Lv Heye, Deng Ao, Chen Yijun, Su Zhenzhen
From the Department of Laboratory Medicine, West China Hospital of Sichuan University, Chengdu, China (Lv, Su).
the Department of Laboratory Medicine, West China Tianfu Hospital of Sichuan University, Chengdu, China (Deng, Chen).
Arch Pathol Lab Med. 2025 Mar 1;149(3):271-275. doi: 10.5858/arpa.2024-0057-OA.
CONTEXT.—: The identification of autoantibodies associated with autoimmune liver disease (ALD) is crucial for diagnosis and management. Various laboratory methods have been introduced to detect autoantibody profiles. However, the variable performance of these assays may create challenges for clinicians and patients.
OBJECTIVE.—: To investigate the concordance rates and diagnostic performance of 2 commercially available assays, line immunoassay (LIA) and digital liquid chip method (DLCM), in patients with ALD.
DESIGN.—: A total of 291 serum samples were collected, consisting of 180 sera from patients with ALD and 111 sera from controls. The samples were detected through LIA and DLCM. The agreement and diagnostic performance of each assay were analyzed.
RESULTS.—: There was substantial to almost perfect agreement among prevalent autoantibodies (anti-mitochondrial antibody M2; antibodies against gp210, Sp100, and Ro52). Nevertheless, the Cohen κ coefficient of some uncommon autoantibodies (anti-LKM-1, anti-LC-1, and anti-SLA/LP) between the 2 methods was not ideal. LIA showed slightly better sensitivity, accuracy, and negative predictive value, while DLCM exhibited slightly higher specificity and positive predictive value.
CONCLUSIONS.—: LIA and DLCM demonstrated comparable performance for the detection of common ALD-related autoantibodies. LIA seemed to be more sensitive, while DLCM displayed more specificity. However, standardization of ALD autoantibody detection still faces challenges between these diverse detection systems. Comprehensive interlaboratory validation is essential to mitigate potential misunderstanding and confusion among patients and clinicians.
鉴定与自身免疫性肝病（ALD）相关的自身抗体对于诊断和管理至关重要。已引入各种实验室方法来检测自身抗体谱。然而，这些检测方法的不同性能可能给临床医生和患者带来挑战。
研究两种市售检测方法，即线性免疫分析法（LIA）和数字液芯片法（DLCM），在ALD患者中的一致性率和诊断性能。
共收集291份血清样本，其中包括180份ALD患者的血清和111份对照血清。通过LIA和DLCM对样本进行检测。分析每种检测方法的一致性和诊断性能。
常见自身抗体（抗线粒体抗体M2；抗gp210、Sp100和Ro52抗体）之间存在高度到几乎完美的一致性。然而，两种方法之间某些不常见自身抗体（抗LKM-1、抗LC-1和抗SLA/LP）的Cohen κ系数并不理想。LIA显示出稍好的敏感性、准确性和阴性预测值，而DLCM表现出稍高的特异性和阳性预测值。
LIA和DLCM在检测常见ALD相关自身抗体方面表现出可比的性能。LIA似乎更敏感，而DLCM显示出更高的特异性。然而，在这些不同的检测系统之间，ALD自身抗体检测的标准化仍面临挑战。全面的实验室间验证对于减少患者和临床医生之间潜在的误解和困惑至关重要。
