癌胚抗原(CEA)测定(化学发光法测定)

癌胚抗原(CEA)测定(化学发光法测定) 癌胚抗原 (CEA)测西安长安医院 文件编号:CA-JY-CZ-MY 检 验 科 第 二 版 定(化学发光法测定) 执行日期:2010-1-4 共5页 第1页 , 原理 癌胚抗原是一种糖蛋白，由胎儿胃肠道上皮组织、胰和肝的细胞所合 成，属于非器官特异型肿瘤相关抗原物。适用于结肠癌、肺癌、胃癌的 辅助诊断。本检验科使用日本东曹AIA-1800型全自动免疫分析仪进行测 定，采用微粒子捕捉酶免疫分析技术(MEIA)。 CEA测定利用双抗体夹心法原理:已包被了抗体的塑料微珠试剂中，加 入待测标本后，经温育，再加入碱性磷酸酶标记的抗体、形成“抗体, 抗原,酶标记抗体复合物”。然后将其转移到玻璃纤维柱上，用缓冲液洗 涤，没有结合的抗原、酶标抗体被洗掉，结合抗原抗体的塑料微珠则被 保留在纤维柱滤膜的上方。这时再加入底物:4-甲基伞型酣磷酸盐 (4-Mup)。酶标抗体上的碱性磷酸酶将4-Mup分解,脱磷酸后形成甲基伞型 酣(4-Mu)，它在365nm激发光的照射下，发出448nm的荧光，经过荧光 读数仪的记录、放大，计算出所测物质的含量。 2 标本采集与处理 2.1原始样本类型:血清、血浆或全血(应用抗凝剂为肝素钠、枸橼酸钠、 ACD、CPDA-1或EDTA)、尿液(晨尿、随即尿、24小时尿等)或其他体 液(羊水等)。 2.2样本量:根据不同项目样本量不等(83μl-238μl)。 2.3患者准备:严禁使用接受过鼠单克隆抗体诊断或治疗的病人样本，引起 体内含有人抗鼠抗体(HAMA)，当这些样品在使用含鼠单克隆抗体分 析试剂进行测试时，引起结果升高或降低。 2.4样本采集方法:一般采用静脉采血。 样本采集要求: rational concept to allow network more in line with the objective laws of the future development of the city. 1.5.2 planning research areas: throughout the city, with an area of 13,000 km2, cover 2 districts and 8 counties of the city, including downtown and city levels. Planning range: main for City Center City, area for 1268km2, North to cases field Xiang, and Jin Pingzhen, and Gao Dian Zhen, and huangshazhen, and Liu home town North Township territories, East Nan XI Zhen, and Jiangnan East Township territories, South to horse home, and song home, and Li Zhuang Zhen, and South wide town, and Zhao field Street do South administrative border, West to baixizhen, and dish dam town, and thought slope Xiang West Township territories. 1.6 planning target 1.6.1 General target this items research to will Yibin city built Yangtze River upstream chuan Yunnan Guizhou combined Department Regional Center City, support city space of ordered expand for target, reference Yibin city integrated traffic planning (2014-2030 years) and the Yibin City City general planning (2013-2030 years) of research results, using science, and advanced of network research method, building more level, and more mode of track traffic system, Meet at different levels of the city's rail transportation needs and quality requirements. 1.6.2 target 1, refined urban development axis of urban development concepts, judgments, rail-guided downtown from solo to group-development of the network, from one Center to center city with axial development. 2, network planning adapted to Yibin City status and future development needs, demonstrates rational scale of rail transport to meet the needs 避免过度溶血，必须在无菌体条件下采集; 确保离心速度(10000转/分钟)和时间(10分钟)，避免颗粒物质的干扰。 避免样品的反复冻融，溶解后的样品需低速震荡或轻轻颠倒混匀已获得 稳定的结果。若样品中有颗粒物质，红血球或浑浊物质必须离心使其澄 清后再进行测试。 2.5样品的稳定期和保存:上机3小时内完成检测;2?-8?标本可保存1-14天; 若需长期保存(1年内)，必须将血清分离出来，冷冻保存(-10?或更冷)。 3 试剂 3.1 所有试剂均购自东曹公司 TOSOH?相关校准品 TOSOH?相关校准品1 TOSOH?相关校准品2 TOSOH?样本稀释液 TOSOH4- ?基质:甲基伞形酮酰磷酸 TOSOH?基质溶解液 TOSOH?清洗液 TOSOH?缓冲液 3.2 试剂准备与检查: 从冰箱中取出1号液(底物液)放入仪器 从冰箱中取出相关测试试剂放入仪器 检查所有试剂和缓冲液是否在有效期内，超过有效期的试剂不可使用 检查所有试剂和缓冲液是否足够 检查所有消耗品(纤维杯或反应杯)是否足够，废液或废物是否清空 3.3 试剂保存条件: 试剂盒、品、质控品在2?-8?保存。其他试剂室温保存。 3.4 试剂性能可接受性: 按测定项目资料手册中质量控制章节所规定内容进行质量控制，结果必 须在实验室规定的可接受范围内。 rational concept to allow network more in line with the objective laws of the future development of the city. 1.5.2 planning research areas: throughout the city, with an area of 13,000 km2, cover 2 districts and 8 counties of the city, including downtown and city levels. Planning range: main for City Center City, area for 1268km2, North to cases field Xiang, and Jin Pingzhen, and Gao Dian Zhen, and huangshazhen, and Liu home town North Township territories, East Nan XI Zhen, and Jiangnan East Township territories, South to horse home, and song home, and Li Zhuang Zhen, and South wide town, and Zhao field Street do South administrative border, West to baixizhen, and dish dam town, and thought slope Xiang West Township territories. 