雅培ARCHITECT i2000化学发光仪测定6种肿瘤标记物项目的方法学性能评价

目的通过对雅培ARCHITECT i2000型化学发光仪测定6种肿瘤标志物的方法学性能评价,探讨临床免疫学定量检测的方法学性能验证评价方案和实验方法。方法按照CLSI推荐的方法测定6项肿瘤标志物(AFP,CEA,t-PSA,CA125,CA153,CA19-9XR)的精密度、准确度、线性范围、分析灵敏度(最低检测限)、生物参考区间、携带污染率等指标进行验证。结果 6项肿瘤标志物的方法学评价结果均在厂家提供的范围之内,肿瘤标志物检测项目的生物参考区间范围不受地区和人群等因素的影响。结论雅培ARCHITECT i2000化学发光分析仪检测系统性能能满足临床要求,评价方案科学可靠,厂家提供的数据必须经验证后才能引用。     

雅培i2000SR全自动化学发光分析仪检测甲状腺功能五项的性能验证

目的评价和验证雅培i2000SR全自动化学发光分析仪检测甲状腺功能五项[促甲状腺激素(TSH)、游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、总三碘甲状腺原氨酸(TT3)、总甲状腺素(TT4)]的方法学性能,并探讨甲状腺功能五项检测对甲状腺疾病的临床应用价值。方法选取该院2018年接受治疗的180例甲状腺功能异常患者,包括90例甲状腺功能亢进患者(甲亢组)和90例甲状腺功能减退患者(甲减组),同时选取健康体检者90例(健康对照组),比较不同组之间各指标检测结果的差异。根据ISO15189《医学实验室质量和能力认可准则》的要求,参照美国临床实验室标准协会(CLSI)EP系列文件和相关标准对甲状腺功能五项的精密度、正确度、分析测量范围、参考区间、不确定度进行评价分析,将结果与公认的质量目标或厂家声明的性能指标进行比较。结果甲状腺功能五项的批内精密度和批间精密度分别为1.08%～4.55%和1.08%～5.11%;正确度符合实验室要求;TSH、FT3、FT4、TT3、TT4验证的线性范围均在厂家线性范围内,二者具有良好的线性关系(R2≥0.993 2);参考区间符合率达到100%;不确定度的评定结果符合要求。与甲减组比较,甲亢组TSH水平明显降低(P0.05),FT3、FT4、TT3、TT4水平明显升高(P0.05);与健康对照组比较,甲减组TSH水平明显升高(P0.05),甲亢组FT3、FT4、TT3、TT4水平明显升高(P0.05)。结论雅培i2000SR全自动化学发光分析仪检测甲状腺功能五项的性能验证结果符合临床要求,精密度高,准确度高,线性范围宽,测定结果准确可靠,可用于大批量临床标本的检测,且TSH、FT3、FT4、TT3、TT4对甲状腺疾病的诊断具有重要的价值。     

化学发光微粒免疫分析技术检测输血四项的性能评估

目的 验证和评价雅培ARCHITECT-i2000SR化学发光分析仪检测乙肝表面抗原(HBsAg)、抗人类免疫缺陷病毒(HIV)、抗梅毒螺旋体(TP)、抗丙型肝炎病毒(HCV)抗体的性能。方法 对ARCHITECT-i2000SR的精密度、污染携带、参考区间、分析测量范围进行验证; 化学发光微粒免疫分析(CMIA)和ELISA法检测相同标本,进行方法学比对。结果 HBsAg,HIV,TP,HCV抗体的精密度、携带污染和HBsAg参考区间均符合ARCHITECT-i2000SR的性能标准; HBsAg线性回归:Y=1.102X-6.678 6(r=0.995 5,P<0.05),HBsAg线性范围为:1.08～208.6IU/ml; 两种方法检测输血前四项结果的一致性为优。结论 ARCHITECT-i2000SR检测输血前四项的主要性能验证结果与厂家声明的范围基本一致,可用于临床样本的检测。     

雅培ARCHITECT i2000化学发光仪测定肿瘤标记物的线性评价

目的通过对雅培ARCHITECT i2000型化学发光仪测定3种肿瘤标志物的线性评价,探讨临床免疫学定量检测的方法学性能验证评价方案和实验方法,验证仪器一段时间内的性能。方法按照CLSI推荐的方法对3项肿瘤标志物(CA125、CA153、CA199)的线性指标进行验证。结果 3项肿瘤标志物的线性结果均在厂家提供的范围之内。结论雅培ARCHITECT i2000化学发光分析仪检测系统性能能满足临床要求,评价方案科学可靠,厂家提供的数据必须经验证后才能引用,仪器必须至少每年进行一次性能验证,以确保检验结果的准确性。     

