不同品牌校准品对血清碱性磷酸酶检测结果可比性的影响

doi:10.3969/j.issn.1673-8640.2022.02.018

摘要/Abstract

摘要：

目的探讨不同品牌校准品和基质对碱性磷酸酶（ALP）检测结果可比性的影响,为进一步开展血清ALP检测标准化和检测结果互认提供参考。方法选用临床实验室常用的2种校准品（AU校准品、C.f.a.s.校准品）和ALP国家二级标准物质（简称标准物质）分别于AU5800全自动生化分析仪（简称AU5800）和cobas c501全自动生化分析仪（简称c501）上对ALP项目进行校准。检测收集的25例新鲜临床血清样本和上海市临床检验中心常规化学室间质量评价5个浓度水平样本,各测定2次。以标准物质校准后的检测值为参比系统,计算2种校准品与标准物质校准后的检测值的相对偏移和相关性。以c501检测值为参比系统,计算采用同一校准品校准后,2台仪器检测值的相对偏移和相关性。结果以标准物质校准后的检测值为参比系统,两两系统的偏移绝对值均<10%,c501呈负偏移,AU5800呈正偏移,室间质量评价样本与临床样本的偏移均无明显差异。以c501检测值为参比系统,使用标准物质校准后,系统间临床血清样本测定值差异缩小;使用非系统配套校准品校准后,系统间差异增大。室间质量评价样本与临床血清样本呈现了相反的结果。结论使用具有溯源性和互换性的标准物质有利于各检测系统和实验室间检测结果的一致性和可比性。使用非系统配套校准品会增加各系统间差异,无法互通。此外,具有基质效应的室间质量评价样本并不能完全展示各系统的真实检测结果。

关键词: 碱性磷酸酶, 校准品, 可比性, 互换性

Abstract:

Objective To discuss the influence of different-brand calibrators and matrix on the comparability of alkaline phosphatase（ALP） determination,and to provide a reference for further standardization of serum ALP determination and clinical result mutual accreditation. Methods ALP was calibrated on AU5800 analyzer and cobas c501 analyzer by 2 commonly used calibrators（AU calibration and C.f.a.s. calibration） and ALP national secondary reference material. Totally,25 fresh clinical samples and 5 concentration level samples of routine chemistry of Shanghai external quality assessment were determined for 2 times. Taking the test value after calibration of the reference material as the reference system,the bias and correlation between determination values after calibrating the matching calibration and reference material were calculated. Taking the determination value of the c501 as the reference system,the bias and correlation between determination values obtained by the 2 instruments after the same calibrator were calculated and calibrated. Results Taking the determination value after calibration of the reference material as the reference system,the absolute value of the bias of the 2 systems was <10%. The c501 had a negative bias,while the AU5800 had a positive bias. There was no statistical significance in the bias between the external quality assessment samples and the clinical samples. Taking c501 determination value as the reference system,after using reference material to calibrate clinical serum samples,the differences between the systems were reduced. After the calibration of the non-matching system,the differences between the systems were increased. The external quality assessment samples presented the opposite results from the serum samples. Conclusions The use of traceability and commutability reference materials is beneficial to the consistency and comparability of the determination results between different determination systems and laboratories. The use of non-matching system calibrators will increase the differences between systems and will not be interchangeable. In addition,the external quality assessment samples with matrix effect can not fully show the real determination results of each system.

Key words: Alkaline phosphatase, Calibrator, Comparability, Commutability

中图分类号:

R446.1

林斐然, 欧元祝, 刘文彬, 虞啸炫, 葛丹红, 赵冉. 不同品牌校准品对血清碱性磷酸酶检测结果可比性的影响[J]. 检验医学, 2022, 37(2): 183-187.

LIN Feiran, OU Yuanzhu, LIU Wenbin, YU Xiaoxuan, GE Danhong, ZHAO Ran. Influence of different-brand calibrators on the comparability of serum alkaline phosphatase determination results[J]. Laboratory Medicine, 2022, 37(2): 183-187.

图/表 5

参考文献 10

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样本序号	c501配套系统与标准物质-c501系统	AU5800配套系统与标准物质-AU5800系统
1	-2.35	0.56
2	-4.15	2.41
3	-5.63	9.87
4	-4.77	2.52
5	-5.49	3.93
6	-5.59	4.55
7	-6.74	3.99
8	-7.53	7.05
9	-6.81	5.98
10	-6.74	2.89
11	-8.12	4.78
12	-7.48	3.71
13	-7.68	5.90
14	-8.81	6.66
15	-7.28	5.05
16	-9.34	2.71
17	-7.32	3.47
18	-8.07	2.75
19	-8.90	5.08
20	-7.46	2.73
21	-7.85	6.84
22	-7.90	5.52
23	-8.36	7.83
24	-8.70	8.72
25	-7.04	8.98
26	-8.50	2.30
27	-7.10	5.19
28	-7.79	7.61
29	-6.77	2.54
30	-8.23	4.55

