CN112684189A - 改进tsh检测结果一致性的定标方法、tsh候选标准物质及其制备方法 - Google Patents
改进tsh检测结果一致性的定标方法、tsh候选标准物质及其制备方法 Download PDFInfo
- Publication number
- CN112684189A CN112684189A CN202011282093.3A CN202011282093A CN112684189A CN 112684189 A CN112684189 A CN 112684189A CN 202011282093 A CN202011282093 A CN 202011282093A CN 112684189 A CN112684189 A CN 112684189A
- Authority
- CN
- China
- Prior art keywords
- tsh
- concentration
- standard substance
- candidate
- serum
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000126 substance Substances 0.000 title claims abstract description 165
- 238000001514 detection method Methods 0.000 title claims abstract description 92
- 238000000034 method Methods 0.000 title claims abstract description 39
- 238000002360 preparation method Methods 0.000 title claims abstract description 9
- 210000002966 serum Anatomy 0.000 claims abstract description 80
- 238000002156 mixing Methods 0.000 claims abstract description 16
- 238000000338 in vitro Methods 0.000 claims abstract description 6
- 239000000243 solution Substances 0.000 claims description 71
- 108091003079 Bovine Serum Albumin Proteins 0.000 claims description 27
- 229940098773 bovine serum albumin Drugs 0.000 claims description 27
- 238000010790 dilution Methods 0.000 claims description 24
- 239000012895 dilution Substances 0.000 claims description 24
- 239000012981 Hank's balanced salt solution Substances 0.000 claims description 18
- 239000011550 stock solution Substances 0.000 claims description 15
- 239000003085 diluting agent Substances 0.000 claims description 12
- 238000012360 testing method Methods 0.000 claims description 10
- 238000005303 weighing Methods 0.000 claims description 10
- 238000007865 diluting Methods 0.000 claims description 5
- 230000008569 process Effects 0.000 claims description 5
- 238000012935 Averaging Methods 0.000 claims description 3
- 238000003908 quality control method Methods 0.000 claims description 3
- 230000001976 improved effect Effects 0.000 abstract description 8
- 239000003153 chemical reaction reagent Substances 0.000 abstract description 6
- 102000011923 Thyrotropin Human genes 0.000 description 324
- 108010061174 Thyrotropin Proteins 0.000 description 324
- 102100025643 60S ribosomal protein L12 Human genes 0.000 description 25
- 239000000758 substrate Substances 0.000 description 16
- 239000007788 liquid Substances 0.000 description 10
- 238000003018 immunoassay Methods 0.000 description 6
- 206010018910 Haemolysis Diseases 0.000 description 4
- 206010023126 Jaundice Diseases 0.000 description 4
- 230000008588 hemolysis Effects 0.000 description 4
- 230000006872 improvement Effects 0.000 description 4
- 238000005259 measurement Methods 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 238000003127 radioimmunoassay Methods 0.000 description 4
- 230000002159 abnormal effect Effects 0.000 description 3
- 238000003745 diagnosis Methods 0.000 description 3
- 238000004445 quantitative analysis Methods 0.000 description 3
- 108010062540 Chorionic Gonadotropin Proteins 0.000 description 2
- 102000011022 Chorionic Gonadotropin Human genes 0.000 description 2
- 102000012673 Follicle Stimulating Hormone Human genes 0.000 description 2
- 108010079345 Follicle Stimulating Hormone Proteins 0.000 description 2
- 102000009151 Luteinizing Hormone Human genes 0.000 description 2
- 108010073521 Luteinizing Hormone Proteins 0.000 description 2
- 210000001268 chyle Anatomy 0.000 description 2
- 238000001739 density measurement Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000011984 electrochemiluminescence immunoassay Methods 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 229940028334 follicle stimulating hormone Drugs 0.000 description 2
- 229940088597 hormone Drugs 0.000 description 2
- 239000005556 hormone Substances 0.000 description 2
- 229940084986 human chorionic gonadotropin Drugs 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 229940040129 luteinizing hormone Drugs 0.000 description 2
- 239000011259 mixed solution Substances 0.000 description 2
- 239000008055 phosphate buffer solution Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- XUIIKFGFIJCVMT-GFCCVEGCSA-N D-thyroxine Chemical compound IC1=CC(C[C@@H](N)C(O)=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-GFCCVEGCSA-N 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000003886 Glycoproteins Human genes 0.000 description 1
- 108090000288 Glycoproteins Proteins 0.000 description 1
