CAJ | 학술논문

目的：通过对迈克IS1200全自动化学发光测定仪进行性能验证及评价，探讨迈克IS1200全自动化学发光测定仪临床应用的可行性。方法参考ISO15189：2007《医学实验室质量和能力认可准则》的国际标准和相关文献，同时结合实际工作，对IS1200的稳定性、精密度、正确度、线性相关性、携带污染率、仪器间的比对等分析性能进行验证及评价。结果迈克IS1200仪器性能稳定，稳定性试验4 h后的相对偏倚为3．43％，8 h后的相对偏倚为5．04％，批内不精密度小于5％，总不精密度小于10％，携带污染率小于2 ppm ，线性相关系数为0．99992。结论迈克IS1200仪器稳定性较好，线性良好，携带污染率低，良好的精密度和正确度，可应用于临床。
목적：통과대매극IS1200전자동화학발광측정의진행성능험증급평개，탐토매극IS1200전자동화학발광측정의림상응용적가행성。방법삼고ISO15189：2007《의학실험실질량화능력인가준칙》적국제표준화상관문헌，동시결합실제공작，대IS1200적은정성、정밀도、정학도、선성상관성、휴대오염솔、의기간적비대등분석성능진행험증급평개。결과매극IS1200의기성능은정，은정성시험4 h후적상대편의위3．43％，8 h후적상대편의위5．04％，비내불정밀도소우5％，총불정밀도소우10％，휴대오염솔소우2 ppm ，선성상관계수위0．99992。결론매극IS1200의기은정성교호，선성량호，휴대오염솔저，량호적정밀도화정학도，가응용우림상。
Objective To explore the feasibility of clinical applications of Maker IS1200 automated chemilumi‐nescent analyzer based on the performance verification and evaluation .Methods According to the standard of ISO15189 :2007 established by Chinese Pharmaceutical Industry ,related literature ,and combined with practical work , the stability ,precision ,accuracy ,linearity correlation ,carryover contamination rate and comparison between different instrument of IS1200 were conducted .Results The relative bias was 3 .43% after 4 h stability test and 5 .04% after 8 .In the same batch ,the imprecision was less than 5% ,the total imprecision was less than 10% ,and carryover con‐tamination rate was less than 2 ppm ,the linear correlation coefficient was 0 .999 92 .Conclusion The Maker IS1200 could be applied in clinica due to the stabile performance ,good linearity ,low carryover contamination rate ,good preci‐sion and accuracy .