样本序号	c501配套系统与标准物质-c501系统	AU5800配套系统与标准物质-AU5800系统
1	-2.35	0.56
2	-4.15	2.41
3	-5.63	9.87
4	-4.77	2.52
5	-5.49	3.93
6	-5.59	4.55
7	-6.74	3.99
8	-7.53	7.05
9	-6.81	5.98
10	-6.74	2.89
11	-8.12	4.78
12	-7.48	3.71
13	-7.68	5.90
14	-8.81	6.66
15	-7.28	5.05
16	-9.34	2.71
17	-7.32	3.47
18	-8.07	2.75
19	-8.90	5.08
20	-7.46	2.73
21	-7.85	6.84
22	-7.90	5.52
23	-8.36	7.83
24	-8.70	8.72
25	-7.04	8.98
26	-8.50	2.30
27	-7.10	5.19
28	-7.79	7.61
29	-6.77	2.54
30	-8.23	4.55

样本序号	标准物质-c501系统与标准物质-AU5800 系统	c501配套系统与C.f.a.s.-AU5800 系统	AU校准品-c501系统与AU5800配套系统	c501配套系统与AU5800配套系统
1	0.72	-24.63	-21.22	3.72
2	2.54	-22.12	-18.91	9.56
3	-3.51	-21.60	-17.03	12.34
4	0.94	-22.47	-18.54	8.67
5	2.45	-21.29	-17.19	12.67
6	-0.73	-22.67	-19.52	9.93
7	-0.65	-21.31	-19.33	10.78
8	-1.44	-20.31	-17.24	14.10
9	0.88	-20.23	-16.50	14.73
10	1.12	-20.02	-18.94	11.57
11	0.11	-19.93	-17.86	14.17
12	-1.10	-22.06	-19.60	10.87
13	-2.08	-20.83	-18.86	12.32
14	-0.19	-19.70	-15.92	16.73
15	-1.36	-20.65	-19.06	11.75
16	-0.50	-19.88	-19.09	12.72
17	0.22	-21.46	-19.16	11.89
18	0.51	-19.93	-19.09	12.34
19	-3.55	-21.10	-20.19	11.25
20	-1.37	-21.31	-20.43	9.49
21	-0.21	-18.30	-17.07	15.70
22	0.10	-19.41	-17.06	14.67
23	-0.94	-19.65	-14.78	16.55
24	-2.80	-19.52	-16.59	15.75
25	-1.13	-19.06	-15.74	15.90
26	15.47	-8.56	-6.85	29.10
27	15.74	-7.08	-4.90	31.04
28	11.93	-7.25	-4.92	30.63
29	13.94	-7.69	-9.02	25.31
30	9.87	-9.93	-9.48	25.17

样本序号	标准物质-c501系统与标准物质-AU5800 系统	c501配套系统与C.f.a.s.-AU5800 系统	AU校准品-c501系统与AU5800配套系统	c501配套系统与AU5800配套系统
1	0.72	-24.63	-21.22	3.72
2	2.54	-22.12	-18.91	9.56
3	-3.51	-21.60	-17.03	12.34
4	0.94	-22.47	-18.54	8.67
5	2.45	-21.29	-17.19	12.67
6	-0.73	-22.67	-19.52	9.93
7	-0.65	-21.31	-19.33	10.78
8	-1.44	-20.31	-17.24	14.10
9	0.88	-20.23	-16.50	14.73
10	1.12	-20.02	-18.94	11.57
11	0.11	-19.93	-17.86	14.17
12	-1.10	-22.06	-19.60	10.87
13	-2.08	-20.83	-18.86	12.32
14	-0.19	-19.70	-15.92	16.73
15	-1.36	-20.65	-19.06	11.75
16	-0.50	-19.88	-19.09	12.72
17	0.22	-21.46	-19.16	11.89
18	0.51	-19.93	-19.09	12.34
19	-3.55	-21.10	-20.19	11.25
20	-1.37	-21.31	-20.43	9.49
21	-0.21	-18.30	-17.07	15.70
22	0.10	-19.41	-17.06	14.67
23	-0.94	-19.65	-14.78	16.55
24	-2.80	-19.52	-16.59	15.75
25	-1.13	-19.06	-15.74	15.90
26	15.47	-8.56	-6.85	29.10
27	15.74	-7.08	-4.90	31.04
28	11.93	-7.25	-4.92	30.63
29	13.94	-7.69	-9.02	25.31
30	9.87	-9.93	-9.48	25.17

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