罗氏电化学发光免疫分析(精)

罗氏Cobas E601全自动电化学发光免疫分析仪检测癌胚抗原(CEA)的研究分析

发布时间：2022-11-21T01:39:17.158Z 来源：《医师在线》2022年19期 作者： 秦英杰

[导读] 目的：研究分析罗氏Cobas E601全自动电化学发光免疫分析仪对CEA的检测性能

秦英杰

锡山人民医院东亭分院 江苏无锡 214000

【摘要】目的：研究分析罗氏Cobas E601全自动电化学发光免疫分析仪对CEA的检测性能。方法：从我院2021年1月～2021年6月的体检人员中选择120例，将血液样本作为分析对象，通过罗氏Cobas?E601分析仪对CEA的检测结果进行分析。结果：在不同浓度、不同批次、

批内下，SV（变异系数）结果符合规定范围，检测值在认定范围。结论：罗氏Cobas?E601全自动电化学发光免疫分析仪对CEA的检测准确

性、精密度能够得到保证，值得应用。

【关键词】全自动电化学发光免疫分析仪；癌胚抗原；精密度；准确度

【中图分类号】 R446.6 【文献标识码】A

CEA属于肿瘤标志物的一种，除了胃癌以外，在乳腺癌、肺癌等癌症中也表现为CEA水平升高。为此，以CEA指标为基础进行检测能有效判断肿瘤发展程度，利于病情诊断检测[1]。全自动电化学发光免疫分析仪作为现阶段技术较为成熟的检测仪器，具有处理样本及检测

速度快的特点[2]。为此，本研究将严格按照实验室质量要求，对罗氏Cobas?E601全自动电化学发光免疫分析仪检测性能进行探究分析，现

报道内容如下。

1 资料与方法

1.1一般资料

1.1体检人员资料

选择我院2021年1月～2021年6月期间内体检的人员共120名，所有送检的标本均无溶血、无脂血情况，为新鲜标本。其中，男性体检人员共63例、女性共57例，年龄均值范围：[28~76（48.55±5.13）]岁。纳入标准：①年龄≥18岁；②自愿参加此研究；③入院基本资料完全。

排除标准： ①凝血功能障碍；②妊娠期、哺乳期患者。

Elecsys Anti-HBs II REF SYSTEM ********************** 300 cobas e 801

2017-09, V 1.0 Can English 1 / 4 English System information Short name ACN (application code number) AHBS 2 10138 Intended use Immunoassay for the in vitro quantitative determination of human antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma. Anti-HBs assays are used within the scope of hepatitis B vaccination to check the necessity and success of vaccination. In addition, anti-HBs assays are used to monitor the course of disease following acute hepatitis B infection. This test is not intended for diagnosis. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 801 immunoassay analyzer. Note: Please note that the catalogue number appearing on the package insert retains only the first 8 digits of the licensed 11-digit Catalogue Number: 07026854190 for the Elecsys Anti-HBs II assay. The last 3 digits -190 have been replaced by -119 for logistic purposes. Summary Anti-HBs is a specific (generally IgG) antibody that is directed against the hepatitis B surface antigen (HBsAg).1,2 Anti‑HBs can be detected several weeks after the disappearance of hepatitis B surface antigen.3,4 Anti‑HBs can be formed following a hepatitis B infection or after hepatitis B vaccination.3,4 Antibodies are formed against the HBsAg determinant a, which is common to all subtypes, and against subtype-specific determinants.1,5,6 Anti‑HBs assays are used within the scope of hepatitis B vaccination to check the necessity and success of vaccination.2,4,7 In addition, anti‑HBs assays are used to monitor the course of disease following acute hepatitis B infection.3 The Elecsys Anti‑HBs II assay uses a mixture of purified antigens from human serum (HBsAg subtype ad), and recombinant HBsAg subtype ay from CHO (Chinese Hamster Ovary) cells. Test principle Sandwich principle. Total duration of assay: 18 minutes.  1st incubation: Anti‑HBs in the sample (24 μL), biotinylated HBsAg (ad/ay), and HBsAg (ad/ay) labeled with a ruthenium complexa) react to form a sandwich complex.  2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.  The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.  Results are determined via a calibration curve which is instrument-specifically generated by 2‑point calibration and a master curve provided via the cobas link. a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)32+) Reagents – working solutions The cobas e pack (M, R1, R2) is labeled as AHBS 2. M Streptavidin-coated microparticles, 1 bottle, 13.2 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 HBsAg~biotin, 1 bottle, 16.7 mL: Biotinylated HBsAg (ad/ay) human/recombinant, > 0.5 mg/L; MESb) buffer 85 mmol/L, pH 6.5; preservative. R2 HBsAg~Ru(bpy)32+, 1 bottle, 15.8 mL: HBsAg (ad/ay) human/recombinant, labeled with ruthenium complex > 0.3 mg/L; MES buffer 85 mmol/L, pH 6.5; preservative. b) MES = 2-morpholino-ethane sulfonic acid AHBS 2 Cal1 Calibrator 1, 1 bottle of 1.3 mL: Anti‑HBs (human) in human serum; preservative. AHBS 2 Cal2 Calibrator 2, 1 bottle of 1.3 mL: Anti‑HBs (human) in human serum; preservative. Precautions and warnings For in vitro diagnostic use. Exercise the normal precautions required for handling all laboratory reagents. Disposal of all waste material should be in accordance with local guidelines. Safety data sheet available for professional user on request. This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008: n‑Octyl‑N,N‑dimethyl‑3‑ammonio‑1‑propanesulfonate EUH 208 May produce an allergic reaction. Product safety labeling primarily follows EU GHS guidance. All human material should be considered potentially infectious. The calibrators (AHBS 2 Cal1 and AHBS 2 Cal2) have been prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA‑approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A. The HBsAg starting material used was inactivated prior to labeling with biotin or ruthenium by heating to 60 °C for 15 hours. In addition, any virus particles remaining were removed by ultracentrifugation. However, as no inactivation or testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.8,9 Avoid foam formation in all reagents and sample types (specimens, calibrators and controls). Reagent handling The reagents (M, R1, R2) in the kit are ready-for-use and are supplied in cobas e packs. Calibrators The calibrators are supplied ready‑for‑use in bottles compatible with the system. Unless the entire volume is necessary for calibration on the analyzer, transfer aliquots of the ready‑for‑use calibrators into empty snap‑cap bottles (CalSet Vials). Attach the supplied labels to these additional bottles. Store the aliquots at 2‑8 °C for later use. Perform only one calibration procedure per aliquot. All information required for correct operation is available via the cobas link. Storage and stability Store at 2‑8 °C. Do not freeze. Store the cobas e pack upright in order to ensure complete availability of the microparticles during automatic mixing prior to use. Stability of the cobas e pack: unopened at 2‑8 °C up to the stated expiration date on the cobas e 801 analyzer 16 weeks Stability of the calibrators: unopened at 2‑8 °C up to the stated expiration date after opening at 2‑8 °C 16 weeks on the cobas e 801 analyzer at 20‑25 °C use only once Store calibrators upright in order to prevent the calibrator solution from adhering to the snap‑cap.

