[1]黄晓楠,刘玉林.全自动化学发光分析仪检测孕酮和人绒毛膜促性腺激素的性能验证[J].医学信息,2022,35(11):134-137.[doi:10.3969/j.issn.1006-1959.2022.11.035]
　HUANG Xiao-nan,LIU Yu-lin.Performance verification of Automatic Chemiluminescence Analyzer for Detection of Progesterone and Human Chorionic Gonadotropin[J].Medical Information,2022,35(11):134-137.[doi:10.3969/j.issn.1006-1959.2022.11.035]
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全自动化学发光分析仪检测孕酮和人绒毛膜促性腺激素的性能验证()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
35卷
期数:
2022年11期
页码:
134-137
栏目:
论著
出版日期:
2022-06-01

文章信息/Info

Title:
Performance verification of Automatic Chemiluminescence Analyzer for Detection of Progesterone and Human Chorionic Gonadotropin
文章编号:
1006-1959（2022）11-0134-04
作者:
黄晓楠; 刘玉林
（遂宁市中心医院检验科，四川 遂宁 629000）
Author(s):
HUANG Xiao-nan; LIU Yu-lin
(Department of Clinical Laboratory,Suining Central Hospital,Suining 62900,Sichuan,China)
关键词:
化学发光分析仪; 孕酮; 人绒毛膜促性腺激素; 性能验证
Keywords:
Chemiluminescent analyzer; Progesterone; Human chorionic gonadotropin; Performance verification
分类号:
R446.6
DOI:
10.3969/j.issn.1006-1959.2022.11.035
文献标志码:
A
摘要:
目的 验证雅培i2000SR全自动化学发光分析仪检测孕酮（PROG）和人绒毛膜促性腺激素（β-hCG）的方法学性能。方法 依据CNAS-CL02：《医学实验室质量和能力认可准则》（ISO 15189:2012）对PROG和β-hCG的精密度、正确度、线性范围、临床可报告范围进行评价分析，将结果与厂家声明的性能指标进行比较。结果 PROG和β-hCG的批内精密度和批间精密度符合厂家声明，能满足临床要求；正确度符合实验室要求；线性范围均在厂家线性范围内，二者具有良好的线性关系（R２≥0.99）；PROG和β-hCG临床可报告范围分别为：0.1~389.3 nmol/L和2.46~206 597.1 mIU/ml。结论 雅培雅培i2000SR全自动化学发光分析仪检测PROG和β-hCG的性能验证结果符合临床要求，测定结果准确可靠。
Abstract:
Objective To verify the methodological performance of abbott i2000SR automatic chemiluminescence analyzer for detection of progesterone (PROG) and human chorionic gonadotropin (β-hCG).Methods The precision, accuracy, linear range and clinical replayable range of PROG and β-hCG were evaluated and analyzed according to CNAS-CL02:Accreditation Criteria for Quality and Competence of Medical Laboratories (ISO 15189:2012), and the results were compared with the performance indicators declared by manufacturers.Results The intra-batch and inter-batch precision of PROG and β-hCG were in line with the manufacturer’s statement and could meet the clinical requirements. Accuracy in accordance with laboratory requirements; all linear ranges were within the linear range of the manufacturer, and they had a good linear relationship (R2≥0.99). The clinical reporting ranges of PROG and β-hCG were 0.1-389.3 nmol/L and 2.46-206 597.1 mIU/ml, respectively.Conclusion Abbott i2000SR automatic chemiluminescence analyzer for the detection of PROG and β-hCG proved that the results were accurate and reliable in accordance with clinical requirements.

参考文献/References:

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更新日期/Last Update: 1900-01-01