中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2015年
7期
475-479
,共5页
禹松林%方慧玲%程歆琦%张瑞苹%韩建华%秦绪珍%夏良裕%苏薇%程倩%邱玲
禹鬆林%方慧玲%程歆琦%張瑞蘋%韓建華%秦緒珍%夏良裕%囌薇%程倩%邱玲
우송림%방혜령%정흠기%장서평%한건화%진서진%하량유%소미%정천%구령
25羟维生素D2%色谱法,液相%串联质谱法
25羥維生素D2%色譜法,液相%串聯質譜法
25간유생소D2%색보법,액상%천련질보법
25-hydroxyvitamin D2%Chromatography liquid%Tandem mass spectrometry
目的比较5种自动化免疫学方法测定25羟维生素D(25OHD)和液相色谱串联质谱法(LC-MS/MS)测定25OHD方法的一致性。方法本研究属于方法学比对。2014年5月至7月选择245份临床血清样本(总25OHD浓度范围:2.8 ng/ml~64.0 ng/ml,其中154份不含25OHD2,91份含有不同浓度的25OHD2),应用雅培、索林、IDS、罗氏、西门子五个厂家(文中依次以A, B, C, D, E代表)的自动化免疫学方法和本实验室建立的LC-MS/MS方法共同测定,以LC-MS/MS方法作为参照标准,比较测定结果的一致性,并以25 OHD<20 ng/ml、20~30 ng/ml、>30 ng/ml为临床判定维生素D缺乏、不足和充足的标准,判定各种方法的符合率。测定临床样本之前对各方法进行精密度评价。用MedCalc软件统计处理数据,采用Bland-Altaman 图比较2种方法的差异,以Passing & Bablok回归分析2种方法之间的相关性。结果6种方法测定245例样本的中位数(2.5%~97.5%范围)分别为:23.5(5.8~44.2) ng/ml (LC-MS/MS),20.6(7.1~43.5)ng/ml (A),19.0(5.4~38.0) ng/ml (B),23.0(10.0~38.1) ng/ml (C),20.1(5.1~46.0) ng/ml (D),31.3(12.3~71.1) ng/ml (E), Passing&Bablok 回归分析显示B方法与LC-MS/MS相关性最好(r=0.894),而A、C和D方法与LC-MS/MS平均偏差相对较小,E方法与LC-MS/MS平均偏差最大。在不含25OHD2的样本中,5种自动化免疫学方法得出的结果与LC-MS/MS方法得出的结果的相关性均在0.84以上,相关性最好的为B (r=0.930),但当样本中含有25OHD2时,各种方法与LC-MS/MS的相关性均下降。以统一的临床判定阈值,与LC-MS/MS得到的临床判定结果相比,A、B、C、D和E的一致率分别为68.6%、64.9%、67.8%、70.6%和51.8%。结论不同检测系统检测结果相差较大,25OHD2对各种免疫学方法均有较大影响。不同检测系统临床判定一致率均较低,可能需要建立各自相应的判定阈值。(中华检验医学杂志,2015,38:475-479)
目的比較5種自動化免疫學方法測定25羥維生素D(25OHD)和液相色譜串聯質譜法(LC-MS/MS)測定25OHD方法的一緻性。方法本研究屬于方法學比對。2014年5月至7月選擇245份臨床血清樣本(總25OHD濃度範圍:2.8 ng/ml~64.0 ng/ml,其中154份不含25OHD2,91份含有不同濃度的25OHD2),應用雅培、索林、IDS、囉氏、西門子五箇廠傢(文中依次以A, B, C, D, E代錶)的自動化免疫學方法和本實驗室建立的LC-MS/MS方法共同測定,以LC-MS/MS方法作為參照標準,比較測定結果的一緻性,併以25 OHD<20 ng/ml、20~30 ng/ml、>30 ng/ml為臨床判定維生素D缺乏、不足和充足的標準,判定各種方法的符閤率。測定臨床樣本之前對各方法進行精密度評價。用MedCalc軟件統計處理數據,採用Bland-Altaman 圖比較2種方法的差異,以Passing & Bablok迴歸分析2種方法之間的相關性。結果6種方法測定245例樣本的中位數(2.5%~97.5%範圍)分彆為:23.5(5.8~44.2) ng/ml (LC-MS/MS),20.6(7.1~43.5)ng/ml (A),19.0(5.4~38.0) ng/ml (B),23.0(10.0~38.1) ng/ml (C),20.1(5.1~46.0) ng/ml (D),31.3(12.3~71.1) ng/ml (E), Passing&Bablok 迴歸分析顯示B方法與LC-MS/MS相關性最好(r=0.894),而A、C和D方法與LC-MS/MS平均偏差相對較小,E方法與LC-MS/MS平均偏差最大。在不含25OHD2的樣本中,5種自動化免疫學方法得齣的結果與LC-MS/MS方法得齣的結果的相關性均在0.84以上,相關性最好的為B (r=0.930),但噹樣本中含有25OHD2時,各種方法與LC-MS/MS的相關性均下降。以統一的臨床判定閾值,與LC-MS/MS得到的臨床判定結果相比,A、B、C、D和E的一緻率分彆為68.6%、64.9%、67.8%、70.6%和51.8%。結論不同檢測繫統檢測結果相差較大,25OHD2對各種免疫學方法均有較大影響。不同檢測繫統臨床判定一緻率均較低,可能需要建立各自相應的判定閾值。(中華檢驗醫學雜誌,2015,38:475-479)
목적비교5충자동화면역학방법측정25간유생소D(25OHD)화액상색보천련질보법(LC-MS/MS)측정25OHD방법적일치성。방법본연구속우방법학비대。2014년5월지7월선택245빈림상혈청양본(총25OHD농도범위:2.8 ng/ml~64.0 ng/ml,기중154빈불함25OHD2,91빈함유불동농도적25OHD2),응용아배、색림、IDS、라씨、서문자오개엄가(문중의차이A, B, C, D, E대표)적자동화면역학방법화본실험실건립적LC-MS/MS방법공동측정,이LC-MS/MS방법작위삼조표준,비교측정결과적일치성,병이25 OHD<20 ng/ml、20~30 ng/ml、>30 ng/ml위림상판정유생소D결핍、불족화충족적표준,판정각충방법적부합솔。측정림상양본지전대각방법진행정밀도평개。용MedCalc연건통계처리수거,채용Bland-Altaman 도비교2충방법적차이,이Passing & Bablok회귀분석2충방법지간적상관성。