.

1 / 11'. 罗氏电化学发光免疫分析仪测试项目定标物保存方法

甲状腺项目

定标液

及其货号

定标频率

靶值Cal 1/Cal 2 未开包装

稳定时间

（2-8C） 打开后

稳定时间

（2-8 C） 定标物状态 可否冰

冻保存 每瓶容量/

每次吸样量 冻干，

需溶解 液体，

打开即用

FT3

1．当需要时，如质控不在范围内

2．每月，使用同一批号试剂

3．每周，使用同一盒试剂

 2/40 pmol/l

 1.3/26-- pg/ml 有效期限 8 周 是 - 1 ml

15 l

FT4

 10/45 pmol/l

 0.78/3.5 ng/dl 有效期限 12 周 是 - 1 ml

15 l

T3

 1.25/8.5 nmol/l

 0.8/5.5 ng/ml 有效期限 8 周 是 -

1 ml

30 l

T4

 50/230 nmol/l

 3.9/17.9 µg/dl 有效期限 12 周 是 - 1 ml

15 l

TSH

 0/1.5 µIU/ml 有效期限 12 周 是 - 1.3 ml

50 l

T-uptake

 0.5/1.3 TBI 有效期限 12周 是 - 1 ml

15 l

TG

 4/800 ng/ml 有效期限 3周 是 1 次

(-20C / 3 月) 1 ml

20 l

Anti-TG

 40/3250 IU/ml 有效期限 6 周 是 不可 1.5 ml

10 µl

Anti-TPO

  35/350 IU/ml 有效期限 8小时 是 1 次

(-20C / 8周) 1.5 ml

20 µl

Anti-TSHR   1/25 IU/l 有效期限 是 1 次

(-20C / 3 月) 2 ml

50 µl

- 无信息 # 定标物和质控物是测试包装内的一部分

罗氏E411全自动电化学发光免疫分析仪常见问题及处理

发表时间：2015-10-23T14:00:43.717Z 来源：《医药前沿》2015年第24期供稿 作者： 陆绍科

[导读] 贵州省独山县人民医院 贵州 独山 处理方法：打开试剂盒盖子，检查试剂如加得太满，用移液器将试剂吸出后重新执行试剂扫描或手工注册即可。

陆绍科

（贵州省独山县人民医院 贵州 独山 558200）

【摘要】 罗氏E411全自动电化学发光免疫分析仪它具有操作简便，自动化程度高，精密度高，重复性好样品用量少,节省试剂,检测速度快等优点。是国际公认的“金标准”，而在使用过程中往往会出现一些小故障,需要自行尽快排除,以至于不影响日常工作。

【中图分类号】R197.3 【文献标识码】A 【文章编号】2095-1752（2015）24-0303-02

仪器在运行过程中，当出现报警信息时，在屏幕上方状态栏的颜色会发生改变，报警颜色呈红色或黄色，当报警颜色为红色时，仪器将发生停止工作，同时报警代码简要的描述以及报警类型及中文提示都会显示出来。笔者就使用该仪器现场解决处理的一些经验报告如

下。

1. 吸样针检测到某项目试剂盒中有气泡

1.1 报警此信息多数都是由于用户为了节约试剂,将多个试剂拼装后，拼装的试剂加得太满所致。

处理方法：打开试剂盒盖子，检查试剂如加得太满，用移液器将试剂吸出后重新执行试剂扫描或手工注册即可。在不能确认是哪瓶试剂所致的报警时，可执行试剂扫描，当试剂针探测到某个试剂有问题时就会马上报警，此致即可确认是某个试剂的问题即可将其取出。

1.2 报此信息的另一个问题是：试剂在运输过程中受到振动可能的产生气泡。

处理方法：此时应将试剂静置30分钟后再用。日常工作在取出试剂使用时应当避免人为晃动或颠倒试剂。

2.由于电导率升高导致某项目试剂的液面误检/运动过程中，样本/试剂针液面感应错误

2.1 报警此信息多数是样本/试剂针表面有静电或有污物附着，