ABI Quantistudio Dx实时定量PCR仪HBV-DNA检测的性能验证

Abstract
Figure/Table
References
Related Citation (3)

Download: PDF (738 KB) HTML (1 KB)
Export: BibTeX | EndNote (RIS)

Abstract Objective To verify the performance of ABI Quantistudio Dx Real-time PCR HBV-DNA detection system.Methods According to CNAS-CL36 and GB/T 22576-2008, the analytical performance, such as precision, accuracy, limit of detection and linearity,was determined by ABI Quantistudio Dx real-time PCR system. Patient specimens, quality products, and reference materials from the National Center for Clinical Laboratories (NCCL) were employed for performance verification.Results The coefficient of variation (CV) of intra-assay of specimens with low concentration and high concentration of ABI Quantistudio Dx real-time PCR system was 2.09% and 1.3%, respectively, while the CV of inter-assay of specimens with a low concentration and high concentration was 3.92% and 2.88%, respectively. Analysis of reference materials from NCCL showed that test results were highly accurate. The detection limit of this system was 50 IU/ml. The linear regression equation was Y=1.0001X, R²=0.9976. The linearity ranged from 1.00×10² to 1.00×10⁸ U/ml.Conclusions The performance of ABI Quantistudio Dx Real-time PCR HBV-DNA detection system meets the needs of clinical detection.

Key words： performance verification real-time quantification PCR hepatitis B virus DNA quantification

Received: 10 October 2018

ZTFLH:

R446.9

	Service

	E-mail this article
	Add to my bookshelf
	Add to citation manager
	E-mail Alert
	RSS
	Articles by authors
	LI Pengfei
	GAO Feng
	and ZHANG Yanhui

Cite this article:

LI Pengfei,GAO Feng,and ZHANG Yanhui. Performance verification of ABI Quantistudio Dx real-time fluorescent quantitative PCR HBV-DNA detection system[J]. Med. J. Chin. Peop. Armed Poli. Forc., 2019, 30(2): 109-112.

URL:

http://journal08.magtechjournal.com/Jwk_wjyx/EN/ OR http://journal08.magtechjournal.com/Jwk_wjyx/EN/Y2019/V30/I2/109

[1]	邢卉春, 庞婷. 从2015年中国《慢性乙型肝炎防治指南》看乙肝防治研究动态[J].武警医学, 2016,27(5):433-436.
[2]	中国国家标准化管理委员会. GB/T22576-2008医学实验室质量和能力的专用要求[S]. 北京: 中国国家标准化管理委员会, 2010.
[3]	中国合格评定国家认可委员会. CNAS-CL02-A009:医学实验室质量和能力认可准则在分子诊断领域的应用说明[S]. 北京:中国合格评定国家认可委员会, 2018.
[4]	Clinical and laboratory standards institute. EP15-A2: User verification of performance for precision and trueness: approved guideline-second edition[S].Wayne, PA, USA: NCCLS, 2005.
[5]	Clinical and laboratory standards institute. EP6-A: Evaluation of the linearity of quantitative measurement procedures: a statistical approach, approved guideline[S]. Wayne, PA, USA: NCCLS, 2003.
[6]	辛娜, 杨超, 白跳艳, 等. 自建 HBV-DNA 实时荧光定量 PCR检测系统性能验证方法及结果分析[J]. 山西医科大学学报, 2016,47(4):365-368.
[7]	Li M, Chen L, Liu L M, et al. Performance verification and comparison of Tian Long automatic hypersensitive hepatitis B virus DNA quantification system with roche CAP/CTM system [J]. World J Gastroenterol, 2017, 23(37):6845-6853.
[8]	王娇, 钱军, 石英, 等. Mx3000pTM实时荧光定量PCR仪HBV-DNA检测系统的性能验证 [J].中国医药导报, 2018, 15(15): 65-68.
[9]	俞刚, 陈瑜, 张佳, 等. 罗氏Light Cycler 480实时荧光定量PCR系统检测HBV-DNA性能验证 [J]. 标记免疫分析与临床, 2016, 23(10):1215-1225.
[10]	巢薇. ABI 7300实时荧光定量PCR仪的性能评估 [J]. 国际检验医学杂志, 2015, 36(4): 494-495.
[11]	胥明勇, 朱华强. ABI 7500 HBV-DNA检测系统性能评价 [J]. 实验与检验医学, 2017, 35(4):489-491.
[12]	赵芹, 辛青松, 李峥嵘, 等. ABI ViiA 7 Taqman HBV-DNA检测系统性能验证 [J]. 国际检验医学杂志, 2015, 36(5):669-671.
[13]	杨佳佳, 张彦懿, 刘华伟, 等. HBV-DNA实时荧光定量PCR检测试剂盒性能验证[J]. 国际检验医学杂志, 2018, 39(2):213-217.
[14]	高峰, 高慧华, 杨学文. 脂血因素对荧光定量PCR检测乙肝病毒DNA的影响及解决措施[J]. 临床检验杂志, 2007, 25(5):359-360.
[15]	Killeen A A, Long T, Souers R, et al. Verifying performance characteristics of quantitative analyticalsystems: calibration verification, linearity, and analytical measurement range[J]. Arch Pathol Lab Med, 2014, 138(9):1173-1181.