Comparative evaluation of four fully automated immunoanalyzers for the simultaneous detection of HBeAg and Anti-Hbe

Junhyup Song; Seung Jun Choi; Sinyoung Kim; Younhee Park

doi:Background: Hepatitis B envelope Antigen (HBeAg) and anti-hepatitis B envelope Antigen (anti-HBe) are crucial markers for evaluating hepatitis B virus infection status and guiding clinical decisions. Considering the increasing prevalence of HBeAg-negative variants, accurate detection of both markers is essential. This study aimed to examine the analytical performance of four fully automated immunoanalyzers for the simultaneous detection of HBeAg and Anti-HBe and to assess the inter-platform concordance.

Methods: In total, 439 leftover serum samples from routine clinical testing for HBeAg or anti-HBe testing were analyzed using four immunoanalyzers: Architect i2000 and Alinity i (Abbott), Cobas e801 (Roche), and Atellica IM 1600 (Siemens). Samples not tested immediately were stored at 4 °C and analyzed within 24 hours of storage. Verification of Precision followed the CLSI EP15-A3 guidelines, and methods were compared according to the CLSI EP09-A3 guidelines. Qualitative agreement was assessed using Cohen's κ, whereas quantitative correlation was evaluated using Deming regression and R² values.

Results: Architect i2000 and Alinity i exhibited the highest correlation (R² = 0.9960) and concordance (κ = 0.953 for HBeAg, κ = 0.971 for anti-HBe). Cobas e801 showed strong overall correlation with Architect i2000 (R² = 0.9838), but displayed a systematic negative bias near the cutoff, substantially reducing qualitative agreement. Atellica IM 1600 demonstrated relatively weaker correlation with the other three platforms.

Conclusions: Inter-platform discrepancies observed may impact clinical interpretation. As these discrepancies primarily stem from systematic bias, they can be readily mitigated by adjusting the reference values. Overall, further harmonization efforts are essential to enhance inter-platform agreement and ensure consistency in clinical decision-making.

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Comparative evaluation of four fully automated immunoanalyzers for the simultaneous detection of HBeAg and Anti-Hbe

DC Field	Value	Language
dc.contributor.author	김신영	-
dc.contributor.author	박윤희	-
dc.contributor.author	최승준	-
dc.date.accessioned	2025-10-15T01:48:53Z	-
dc.date.available	2025-10-15T01:48:53Z	-
dc.date.issued	2025-09	-
dc.identifier.uri	https://ir.ymlib.yonsei.ac.kr/handle/22282913/207468	-
dc.description.statementOfResponsibility	T202506066.pdf	-
dc.language	English	-
dc.publisher	Public Library of Science	-
dc.relation.isPartOf	PLOS ONE	-
dc.rights	CC BY-NC-ND 2.0 KR	-
dc.subject.MESH	0	-
dc.title	Comparative evaluation of four fully automated immunoanalyzers for the simultaneous detection of HBeAg and Anti-Hbe	-
dc.type	Article	-
dc.contributor.college	College of Medicine (의과대학)	-
dc.contributor.department	Dept. of Laboratory Medicine (진단검사의학교실)	-
dc.contributor.googleauthor	Junhyup Song	-
dc.contributor.googleauthor	Seung Jun Choi	-
dc.contributor.googleauthor	Sinyoung Kim	-
dc.contributor.googleauthor	Younhee Park	-
dc.identifier.doi	Background: Hepatitis B envelope Antigen (HBeAg) and anti-hepatitis B envelope Antigen (anti-HBe) are crucial markers for evaluating hepatitis B virus infection status and guiding clinical decisions. Considering the increasing prevalence of HBeAg-negative variants, accurate detection of both markers is essential. This study aimed to examine the analytical performance of four fully automated immunoanalyzers for the simultaneous detection of HBeAg and Anti-HBe and to assess the inter-platform concordance. Methods: In total, 439 leftover serum samples from routine clinical testing for HBeAg or anti-HBe testing were analyzed using four immunoanalyzers: Architect i2000 and Alinity i (Abbott), Cobas e801 (Roche), and Atellica IM 1600 (Siemens). Samples not tested immediately were stored at 4 °C and analyzed within 24 hours of storage. Verification of Precision followed the CLSI EP15-A3 guidelines, and methods were compared according to the CLSI EP09-A3 guidelines. Qualitative agreement was assessed using Cohen's κ, whereas quantitative correlation was evaluated using Deming regression and R² values. Results: Architect i2000 and Alinity i exhibited the highest correlation (R² = 0.9960) and concordance (κ = 0.953 for HBeAg, κ = 0.971 for anti-HBe). Cobas e801 showed strong overall correlation with Architect i2000 (R² = 0.9838), but displayed a systematic negative bias near the cutoff, substantially reducing qualitative agreement. Atellica IM 1600 demonstrated relatively weaker correlation with the other three platforms. Conclusions: Inter-platform discrepancies observed may impact clinical interpretation. As these discrepancies primarily stem from systematic bias, they can be readily mitigated by adjusting the reference values. Overall, further harmonization efforts are essential to enhance inter-platform agreement and ensure consistency in clinical decision-making.	-
dc.contributor.localId	A00675	-
dc.contributor.localId	A01606	-
dc.contributor.localId	A05522	-
dc.relation.journalcode	J02540	-
dc.identifier.eissn	1932-6203	-
dc.identifier.pmid	40901851	-
dc.subject.keyword	Automation	-
dc.subject.keyword	Hepatitis B Antibodies* / blood	-
dc.subject.keyword	Hepatitis B e Antigens* / blood	-
dc.subject.keyword	Hepatitis B e Antigens* / immunology	-
dc.subject.keyword	Hepatitis B virus / immunology	-
dc.subject.keyword	Hepatitis B* / blood	-
dc.subject.keyword	Hepatitis B* / diagnosis	-
dc.subject.keyword	Hepatitis B* / immunology	-
dc.subject.keyword	Humans	-
dc.subject.keyword	Immunoassay / instrumentation	-
dc.subject.keyword	Immunoassay / methods	-
dc.contributor.alternativeName	Kim, Sin Young	-
dc.contributor.affiliatedAuthor	김신영	-
dc.contributor.affiliatedAuthor	박윤희	-
dc.contributor.affiliatedAuthor	최승준	-
dc.citation.volume	20	-
dc.citation.number	9	-
dc.citation.startPage	e0331381	-
dc.identifier.bibliographicCitation	PLOS ONE, Vol.20(9) : e0331381, 2025-09	-
dc.identifier.articleno	10.1371/ journal.pone.0331381	-

Appears in Collections:: 1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers

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