Zhang Chao, Zhang Chuanbao
National Center for Clinical Laboratories, National Center of Gerontology, Institute of Geriatric Medicine, Beijing Hospital, Chinese Academy of Medical Sciences, Beijing, P. R. China.
J Clin Lab Anal. 2022 Jul;36(7):e24490. doi: 10.1002/jcla.24490. Epub 2022 May 19.
To explore the quality control and implementation of the quantitative detection of liver fibrosis biomarkers, laminin (LN), collagen IV (Col Ⅳ), procollagen III amino-terminal propeptide (PⅢNP), hyaluronic acid (HA), and cholyglycine (CG), in China.
Two quality control products were measured in different laboratories using different measurement methods and reagents, and the acquired results were subjected to analysis. The quantitative detection technique was based on the conventional assessment criteria, with a target value ±30% being employed.
Hundred labs were involved in the External Quality Assessment with 88 laboratories completing the assessment, and the pass rates were 84%, 80.2%, 67.5%, 77.3%, and 58.3% for HA, LN, PⅢNP, Col Ⅳ, and CG, respectively. Chemiluminescence immunoassay was used most for HA (90.1%), LN (90.1%), PⅢNP (87.9%), and Col Ⅳ (82.9%) determination, whereas the chemiluminescence immunoassay (31.6%), latex-enhanced immunoturbidimetry (36.7%), and homogeneous enzyme immunoassay (26.7%) were used for CG determination. The coefficients of variation for HA, LN, PⅢNP, Col Ⅳ, and CG in different laboratories were 3.3%-19.49%, 1.74%-38.81%, 1.97%-41.29%, 2.85%-41.69%, and 2.71%-41.8%, respectively.
The clinical quantitative detection of liver fibrosis biomarkers is highly performed in China. The existing problems are that there are many manufacturers producing reagents and instruments, the quality of reagents is uneven, the specificity and sensitivity of reagents are greatly different, the comparability of results of various systems is poor, and the accuracy and consistency between different systems are lacking. All above underscores the critical importance of EQA in improving and monitoring the identification of biomarkers for liver fibrosis.
探讨我国肝纤维化生物标志物层粘连蛋白（LN）、Ⅳ型胶原（Col Ⅳ）、Ⅲ型前胶原氨基端前肽（PⅢNP）、透明质酸（HA）和甘氨胆酸（CG）定量检测的质量控制及实施情况。
在不同实验室使用不同测量方法和试剂对两种质量控制品进行测量，并对所得结果进行分析。定量检测技术基于常规评估标准，采用目标值±30%。
100家实验室参与了室间质量评价，88家实验室完成了评价，HA、LN、PⅢNP、Col Ⅳ和CG的合格率分别为84%、80.2%、67.5%、77.3%和58.3%。HA（90.1%）、LN（90.1%）、PⅢNP（87.9%）和Col Ⅳ（82.9%）测定大多采用化学发光免疫分析法，而CG测定采用化学发光免疫分析法（31.6%）、乳胶增强免疫比浊法（36.7%）和均相酶免疫分析法（26.7%）。不同实验室HA、LN、PⅢNP、Col Ⅳ和CG的变异系数分别为3.3% - 19.49%、1.74% - 38.81%、1.97% - 41.29%、2.85% - 41.69%和2.71% - 41.8%。
我国肝纤维化生物标志物的临床定量检测水平较高。存在的问题是试剂和仪器生产厂家众多，试剂质量参差不齐，试剂特异性和灵敏度差异较大，各系统结果可比性差，不同系统间缺乏准确性和一致性。以上所有情况凸显了室间质量评价在改进和监测肝纤维化生物标志物鉴定方面的至关重要性。
