货号 IA2638 批号 1304EC 规格 10 x 5ml 效期 : 羟基孕酮 nmol/l DRG ELISA ng/ml 羟基维生素 D nmol/l Siemens

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1 0843 免疫多项检测用质控品货号 : IA2638 批号 : 1304EC 规格 : 12 x 5ml 效期 : 注释 : : 注册商标 (1). 只适用于德国根据德国内科医生联邦议院的方针制订 ( 中文说明已略, 如需请另行参见英文说明 ) (2). 德国内科医生联邦议院官方认可的参考实验室测定的浓度值 (3). DGKC: 德国临床化学协会 (4). IFCC: 国际临床化学联盟 (5). SCE: 斯堪的纳维亚酶委员会赋值每一批质控血清都要送到参考实验室, 根据国际参考标准进行赋值若没有国际参考标准, 就使用参考方法朗道也将质控血清送到全世界 3000 多家实验室, 然后将结果用相同的统计分析赋值质控值是平均值 ±2S.D. 该结果非常准确可靠, 实验室尽可放心使用该质控品包含了醛固酮和雌三醇, 但是没有提供相应的靶值保存和稳定性开瓶前 : 可在 +2 到 +8 保存到有效期末复溶后 : 可在 2-8 保存 7 天,-20 保存 4 周 25 羟基维生素 D 和 1,25 羟基维生素 D 在 2-8 稳定 5 天,C 肽在 2-8 稳定 1 天,PTH 和甲状腺球蛋白复溶后如果 2-8 保存, 需要在 4 小时内检测, 若 -20 保存, 则需在 2 周内检测对于促甲状腺皮质激素 (ACTH), 醛固酮和 C 肽没有冷冻稳定性说明每次使用只吸取所需用量, 剩余的样品不可以返回原瓶注意 : 对于复溶后的血清, 细菌的污染可以降低许多组分的稳定性, 如果样品被细菌污染, 应该将该瓶样品抛弃, 重新复溶一瓶新的血清使用说明本品为免疫多项检测用质控品, 又称免疫质控, 为冻干粉 1. 小心打开瓶盖, 往瓶中加入 5ml 蒸馏水, 在的条件下复溶, 盖上瓶盖, 放置 30 分钟轻轻翻转瓶子, 确保内容物完全溶解, 不要振荡, 避免气泡的产生 2. 参照各个分析仪的质控说明 3. 冷藏未使用的材料, 再次使用前, 确保样品充分混合均匀多项免疫质控品 (3 个水平 ) 水平 1: 10 x 5 ml 注意事项该质控品采用人基质血清, 对所有捐献者的血清均进行了 HIV(HIV1 HIV2) 抗体肝炎 B 表面抗原 (HbsAg) 和肝炎 C 病毒 (HCV) 抗体的测试, 发现均呈阴性所采用的方法均经 FDA 认证然而, 既然没有一种方法能够完全保证其没有传染物质, 因此该质控品和所有的病人样品均应当按照能够传播疾病的样品小心处理仅用于体外诊断 PAGE 1 OF 10

2 货号 IA2638 批号 1304EC 规格 10 x 5ml 效期 : 羟基孕酮 nmol/l DRG ELISA ng/ml 羟基维生素 D nmol/l Siemens Advia Centaur nmol/l Roche Cobas E411 nmol/l Abbott Architect 促肾上腺皮质激素 ACTH pmol/l Siemens Immulite 2000/2500 pg/ml 醛固酮 pmol/l DRG ELISA pg/ml 甲胎蛋白 AFP KIU/l = lu/ml Siemens Advia Centaur ng/ml KIU/l = lu/ml Siemens Immulite 2000/2500 ng/ml KIU/l = lu/ml BioMerieux Vidas ng/ml KIU/l = lu/ml Roche Cobas E411 ng/ml KIU/l = lu/ml Roche Cobas 6000/8000 ng/ml KIU/l = lu/ml Beckman DxI800 ng/ml KIU/l = lu/ml Beckman Access ng/ml KIU/l = lu/ml Abbott Architect ng/ml 丁胺卡那霉素 µmol/l Gravimetric µg/ml β-2- 微球蛋 µg/ml = mg/l BioMerieux Vidas C- 肽 nmol/l Siemens Immulite 2000/2500 ng/ml nmol/l Roche Cobas E411 ng/ml nmol/l Abbott Architect ng/ml CA 15-3 U/ml Siemens Advia Centaur U/ml Siemens Immulite 2000/2500 U/ml BioMerieux Vidas U/ml Roche Cobas E411 U/ml Roche Cobas 6000/8000 U/ml Beckman DxI800 U/ml Beckman Access U/ml Abbott Architect RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, 单位 ed Kingdom, BT29 4QY PAGE 2 OF 10