1.6 planning target 1.6.1 General target this items research to will Yibin city built Yangtze River upstream chuan Yunnan Guizhou combined Department Regional Center City, support city space of ordered expand for target, reference Yibin city integrated traffic planning (2014-2030 years) and the Yibin City City general planning (2013-2030 years) of research results, using science, and advanced of network research method, building more level, and more mode of track traffic system, Meet at different levels of the city's rail transportation needs and quality requirements. 1.6.2 target 1, refined urban development axis of urban development concepts, judgments, rail-guided downtown from solo to group-development of the network, from one Center to center city with axial development. 2, network planning adapted to Yibin City status and future development needs, demonstrates rational scale of rail transport to meet the needs 4 操作步骤 1 开机前检查 a 察看电源是否正常安全通电 b 推主机下部的前门，打开后检查洗净水与分注液的用量是否满足当日 用量废试样杯与废吸嘴是否丢弃 2 开机 a更换75%酒精，放置基质液 b 打开电脑主机及AIA-1800电源, 点击主业面进入root c 试样吸嘴的设置及酶标识试剂，检体稀释液的设置，按主机操作版面 Reagent/Tip键，LED指示灯变为绿色，打开试剂吸嘴护罩，将酶 标识试剂，检体稀释液设置在试剂托架上，将条形码 标识面朝前 d 试剂杯的设置，按主机操作版面的Cup Sorter键，LED指示灯 变为绿色，拉开分类器抽屉将试剂托盘设置在分类器托盘上，将分类器 抽屉推到底 3 开机日检 4 日检通过后，进行标本检测，在树形菜单上进入界面设置标 本检测项目，Assay键点击开始测定 5 测定完毕后，按主机操作版面的Cup Sorter及Reagent/Tip键，LED指 示灯变为绿色，打开试剂吸嘴护罩及分类器抽屉，收集试剂放入冰箱， 更换基质液， 放置75%酒精 6 点击关机，待窗口消失，关闭AIA-1800电源，在关闭电脑及主电 源 5 质量控制: 每批试剂都要使用东曹公司标准品作质量控制，请参见AIA-1800仪器操作手rational concept to allow network more in line with the objective laws of the future development of the city. 1.5.2 planning research areas: throughout the city, with an area of 13,000 km2, cover 2 districts and 8 counties of the city, including downtown and city levels. Planning range: main for City Center City, area for 1268km2, North to cases field Xiang, and Jin Pingzhen, and Gao Dian Zhen, and huangshazhen, and Liu home town North Township territories, East Nan XI Zhen, and Jiangnan East Township territories, South to horse home, and song home, and Li Zhuang Zhen, and South wide town, and Zhao field Street do South administrative border, West to baixizhen, and dish dam town, and thought slope Xiang West Township territories. 1.6 planning target 1.6.1 General target this items research to will Yibin city built Yangtze River upstream chuan Yunnan Guizhou combined Department Regional Center City, support city space of ordered expand for target, reference Yibin city integrated traffic planning (2014-2030 years) and the Yibin City City general planning (2013-2030 years) of research results, using science, and advanced of network research method, building more level, and more mode of track traffic system, Meet at different levels of the city's rail transportation needs and quality requirements. 1.6.2 target 1, refined urban development axis of urban development concepts, judgments, rail-guided downtown from solo to group-development of the network, from one Center to center city with axial development. 2, network planning adapted to Yibin City status and future development needs, demonstrates rational scale of rail transport to meet the needs 册。 6 结果计算(定量分析): 利用点对点数据产生方法来产生标准曲线，并根据标准曲线机器会自动计 算最终样品浓度; 7 格式: 各种定量单位通常采用ng/mL 8 参考值: 0-10ng/mL 9 临床意义: 癌胚抗原是一种糖蛋白，由胎儿胃肠道上皮组织、胰和肝的细胞所合 成，属于非器官特异型肿瘤相关抗原物。适用于结肠癌、肺癌、胃癌的辅 助诊断。 9.1 主要用于对结肠直肠癌、胃癌、胰腺癌、肝细胞癌、肺癌、乳癌以及甲状 腺髓质癌等患者的临床监测。 9.2 结肠直肠癌患者CEA测定的敏感性高于其他肿瘤标志物故常选CEA。初诊时 15% DukesA期患者CEA升高，而在C期和D期患者升高率分别达55%和70%。 术前CEA升高的患者，无复发期和存活期都较短。 10 方法学性能 精密度:采用NCCLS中的EPS-T2标准，测WithinRun,BetweenRun,Retween Day和Total四个方面进行精密度的评价，检测为:测6套以上的血清 盘，(每套3个以上的样品)，在3-4个试验点，每天分两个时间段，每个 样品做复管(每个样品累计测80次以上)，连续测20天以上，使用一个以 上批号试剂和标准曲线。