两台仪器检测 N T‐proB N P 结果比对分析

目的通过Cobas h232和Roche Elecsys E170测定N‐末端前脑钠肽(NT‐proBNP)的方法比对,探讨两台仪器间测定数据是否具有可比性和一致性.方法依据美国国家临床实验室标准委员会EP9‐A2文件要求,对两台仪器检测结果进行比对和偏差评估.结果 Cobas h232与Roche Elecsys E170相比较,r2≥0.95,相对偏倚小于12.5%.结论两台仪器测定具有很好的相关性,结果具有可比性.     

两台全自动电化学发光分析仪测定结果的比对评估

目的对同一实验室的Roche Elecsys2010和Roche Cobas E601两台全自动电化学发光仪进行方法学对比及偏差评估。探讨肿瘤标志物甲胎蛋白（AFP）、癌胚抗原（CEA）、糖类抗原126（CA125）、糖类抗原199（CA199）在不同仪器间测定结果是否具有可比性,以确保不同免疫分析系统检测结果的准确性及一致性。方法按照美国临床实验室标准化委员会（NCCLS）EP9-A文件的要求,以Roche Cobas E601全自动电化学发光仪为目标检测系统（X）,Roche Elecsys2010为待评系统（Y）,对患者血清样品进行检测,计算两个分析系统的相对偏差。结果两个检测系统测定结果预期偏倚在方法线性范围内均可以接受。结论两个检测系统测定结果具有可比性,可满足临床需要。     

罗氏Modular E170与Cobas e601电化学发光免疫分析系统检测血清甲胎蛋白的比对分析

目的探讨同一临床实验室内罗氏Modular E170与Cobas e601两台电化学发光仪检测结果的可比性,确保两套分析系统检测血清甲胎蛋白结果的准确性和一致性。方法根据美国临床和实验室标准协会(CLSI)指南文件EP9-A2文件要求,以罗氏Modular E170电化学发光免疫分析仪为对比仪器,罗氏Cobas e601电化学发光免疫分析仪为实验仪器,采用用患者血清样本检测甲胎蛋白(AFP)含量,通过实验数据的比对分析,对两套分析系统之间的预期偏倚进行评估。结果在AFP测定的线性范围内,两系统相关性好,在AFP医学决定水平处的预期偏倚均可接受。结论两套系统检测AFP结果具有较好的一致性。临床实验室内同一检测项目同时在两套或两套以上系统检测时应进行比对和偏倚评估,确保检测结果具有可比性。     

电化学发光测定血清β-HCG的比对

目的通过同一实验室两台化学发光仪器间测定血清β-hCG的方法比对和预期偏倚评估,探讨两台化学发光仪器之间测定数据是否具有可比性,或检测结果的偏倚是否在允许范围内,以确保测定结果具有可比性和一致性,为实验室不同仪器测定结果互认提供依据。方法 2009年11月2日6日,参考美国CLSIEP9-A2文件,以Roche cobase601为参比方法 ,Roche cobase411为待评方法 ,用40份患者新鲜血清标本,测定血清β-HCG,对两台仪器之间的预期偏倚进行评估。结果相关系数r=0.9988,截距a=3.48,斜率b=1.03,以20%为允许限,两仪器测定的结果在允许范围内。结论两仪器测定血清β-HCG的偏倚在实验室允许范围内,测定具有很好的相关性,结果具有可比性。     

不同生化分析仪测定结果的比对分析及偏倚评估

目的通过对本科室OLYMPUS AU5400与罗氏Cobas c311生化分析仪的比对分析和预期偏倚评估,探讨两台生化分析仪之间的检测结果的可比性,以保证检测结果的准确。方法按照美国临床实验室标准化协会(CLSI)EP9-A2文件的要求,以OLYMPUS AU5400生化分析仪作为比较方法,罗氏Cobas c311生化分析仪作为实验方法,用患者血清对AST、CK等7个项目进行检测,在医学决定水平处计算其系统间的偏倚,以美国CLIA’88规定的允许误差的1/2作为标准进行评估。结果所测定的7个项目的回归系数r均大于0.975,两台仪器在医学决定水平处的预期偏倚和相对偏倚均小于1/2 CLIA’88的允许误差。结论AST、CK等7个项目在两台生化分析仪上的检测结果是一致的,具有可比性。     