결과6충방법측정245례양본적중위수(2.5%~97.5%범위)분별위:23.5(5.8~44.2) ng/ml (LC-MS/MS),20.6(7.1~43.5)ng/ml (A),19.0(5.4~38.0) ng/ml (B),23.0(10.0~38.1) ng/ml (C),20.1(5.1~46.0) ng/ml (D),31.3(12.3~71.1) ng/ml (E), Passing&Bablok 회귀분석현시B방법여LC-MS/MS상관성최호(r=0.894),이A、C화D방법여LC-MS/MS평균편차상대교소,E방법여LC-MS/MS평균편차최대。재불함25OHD2적양본중,5충자동화면역학방법득출적결과여LC-MS/MS방법득출적결과적상관성균재0.84이상,상관성최호적위B (r=0.930),단당양본중함유25OHD2시,각충방법여LC-MS/MS적상관성균하강。이통일적림상판정역치,여LC-MS/MS득도적림상판정결과상비,A、B、C、D화E적일치솔분별위68.6%、64.9%、67.8%、70.6%화51.8%。결론불동검측계통검측결과상차교대,25OHD2대각충면역학방법균유교대영향。불동검측계통림상판정일치솔균교저,가능수요건립각자상응적판정역치。(중화검험의학잡지,2015,38:475-479)
Objective To compare the concordance of five automated 25OHD immunoassays with liquid chromatography tandem mass spectrometry method ( LC-MS/MS) .Methods During May to July in 2014, 245 clinical serum samples that requested 25OHD tests were selected, with a total 25OHD range of 2.8 ng/ml-64.0 ng/ml, in which 154 samples did not contain 25OHD2 and 91 samples contains both 25OHD2 and 25OHD3 .To used a LC-MS/MS method that built in our laboratory to measure 25OHD, five commercial automated chemiluminescent immunoassays from Abbott Diagnostics ( A ) , DiaSorin LIASON (B), IDS-iSYS(C), Roche Diagnostics(D), and Siemens ADVIA Centaur(E).Taking the reference method LC-MS/MS as a standard , to compared the concordance and performance of the five automated 25OHD immunoassays.And used the commonly accepted cutoffs for 25OHDdeficiency (<20 ng/ml), and insufficiency ( 20 -30 ng/ml ) , and sufficiency (≥30 ng/ml ) to compare the uniformity of different methods .Statistical analysiswere performed by MedCalc software , Passing & Bablok regression , Bland &Altaman plots and Box and whisker plots were performed to compare the differences of the methods .Results The medium ( range:2.5% -97.5%) 25OHD of the 245 serum samples of the six methods was 23.5 (5.8-44.2) ng/ml(LC-MS/MS),20.6 (7.1-43.5)ng/ml(A),19.0 (5.4-38.0) ng/mL (B),23.0 (10.0-38.1) ng/ml(C),20.1 (5.1 -46.0) ng/ml (D),31.3 (12.3 -71.1) ng/ml (E), respectively .Passing and Bablok regression showed that method B had the best correlation coefficient with LC-MS/MS (r=0.894), while methods A, C and D had relatively small bias compared withLC-MS/MS and method E had the large bias .If the serum samples did not contain 25OHD2 , all the five automated immunoassays correlated well with LC-MS/MS with a correlation coefficient higher than 0.84, and B has the best correlation with LC-MS/MS ( r=0.930 ) .While all the correlation coefficient between immunoassays and LC-MS/MS decreasedwhen analyzing the samplescontaining 25OHD2.Using the clinical cutoffs, A, B, C, D and E had a concordance of 68.6%, 64.9%, 67.8%, 70.6% and 51.8% compared with LC-MS/MS, respectively .Conclusions There are significant differences between different detection systems of 25OHD.All the immunoassays results were affected by the existence of 25OHD2 .The concordance of serum 25OHD resultswas poor between different methods , and it may be necessary to built exclusive cutoffs for different methods.