Validation of Analytical Performance and Diagnostic Effectiveness of Anti-CCP Antibody Based on the Light-Initiated Chemiluminescence Assay.

IF 1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY Annals of clinical and laboratory science Pub Date : 2024-11-01

Shi-Zhen Guan, Hong-Jing Zhang, Shan-Shan Cheng, Yi Wang, Hong-Wei Yang, Hui-Qiang Li

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引用次数: 0

Abstract

Objective: To evaluate the analytical and diagnostic performance of anti-cyclic citrullinated peptide (anti-CCP) antibody measured by the light-initiated chemiluminescence assay (LICA).

Methods: A total of 193 patients with rheumatoid arthritis (RA) and 211 controls were included. Serum anti-CCP levels were assessed by LICA and enzyme-linked immunosorbent assay (ELSIA). The analytical performance of LICA anti-CCP assay was evaluated according to the clinical guidelines. The diagnostic performance of LICA anti-CCP assay was evaluated by a series of indicators such as sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) compared with ELISA. The dynamic consistency of the two methods was compared by patient follow-up.

Results: The LICA anti-CCP assay showed coefficient of variation of 0.6% - 3.3% and linearity within 10-500 U/mL with a correlation coefficient of 0.991. The LICA and ELISA showed similar sensitivity (88.60% vs 92.94%) and specificity (97.60% vs 94.95%) on determination of anti-CCP. The AUCs of anti-CCP detected by LICA and ELISA were 0.971 and 0.955 (P=0.052), respectively. Follow-up showed that the changes of anti-CCP measured by the two methods were consistent.

Conclusions: LICA anti-CCP assay has good analytical and diagnostic performance for RA, which is comparable to ELISA, and has dynamic consistency.

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基于光致化学发光法的抗ccp抗体分析性能及诊断有效性验证。

目的：评价光致化学发光法（LICA）检测抗环瓜氨酸肽（anti-CCP）抗体的分析和诊断性能。方法：纳入类风湿性关节炎（RA）患者193例，对照组211例。采用LICA和ELSIA检测血清抗ccp水平。根据临床指南评价LICA抗ccp法的分析性能。通过灵敏度、特异度、受试者工作特征曲线下面积（AUC）等一系列指标与ELISA比较，评价LICA抗ccp检测的诊断性能。通过患者随访比较两种方法的动态一致性。结果：LICA抗ccp检测变异系数为0.6% ~ 3.3%，在10 ~ 500 U/mL范围内呈线性关系，相关系数为0.991。LICA和ELISA检测抗ccp的灵敏度（88.60% vs 92.94%）和特异性（97.60% vs 94.95%）相似。LICA和ELISA检测抗ccp的auc分别为0.971和0.955 （P=0.052）。随访显示两种方法测得的抗ccp变化一致。结论：LICA抗ccp检测对RA具有良好的分析和诊断性能，与ELISA相当，且具有动态一致性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of clinical and laboratory science 医学-医学实验技术

CiteScore

1.60

自引率

0.00%

发文量

112

审稿时长

6-12 weeks

期刊介绍： The Annals of Clinical & Laboratory Science welcomes manuscripts that report research in clinical science, including pathology, clinical chemistry, biotechnology, molecular biology, cytogenetics, microbiology, immunology, hematology, transfusion medicine, organ and tissue transplantation, therapeutics, toxicology, and clinical informatics.