总的CV%值控制在8%以内。 正确度(准确度):采用与东芝原有的商品化试剂或市售的其他经典的商品 化试剂(如:HPLC或RIA)进行相关性的比较，回归方式一般采用Least Squares Linear Regression和/或Passing-Bablok Linear Regression 方式，比较Intercept(截距)，Slope(斜率)和Correlation Coefficient (相关参数)等参数，并注明参与比较的样品类型，数量和样品的浓度范rational concept to allow network more in line with the objective laws of the future development of the city. 1.5.2 planning research areas: throughout the city, with an area of 13,000 km2, cover 2 districts and 8 counties of the city, including downtown and city levels. Planning range: main for City Center City, area for 1268km2, North to cases field Xiang, and Jin Pingzhen, and Gao Dian Zhen, and huangshazhen, and Liu home town North Township territories, East Nan XI Zhen, and Jiangnan East Township territories, South to horse home, and song home, and Li Zhuang Zhen, and South wide town, and Zhao field Street do South administrative border, West to baixizhen, and dish dam town, and thought slope Xiang West Township territories. 1.6 planning target 1.6.1 General target this items research to will Yibin city built Yangtze River upstream chuan Yunnan Guizhou combined Department Regional Center City, support city space of ordered expand for target, reference Yibin city integrated traffic planning (2014-2030 years) and the Yibin City City general planning (2013-2030 years) of research results, using science, and advanced of network research method, building more level, and more mode of track traffic system, Meet at different levels of the city's rail transportation needs and quality requirements. 1.6.2 target 1, refined urban development axis of urban development concepts, judgments, rail-guided downtown from solo to group-development of the network, from one Center to center city with axial development. 2, network planning adapted to Yibin City status and future development needs, demonstrates rational scale of rail transport to meet the needs 围。 编写者:李 伟 审批者:闵金凤 审批日期:2010-1-4 复审人: 复审结果: 复审日期: rational concept to allow network more in line with the objective laws of the future development of the city. 1.5.2 planning research areas: throughout the city, with an area of 13,000 km2, cover 2 districts and 8 counties of the city, including downtown and city levels. Planning range: main for City Center City, area for 1268km2, North to cases field Xiang, and Jin Pingzhen, and Gao Dian Zhen, and huangshazhen, and Liu home town North Township territories, East Nan XI Zhen, and Jiangnan East Township territories, South to horse home, and song home, and Li Zhuang Zhen, and South wide town, and Zhao field Street do South administrative border, West to baixizhen, and dish dam town, and thought slope Xiang West Township territories. 1.6 planning target 1.6.1 General target this items research to will Yibin city built Yangtze River upstream chuan Yunnan Guizhou combined Department Regional Center City, support city space of ordered expand for target, reference Yibin city integrated traffic planning (2014-2030 years) and the Yibin City City general planning (2013-2030 years) of research results, using science, and advanced of network research method, building more level, and more mode of track traffic system, Meet at different levels of the city's rail transportation needs and quality requirements. 1.6.2 target 1, refined urban development axis of urban development concepts, judgments, rail-guided downtown from solo to group-development of the network, from one Center to center city with axial development. 2, network planning adapted to Yibin City status and future development needs, demonstrates rational scale of rail transport to meet the needs