3 货号 IA2638 批号 1304EC 规格 10 x 5ml 效期 : 低分析物单位靶值值高值方法 CA 19-9 U/ml Siemens Advia Centaur U/ml Siemens Immulite 2000/2500 U/ml BioMerieux Vidas U/ml Roche Cobas E411 U/ml Roche Cobas 6000/8000 U/ml Beckman Access U/ml Abbott Architect CA125 U/ml Siemens Immulite 2000/2500 U/ml BioMerieux Vidas U/ml Roche Cobas E411 U/ml Roche Cobas 6000/8000 U/ml Beckman DxI800 U/ml Beckman Access U/ml Siemens Advia Centaur U/ml Abbott Architect 立痛定 µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml 癌胚抗原 CEA ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Siemens Immulite 2000/2500 ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Roche Cobas 6000/8000 ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Beckman Access ng/ml = µg/l Abbott Architect 皮质醇 nmol/l Siemens Advia Centaur µg/dl nmol/l Siemens Immulite 2000/2500 µg/dl nmol/l BioMerieux Vidas µg/dl nmol/l Roche Cobas E411 µg/dl nmol/l Roche Cobas 6000/8000 µg/dl nmol/l Beckman DxI800 µg/dl nmol/l Beckman Access µg/dl nmol/l Abbott Architect µg/dl 去表雄酮硫酸盐 DHEA-S µmol/l Siemens Immulite 2000/2500 µmol/l Siemens Advia Centaur µmol/l Beckman DxI800 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, 单位 ed Kingdom, BT29 4QY PAGE 3 OF 10

4 货号 IA2638 批号 1304EC 规格 10 x 5ml 效期 : 去表雄酮硫酸盐 DHEA-S µmol/l Beckman Access µmol/l Abbott Architect 地高辛 nmol/l Siemens Immulite 2000/2500 ng/ml nmol/l Siemens Advia Centaur ng/ml nmol/l Beckman DxI800 ng/ml nmol/l Beckman Access ng/ml nmol/l Gravimetric ng/ml nmol/l Abbott Architect ng/ml nmol/l Roche Cobas 6000/8000 ng/ml 乙琥胺 µmol/l Gravimetric µg/ml 铁蛋白 ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Siemens Immulite 2000/2500 ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Roche Cobas 6000/8000 ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Beckman Access ng/ml = µg/l Abbott Architect 叶酸 nmol/l Siemens Immulite 2000 ng/ml nmol/l Siemens Advia Centaur ng/ml nmol/l Roche Cobas E411 ng/ml nmol/l Roche Cobas 6000/8000 ng/ml nmol/l Abbott Architect ng/ml 游离 T3 pmol/l Siemens Advia Centaur ng/dl pg/ml pmol/l Siemens Immulite 2000/2500 ng/dl pg/ml pmol/l BioMerieux Vidas ng/dl pg/ml pmol/l Roche Cobas E411 ng/dl pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, 单位 ed Kingdom, BT29 4QY PAGE 4 OF 10

5 货号 IA2638 批号 1304EC 规格 10 x 5ml 效期 : 游离 T3 pmol/l Roche Cobas 6000/8000 ng/dl pg/ml pmol/l Beckman DxI800 ng/dl pg/ml pmol/l Beckman Access ng/dl pg/ml pmol/l Abbott Architect ng/dl pg/ml 游离 T4 pmol/l Siemens Advia Centaur ng/dl pg/ml pmol/l Siemens Immulite 2000/2500 ng/dl pg/ml pmol/l BioMerieux Vidas ng/dl pg/ml pmol/l Roche Cobas E411 ng/dl pg/ml pmol/l Roche Cobas 6000/8000 ng/dl pg/ml pmol/l Beckman DxI800 ng/dl pg/ml pmol/l Beckman Access ng/dl pg/ml pmol/l Abbott Architect ng/dl pg/ml 卵泡刺激素 FSH mu/ml Siemens Advia Centaur mu/ml Siemens Immulite 2000/2500 mu/ml BioMerieux Vidas mu/ml Roche Cobas E411 mu/ml Roche Cobas 6000/8000 mu/ml Beckman DxI800 mu/ml Beckman Access mu/ml Abbott Architect RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, 单位 ed Kingdom, BT29 4QY PAGE 5 OF 10 applications@randox.com Website:

6 货号 IA2638 批号 1304EC 规格 10 x 5ml 效期 : 庆大霉素 µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml 生长激素 (GH) µu/ml Siemens Immulite 2000/2500 ng/ml IG E KIU/l = IU/ml Siemens Advia Centaur KIU/l = IU/ml Randox Immunoturbidimetric 胰岛素 mu/l Siemens Advia Centaur mu/l Roche Cobas E411 mu/l Beckman DxI800 mu/l Beckman Access mu/l Abbott Architect 促黄体素 mu/ml Siemens Advia Centaur (LH) mu/ml Siemens Immulite 2000 mu/ml BioMerieux Vidas mu/ml Roche Cobas E411 mu/ml Roche Cobas 6000/8000 mu/ml Beckman Access mu/ml Abbott Architect mu/ml Beckman DxI800 雌二醇 pmol/l Siemens Advia Centaur pg/ml pmol/l Siemens Immulite 2000/2500 pg/ml pmol/l BioMerieux Vidas pg/ml pmol/l Roche Cobas E411 pg/ml pmol/l Roche Cobas 6000/8000 pg/ml pmol/l Beckman DxI800 pg/ml pmol/l Beckman Access pg/ml pmol/l Abbott Architect pg/ml 扑热息痛 mmol/l Gravimetric mg/l 甲状旁腺激素 pmol/l Siemens Advia Centaur (PTH) pg/ml pmol/l Siemens Immulite 2000 pg/ml pmol/l Roche Cobas E411 pg/ml pmol/l Roche Cobas 6000/8000 pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, 单位 ed Kingdom, BT29 4QY PAGE 6 OF 10

7 货号 IA2638 批号 1304EC 规格 : 10 x 5ml 效期 : 甲状旁腺激素 pmol/l Abbott Architect (PTH) pg/ml 苯巴比妥 µmol/l Gravimetric µg/ml 苯妥英钠 µmol/l Siemens Advia Centaur µg/ml µmol/l Siemens Immulite 2000/2500 µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml 扑米酮 µmol/l Gravimetric µg/ml 孕酮 nmol/l Siemens Advia Centaur ng/ml nmol/l Siemens Immulite 2000/2500 ng/ml nmol/l BioMerieux Vidas ng/ml nmol/l Roche Cobas E411 ng/ml nmol/l Roche Cobas 6000/8000 ng/ml nmol/l Beckman DxI800 ng/ml nmol/l Beckman Access ng/ml nmol/l Abbott Architect ng/ml 催乳素 µu/ml Siemens Advia Centaur µu/ml Siemens Immulite 2000/2500 µu/ml Roche Cobas E411 µu/ml Roche Cobas 6000/8000 µu/ml Beckman DxI800 µu/ml Beckman Access µu/ml Abbott Architect 游离 PSA ng/ml = µg/l Siemens Immulite 2000/2500 ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Beckman Access ng/ml = µg/l Abbott Architect ng/ml = µg/l Beckman DxI800 总 PSA ng/ml = µg/l Siemens Advia Centaur RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, 单位 d Kingdom, BT29 4QY PAGE 7 OF 10 applications@randox.com Website:

8 货号 IA2638 批号 1304EC 规格 : 10 x 5ml 效期 : 总 PSA ng/ml = µg/l BioMerieux Vidas ng/ml = µg/l Roche Cobas E411 ng/ml = µg/l Roche Cobas 6000/8000 ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Beckman Access ng/ml = µg/l Abbott Architect 水杨酸 mmol/l Gravimetric mg/dl 性激素结合球蛋白 SHBG nmol/l Siemens Immulite 2000/2500 nmol/l Roche Cobas E411 nmol/l Beckman DxI800 nmol/l Beckman Access T 吸收 %U Siemens Immulite 2000 睾酮 nmol/l Siemens Advia Centaur ng/ml ng/dl nmol/l Siemens Immulite 2000/2500 ng/ml ng/dl nmol/l BioMerieux Vidas ng/ml ng/dl nmol/l Roche Cobas E411 ng/ml ng/dl nmol/l Roche Cobas 6000/8000 ng/ml ng/dl nmol/l Beckman DxI800 ng/ml ng/dl nmol/l Beckman Access ng/ml ng/dl nmol/l Abbott Architect ng/ml ng/dl 茶碱 µmol/l Gravimetric µg/ml µmol/l Roche Cobas 6000/8000 µg/ml 促甲状腺激素 TSH µu/ml = mlu/l Siemens Advia Centaur µu/ml = mlu/l Siemens Immulite 2000/2500 µu/ml = mlu/l BioMerieux Vidas µu/ml = mlu/l Roche Cobas E411 µu/ml = mlu/l Roche Cobas 6000/8000 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, 单位 d Kingdom, BT29 4QY PAGE 8 OF 10

9 货号 IA2638 批号 1304EC 规格 : 10 x 5ml 效期 : 促甲状腺激素 TSH µu/ml = mlu/l Beckman DxI800 µu/ml = mlu/l Beckman Access µu/ml = mlu/l Abbott Architect 妥布霉素 µmol/l Gravimetric µg/ml 总 β hcg mu/ml=iu/l Siemens Advia Centaur IU/ml mu/ml=iu/l Siemens Immulite 2000 IU/ml mu/ml=iu/l BioMerieux Vidas IU/ml mu/ml=iu/l Roche Cobas 6000/8000 IU/ml mu/ml=iu/l Beckman DxI800 IU/ml mu/ml=iu/l Beckman Access IU/ml mu/ml=iu/l Abbott Architect IU/ml 总 T3 nmol/l Siemens Advia Centaur ng/ml ng/dl nmol/l Siemens Immulite 2000/2500 ng/ml ng/dl nmol/l BioMerieux Vidas ng/ml ng/dl nmol/l Roche Cobas E411 ng/ml ng/dl nmol/l Beckman Access ng/ml ng/dl nmol/l Abbott Architect ng/ml ng/dl 总 T4 nmol/l Siemens Advia Centaur µg/dl ng/ml nmol/l Siemens Immulite 2000/2500 µg/dl ng/ml nmol/l BioMerieux Vidas µg/dl ng/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, 单位 d Kingdom, BT29 4QY PAGE 9 OF 10

10 货号 IA2638 批号 1304EC 规格 : 10 x 5ml 效期 : 分析物单位靶值低值高值方法总 T4 nmol/l Roche Cobas E411 µg/dl ng/ml nmol/l Abbott Architect µg/dl ng/ml 丙戊酸 µmol/l Siemens Immulite 2000/2500 µg/ml µmol/l Siemens Advia Centaur µg/ml µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml 万古霉素 µmol/l Roche Cobas 6000/8000 µg/ml µmol/l Gravimetric µg/ml 维生素 B12 pmol/l Siemens Advia Centaur pg/ml pmol/l Siemens Immulite 2000 pg/ml pmol/l Roche Cobas E411 pg/ml pmol/l Roche Cobas 6000/8000 pg/ml pmol/l Beckman DxI800 pg/ml pmol/l Beckman Access pg/ml pmol/l Abbott Architect pg/ml RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 10 OF 10

范围分析物单位靶值低值高值方法学 17- 羟基孕酮 nmol/l DRG ELISA ng/ml 羟基维生素 D nmol/l Siemens Advia Centaur nmol/l

范围分析物单位靶值低值高值方法学 17- 羟基孕酮 nmol/l DRG ELISA ng/ml 羟基维生素 D nmol/l Siemens Advia Centaur nmol/l 0843 免疫多项检测用质控品货号 : IA2640 / IA2633 批号 : 1364EC 规格 :10x 5ml / 12 x 5ml 效期 : 2016-10 注释 : : 注册商标 (1). 只适用于德国根据德国内科医生联邦议院的方针制订范围 ( 中文说明已略, 如需请另行参见英文说明 ) (2). 德国内科医生联邦议院官方认可的参考实验室测定的浓度值 (3). DGKC: 德国临床化学协会