CAJ | 학술논문

目的：比较4种颗粒增强免疫透射比浊法（ PETIA）与1种颗粒增强免疫散射比浊法（PENIA）胱抑素C（Cys C）检测系统结果的一致性。方法实验性能验证。选择2013年3月北京协和医院内科门诊患者的检测后剩余血清标本共40例用于方法学比对实验。参考CLSI EP15-A2及EP9-A2方案进行比对结果分析。在OlympusAU5400自动生化分析仪上分别应用上海景源、北京利德曼、北京九强和四川迈克生产的PETIA法Cys C试剂（标为A、B、C、D）和西门子BNⅡ上的PENIA法Cys C检测系统（标为E）测定40份比对血清，将4种PETIA法Cys C检测系统A、B、C、D与PETIA法均值以及与PENIA法系统E结果进行相关分析，比较与PETIA法均值以及与PENIA法系统E的偏差和百分偏差。以1、2、3、4 mg/L为医学决定水平，比较各检测系统在医学决定水平处的预期偏差。采用5种检测系统分别测定参考物质ERM-DA471/IFCC，计算各系统的偏倚和百分偏倚。结果系统A、B、C、D、E测定40份比对血清结果分别为1.29（0.89～2.43）、1.30（0.96～2.59）、1.22（0.90～2.44）、1.27（0.96～2.47）、1.14（0.82～2.05）mg/L。偏差图显示在Cys C小于4 mg/L时不同系统的差异较小。 PETIA法A、B、C、D与其均值相关良好，与均值的平均偏差（百分偏差）在-0.017～0.031 mg/L（-3.1％～2.1％）之间，均小于来源于生物学变异的允许偏倚（3.4％）。 A、B、C、D与其均值在医学决定水平处的偏差在-0.176～0.178 mg/L之间。系统A、B、C、D与PENIA法系统E测定结果相关良好，平均偏差（百分偏差）在0.278～0.326 mg/L（12.6％～18.5％）之间，在医学决定水平处的偏差（百分偏差）在0.055～1.079 mg/L （5.51％～26.98％）之间。 PETIA法A、B、C、D Cys C测定ERM-DA471/IFCC的偏倚在0.22～0.39 mg/L（3.9％～7.0％）之间，超出参考物质靶值允许范围，且均大于来源于生物学变异的 Cys C 允许偏倚（3.4％）。 PENIA 法检测系统 E 偏倚为-0.1 mg/L （-1.7％），在ERM-DA471/IFCC靶值允许范围内。结论所评估的4种PETIA法Cys C检测系统的一致性较理想，较未溯源前明显改善，但PETIA法测定结果高于PENIA法。在Cys C低浓度区（4 mg/L以下）时不同系统的差异较小，高浓度区时的差异较大。目的：比較4種顆粒增彊免疫透射比濁法（ PETIA）與1種顆粒增彊免疫散射比濁法（PENIA）胱抑素C（Cys C）檢測繫統結果的一緻性。方法實驗性能驗證。選擇2013年3月北京協和醫院內科門診患者的檢測後剩餘血清標本共40例用于方法學比對實驗。參攷CLSI EP15-A2及EP9-A2方案進行比對結果分析。在OlympusAU5400自動生化分析儀上分彆應用上海景源、北京利德曼、北京九彊和四川邁剋生產的PETIA法Cys C試劑（標為A、B、C、D）和西門子BNⅡ上的PENIA法Cys C檢測繫統（標為E）測定40份比對血清，將4種PETIA法Cys C檢測繫統A、B、C、D與PETIA法均值以及與PENIA法繫統E結果進行相關分析，比較與PETIA法均值以及與PENIA法繫統E的偏差和百分偏差。以1、2、3、4 mg/L為醫學決定水平，比較各檢測繫統在醫學決定水平處的預期偏差。採用5種檢測繫統分彆測定參攷物質ERM-DA471/IFCC，計算各繫統的偏倚和百分偏倚。結果繫統A、B、C、D、E測定40份比對血清結果分彆為1.29（0.89～2.43）、1.30（0.96～2.59）、1.22（0.90～2.44）、1.27（0.96～2.47）、1.14（0.82～2.05）mg/L。偏差圖顯示在Cys C小于4 mg/L時不同繫統的差異較小。 PETIA法A、B、C、D與其均值相關良好，與均值的平均偏差（百分偏差）在-0.017～0.031 mg/L（-3.1％～2.1％）之間，均小于來源于生物學變異的允許偏倚（3.4％）。 A、B、C、D與其均值在醫學決定水平處的偏差在-0.176～0.178 mg/L之間。繫統A、B、C、D與PENIA法繫統E測定結果相關良好，平均偏差（百分偏差）在0.278～0.326 mg/L（12.6％～18.5％）之間，在醫學決定水平處的偏差（百分偏差）在0.055～1.079 mg/L （5.51％～26.98％）之間。 PETIA法A、B、C、D Cys C測定ERM-DA471/IFCC的偏倚在0.22～0.39 mg/L（3.9％～7.0％）之間，超齣參攷物質靶值允許範圍，且均大于來源于生物學變異的 Cys C 允許偏倚（3.4％）。 PENIA 法檢測繫統 E 偏倚為-0.1 mg/L （-1.7％），在ERM-DA471/IFCC靶值允許範圍內。結論所評估的4種PETIA法Cys C檢測繫統的一緻性較理想，較未溯源前明顯改善，但PETIA法測定結果高于PENIA法。在Cys C低濃度區（4 mg/L以下）時不同繫統的差異較小，高濃度區時的差異較大。
목적：비교4충과립증강면역투사비탁법（ PETIA）여1충과립증강면역산사비탁법（PENIA）광억소C（Cys C）검측계통결과적일치성。방법실험성능험증。선택2013년3월북경협화의원내과문진환자적검측후잉여혈청표본공40례용우방법학비대실험。삼고CLSI EP15-A2급EP9-A2방안진행비대결과분석。재OlympusAU5400자동생화분석의상분별응용상해경원、북경리덕만、북경구강화사천매극생산적PETIA법Cys C시제（표위A、B、C、D）화서문자BNⅡ상적PENIA법Cys C검측계통（표위E）측정40빈비대혈청，장4충PETIA법Cys C검측계통A、B、C、D여PETIA법균치이급여PENIA법계통E결과진행상관분석，비교여PETIA법균치이급여PENIA법계통E적편차화백분편차。이1、2、3、4 mg/L위의학결정수평，비교각검측계통재의학결정수평처적예기편차。채용5충검측계통분별측정삼고물질ERM-DA471/IFCC，계산각계통적편의화백분편의。결과계통A、B、C、D、E측정40빈비대혈청결과분별위1.29（0.89～2.43）、1.30（0.96～2.59）、1.22（0.90～2.44）、1.27（0.96～2.47）、1.14（0.82～2.05）mg/L。편차도현시재Cys C소우4 mg/L시불동계통적차이교소。 PETIA법A、B、C、D여기균치상관량호，여균치적평균편차（백분편차）재-0.017～0.031 mg/L（-3.1％～2.1％）지간，균소우래원우생물학변이적윤허편의（3.4％）。 A、B、C、D여기균치재의학결정수평처적편차재-0.176～0.178 mg/L지간。계통A、B、C、D여PENIA법계통E측정결과상관량호，평균편차（백분편차）재0.278～0.326 mg/L（12.6％～18.5％）지간，재의학결정수평처적편차（백분편차）재0.055～1.079 mg/L （5.51％～26.98％）지간。 PETIA법A、B、C、D Cys C측정ERM-DA471/IFCC적편의재0.22～0.39 mg/L（3.9％～7.0％）지간，초출삼고물질파치윤허범위，차균대우래원우생물학변이적 Cys C 윤허편의（3.4％）。 PENIA 법검측계통 E 편의위-0.1 mg/L （-1.7％），재ERM-DA471/IFCC파치윤허범위내。결론소평고적4충PETIA법Cys C검측계통적일치성교이상，교미소원전명현개선，단PETIA법측정결과고우PENIA법。재Cys C저농도구（4 mg/L이하）시불동계통적차이교소，고농도구시적차이교대。
