实验室认可中两台荧光定量PCR仪的比对性研究

The Comparative Analysis of Two Real-time Quantitative Polymerase Chain Reaction Instruments in the Accreditation

目的对ABI-7300荧光定量PCR仪和上海宏石SLAN96P荧光定量PCR仪进行比对和偏差分析。方法在本院检验科ISO15189实验室认可中使用ABI7300和宏石SLAN96P荧光定量PCR仪同时检测20例涵盖整个仪器线性的HBVDNA标本,以ABI-7300荧光定量PCR仪作为参比仪器,SLAN96P荧光定量PCR仪作为实验仪器,进行回归分析,计算偏倚%,评价其是否可接受。结果 ABI-7300荧光定量PCR仪与SLAN96P荧光定量PCR仪检测HBV-DNA的定量结果相对偏倚为6.9%,符合CNAS-CL36《医学实验室质量和能力认可准则在基因扩增检验领域的应用说明》明确要求即系统误差绝对值小于7.5%。结论 ABI-7300荧光定量PCR仪与SLAN96P荧光定量PCR仪检测的HBV-DNA结果具有可比性,可为临床提供可接受的检验结果。

Objective The ABI-7300 fluorescence quantitative PCR instrument and Shanghai Hongshi SLAN96P fluorescence quantitative PCR instrument were compared for a deviation analysis. Methods ABI7300 and SLAN96P fluorescent quantitative PCR instrument were used to detect 20 HBV-DNA samples covering the entire instrument spectrum. ABI-7300 fluorescence quantitative PCR was used as the reference instrument while SLAN96P fluorescence quantitative PCR instrument was used as an experimental instrument. We conducted regression analysis and calculated the bias% to evaluate whether it is acceptable. Results The bias% of detecting the samples by ABI-7300 and SLAN96P fluorescence quantitative PCR instrument was 6. 9% ,which was in accordance with CNAS-CL36 ＂Medical Laboratory Quality and Competency Approval Criteria in the field of gene amplification test＂, It required that the absolute value of the system error should be less than 7.5%. Conclusion The ABI-7300 fluorescence quantitative PCR instrument and the SLAN96P fluorescence quantitative PCR had comparable results in detection of HBV- DNA, which can provide clinically acceptable test results.