四种国产和两种进口酶法肌酐试剂的分析性能及准确度验证
사충국산화량충진구매법기항시제적분석성능급준학도험증
Analytical performance and accuracy verification of four domestic and two imported enzymatic creatinine assay kits
  • 万方数据
    中华检验医学杂志 중화검험의학잡지
    CHINESE JOURNAL OF LABORATORY MEDICINE
    2013年 9期 806-811 ,共6页

    国秀芝%邱玲%吴洁%赵芳%程歆琦%佟大伟%嵇巍%刘茜%韩建华

    국수지%구령%오길%조방%정흠기%동대위%혜외%류천%한건화

    肌酸酐%指示剂和试剂%试剂盒,诊断 肌痠酐%指示劑和試劑%試劑盒,診斷
    기산항%지시제화시제%시제합,진단
    Creatinine%Indicators and reagents%Reagent kits,diagnostic
    目的 比较4种市售国产酶法肌酐(Cr)(迈克、九强、中生、柏定,标为A、B、C、D)和2种进口酶法Cr试剂(积水、和光,标为E、F)的分析性能及准确度差异.方法 实验性能验证.从2010年5月就诊于我院肾内科的患者和体检中心查体人群中选择慢性肾脏病患者和表面健康人的血清标本共70例进行性能验证实验.其中CKD患者30例(男15例,女15例),年龄18 ～ 80岁.表面健康人40名(男20名,女20名),年龄20 ～ 60岁.参考CLSI EP15-A方案用6种试剂分别测定2个水平质控血清,每天测4次,连续测5d,计算批内及总不精密度(CV)；参考EP6-A方案,测定不同比例的高、低浓度混合血清和混合尿液标本评价线性范围；部分参考EP7-P方案,用测定含特定浓度干扰物(胆红素、血红蛋白、乳糜)的血清以评价抗干扰能力；验证血清样本的稀释准确性；测定50份新鲜患者血清比较各试剂测定结果的相关性和偏差.计算各试剂测定NIST SRM 967a、NIST SRM 909b标准物质的偏倚以验证各试剂的准确度.结果 6种Cr试剂的批内CV在0.5％ ～1.2％之间,总CV在0.5％～1.9％之间,4种国产试剂与2种进口试剂的不精密度无明显差异,均小于来源于生物变异的允许不精密度(3.0％).4种国产与2种进口酶法Cr验证的线性范围均较宽.当血清中结合胆红素≤332 μmol/L、游离胆红素≤327 μmol/L、乳糜浊度≤1530 FTU时对6种Cr的测定均未产生明显干扰(百分偏差≤±10％)；血红蛋白(Hb)≤4.83 g/L时对试剂C、D、F检测Cr不受干扰；试剂A、B、E分别在Hb 3.381、3.864、4.347 g/L以下不受干扰.血清样本2～16倍稀释后与原倍测定结果的百分偏差在95.96％ ～ 108.62％之间.各试剂测定新鲜血血清样本结果与6种试剂测定均值之间的平均百分偏差在-4.91％ ～4.75％,相关均良好(r均为1.000).各试剂检测NIST 967a水平1(66.5 μmol/L)和水平2(346.2 μmol/L)的百分偏倚分别为-1.85％ ～2.81％和-2.28％～2.05％,均未超出Cr来源于生物变异的允许偏倚(4.0％).检测NIST 909b水平1(56.18 μmol/L)和水平2(467.4 μmol/L)的百分偏倚分别为-13.4％ ～ 1.01％和-6.49％～-1.79％,均超出靶值允许范围.结论 4种国产酶法Cr试剂和2种进口试剂精密度良好,线性范围宽,稀释准确性满足临床需要,抗干扰能力较强,准确度均较高,国产和进口试剂的以上性能未发现明显差异.
    목적 비교4충시수국산매법기항(Cr)(매극、구강、중생、백정,표위A、B、C、D)화2충진구매법Cr시제(적수、화광,표위E、F)적분석성능급준학도차이.방법 실험성능험증.종2010년5월취진우아원신내과적환자화체검중심사체인군중선택만성신장병환자화표면건강인적혈청표본공70례진행성능험증실험.기중CKD환자30례(남15례,녀15례),년령18 ～ 80세.표면건강인40명(남20명,녀20명),년령20 ～ 60세.삼고CLSI EP15-A방안용6충시제분별측정2개수평질공혈청,매천측4차,련속측5d,계산비내급총불정밀도(CV)；삼고EP6-A방안,측정불동비례적고、저농도혼합혈청화혼합뇨액표본평개선성범위；부분삼고EP7-P방안,용측정함특정농도간우물(담홍소、혈홍단백、유미)적혈청이평개항간우능력；험증혈청양본적희석준학성；측정50빈신선환자혈청비교각시제측정결과적상관성화편차.계산각시제측정NIST SRM 967a、NIST SRM 909b표준물질적편의이험증각시제적준학도.결과 6충Cr시제적비내CV재0.5％ ～1.2％지간,총CV재0.5％～1.9％지간,4충국산시제여2충진구시제적불정밀도무명현차이,균소우래원우생물변이적윤허불정밀도(3.0％).4충국산여2충진구매법Cr험증적선성범위균교관.당혈청중결합담홍소≤332 μmol/L、유리담홍소≤327 μmol/L、유미탁도≤1530 FTU시대6충Cr적측정균미산생명현간우(백분편차≤±10％)；혈홍단백(Hb)≤4.83 g/L시대시제C、D、F검측Cr불수간우；시제A、B、E분별재Hb 3.381、3.864、4.347 g/L이하불수간우.혈청양본2～16배희석후여원배측정결과적백분편차재95.96％ ～ 108.62％지간.각시제측정신선혈혈청양본결과여6충시제측정균치지간적평균백분편차재-4.91％ ～4.75％,상관균량호(r균위1.000).각시제검측NIST 967a수평1(66.5 μmol/L)화수평2(346.2 μmol/L)적백분편의분별위-1.85％ ～2.81％화-2.28％～2.05％,균미초출Cr래원우생물변이적윤허편의(4.0％).검측NIST 909b수평1(56.18 μmol/L)화수평2(467.4 μmol/L)적백분편의분별위-13.4％ ～ 1.01％화-6.49％～-1.79％,균초출파치윤허범위.결론 4충국산매법Cr시제화2충진구시제정밀도량호,선성범위관,희석준학성만족림상수요,항간우능력교강,준학도균교고,국산화진구시제적이상성능미발현명현차이.