蛋白芯片检测肿瘤标志物及其与其他方法的比较

目的研究多肿瘤标志物蛋白芯片检测系统（C-12）检测肿瘤标志物的性能及其与国外检测系统的比较。方法分别选用湖州数康生物科技有限公司C-12、Roche Modular E170、Elecsys 2010和Abbott 120004种检测系统对甲胎蛋白（AFP）、癌胚抗原（CEA）、前列腺特异性抗原（PSA）、游离PSA（f-PSA）、糖类抗原125（CA125）、糖类抗原153（CA153）、神经元特异性烯醇化酶（NSE）、糖类抗原242（CA242）、人绒毛膜促性腺激素（β-HCG）和糖类抗原199（CA199）临床常见肿瘤标志物进行检测,所测得的数据进行统计学分析。结果C-12与Roche Modular E170、Elecsys 2010和Abbott I20004种检测系统在肿瘤标志物的检测中符合率呈显著正相关,而且敏感性、特异性、阳性预测值、阴性预测值等均有很高的一致性。结论C-12与Roche Modular E170、Elecsys 2010和Abbott I2000在检测肿瘤标志物中具有较高的一致性,对肿瘤标志物的检测具有较高的实用价值。     

荧光定量PCR仪检测HBV DNA结果比对分析

目的对Roche Light Cycler 480Ⅱ型荧光定量PCR仪(Roche 480)和ABI 7500检测乙型肝炎病毒DNA(HBV DNA)结果进行比对和偏倚评估,探讨不同检测系统间检测结果的可比性和偏倚的可接受性。方法按照美国临床实验室标准化委员会EP9-A2标准要求,以Roche 480为参比仪器,ABI 7500为实验仪器,对患者HBV DNA项目进行检测,通过比较这两种荧光定量PCR仪器间的系统误差,判断检测结果的可比性。结果Roche 480及ABI 7500检测HBV DNA具有良好的相关性(r=0.993 1),偏差在可接受范围内,系统误差临床可接受。结论 Roche 480及ABI 7500检测结果具有较好的一致性,可同时用于肝炎病毒DNA的检测。     

蛋白芯片检测肿瘤标志物及其与其他方法的比较

目的研究多肿瘤标志物蛋白芯片检测系统(C-12)检测肿瘤标志物的性能及其与国外检测系统的比较。方法分别选用湖州数康生物科技有限公司C-12、Roche Modular E170、Elecsys 2010和Abbott I2000 4种检测系统对甲胎蛋白(AFP)、癌胚抗原(CEA)、前列腺特异性抗原(PSA)、游离PSA(f-PSA)、糖类抗原125(CA125)、糖类抗原153(CA153)、神经元特异性烯醇化酶(NSE)、糖类抗原242(CA242)、人绒毛膜促性腺激素(β-HCG)和糖类抗原199(CA199)临床常见肿瘤标志物进行检测,所测得的数据进行统计学分析。结果C-12与Roche Modular E170、Elecsys 2010和Abbott I2000 4种检测系统在肿瘤标志物的检测中符合率呈显著正相关,而且敏感性、特异性、阳性预测值、阴性预测值等均有很高的一致性。结论C-12与Roche Modular E170、Elecsys 2010和Abbott I2000在检测肿瘤标志物中具有较高的一致性,对肿瘤标志物的检测具有较高的实用价值。     

两种不同型号全自动生化分析仪测定结果的比对及校正

目的通过对OlympusAU5400全自动生化分析仪和Vitros350干片式生化分析仪进行方法比对,探讨不同型号仪器间检测结果是否具有可比性。方法以OlympusAU5400作为参考仪器,Vitros350作为比对仪器,随机收集100例新鲜血清标本。分别在两台仪器上测定尿素（Urea）、乳酸脱氢酶（LDH）、肌酸激酶（cK）三个项目,参照NCCLS的EP9一A文件分析两台仪器检测结果的可比性并对偏差进行校正。结果两种仪器检测Urea的结果一致,LDH和CK结果需进行比对校正。结论当同一项目在不同仪器上检测时,结果应进行比对扣校准,以保证检测测结果的一致性。     

新鲜全血在不同血液分析仪比对试验中的应用

目的通过比对试验,保证科室两台血液分析仪检测结果的准确性和可比性。方法用新鲜抗凝全血通过重复性试验和比对试验,测定两台仪器的精密度,评价两台仪器检测结果的准确性和一致性。结果两台仪器测定白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、红细胞平均体积(MCV)和血小板(PLT)的精密度均在美国临床实验室改进修正案(CLIA’88)规定的允许误差的1/4范围内;试验仪器的各项参数与参比仪器具有良好的相关性,相关系数(r)均>0.98,平均相对偏差均在CLIA’88规定的允许误差的1/2范围内。结论在保证仪器稳定性和重复性前提下,定期进行比对试验可实现不同仪器检测结果的准确性和一致性。     

Multicenter analytical performance evaluation of the Elecsys proBNP assay.