Objective To assess the consistency of four standardized cystatin C particle-enhanced turbidimetric assay (PETIA) and one particle-enhanced nephelometric immunoassay (PENIA) measurement systems Methods Performance verification test was conducted according to CLSI EP 15-A2 and EP9-A2. Fourty serum samples in comparative test were obtained from the remaining serum samples of outpatients in Peking Union Medical College Hospital in March 2013.Fourty serum samples were tested on Olympus AU5400 automatic biochemical analyzer ( four PETIA Cys C reagents:Shanghai Jingyuan Co ., Ltd, Beijing Leadman Biochemistry Co ., Ltd, Beijing Strong Biotechnologies , Maker Biotechnology in Sichuan , and labelled as A, B, C, D respectively) and PENIA N Latex Cys C measurement system on Siemens BNⅡ(labelled as E).Correlation analysis were performed among four PETIA methods one PENIA method Differences of each detection system were compared in the medical decision level 1,2,3,4 mg/L.The reference material ERM-DA471/IFCC was measured by five systems and bias ( percentage bias ) was calculate for each system.Results Results of systems A, B, C, D, E were 1.29(0.89-2.43), 1.30 (0.96-2.59), 1.22(0.90-2.44), 1.27(0.96-2.47), 1.14(0.82-2.05)mg/L.Chart shows bias among these five systems was small when Cys C concentration was less than 4mg/L.PETIA method A, B, C, D correlated with their mean value well , with the average deviation from their mean value ( percent deviation) at -0.017 -0.031 mg/L ( -3.1%-2.1%), and all were less than allowed bias from the biological variation (3.4%).The deviation of PETIA method A, B, C, D with their mean value in medical decision level at -0.176 -0.178 mg/L.Systems A, B, C, D correlated well with the result of PENIA method system E , and the mean deviation ( percent deviation ) was at 0.278 -0.326 mg/L ( 12.6%-18.5%) , and the deviation ( percent deviation ) in the medical decision level 0.055 -1.079 mg/L (5.51%-26.98%).Bias of PETIA method A, B, C, D Cys C system measuringERM -DA471/IFCC ranged from 0.22 to 0.39 mg/L ( 3.9%-7.0%) , which exceeded the allowable range of the reference material target value, and were larger than the allowable bias from biological variation (3.4%).Bias ( percent ) of PENIA method system E was -0.1 mg/L ( -1.7%) , within the allowable range of ERM-DA471/IFCC target value .Conclusions The consistency of four assesed PETIA Cys C reagents was relatively ideal, and improved markably after being traced to ERM-DA471/IFCC.Besides, the results of PETIA were higher than those of PENIA .Bias among these five systems was small when Cys C concentration was less than 4 mg/L, and the bias became larger in higher Cys C concentration.