    Objective To assessed the analytical performance of six commercial enzymatic creatinine (Cr) reagents and compared the accuracy among them.Four reagents came from domestic manufactures (Maker Biotechnology,Beijing Strong Biotechnologies,Biosino Bio-technology & Science,BaiDing Biological Engineering,labeled as A,B,C,D respectively) and the other two reagents came from oversea manufactures (Sekisui Medical Technology,Japan and Wako Pure Chemical Industries,Japan,labeled as E,F respectively).Methods Performance verification test.70 serum samples were obtained from chronic kidney disease outpatients and medical center healthy volunteers in Peking Union Medical College Hospital from May 2010.Among 30 patients ureh CKD (15 moles,15 females)aged 18 to 80 years old;40 healthy volunteers (20 males,20 females) aged 20 to 60 years old.To evaluate the within-run imprecision and total imprecision according to the CLSI EP15-A protocol,two level control materials were measured with six reagents in five days,with a frequency of four times a day.To verify the linear ranges according to the EP6-A protocol,a series of samples that mixed by high and low level serum or urine pools with specific ratio were tested.To evaluate the anti-interference ability,we tested the sera added specific concentration of substances (bilirubin,hemoglobin,chyle).To verify the reasonable dilution ratio,diluted sera in different ratio were tested.Correlations and deviation among the detection results of six reagents were evaluated by testing 50 fresh patient samples.Accuracy was evaluated by measuring the NIST SRM 967a and NIST SRM 909b standard substances.Results There were no significant differences between the domestic and imported Cr reagents,with the within-run CV ranging from 0.5％ to 1.2％ and the total CV ranging from 0.5％ to 1.9％,all of which were lower than the allowed biological variation for imprecision (3.0％).Linear ranges of the six Cr reagents were all relatively wide.No significant interference (bias％ ≤ ± 10％)was found in the test of six reagents when conjugated bilirubin ≤ 332 μmol/L,unconjugated bilirubin ≤ 327μmol/L,or chyle turbidity ≤ 1530 FTU; no significant interference was found for the test of C,D,F reagents when Hb≤4.83 g/L; and for A,B,E when Hb ≤3.381,3.864,4.347g/L,respectively.Percent deviation of the measured results of dulited serum samples diluted by 2 to 16 times compared to the results of the original samples ranged from 95.96％ to 108.62％.Fresh patient samples comparison tests exhibited good correlation among the six reagents (r =1.000),although there were some differences (-4.91％ to-4.75％).For NIST 967a,the percent bias ranged from-1.85％ to 2.81％ (level 1,66.5 μmol/L),and from-2.28％ to 2.05％ (level 2,346.2 μmol/L),none of the six reagents exceeded the allowed Cr bias derived from biological variation (4.0％).For NIST 909b,the percent bias ranged from-13.4％ to 1.01％ for level 1 (56.18 μmol/L),while its value ranged from-6.49％ to -1.79％ for level 2 (467.4 μmol/L),and these biases all exceeded the allowable range of target value.Conclusions Assessment of four domestic enzymatic Cr reagents and two imported reagents show high precision,wide linear range,and their dilution accuracy can meet the clinical needs.Moreover,the six regents show good anti-interference capability (bilirubin,hemoglobin,chyle) and high accuracy.No significant differences have been found in the above assessed properties among these reagents.
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