ARCHITECT i2000全自动免疫分析仪检测HBsAg的性能评估

目的对ARCHITECT i2000全自动免疫分析仪进行使用前的性能评估。方法以ARCHITECT i2000全自动免疫分析仪的定量检测项目HBsAg进行精密度、符合率、检出限、携带污染率检测。结果 HBsAg批内精密度、批间精密度均小于5.1%,精密度、符合率、检出限及携带污染率均符合ARCHITECT i2000全自动免疫分析仪的性能要求。结论 ARCHITECT i2000全自动免疫分析仪HBsAg的精密度、符合率、检出限及携带污染率均达到性能要求,同时能满足临床实验室检测要求。     

化学发光微粒免疫分析技术检测血清人绒毛膜促性腺激素β亚基的性能评估

目的探讨AIA-2000 ST全自动化学发光免疫分析仪检测血清人绒毛膜促性腺激素β亚基(β-HCG)的基本分析性能是否符合质量要求,确定其临床检测的可行性。方法根据国际标准化组织(ISO)15189的相关要求,对AIA-2000 ST检测血清β-HCG的重复精密度、期间精密度、正确度、线性范围(可报告范围)和参考区间进行验证和评价,并结合生产厂家给出的性能参数进行比较。结果 AIA-2000 ST全自动化学发光免疫分析仪在高、低浓度水平检测血清β-HCG的批内精密度均1/4实验室允许总误差(TEa,1.21%、3.78%比7.50%),期间精密度均1/3TEa(2.90%、3.78%比10.00%);正确度验证结果显示,定标液Cal 1、Cal 2的绝对偏倚(0%、2.15%)和相对偏倚(0%、1.02%)均≤1/2TEa(15%);线性范围和参考区间与厂家提供的数据基本一致,符合临床要求。结论 AIA-2000 ST全自动化学发光免疫分析仪检测血清β-HCG的主要性能验证结果与厂家声明的范围基本一致,该系统对检测血清β-HCG具有高灵敏度和高特异度,且精密度符合临床要求,可用于临床样本的检测。     

一氧化氮检测试剂盒的性能验证和临床应用评价

目的对一氧化氮检测试剂盒进行性能验证和临床应用评价。方法根据美国临床和实验室标准协会(CLSI)的标准要求,使用7600-020日立全自动生化分析仪,对一氧化氮检测试剂盒的精密度、正确度、检出限、线性范围、参考区间进行验证,并将检测结果和厂家提供的性能指标进行比较。结果该试剂盒检测一氧化氮的批内精密度为3.69%、批间精密度为4.84%,均小于厂家提供的指标;正确度在允许偏倚范围内;检出限为2.52μmol/L;线性斜率为0.982 5,r^2为0.999,大于0.995符合要求;生物参考区间符合率95%。结论该一氧化氮检测试剂盒在7600-020全自动生化分析仪上主要分析性能符合厂家的声明,结果准确、可靠,可以用于临床检验分析。     

血清Lp-PLA2质量与活性检测结果的一致性评价

目的评价两种测定脂蛋白相关磷脂酶A2(Lp-PLA2)质量与活性的试剂在雅培C16000自动生化分析仪上检测结果的一致性。方法根据美国临床和实验室标准化协会(CLSI)文件相关要求,评价两种试剂的精密度、正确度、线性范围及参考区间,同时对A、B两种试剂检测患者标本的一致性进行评价。结果 A试剂和B试剂各水平重复性分别为1.96%和2.43%、0.58%和0.78%,实验室内精密度分别为3.10%和3.23%、0.76%和1.96%,均小于厂商声称的重复性,即A试剂重复性≤5%,B试剂重复性≤10%;正确度验证A试剂和B试剂偏倚分别为0.33%和2.17%、2.94%和3.92%,均小于所选用的1/2允许总误差(12%)的标准;线性范围A试剂为29.0～792.5ng/mL,B试剂为74～1 486U/L,回归系数R2分别为0.997 0和0.999 6,相关系数(r)分别为0.998 5和0.999 8,A、B试剂线性均符合CLSI EP6-A文件及试剂厂家的要求;A、B两种试剂方法学比较中,回归系数R2=0.599 1,r=0.774 0,两种试剂检测方法间有一定相关性,但一致性较差;参考区间A试剂的验证范围:10～200ng/mL,B试剂的验证范围:男性230～728U/L,女性194～640U/L(18～49岁),208～698U/L(50～88岁),均通过验证,两种试剂厂家提供的参考区间可运用于临床。结论两种应用于全自动生化分析仪C16000测定Lp-PLA2的试剂精密度、正确度及线性均良好,提供的参考区间可用,但两种试剂方法学间比较一致性较差。     

