doi:10.3969/j.issn.1673-8640.2025.12.014

Abstract

CLC Number:

R446.1

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References 10

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[5]	中华人民共和国国家质量监督检验检疫总局. GB/T 21415—2008 体外诊断医疗器械生物样品中量的测量校准品和控制物质赋值的计量学溯源性[S]. 北京: 中华人民共和国国家质量监督检验检疫总局, 2008.
[6]	国家市场监督管理总局. JJF 1343—2022 标准物质的定值及均匀性、稳定性评估[S]. 北京: 国家市场监督管理总局, 2022.
[7]	中华人民共和国卫生部. WS/T 356—2011 基质效应与互通性评估指南[S]. 北京: 中华人民共和国卫生部, 2011.
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[10]	JØRGENSEN N R, MØLLEHAVE L T, HANSEN Y B L, et al. Comparison of two automated assays of BTM(CTX and P1NP)and reference intervals in a Danish population[J]. Osteoporos Int, 2017, 28(7):2103-2113. DOI

项目	离均差平方和	自由度	均方	F值	P值	F_0.05值
水平1
组间	106.64	10	10.664 0	1.964 3	0.089 9	2.296 7
组内	119.44	22	5.428 9
总计	226.08	32
水平2
组间	5 732.95	10	573.295 3	1.006 0	0.468 6	2.296 7
组内	12 537.78	22	569.899 0
总计	18 270.7315 8	32

项目	离均差平方和	自由度	均方	F值	P值	F_0.05值
水平1
组间	106.64	10	10.664 0	1.964 3	0.089 9	2.296 7
组内	119.44	22	5.428 9
总计	226.08	32
水平2
组间	5 732.95	10	573.295 3	1.006 0	0.468 6	2.296 7
组内	12 537.78	22	569.899 0
总计	18 270.7315 8	32

项目	∣k∣	t_{（0.95,n-2）}·s_k	结果判定
水平1
20~25 ℃ 12 h	0.065 9	1.275 0	稳定
2~8 ℃ 31 d	0.001 1	0.664 1	稳定
-20 ℃ 31 d	0.001 4	0.651 9	稳定
水平2
20~25 ℃ 12 h	0.099 1	0.873 6	稳定
2~8 ℃ 31 d	0.011 2	0.650 5	稳定
-20 ℃ 31 d	0.000 2	0.686 9	稳定

项目	∣k∣	t_{（0.95,n-2）}·s_k	结果判定
水平1
20~25 ℃ 12 h	0.065 9	1.275 0	稳定
2~8 ℃ 31 d	0.001 1	0.664 1	稳定
-20 ℃ 31 d	0.001 4	0.651 9	稳定
水平2
20~25 ℃ 12 h	0.099 1	0.873 6	稳定
2~8 ℃ 31 d	0.011 2	0.650 5	稳定
-20 ℃ 31 d	0.000 2	0.686 9	稳定

项目	实验室1/（ng·mL^-1）	实验室2/（ng·mL^-1）	实验室3/（ng·mL^-1）	总均值/（ng·mL^-1）	总标准偏差/（ng·mL^-1）	RSD/%
水平1	150.69	150.65	151.15	150.83	3.31	2.19
水平2	1 495.54	1 490.42	1 492.56	1 492.84	21.41	1.43

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