AU5831自动生化分析仪2种试剂检测唾液酸化糖链抗原-6临床应用评价

彭定辉; 任玉国; 庄伟; 廖凡路; 唐鹏; 陈薇

doi:10.13201/j.issn.1004-2806.2023.02.010

AU5831自动生化分析仪2种试剂检测唾液酸化糖链抗原-6临床应用评价

- 1.
  武汉大学中南医院检验科(武汉，430071)
- 2.
  济南市人民医院

详细信息

通讯作者: 陈薇，E-mail：602400856@qq.com

中图分类号: R457.1

收稿日期: 2022-09-02

修回日期: 2022-11-09

刊出日期: 2023-02-01

Clinical evaluation of AU5831 automatic biochemical analyzer for Krebs Von den Lungen-6 kit

- 1.
  Laboratory Department of Central South Hospital of Wuhan University, Wuhan, 430071, China
- 2.
  Jinan People's Hospital

More Information

Corresponding author: CHEN Wei, E-mail: 602400856@qq.com

Received Date: 02 September 2022

Revised Date: 09 November 2022

Publish Date: 01 February 2023

摘要

摘要: 目的运用AU5831自动生化分析仪和2种试剂检测唾液酸化糖链抗原-6(KL-6)，评价试验产品与参比产品的临床使用效能。方法选取300例研究标本，其中间质性肺疾病患者标本75例，无间质性肺疾病病症患者标本205例，干扰病例样本20例，使用2种试剂的胶乳免疫比浊法和胶乳凝集法对研究样本进行平行盲法检测，比较试验产品与参比产品的检测结果，进行离群值检验、回归分析、Bland-Altman一致性分析及医学决定水平的预期偏倚分析。结果试验产品与参比产品各检测KL-6 300例。根据NCCLS EP9-A2文件进行方法间离群值检查，以绝对差值和相对差值的均值4倍为限值，数据均未超出检测限(TLE)数值，无离群值。Deming回归方程为Y=0.907 9+0.995 1X(Pearson相关系数：0.999 9，95%CI 0.999 9~0.999 9)，满足评价标准。Bland-Altman分析，一致性界限外无散点。试验产品与参比产品的一致性检验发现κ=0.965，认为试验产品与参比产品一致性良好。结论 AU5831自动生化分析仪检测KL-6的2种试剂盒在临床应用中具有可比性，一致性较好，可用于临床检测。
- 唾液酸化糖链抗原-6 /
- 胶乳免疫比浊法 /
- 间质性肺炎 /
- 临床评价
Abstract: Objective AU5831 automatic biochemical analyzer and two reagents were used to detect Krebs Von den Lungen-6(KL-6), and to evaluate the clinical efficacy of the test kit and reference product.Methods A total of 300 research specimens were selected in our hospital, including 75 specimens from patients with interstitial lung disease, 205 specimens from patients without interstitial lung disease symptoms, and 20 specimens from interference cases. Latex immunoturbidimetry and latex agglutination were used to detect the clinical samples by parallel blind method. Based on the experiment results, outlier test, regression analysis, Bland-Altman consistency analysis, expected bias analysis at the level of medical decision and consistency analysis of qualitative results were selected for the study.Results KL-6 was detected in 300 samples of test product and reference product respectively. According to NCCLS EP9-A2 document, the outliers between methods were checked which was limited to 4 times the mean value of absolute difference and relative difference, and no outlier was found. Deming regression equation was develop as: Y=0.907 9+0.995 1X with pearson correlation coefficient: 0.999 9. The 95% confidence interval was 0.999 9-0.999 9. There were no scattered points outside the limits of agreement. The consistency test of the test product and the reference product found that κ=0.965, and the consistency between the test product and the reference product was considered to be good.Conclusion The two kits for the detection of KL-6 by the AU5831 automatic biochemical analyzer are comparable in clinical application and have good consistency, which can be used for clinical detection.
- Krebs Von den Lungen-6 /
- latex immunoturbidimetric assay /
- interstitial pneumonia /
- clinical evaluation

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图 1 相关性分析图

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图 2 2种试剂测定值差值的Bland-Altma图

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表 1 试验产品和参比产品检测结果分析表

项目	分组	参比产品		κ	灵敏性/%	特异性/%	总符合率/%	P
项目	分组	阳性例数	阴性例数	κ	灵敏性/%	特异性/%	总符合率/%	P
试验产品	阳性例数阴性例数	74 2	2 222	0.965	97.37 (93.84，100.00)	99.11 (95.58，100.00)	98.59 (95.06，100.00)	1.00

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表 2 干扰试验方差分析

差异源	SS	DF	MS	F	P	Fcrit
组间	66.822 25	1	66.822 25	0.017 823	0.894 501	4.098 172
组内	142 471.6	38	3 749.252
总计	142 538.4	39

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