摘要:目的 建立甘胆酸（CG）化学发光免疫检测方法。方法 采用竞争法，固相微孔板包被技术，通过与参比试剂盒临床结果相关性的比较，保证其具有同等的临床诊断价值。 结果 本试剂盒的线性范围为0.25～40μg/mL,灵敏度为0.05μg/mL，批内精密度分别为7.1%和7.4%；批间精密度为11.3%和15.74%；样品的回收率在85%～115%之间。与透明质酸、Ⅳ型胶原、Ⅲ型前胶原氨端肽、层粘连蛋白、胆酸以及鹅脱氧胆酸的交叉反应率在0.010%～1.480%之间，均不会对CG的正常测定构成干扰。通过临床样品正常值的测定确定了正常值范围，与有关文献报道基本一致。同时，与北京北方生物技术研究所的放免药盒临床结果进行科学比较，两组结果的相关系数r为0.947。 结论 该试剂盒与参比试剂盒的测定结果具有较高的符合率，应用于临床，可为慢性肝炎复发、轻度肝硬变、肝癌、肝胆胃肠消化系统疾病的研究诊断提供可靠的指标。同时，肝胆酸与血清Ⅳ型胶原、透明质酸和前白蛋白(PA)动态联检对于肝硬化的诊断、疗效及预后判断具有重要的临床意义。

Abstract: Objective To establish a quantitative chemiluminescence immunoassay for glycocholic acid. Methods The competition model and the microplate coating technology were used to assure the test kits have same clinical diagnostic value by comparing the clinical result with the reference kits. Results The linear range of the test kit was 0.25 to 40μg/ml. The sensitivity was 0.05μg/ml. The coefficients of variation for intra-assay were 7.1% and 7.4%, and for inter-assay were 11.3% and 15.74% respectively. The recovery rate of the samples was in the range of 85% to 115%. The cross-reactivity rate of hyaluronic acid, IVC, PⅢNP, Laminin, Cholic acid and Chenodeoxycholic with Glycocholic acid was 0.010%～1.480%. The results determined with test kits were consistent with RIA kits, and the correlation coefficient r was 0.947 between the two groups of detection results. Conclusion The test chemiluminescence immunoassay kit could provide reliable indicators for clinical diagnosis and research for chronic hepatitis, cirrhosis, liver cancer and digestive disease. Meanwhile, combined test of glycocholic acid with the CIV, HA and PA could have very important clinical significance for the diagnosis, treatment and prognosis of cirrhosis.