上海宏石SLAN96P荧光定量PCR仪性能验证

Performance Verification of the Shanghai Hongshi SLAN96P Real-time Quantitative Polymerase Chain Reaction Instrument in the ISO15189 Accreditation

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 HongShi 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.