【摘要】：目的:比較國(guó)內(nèi)三種主流方法:液相色譜-質(zhì)譜法(LC-MS/MS)、電化學(xué)發(fā)光法(ECLIA)以及酶聯(lián)免疫法(ELISA),同時(shí)測(cè)定同批血清25-羥維生素D(25(OH)D)的差異性、一致性。方法:于2015-07-01至2015-07-07,到河北醫(yī)科大學(xué)第二醫(yī)院兒科內(nèi)分泌門診行健康體檢的兒童,共64份高低不同維生素D狀況的血清。每份血清同時(shí)應(yīng)用LC-MS/MS測(cè)定25(OH)D2、25(OH)D3濃度、ECLIA測(cè)定總25(OH)D濃度及ELISA(IDS)測(cè)定總25(OH)D濃度,進(jìn)而應(yīng)用SPSS17.0軟件對(duì)每?jī)煞N方法測(cè)定結(jié)果進(jìn)行比較、直線相關(guān)關(guān)系分析、Bland-Altman法一致性檢驗(yàn)。結(jié)果:1 LC-MS/MS測(cè)定64例血清25(OH)D數(shù)據(jù)符合正態(tài)分布,均數(shù)為65.37nmol/L,標(biāo)準(zhǔn)差為15.73nmol/L;ELISA和ECLIA測(cè)定結(jié)果均為非正態(tài)分布,中位數(shù)分別為:61.92nmol/L、60.18 nmol/L。Wilcoxon檢驗(yàn)示每?jī)煞N方法之間均數(shù)(中位數(shù))差異均無(wú)統(tǒng)計(jì)學(xué)意義。箱式圖示三種方法測(cè)定結(jié)果的平均水平均接近;ELISA與LC-MS/MS測(cè)定結(jié)果整體分布較一致,而ECLIA與其他兩種方法相比,整體數(shù)據(jù)分布存在較大差異;2若將25(OH)D濃度50nmol/L、50-72.5nmol/L分別定義為維生素D缺乏、不足的切值,64例兒童中維生素D缺乏癥的比例分別是:15.63%(ELISA)、17.18%(LC-MS/MS)、31.25%(ECLIA);維生素D不足的比例分別是:57.82%(ELISA)、54.69%(LC-MS/MS)、39.06%(ECLIA)。ELISA和LC-MS/MS結(jié)果一致,ECLIA與前兩者差異較大;3每?jī)煞N方法之間線性回歸方程及相關(guān)系數(shù)為:Y(ECLIA)=1.32X(LC-MS/MS)-22.2(r=0.93);Y(ECLIA)=1.05X(ELISA)-4.73(r=0.81;Y(ELISA)=0.91X(LC-MS/MS)+5.79(r=0.84)。三種方法間均具有高度正相關(guān)性;4 ECLIA與LC-MS/MS的Bland-Altman圖:4/64的點(diǎn)位于95%一致性界限外,在一致性界限內(nèi)兩方法相比,差值絕對(duì)值最大為17.05nmol/L,比值最大、最小分別為1.3、0.65;ELISA與LC-MS/MS:4/64的點(diǎn)位于95%一致性界限外,一致性界限內(nèi)差值絕對(duì)值最大18.17nmol/L,比值最大、最小分別為1.3、0.75;ECLIA與ELISA:3/64的點(diǎn)位于95%一致性界限外,界限內(nèi)差值絕對(duì)值最大為29.42nom/L,比值最大、最小分別為1.5、0.6。結(jié)論:當(dāng)血清總25(OH)D濃度在一定范圍內(nèi),且25(OH)D2含量極低時(shí),ECLIA、LC-MS/MS、ELISA測(cè)定血清25(OH)D具有高度正向相關(guān)性,結(jié)合箱式圖、直線回歸方程、一致性檢驗(yàn)分析,ECLIA所測(cè)血清25(OH)D水平與LC-MS/MS、ELISA具有一定差異性,而LC-MS/MS、ELISA差異性小、一致性佳。
[Abstract]:Objective: to compare the differences of simultaneous determination of 25 hydroxyvitamin D (25 (OH) D) in serum with three main methods: liquid chromatography-mass spectrometry (LC-MS/MS), electrochemiluminescence (ECLIA) and enzyme-linked immunosorbent assay (ELISA),). Consistency. Methods: 64 children with different levels of vitamin D were enrolled in the pediatric endocrine clinic of the second Hospital of Hebei Medical University from January 2015-07-07 to 2015-07-07. The concentrations of 25 (OH) D2X 25 (OH) D3, 25 (OH) D and 25 (OH) D in each serum were determined by LC-MS/MS, ECLIA and ELISA (IDS), respectively. SPSS17.0 software is used to compare the results of each method, linear correlation analysis and Bland-Altman consistency test. Results: 1 the data of serum 25 (OH) D measured by LC-MS/MS in 64 cases accord with normal distribution, the mean is 65.37 nmol / L, the standard deviation is 15.73 nmol / L; The results of ELISA and ECLIA were non-normal distribution, the median was 61.92 nmol / L ~ (60. 18) nmol/L.Wilcoxon test showed that there was no significant difference between the two methods. The average level of the three methods is close to that of the other three methods, the whole distribution of ELISA and LC-MS/MS is the same, and that of ECLIA is different from that of other two methods. 2 if the 25 (OH) D concentration of 50nmol / L (50-72.5nmol / L) is defined as vitamin D deficiency, the proportion of vitamin D deficiency in 64 children is 15.63% (ELISA),. 17.18% (LC-MS/MS), 31.25% (ECLIA); The rates of vitamin D deficiency were 57.82% (ELISA), 54.69% (LC-MS/MS), 39.06% (ECLIA). ELISA and LC-MS/MS results were the same, and the difference between ECLIA and LC-MS/MS was significant. 3 the linear regression equation and correlation coefficient between the two methods were: Y (ECLIA) = 1.32X (LC-MS/MS) -22.2 (r = 0.93); Y (ECLIA) = 1.05X (ELISA) -4.73 (r = 0.81); Y (ELISA) = 0.91X (LC-MS/MS) 5.79 (r = 0.84). There was a high positive correlation among the three methods. (4) Bland-Altman diagram of ECLIA and LC-MS/MS: the point of 4 / 64 is outside the 95% consistency limit. Compared with the two methods, the absolute value of the difference is 17.05 nmol / L, the ratio is the largest, the minimum is 1.3nmol / L, and the minimum is 1.3nmol / L, respectively. The point between ELISA and LC-MS/MS:4/64 lies outside the 95% consistency limit. The absolute value of the absolute value within the consistency limit is 18.17nmol / L, the ratio is the largest, the minimum is 1.3nmol / L, and the minimum is 1.3nmol / L, respectively. The point of ECLIA and ELISA:3/64 is outside the 95% consistency limit. The absolute value of the difference within the limit is 29.42 Nm / L, the ratio is the largest, the minimum is 1.5 鹵0.6. Conclusion: when the total concentration of 25 (OH) D in serum is within a certain range and the content of 25 (OH) D2 is very low, there is a high positive correlation between ECLIA,LC-MS/MS,ELISA and serum 25 (OH) D, combined with box diagram and linear regression equation. Consistency analysis showed that the serum 25 (OH) D level measured by ECLIA was different from that of LC-MS/MS,ELISA to some extent, while LC-MS/MS,ELISA had little difference and good consistency.
【學(xué)位授予單位】：河北醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R446.6

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