The purpose of this multicenter study was to evaluate the technical performance of the automated Elecsys proBNP (brain natriuretic peptide) assay, which is indicated as an aid in the diagnosis of individuals suspected of having congestive heart failure. The Elecsys proBNP assay is an electrochemiluminescent immunoassay employing two polyclonal NT-proBNP-specific antibodies in a sandwich test format. The study was performed on the three Elecsys analyzers (E 1010, E 2010, and E 170) at eight different sites world-wide. Within- and total precision were < or = 3%, with total precision slightly higher on the Elecsys E 170 instrument with multiple modules. Reproducibility among sites and platforms was < 5%. Precision at particularly low NT-proBNP concentrations was assessed down to approximately 25 pg/ml with CVs of 12.6% at 29.2 pg/ml and 9.6% at 38.5 pg/ml for the Elecsys 1010/2010 and E 170, respectively. Linearity was evaluated up to 25,000 pg/ml with a sample-based non-linear response observed with recoveries of < 90% for proBNP concentrations < 10,000 pg/ml. Slopes ranged between 0.92 and 1.02 and intercepts from -5.3 to 10.4 pg/ml (r > or = 0.998) among the three types of analyzers. Slopes were 4.95 and 4.53 in comparison to the Biosite Triage and Shionogi BNP assays. There was no assay interference, and no effect of barrier gels, tube composition, or freeze-thaw. NT-proBNP concentrations in EDTA plasma were up to 10% lower than in serum or heparinized plasma and the analyte was stable at 4 degrees C for up to 72 hours (the maximum time tested). There was no circadian rhythm in normal subjects or congestive heart failure patients and there was no effect of drawing position. In summary, the Elecsys proBNP assay exhibits good technical performance and is suitable for use in routine clinical laboratories to aid in the diagnosis of congestive heart failure.     

Multicenter evaluation of a rapid electrochemiluminescent adrenocorticotropic hormone (ACTH) immunoassay

BACKGROUND: Measuring plasma adrenocorticotropic hormone (ACTH) is a key step in the differential diagnosis of hypothalamic-pituitary-adrenal disorders. METHODS: The recently developed electrochemiluminescence Elecsys ACTH immunoassay (Roche Diagnostics, Mannheim, Germany) was evaluated at six clinical laboratories on the Modular E170 and/or the Elecsys 2010 (Roche Diagnostics) immunoanalysers. RESULTS: The within-run and between-run imprecision was 相似文献   

Comparison of the results for three automated immunoassay systems in determining serum HBV markers

BACKGROUND: Automated immunoassay analyzers are used to identify hepatitis B virus (HBV) serum markers. In regions with high prevalence of HBV, it is imperative to compare test results from different immunoassay analyzers. METHODS: Samples from 496 subjects were collected and HBV markers were determined (double-blind, parallel manner) using Abbott AxSYM, Roche Modular Analytics E170, and Abbott Architect i2000). RESULTS: Concurrence between AxSYM and E170 was 97.78% for HBsAg, 91.13% for anti-HBs, 98.79% for anti-HBc, 98.39% for HBeAg, and 88.91% for anti-HBe. Positive rates of anti-HBs and anti-HBe from AxSYM were lower than E170 (P<0.01). Concurrence between AxSYM and Architect i2000 was 98.79% for HBsAg, 91.33% for anti-HBs, 95.97% for anti-HBc, 98.39% for HBeAg, and 95.77% for anti-HBe. Positive anti-HBs rates from AxSYM were lower than Architect i2000 (P<0.01). Concurrence between E170 and Architect i2000 was 97.38% for HBsAg, 94.15% for anti-HBs, 95.56% for anti-HBc, 99.60% for HBeAg, and 88.10% for anti-HBe. Positive anti-HBe rates using Architect i2000 were lower than E170 (P<0.01). Overall, the greatest differences were observed in samples with low-level serum HBV markers. CONCLUSION: Significant discrepancies were observed among results for the 3 automated immunoassay analyzers, especially for low-level anti-HBs and anti-HBe results.     

