新型血液锌原卟啉测定仪研制  

Development of a new blood zinc protoporphyrin hematofluorometer

作　　者：苏晓舟[1] 王美霞[1] 罗国灵[1] 钟蝶娴[1] 黄汉林[1] 

机构地区：[1]广东省职业病防治院,广东省职业病防治重点实验室,广东广州510300

出　　处：《中国职业医学》2014年第3期282-285,共4页China Occupational Medicine

基　　金：卫生行业科研专项项目(200902006);广东省职业病防治重点实验室(2012A061400007)

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,P>0.05),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 type of blood zinc protoporphyrin （ZPP） hematofluorometer independently. Methods Latest technology of optical-mechanical-electrical integration was used in the development of new ZPP hema- tofluorometer. The principle was that when ZPP was stimulated by specific blue light it could produce characteristic fluore- scence which was proportional to ZPP. The clinical performance and thermal stability were verified by the clinical trial of medical apparatus and instruments and comparison with the similar instruments. Results The new instrument of ZPP was developed successfully. Clinical laboratory tests showed that when ZPP levels in the blood sample ranged between 1.80- 46. 20 p^g/gHB, the linearity was validated, the correlation coefficient ranged from 0. 999 9-1. 000 0, the linearity error was 0. 00% -4. 49% , and the observed values were all within the range of uncertainty of ZPP standard blood samples. The results of repetition tests showed that relative standard deviation was less than 5.00%. The veracity tests showed that the observed values were all within the nominal value of ZPP standard blood samples. Compared with the determination results of the old domestic models, no statistically significant difference was found in new ZPP hematofluorometer （ Z = - 0. 588, P 〉 0. 05）. A good correlation was observed between the determination result of the two instruments and the correlation coefficient ranged from 0. 999 5-0. 999 9. The new ZPP hematofluorometer worked smoothly and stably after 8 hours of con- tinuous work at 25 ~C without obvious heating, and the bias of measured value was 3.78%. A foreign type of ZPP hematofluorometer generated heat severely under the same working conditions, the bias of measured value was 21.20%, and the results was close to the upper limit of nominal value of standard blood sample. Conclusion The new instrument of ZPP has the characteristics of little linearity error, good repeatability, good accuracy and thermal stability.

关 键 词：锌原卟啉 光机电一体化 仪器研制 医疗器械 临床试验 重复性 准确性 热稳定性 

分 类 号：R13[医药卫生—劳动卫生]