新型血液锌原卟啉测定仪研制
发布时间：2018-12-28 18:31
【摘要】：目的独立研制一种新型血液锌原卟啉(ZPP)测定仪。方法基于ZPP受特定蓝色光激发可产生与ZPP水平成一定比例关系的特征性荧光的原理,应用最新的光机电一体化技术研制新型ZPP测定仪,并经医疗器械临床试验和与同类仪器比对实验验证其临床性能和热稳定性。结果新型ZPP测定仪研制成功。线性误差实验结果显示,血样中ZPP在1.80~46.20μg/gHb线性关系良好,相关系数(r)为0.999 9~1.000 0,线性误差为0.00%~4.49%,测量值均在ZPP标准血样的不确定度范围内。重复性实验显示相对标准偏差均5.00%。准确性实验结果显示测量结果在标称值范围内。新型ZPP测定仪与国产ZPP血液荧光计测定结果比较,差异无统计学意义(Z=-0.588,P0.05),两者测定结果相关性良好,r为0.999 5~0.999 9。在25℃下连续8 h工作后,新型ZPP测定仪无明显发热现象,测量值偏倚为3.78%;国外某型号ZPP测定仪整机发热严重,测量值偏倚为21.20%,接近标准血样标称值的上限。结论新型ZPP测定仪线性误差小,重复性、准确性和热稳定性良好。
[Abstract]:Objective to develop a new blood zinc protoporphyrin (ZPP) instrument. Methods based on the principle that ZPP excited by specific blue light can produce characteristic fluorescence which is proportional to the level of ZPP, a new type of ZPP detector is developed by using the latest optoelectromechanical technology. Its clinical performance and thermal stability were verified by clinical trials of medical devices and comparison with similar instruments. Results A new ZPP instrument was developed successfully. The experimental results of linear error showed that the linear relationship of ZPP in blood samples was good at 1.80 渭 g/gHb, the correlation coefficient (r) was 0.999 ~ 1.000, and the linear error was 0.004.49 渭 g/gHb. The measured values were within the range of uncertainty of ZPP standard blood samples. Repeatability experiments showed that the relative standard deviations were 5.00. The accuracy experiment results show that the measured results are within the range of nominal values. There was no significant difference between the new ZPP instrument and the domestic ZPP blood fluorescence meter (P 0.05). The correlation between the two results was good, r = 0.999 ~ 0.999 9. After working at 25 鈩，
本文编号：2394278
[Abstract]:Objective to develop a new blood zinc protoporphyrin (ZPP) instrument. Methods based on the principle that ZPP excited by specific blue light can produce characteristic fluorescence which is proportional to the level of ZPP, a new type of ZPP detector is developed by using the latest optoelectromechanical technology. Its clinical performance and thermal stability were verified by clinical trials of medical devices and comparison with similar instruments. Results A new ZPP instrument was developed successfully. The experimental results of linear error showed that the linear relationship of ZPP in blood samples was good at 1.80 渭 g/gHb, the correlation coefficient (r) was 0.999 ~ 1.000, and the linear error was 0.004.49 渭 g/gHb. The measured values were within the range of uncertainty of ZPP standard blood samples. Repeatability experiments showed that the relative standard deviations were 5.00. The accuracy experiment results show that the measured results are within the range of nominal values. There was no significant difference between the new ZPP instrument and the domestic ZPP blood fluorescence meter (P 0.05). The correlation between the two results was good, r = 0.999 ~ 0.999 9. After working at 25 鈩，
本文编号：2394278
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