Evaluation of automated sex hormone binding globulin immunoassays

BACKGROUND: Sex hormone binding globulin (SHBG) is an important regulator of testosterone and estradiol. STUDY DESIGN: We validated the Diagnostic Products Corporation (DPC) and Roche Diagnostic SHBG immunoassays on the DPC Immulite 2000 and Roche Modular E170 analyzers. RESULTS: The coefficient of variation for SHBG kits from both manufacturers was in the range of 3.9-7.7% (between-run) and 0.95-5.0% (within-run), free of interference from hemoglobin, bilirubin, lipid, and rheumatoid factor, and linear up to at least 170 nM SHBG. The results of the two methods, however, were biased by up to 29% depending on the SHBG concentration. CONCLUSION: The SHBG assays perform well but standardization is needed.     

电化学发光法联合检测HIV抗原抗体试剂的评价

目的 评价Roche电化学发光法联合检测HIV抗原抗体试剂的检测性能.方法 收集包括健康献血员、人类免疫缺陷病毒( HIV)感染者、丙型肝炎病毒(HCV)抗体阳性和高危人群在内的血清样本1 327例.购买美国BBI公司的7套HIV血清转换盘共计51份血清样本.采用Roche cobas e411(架式系统)电化学全自动...     

Comparison of automated assays for the determination of vitamin B12 in serum

OBJECTIVES: To study the agreement of serum cobalamin results obtained with three different widely used analyzers. DESIGN AND METHODS: Comparative measurement of 100 serum samples was performed using the Abbott Architect, the Bayer Centaur, and the Roche Elecsys 2010 analyzer. RESULTS: Relatively close numeric correlation of the results was found with Pearson's r>0.95 for all three comparisons; however, the mean concentration of the highest reading and the lowest reading method differed by 16%. CONCLUSIONS: Relatively good agreement of results from three automated serum cobalamin assays was observed.     

Evaluation of a new automated electrochemiluminescent sex hormone-binding globulin (SHBG) immunoassay.

Serum sex hormone-binding globulin (SHBG) regulates the cellular bioavailability of SHBG-bound steroid hormones. Since variations in SHBG levels may affect the concentration of free, i.e., biologically active testosterone in serum, SHBG levels are commonly measured as a supplement to total testosterone determination. The recently developed electrochemiluminescence Elecsys SHBG immunoassay was evaluated analytically on a Modular E170 (Roche Diagnostics, Mannheim, Germany) immunoanalyzer. Major differences in SHBG concentrations have been described among the commercially available methods; we therefore compared the new method with an established SHBG immunoradiometric assay (IRMA) in 99 routine serum samples. To provide reference values to clinicians, SHBG concentration was measured by Elecsys in 304 serum samples from healthy volunteers and several relevant clinical subgroups. The within-run and total imprecision coefficients of variation were 相似文献   

Results from a multicenter evaluation of the 4th generation Elecsys Troponin T assay

BACKGROUND AND OBJECTIVE: Discrepancies between serum and heparin plasma samples have been described for many commercial troponin assays including the cardiac troponin T (cTnT) assay. Using the current 3rd generation Elecsys Troponin T immunoassay, heparin plasma cannot be recommended for the determination of cTnT due to systematic lower test results caused by a direct interference of the immunoassay by heparin. The purpose of the multicenter study was to evaluate the analytical performance of an improved 4th generation Elecsys Troponin T immunoassay with a special focus on the comparability of cTnT results determined in heparin plasma and serum. METHODS AND RESULTS: The multicenter evaluation was performed in 10 clinical laboratories according to a standardized protocol (Roche Diagnostics, Penzberg, Germany, Study No. B05P008). The Elecsys Troponin T immunoassay was performed on the Modular Analytics E170 and Elecsys 2010 systems. Intraassay imprecision (n = 21) and total imprecision (2 runs/d, 10 days, triplicate measurements) were evaluated using 2 commercial controls (Roche Diagnostics) and 6 different serum pools (cTnT: 0.0140 - 4.102 microg/L). Intraassay CVs ranged from 0.73 to 3.22%. Total imprecision CVs ranged from 3.61 to 35.45% (cTnT < 0.1 microg/L) and 1.82 to 9.09% (cTnT > 0.1 microg/L), respectively. The cut-off for myocardial necrosis was determined to be 0.03 microg/L using the 10% total imprecision CV criteria. Linearity was assessed by serial dilutions of 6 different serum samples using cTnT negative serum pools. Linearity was proven up to 21.3 microg/L (recoveries: 90% - 110%). Regression data of all comparison studies were calculated according to the method of Passing and Bablok. The method comparison between the 4th generation and the commercially available cTnT immunoassay showed highly similar results across the whole measuring range (0.01 - 25.0 microg/L): y = 1.024x -0.001, r = 0.998; n = 988. Using the commercially available cTnT reagent, the serum to heparin plasma comparison yielded a systematic bias to approximately 8% lower cTnT results in heparin plasma. However, suitable comparability was obtained using the 4th generation Elecsys cTnT assay. The regression analysis (serum vs. heparin plasma) across the studied measuring range (cTnT: 0.01 - 14 microg/L) yielded the following equation: y = 0.975x + 0.001; r = 0.986; n = 403. However, rare individual serum to matched heparin plasma samples still yielded poor comparability (deviation > 20%) using the 4th generation Elecsys Troponin T immunoassay. CONCLUSION: Our data confirm an excellent analytical performance of the improved troponin T immunoassay. Most importantly, no systematic bias between cTnT results determined in serum and heparin plasma was observed from data obtained in 7 evaluation sites. The performance of the 4th generation Elecsys Troponin T assay is therefore comparable to other commercially available troponin immunoassays. Further studies are necessary to investigate the cause of poor comparability of cTnT results in rare individual serum to matched heparin plasma samples.     