ARCHTECT i2000SR全自动免疫分析仪日常保养及故障处理

ARCHITECT i2000SR全自动免疫分析仪是美国雅培公司研制开发,1999年上市的第3代大型全自动免疫分析仪,利用化学发光免疫分析技术进行检测,具有灵敏度高、特异性好、随机、快速的特点,每小时达200个测试,本院于2004年末装机运行至今。现就本院使用的ARCHITECT i2000SR全自动免疫分析仪的情况作如下分析。     

强生Vitros 5.1 FS生化分析仪上乳酸脱氢酶的性能验证

目的探讨强生Vitros 5.1 FS生化分析仪上乳酸脱氢酶(LDH)的性能验证。方法根据美国临床和实验室标准化协会的检测仪器评价标准,并参照美国强生公司提供的验证方案对LDH的精密度、正确度、线性范围、最大稀释度、生物参考区间进行验证。结果 LDH批内及批间精密度试验均≤3.30%;正确度试验≤4.00%;线性试验决定系数为0.997 2;LDH用生理盐水稀释最大稀释度为8倍;生物参考区间试验证实《VITROS方法学手册》提供的参考区间313~618U/L可以引用。结论强生Vitros 5.1 FS生化分析仪检测的LDH性能验证基本符合质量目标要求和厂商说明要求,满足临床检验的需求。     

ARCHITECT C16000全自动生化分析仪检测血清胱抑素C的性能评价

目的对ARCHITECT C16000全自动生化分析仪检测血清胱抑素C(Cys C)的分析性能进行评价。方法根据相关标准,验证ARCHITECT C16000全自动生化分析仪检测血清Cys C的精密度、正确度、分析测量范围、临床可报告范围、抗干扰性能、生物参考区间。结果低水平质控品、高水平质控品及混合血清标本的批内变异系数(CV)均小于1/4室间质评允许总误差(6.25%),批间CV均小于1/3室间质评允许总误差(8.33%),也均小于厂商标准(10.00%)。5个水平校准品检测值与靶值相对偏移的绝对值均小于1/2室间质评允许总误差(12.50%)。参比系统和待评系统检测结果一致性好。实测值与预期值的线性回归方程为Y=1.000 X+0.094,r=0.9991,r≥0.975,斜率在0.97~1.03,Cys C的分析测量范围为0.14~9.91 mg/L。Cys C可接受的最大稀释倍数为20倍,临床可报告范围上限为198.20 mg/L。含不同水平游离胆红素、结合胆红素、血红蛋白及乳糜标本的检测值与对照标本检测值相对偏差的绝对值均小于厂商标准(10.00%)。生物参考区间验证中,超出参考区间的Cys C检测结果不超过10.00%,通过验证。结论ARCHITECT C16000全自动生化分析仪检测Cys C的性能符合临床要求,可应用于临床。     

Performance characteristics of the IMMULITE 2000 insulin-like growth factor binding protein-3 assay

BACKGROUND: Insulin-like growth factor binding protein-3 (IGFBP-3) is the chief binding protein for insulin-like growth factors 1 and 2 (IGF-1 and IGF-2). Serum concentrations of IGFBP-3 are regulated by growth hormone (GH) and IGF-1 levels. Serum IGFBP-3 measurements are useful for diagnostic evaluations of short stature in children and acromegaly. METHODS: A IGFBP-3 assay for the IMMULITE 2000 analyzer was evaluated for limit of detection, linearity, intra- and interassay imprecision, comparison to another commercially available assay, interference studies, and an adult reference interval. RESULTS: The limit of detection was 0.006 mg/l. The assay was linear from 0.01 to 15.1 mg/l. The total interassay imprecision was <6% for IGFBP-3 concentrations of 1.1 and 4.4 mg/l. Comparison with a Nichols RIA method showed comparable results. Deming regression analysis gave a slope of 1.02+/-0.02, an intercept of 0.24+/-0.07, and a Sy/x of 0.33 (r=0.98) over the range tested (0.4 to 10.3 mg/l). Interference was <10% for all levels of bilirubin, triglyceride, and hemoglobin tested. The nonparametric reference interval for adults 26 to 61 years was 2.9 to 6.5 ng/ml. CONCLUSIONS: The IMMULITE 2000 IGFBP-3 assay shows acceptable performance and is suitable for routine clinical use.     

