新型血液鋅原卟啉測(cè)定儀研制
發(fā)布時(shí)間：2018-12-28 18:31
【摘要】：目的獨(dú)立研制一種新型血液鋅原卟啉(ZPP)測(cè)定儀。方法基于ZPP受特定藍(lán)色光激發(fā)可產(chǎn)生與ZPP水平成一定比例關(guān)系的特征性熒光的原理,應(yīng)用最新的光機(jī)電一體化技術(shù)研制新型ZPP測(cè)定儀,并經(jīng)醫(yī)療器械臨床試驗(yàn)和與同類儀器比對(duì)實(shí)驗(yàn)驗(yàn)證其臨床性能和熱穩(wěn)定性。結(jié)果新型ZPP測(cè)定儀研制成功。線性誤差實(shí)驗(yàn)結(jié)果顯示,血樣中ZPP在1.80~46.20μg/gHb線性關(guān)系良好,相關(guān)系數(shù)(r)為0.999 9~1.000 0,線性誤差為0.00%~4.49%,測(cè)量值均在ZPP標(biāo)準(zhǔn)血樣的不確定度范圍內(nèi)。重復(fù)性實(shí)驗(yàn)顯示相對(duì)標(biāo)準(zhǔn)偏差均5.00%。準(zhǔn)確性實(shí)驗(yàn)結(jié)果顯示測(cè)量結(jié)果在標(biāo)稱值范圍內(nèi)。新型ZPP測(cè)定儀與國(guó)產(chǎn)ZPP血液熒光計(jì)測(cè)定結(jié)果比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(Z=-0.588,P0.05),兩者測(cè)定結(jié)果相關(guān)性良好,r為0.999 5~0.999 9。在25℃下連續(xù)8 h工作后,新型ZPP測(cè)定儀無(wú)明顯發(fā)熱現(xiàn)象,測(cè)量值偏倚為3.78%;國(guó)外某型號(hào)ZPP測(cè)定儀整機(jī)發(fā)熱嚴(yán)重,測(cè)量值偏倚為21.20%,接近標(biāo)準(zhǔn)血樣標(biāo)稱值的上限。結(jié)論新型ZPP測(cè)定儀線性誤差小,重復(fù)性、準(zhǔn)確性和熱穩(wěn)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，
本文編號(hào)：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，
本文編號(hào)：2394278
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