上海宏石SLAN96P荧光定量PCR仪性能验证
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摘要
目的对上海宏石SLAN96P荧光定量PCR仪进行性能验证和评价。方法在本院检验科ISO15189实验室认可中对宏石SLAN96P荧光定量PCR仪的准确度、精密度、线性范围、生物参考区间进行验证。结果上海宏石SLAN96P荧光定量PCR仪的准确度、精密度、线性范围、生物参考区间均在厂家规定的范围内。结论宏石SLAN96P荧光定量PCR仪各项性能均符合规定要求,可用于临床基因扩增检验。
Objective To evaluate the performance of Shanghai Hong Shi real-time quantitative polymerase chain reaction instrument in order to meet the requirement of the ISO15189 laboratory accreditation.Methods A series of tests with SLAN96P RT-PCR instrument accuracy,precision,linear range and the biological reference interval were detected.Results Accuracy,precision,linear range and the biological reference interval of SLAN96P RT-PCR instrument were all met the requirements.Conclusion The performance of SLAN96P RT-PCR instrument was satisfied,which could be used for clinical molecular biological test.
Objective To evaluate the performance of Shanghai Hong Shi real-time quantitative polymerase chain reaction instrument in order to meet the requirement of the ISO15189 laboratory accreditation.Methods A series of tests with SLAN96P RT-PCR instrument accuracy,precision,linear range and the biological reference interval were detected.Results Accuracy,precision,linear range and the biological reference interval of SLAN96P RT-PCR instrument were all met the requirements.Conclusion The performance of SLAN96P RT-PCR instrument was satisfied,which could be used for clinical molecular biological test.
引文
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[3]邸刚,朱根娣.医用检验仪器应用与维护.第1版.北京:人民卫生出版社,2011.
[4]叶应妩,王毓三,申子瑜.全国临床操作规程.第3版.南京:东南大学出版社,2006.
[5]CLINICAL and Laboratory Standards Institute.User verification of performance for precision and trueness:approved guideline-second edition.EP15-A2,CLSI,2005.
[6]NCCLS.Evaluation of the linearity of quantitative measurement procedures:A statistical approach.Approved guideline NCCLS document EP6-A[S].Wayne,Pa:NCCLS,2003.
[7]张秀明,温冬梅,袁勇.临床生物化学检验质量管理与标准操作程序.北京:人民军医出版社,2010.
[8]朱科伦,朱郇悯,曾文铤,等.乙型肝炎流行病学的研究新进展.广州医药,2010,41(4):1-2.
[9]郭田华.乙型肝炎血清标志物和乙型肝炎病毒DNA检测的临床意义.实用医技杂志,2005,12(12A):3423-3424.
[10]王治国.临床检验质量控制技术.第2版.北京:人民卫生出版社,2010.
[11]中华人民共和国卫生部.临床实验室检验项目参考区间的制定.2012,12.