Cross-reactivities of macroprolactin and big-prolactin in three commercial immunoassays for prolactin: a chromatographic analysis

OBJECTIVES: To compare the recently released Elecsys Prolactin II with the Access and Centaur assays for reactivity with macroPRL, bigPRL and monomeric PRL in samples fractionated using gel filtration chromatography (GFC). METHODS: Prolactin (PRL) concentration was measured before (total PRL) and after GFC over Superdex 75 (n=16-18) using prolactin assays on the Access2 (Beckman Coulter Inc.) and Centaur (Siemens Medical Solutions Diagnostics) analyzers and the Prolactin II assay (Roche Diagnostics) on the Elecsys 2010 analyzer. The amounts of macroPRL, bigPRL and monomeric PRL were quantified from GFC peak areas. RESULTS: Total PRL concentrations in macroPRL-containing specimens were (means+/-SD, n=13), 842+/-496; 851+/-564 mIU/L (Access and Elecsys II, p>0.05) and 695+/-469 mIU/L (Centaur, p<0.05). Monomeric PRL (GFC peak area) was lower by the Centaur (p<0.05; Deming regression) than by the Access or Elecsys II assays. Method comparisons (Bland and Altman) therefore used PRL peak areas expressed as percent total PRL recovered after GFC. The mean differences for macroPRL and bigPRL, respectively, were (a) Elecsys PRL II-Access assay: -2.83% and -2.54% (both p<0.05); (b) Elecsys PRL II-Centaur: -1.56% (p>0.05) and -6.48% (p<0.05) and (c) Access-Centaur: 1.41% (p>0.05) and -3.95% (p<0.05). CONCLUSION: The new Elecsys Prolactin II assay has similar cross-reaction with macroPRL and bigPRL to the Access and Centaur Prolactin assays. The differences detected were small and unlikely to have clinical impact.     

应用FITC系统建立非均衡竞争雌二醇(E2)化学发光法

目的 建立能广泛应用于雌二醇(E2)检测的方法.方法 制备辣根过氧化物酶(HRP)标记兔抗人E2多克隆抗体及异硫氰酸荧光素(FITC)标记E2类似物.以抗FITC抗体包被发光板,FITC-E2类似物与抗FITC抗体结合形成固相抗原,固相抗原与血清中E2竞争结合抗E2抗体-HRP,建立化学发光法(CLIA)血清E2检测系统(FITC系统),进行方法 学评价,并与E2-牛血清清蛋白直接包被系统(非FITC系统)和罗氏公司Elecsys2010系统进行比较.结果 FITC系统检测线性范围为10~3 000 pg/mL,灵敏度为10 pg/mL;批内、批间变异系数均小于5%,优于非FITC系统;与Elecsys2010系统检测结果 的相关系数为0.978 0,测定结果 差异无统计学意义(P＞0.05).结论 成功建立基于FITC系统的非均衡竞争E2检测CLIA系统,精密度、灵敏度等指标均符合临床要求,可用于临床标本检测.