中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2014年
11期
832-835
,共4页
房亚哲%马怀安%郭楠%李宝萍%林英%杨曦明
房亞哲%馬懷安%郭楠%李寶萍%林英%楊晞明
방아철%마부안%곽남%리보평%림영%양희명
C反应蛋白%参考标准%参考值%可重复性结果
C反應蛋白%參攷標準%參攷值%可重複性結果
C반응단백%삼고표준%삼고치%가중복성결과
C-reactive protein%Reference standards%Reference values%Reproducibility of results
目的：制备3个水平C反应蛋白（ CRP ）的定值校准品。方法按国家标准物质技术规范的要求，选择感染疾病检测阴性、无肉眼溶血、脂血、黄疸的体检者或患者血清，按CRP浓度水平分成低、中、高3组，分别混匀、过滤除菌、分装。采用单因素方差分析检验其均匀性、直线回归分析检验其稳定性，通过国际标准物质，采用颗粒增强免疫散射比浊法为CRP定值，评估不确定度。结果（1）均匀性检验中CL、CM、CH三组血清的Ubb分别为0、0.125、0，Ur分别为0.046、0.213、0.785，Ubb均﹤Ur；F值分别为0.803、1.686、0.966，P值均﹥0.05，差异无统计学意义，说明均匀性良好。（2）稳定性研究中室温条件下F 值分别为0.609、0.259、1.557；冷藏条件下 F 值分别为1.217、4.583、0.893，P值均﹥0.05，说明血清CRP在室温、冷藏条件下至少稳定3、30 d。（3）3个水平的CRP定值结果分别为（2.64±0.14）、（31.17±0.63）、（73.85±1.74） mg／L。结论3个水平冰冻混合人血清CRP定值校准品均匀、稳定、定值可靠，可用于临床检测系统的校准评价。
目的：製備3箇水平C反應蛋白（ CRP ）的定值校準品。方法按國傢標準物質技術規範的要求，選擇感染疾病檢測陰性、無肉眼溶血、脂血、黃疸的體檢者或患者血清，按CRP濃度水平分成低、中、高3組，分彆混勻、過濾除菌、分裝。採用單因素方差分析檢驗其均勻性、直線迴歸分析檢驗其穩定性，通過國際標準物質，採用顆粒增彊免疫散射比濁法為CRP定值，評估不確定度。結果（1）均勻性檢驗中CL、CM、CH三組血清的Ubb分彆為0、0.125、0，Ur分彆為0.046、0.213、0.785，Ubb均﹤Ur；F值分彆為0.803、1.686、0.966，P值均﹥0.05，差異無統計學意義，說明均勻性良好。（2）穩定性研究中室溫條件下F 值分彆為0.609、0.259、1.557；冷藏條件下 F 值分彆為1.217、4.583、0.893，P值均﹥0.05，說明血清CRP在室溫、冷藏條件下至少穩定3、30 d。（3）3箇水平的CRP定值結果分彆為（2.64±0.14）、（31.17±0.63）、（73.85±1.74） mg／L。結論3箇水平冰凍混閤人血清CRP定值校準品均勻、穩定、定值可靠，可用于臨床檢測繫統的校準評價。
목적：제비3개수평C반응단백（ CRP ）적정치교준품。방법안국가표준물질기술규범적요구，선택감염질병검측음성、무육안용혈、지혈、황달적체검자혹환자혈청，안CRP농도수평분성저、중、고3조，분별혼균、과려제균、분장。채용단인소방차분석검험기균균성、직선회귀분석검험기은정성，통과국제표준물질，채용과립증강면역산사비탁법위CRP정치，평고불학정도。결과（1）균균성검험중CL、CM、CH삼조혈청적Ubb분별위0、0.125、0，Ur분별위0.046、0.213、0.785，Ubb균﹤Ur；F치분별위0.803、1.686、0.966，P치균﹥0.05，차이무통계학의의，설명균균성량호。（2）은정성연구중실온조건하F 치분별위0.609、0.259、1.557；랭장조건하 F 치분별위1.217、4.583、0.893，P치균﹥0.05，설명혈청CRP재실온、랭장조건하지소은정3、30 d。（3）3개수평적CRP정치결과분별위（2.64±0.14）、（31.17±0.63）、（73.85±1.74） mg／L。결론3개수평빙동혼합인혈청CRP정치교준품균균、은정、정치가고，가용우림상검측계통적교준평개。
Objective To prepare serum calibrators for CRP measurement.Methods Fresh serum without infectious diseases , hemolysis, lipemia and choloplania were collected and divided into 3 groups, low, medium, and high, according to the CRP concentration.Each serum pool was mixed , filtered, sterilized and aliquoted.The materials were tested for homogeneity and stability.The values of the CRP was assigned by particle enhanced immunonephelpmetry , and calibrated with international reference materials.The expanded uncertainty was evaluated.Results The materials were tested to be homogeneous (Ubb﹤Ur, P>0.05) with Ubb values being 0, 0.125, 0, Ur values being 0.046, 0.213, 0.785, and F values being 0.803, 1.686, 0.966 in CL, CM, CH groups respectively.Stability study, where F values are 0.609, 0.259, and 1.557 at 22-25℃, 1.217, 4.583, and 0.893 at 2-8℃(P>0.05), showed that the materials were stable for at least 3 days at 22-25 ℃or 30 days at 2-8 ℃, respectively.The certified values of the 3 levels materials for CRP were ( 2.64 ±0.14 ) , ( 31.17 ±0.63 ) , ( 73.85 ±1.74 ) mg/L, respectively.Conclusion The calibrators prepared for serum CRP measurement were homogeneous , stable and accurately assigned and can be used to calibrate the CRP measure system.
