Song Junhyup, Choi Seung Jun, Kim Sinyoung, Park Younhee
Departments of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
PLoS One. 2025 Sep 3;20(9):e0331381. doi: 10.1371/journal.pone.0331381. eCollection 2025.
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.
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.
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.
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.
乙肝e抗原（HBeAg）和乙肝e抗体（抗-HBe）是评估乙肝病毒感染状态及指导临床决策的关键标志物。鉴于HBeAg阴性变异体的患病率不断上升，准确检测这两种标志物至关重要。本研究旨在检测四种全自动免疫分析仪同时检测HBeAg和抗-HBe的分析性能，并评估不同平台间的一致性。
总共439份用于HBeAg或抗-HBe检测的常规临床检测剩余血清样本，使用四种免疫分析仪进行分析：Architect i2000和Alinity i（雅培）、Cobas e801（罗氏）和Atellica IM 1600（西门子）。未立即检测的样本储存在4℃，并在储存24小时内进行分析。精密度验证遵循CLSI EP15-A3指南，方法比较根据CLSI EP09-A3指南进行。定性一致性使用Cohen's κ评估，而定量相关性使用Deming回归和R²值评估。
Architect i2000和Alinity i表现出最高的相关性（R² = 0.9960）和一致性（HBeAg的κ = 0.953，抗-HBe的κ = 0.971）。Cobas e801与Architect i2000总体相关性较强（R² = 0.9838），但在临界值附近显示出系统性负偏差，显著降低了定性一致性。Atellica IM 1600与其他三个平台的相关性相对较弱。
观察到的不同平台间差异可能影响临床解读。由于这些差异主要源于系统性偏差，通过调整参考值可轻松缓解。总体而言，进一步的协调努力对于提高不同平台间的一致性并确保临床决策的一致性至关重要。