Performance characteristics of the IMMUNLITE 2000 erythropoietin assay

Background: Erythropoietin (EPO) is a glycoprotein hormone produced by specialized cells in the kidney that acts as the primary regulator of erythropoiesis. Serum EPO measurements are useful for diagnostic evaluations of anemia and polycythemia. Methods: The IMMULITE 2000 is an automated random access immunoassay analyzer for the central laboratory. The limit of detection (LOD), linearity, imprecision, comparison to another commercially available assay, and reference interval of a new EPO assay for this analyzer were assessed. Results: The LOD was 0.2 U/l. The assay was linear within an allowable systematic error of 10% over the range tested (2–178 U/l). The total imprecision of the new assay was <7% for concentrations from 15.8 to 68.4 U/l. Comparison with the Advantage EPO assay method showed comparable results. Deming regression analysis gave a slope of 1.13±0.02, an intercept of −1.09±0.97, and a S_y/x of 7.1 (r=0.99) over the range tested (2–200 U/l). Conclusions: The IMMULITE 2000 EPO assay shows acceptable performance and is suitable for routine clinical use.     

迈克IS1200全自动化学发光测定仪的性能评价

目的对迈克IS1200全自动化学发光测定仪的性能进行评价。方法按照美国临床和实验室标准协会文件的要求,通过一系列实验设计,在IS1200上对乙肝5项、艾滋、丙肝和梅毒共8项进行检测,评价其精密度、试剂开瓶稳定性、线性和参考区间,与雅培i2000全自动化学发光分析仪的检测结果进行方法学比对。结果除乙型肝炎E抗原低值的总精密度略高于判断标准15%外,其余指标均符合要求;各项目的试剂开瓶稳定性良好;定量项目乙型肝炎表面抗体检测范围内的线性良好(r20.95);参考区间验证中,各项目均未发现离群值;方法学比对中,除丙型肝炎病毒抗体外,其他项目与雅培i2000全自动化学发光分析仪的相关性良好。结论迈克IS1200全自动化学发光测定仪的检测性能良好,满足实验室免疫检测工作的需求。     

Evaluation of NGAL Test?, a fully-automated neutrophil gelatinase-associated lipocalin (NGAL) immunoassay on Beckman Coulter AU 5822

Abstract Background: The neutrophil gelatinase associated lipocalin (NGAL) has been identified as the most promising biomarker of acute kidney injury (AKI). This study was aimed to evaluate a NGAL immunoassay on Beckman Coulter AU 5822. Methods: NGAL Test? (BioPorto Diagnostics A/S) is a particle-enhanced turbidimetric immunoassay. The within-and between-run imprecision were assessed on three urine samples. The linearity was assessed by serially diluting two urine samples with low and high NGAL concentration. The comparison study was performed with Abbott ARCHITECT NGAL, on 70 urine samples. Results: The within-run imprecision was comprised between 1.0% and 2.3%, whereas the between-run imprecision was between 1.2% and 2.0%. The linearity was excellent in the range between 18 ng/mL and 790 ng/mL (r=1.000; p<0.001). A highly significant agreement was observed between NGAL Test? on Beckman Coulter AU5822 and Abbott ARCHITECT NGAL (r=0.925; p<0.001), although the method exhibited a bias of +65%. Excellent sensitivity and specificity against the ARCHITECT values were found at 200 ng/mL. Conclusions: This analytical evaluation attests that the NGAL Test? has several technical and analytical advantages, including no manual pretreatment, low volume of sample (i.e., 3 μL), fast turnaround time (approx. 10 min), low imprecision, wide dynamic range, optimal linearity.     

