血清甘氨胆酸质控品的制备及应用

doi:10.3969/j.issn.1673-8640.2024.12.013

摘要/Abstract

摘要：

目的制备血清基质甘氨胆酸（GCA）质控品，并评估其性能和适用性。方法收集上海市东方医院临床检验剩余血清（乙型肝炎表面抗原、丙型肝炎病毒抗体、人类免疫缺陷病毒抗体、梅毒螺旋体抗体均阴性），制备成高、低2个浓度水平的GCA质控品。对制备的GCA质控品进行均一性、稳定性、互通性评价后，分发至上海地区14家临床实验室进行适用性调查。了解质谱法和免疫学方法（胶乳增强免疫比浊法、均相酶免疫法）GCA检测结果的差异。结果制备的GCA质控品均一性良好（F值分别为1.151和0.889）。质控品4 ℃保存7 d和-20 ℃、-80 ℃保存6个月稳定性良好[线性方程的斜率/b1/<t_（0.95，_n_-2）·S（b1），斜率与0差异无统计学意义]。质控品测定结果均在新鲜血清样本测定值所建立的拟合回归直线95%可信区间内，具有良好的互通性。初步调查结果显示，高浓度水平质控品质谱法、胶乳增强免疫比浊法、均相酶免疫法GCA检测均值分别为13.65、37.54、44.56 μg·mL^-1；低浓度水平质控品分别为0.49、2.76、2.39 μg·mL^-1。结论制备的GCA质控品均一性、稳定性、互通性较好。质谱法与免疫法测定GCA结果差异较大，研制参考物质，建立溯源体系，是推动临床GCA检测结果可比的努力方向。

关键词: 甘氨胆酸, 质控品, 均匀性, 稳定性, 互通性

Abstract:

Objective To develop and evaluate quality control materials of glycocholic acid（GCA），and to investigate the performance and capability. Methods Remaining sera from Shanghai East Hospital（hepatitis B surface antigen，hepatitis C virus antibody，human immunodeficiency virus antibody，Treponema pallidum antibody all negative） were collected，and high-level and low-level GCA quality control materials were prepared. The homogeneity，stability and commutability of quality control materials were evaluated. They were distributed to 14 clinical laboratories in Shanghai for applicability investigation，in order to understand the difference of GCA determination results between mass spectrometry and immunological methods （latex enhanced immunochromatography，homogeneous enzyme immunoassay）. Results The homogeneity of GCA quality control materials was good （F values were 1.151 and 0.889，respectively）. The storage at 4 ℃ for 7 d and at-20 ℃ and -80 ℃ for 6 months showed good stability [linear equation slope /b1/<t_{（0.95，n-2）}·S（b1），the difference between slope and 0 was not statistically significant]. The results of quality control materials were all within the 95% confidence interval of the fitted regression line established by the fresh serum samples，which had good commutability. The preliminary investigation results showed that the GCA levels of high level quality control material by mass spectrometry，latex enhanced immunochromatography and homogeneous enzyme immunoassay were 13.65，37.54 and 44.56 μg·mL^-1，respectively，and those of low level quality control material were 0.49，2.76 and 2.39 μg·mL^-1，respectively. Conclusions The prepared GCA quality control materials have good homogeneity，stability and commutability. The results of GCA determination by mass spectrometry and immunoassay are different. The development of reference materials and the establishment of traceability system are the efforts to promote the comparability of clinical GCA determination results.

Key words: Glycocholic acid, Quality control material, Homogeneity, Stability, Commutability

中图分类号:

R446.1

金中淦, 陆柳, 叶致含, 居漪, 欧元祝, 虞啸炫, 张素洁. 血清甘氨胆酸质控品的制备及应用[J]. 检验医学, 2024, 39(12): 1208-1213.

JIN Zhonggan, LU Liu, YE Zhihan, JU Yi, OU Yuanzhu, YU Xiaoxuan, ZHANG Sujie. Development and application of quality control materials for GCA in serum[J]. Laboratory Medicine, 2024, 39(12): 1208-1213.

图/表 5

参考文献 14

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样本	平方和（SS）	自由度（df）	均方（MS）	F值	F_α值	P值
低浓度水平质控品
组间	0.022 6	9	0.002 51	1.151	2.40	0.375
组内	0.043 6	20	0.002 18
总变异	0.066 2	29
高浓度水平质控品
组间	11.460 0	9	1.273 00	0.889	2.40	0.552
组内	28.660 0	20	1.433 00
总变异	40.121 0	29

样本	平方和（SS）	自由度（df）	均方（MS）	F值	F_α值	P值
低浓度水平质控品
组间	0.022 6	9	0.002 51	1.151	2.40	0.375
组内	0.043 6	20	0.002 18
总变异	0.066 2	29
高浓度水平质控品
组间	11.460 0	9	1.273 00	0.889	2.40	0.552
组内	28.660 0	20	1.433 00
总变异	40.121 0	29

质检品	回归方程	样本量	b1	S（b1）	t_{（0.95，n-2）}	t_{（0.95，n-2）}·S（b1）	结论
低浓度	Y=0.000 82X+1.66	6	-0.001 7	0.007 8	2.776	0.021 6	稳定
高浓度	Y=-0.032 00X+35.50	6	-0.032 0	0.012 1	2.776	0.033 6	稳定

质检品	回归方程	样本量	b1	S（b1）	t_{（0.95，n-2）}	t_{（0.95，n-2）}·S（b1）	结论
低浓度	Y=0.000 82X+1.66	6	-0.001 7	0.007 8	2.776	0.021 6	稳定
高浓度	Y=-0.032 00X+35.50	6	-0.032 0	0.012 1	2.776	0.033 6	稳定

质检品	回归方程	样本量	b1	S（b1）	t_{（0.95，n-2）}	t_{（0.95，n-2）}·S（b1）	结论
低浓度	Y=0.001 1X+1.74	7	0.001 1	0.001 96	2.571	0.005 03	稳定
高浓度	Y=-0.096 0X+35.84	7	0.096 0	0.043 50	2.571	0.112 00	稳定