Analysis of current status of quantitative detection of biomarkers for liver fibrosis in Clinical labs in China

AIM: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.