免疫比浊法检测血清游离轻链的方法学评价

目的对Beckman Immage 800全自动特种蛋白分析仪检测血清游离κ、λ轻链(sFLC)进行方法学评价。方法通过Beckman Immage 800定量测定sFLC,探讨其精密度、正确度、分析测量范围、干扰和携带污染率,同时对其参考区间进行验证。结果κFLC低、高值批内精密度的变异系数(CV)分别为7.84%、2.95%,批间精密度的CV分别为7.38%、5.57%;λFLC低、高值批内精密度(CV)分别为4.59%、3.94%,批间精密度CV分别为3.97%、2.01%;测定κFLC、λFLC定值质控血清与靶值的偏倚小于5%;κFLC、λFLC分析测量范围分别为10.8~128.0 mg/L、10.1~121.0 mg/L时,a值在0.95~1.05,r2≥0.98;κFLC、λFLC携带污染率分别为0.411%、0.216%;干扰试验结果显示游离胆红素≤342.0μmol/L、结合胆红素≤342.0μmol/L、血红蛋白≤5g/L和乳糜≤2 400浊度时,对sFLC结果无明显影响;40例健康体检者中有1例κFLC测定结果超出厂家推荐的参考区间,40例λFLC检测值均在厂家推荐的参考区间内。结论 Beckman Immage 800全自动特种蛋白分析仪检测sFLC的主要分析性能符合质量目标的要求,能够为临床提供科学、准确的诊疗依据。     

Evaluation of the ARCHITECT STAT troponin-I assay

We evaluated the immunoassay for troponin I (TnI) which is now available on the integrated ARCHITECT analyzer ci8200 from Abbott. Coefficients of variation (CV) for between-day imprecision were 5.6%, 4.7% and 5.1% at TnI levels of 0.13 microg/l (mean of low control), 0.49 microg/l (medium control) and 11.2 microg/l (high control), respectively. All measurements of controls lay within pre-specified concentration ranges. The functional sensitivity at an imprecision level of 10% was found to be 0.04 microg/l, while the 99th percentile of the reference range derived from 130 apparently healthy subjects was determined as 0.02 microg/l with a corresponding CV of 15%. Thus, as none of the currently reported TnI tests the ARCHITECT STAT assay does not meet exactly the ESC/ACC consensus criteria for troponin testing but seems to perform better than many of the tests currently used in practice.     

透射比浊法铁蛋白试剂盒的性能评价

[目的]了解免疫透射比浊法铁蛋白试剂盒的性能指标。[方法]测定该试剂盒的不精密度、线性范围、灵敏度、准确度。[结果]免疫透射比浊法铁蛋白试剂盒的批内精密度1．0％～9．0％，批问精密度7．2％～11．8％，线性范围14～300斗∥L、灵敏度（检测低限）为14¨g／I．、准确度为105．9％。[结论]免疫透射比浊法检测铁蛋白在不精密度、线性范围、灵敏度、准确度方面均能满足临床需要，并且还具有快速、简便及成本低廉的特点，适合临床使用。     

Performance characteristics of the ARCHITECT Galectin-3 assay

ObjectivesGalectin-3 is an emerging biomarker that is commonly increased in patients with heart failure and/or patients at risk for cardiovascular disease. We evaluated the Galectin-3 assay on the Abbott ARCHITECT i1000_SR and ARCHITECT i2000_SR at 2 testing sites.Design and methodsImprecision (%CV), interference, limits of blank (LoB), detection (LoD), and quantitation (LoQ), linearity, method comparison to an ELISA method, comparisons between plasma and serum, and reference intervals were evaluated. Imprecision was performed based on two runs of duplicate testing conducted daily. Verification of LoB, LoD, and LoQ was performed according to Clinical and Laboratory Standards Institute guidelines. Linearity was evaluated by making 5 dilutions of a high patient EDTA plasma pool with a low patient pool. Reference intervals were established using EDTA plasma collected from self-reported healthy volunteers. A second lot of reagent was used at one site for method comparison and imprecision studies.ResultsTotal CV's were ≤ 6.0%. A positive interference was observed for hemolyzed samples over 2.0 g/L hemolysate. The LoB ranged from 0.1 to 0.3 ng/mL, the LoD from 1.4 to 2.1 ng/mL and the LoQ from 3.0 to 3.3 ng/mL. Linearity studies had slopes and correlation coefficients equal to 1.0. Comparison of the i1000_SR and i2000_SR to the ELISA method demonstrated slopes of 1.0 to 1.2 and correlation coefficients of 0.93 to 0.97. The 97.5th percentile of the reference interval was 18.7 and 17.9 ng/mL for the i1000_SR and i2000_SR, respectively.ConclusionsThe Abbott Galectin-3 assay demonstrated acceptable analytical performance on both the ARCHITECT i1000_SR and ARCHITECT i2000_SR.