only in plasma. Plasma and serum obtained from a single blood draw from 157 patients were analyzed using ApoE4 and Pan-ApoE chemiluminescent enzyme immunoassays. The APOE genotype was determined by allele-specific quantitative polymerase chain reaction. Additional experiments assessed assay repeatability, intermediate precision, and sample stability under various storage conditions. ApoE4, Pan-ApoE, and the resulting ApoE4/Pan-ApoE ratio showed minimal bias, strong positive correlation and linearity between plasma and serum. Using matrix-specific thresholds, plasma- and serum-derived ApoE4/Pan-ApoE ratios accurately classified the ApoE4 phenotypes in concordance with APOE ε4 genotypes. The assay demonstrated repeatability of <15 % and <5 % (day 1 and 2), with intermediate precision <10 % for both Pan-ApoE and ApoE4. Plasma and serum showed both comparable stability after multiple freeze-thaw-cycles and up to 120 h at 4 °C, while serum showed deterioration after 120 h storage at 20 °C. Using matrix-specific thresholds, the ApoE4/Pan-ApoE ratio in plasma and serum accurately classified the ApoE4 phenotype in concordance with APOE ε4 genotypes. Serum and plasma showed comparable stability and precision. Thus, serum is a reliable alternative to plasma for measuring Pan-ApoE and ApoE4 with the Lumipulse assays. The use of serum expands sample availability, particularly in retrospective studies or when collected alongside cerebrospinal fluid. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Group: Ab Data: <i>Copyright of Clinical Chemistry & Laboratory Medicine is the property of De Gruyter and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1515/cclm-2026-0032 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 10 StartPage: 1997 Subjects: – SubjectFull: Apolipoprotein E4 Type: general – SubjectFull: Blood plasma Type: general – SubjectFull: Chemiluminescence immunoassay Type: general – SubjectFull: Genotypes Type: general – SubjectFull: Biomarkers Type: general – SubjectFull: Blood sampling Type: general – SubjectFull: Alzheimer's disease Type: general Titles: – TitleFull: Serum as an alternative to plasma for determining the ApoE4 phenotype using Pan-ApoE and ApoE4 chemiluminescent enzyme immunoassays. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Kortmann, Eric – PersonEntity: Name: NameFull: Steinacker, Petra – PersonEntity: Name: NameFull: Guthknecht, Arthur – PersonEntity: Name: NameFull: Weise, Christopher M. – PersonEntity: Name: NameFull: Otto, Markus IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 08 Text: Aug2026 Type: published Y: 2026 Identifiers: – Type: issn-print Value: 14346621 Numbering: – Type: volume Value: 64 – Type: issue Value: 9 Titles: – TitleFull: Clinical Chemistry & Laboratory Medicine Type: main |
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