- AUYYCJSJGJYCDS-LBPRGKRZSA-N Thyrolar Chemical compound IC1=CC(C[C@H](N)C(O)=O)=CC(I)=C1OC1=CC=C(O)C(I)=C1 AUYYCJSJGJYCDS-LBPRGKRZSA-N 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 210000003651 basophil Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008827 biological function Effects 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 238000011088 calibration curve Methods 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 238000011545 laboratory measurement Methods 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 239000011859 microparticle Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 238000012113 quantitative test Methods 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 238000013207 serial dilution Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 210000001685 thyroid gland Anatomy 0.000 description 1
- 208000021510 thyroid gland disease Diseases 0.000 description 1
- 229940034208 thyroxine Drugs 0.000 description 1
- XUIIKFGFIJCVMT-UHFFFAOYSA-N thyroxine-binding globulin Natural products IC1=CC(CC([NH3+])C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-UHFFFAOYSA-N 0.000 description 1
- 229940035722 triiodothyronine Drugs 0.000 description 1
Images
Landscapes
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Description
Claims (9)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202011282093.3A CN112684189A (zh) | 2020-11-17 | 2020-11-17 | 改进tsh检测结果一致性的定标方法、tsh候选标准物质及其制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202011282093.3A CN112684189A (zh) | 2020-11-17 | 2020-11-17 | 改进tsh检测结果一致性的定标方法、tsh候选标准物质及其制备方法 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN112684189A true CN112684189A (zh) | 2021-04-20 |
Family
ID=75446027
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202011282093.3A Pending CN112684189A (zh) | 2020-11-17 | 2020-11-17 | 改进tsh检测结果一致性的定标方法、tsh候选标准物质及其制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN112684189A (zh) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN113219182A (zh) * | 2021-06-03 | 2021-08-06 | 首都医科大学附属北京朝阳医院 | 一种利用室间质量评价数据分析tsh多***可比性的方法 |
CN113740523A (zh) * | 2021-09-14 | 2021-12-03 | 首都医科大学附属北京朝阳医院 | 一种基于量值溯源的tsh多***赋值方法 |
CN114200139A (zh) * | 2021-12-01 | 2022-03-18 | 首都医科大学附属北京朝阳医院 | 一种癌胚抗原参考物质准确赋值的方法 |
CN115831382A (zh) * | 2022-12-26 | 2023-03-21 | 北京大学第三医院(北京大学第三临床医学院) | 激素检测数据的转换方法和*** |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB1528312A (en) * | 1976-05-03 | 1978-10-11 | Mallinckrodt Inc | System for use in a radioimmunoassay for human thyrotropic hormone |
US20120322163A1 (en) * | 2009-11-11 | 2012-12-20 | Gentian As | Immunoassay for assessing related analytes of different origin |
CN106226425A (zh) * | 2016-07-15 | 2016-12-14 | 首都医科大学附属北京朝阳医院 | 血清糖化白蛋白检测方法及其专用候选标准物质 |
CN108303548A (zh) * | 2018-02-08 | 2018-07-20 | 北京市临床检验中心 | 一种改进c反应蛋白检测结果一致性的定标方法 |
CN108333021A (zh) * | 2018-02-08 | 2018-07-27 | 北京市临床检验中心 | 一种基于量值溯源的c反应蛋白多***定值方法 |
-
2020
- 2020-11-17 CN CN202011282093.3A patent/CN112684189A/zh active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB1528312A (en) * | 1976-05-03 | 1978-10-11 | Mallinckrodt Inc | System for use in a radioimmunoassay for human thyrotropic hormone |
US20120322163A1 (en) * | 2009-11-11 | 2012-12-20 | Gentian As | Immunoassay for assessing related analytes of different origin |
CN106226425A (zh) * | 2016-07-15 | 2016-12-14 | 首都医科大学附属北京朝阳医院 | 血清糖化白蛋白检测方法及其专用候选标准物质 |
CN108303548A (zh) * | 2018-02-08 | 2018-07-20 | 北京市临床检验中心 | 一种改进c反应蛋白检测结果一致性的定标方法 |
CN108333021A (zh) * | 2018-02-08 | 2018-07-27 | 北京市临床检验中心 | 一种基于量值溯源的c反应蛋白多***定值方法 |
Non-Patent Citations (6)
Title |
---|
于婷 等: "甲状腺素(T_4)第三次免疫测定用国家标准品的建立", 放射免疫学杂志, no. 06, pages 773 - 776 * |
刘英 等: "循证医学方法对TRIFMA与ECLIA测定TSH方法学评价", 职业卫生与病伤, no. 03, pages 165 - 167 * |
杜彦丹 等: "Roche E2010检测***测定促甲状腺激素(TSH)分析灵敏度与功能灵敏度的验证", 内蒙古医学杂志, no. 05, pages 568 - 570 * |
赵敏 等: "甲功五项化学发光免疫分析的基质效应对临床测值的影响", 现代生物医学进展, no. 19, pages 3714 - 3718 * |
赵静峰 等: "全自动微粒子化学发光免疫分析法与放射免疫分析法测定血清促甲状腺激素的对比分析", 实用心脑肺血管病杂志, no. 09, pages 96 * |
闫玉峰 等: "IFCC 促甲状腺激素国际溯源和检测一致性系列研究", 国际检验医学杂志, vol. 37, no. 4, pages 496 - 498 * |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN113219182A (zh) * | 2021-06-03 | 2021-08-06 | 首都医科大学附属北京朝阳医院 | 一种利用室间质量评价数据分析tsh多***可比性的方法 |
CN113219182B (zh) * | 2021-06-03 | 2022-10-14 | 首都医科大学附属北京朝阳医院 | 一种利用室间质量评价数据分析tsh多***可比性的方法 |
CN113740523A (zh) * | 2021-09-14 | 2021-12-03 | 首都医科大学附属北京朝阳医院 | 一种基于量值溯源的tsh多***赋值方法 |
CN114200139A (zh) * | 2021-12-01 | 2022-03-18 | 首都医科大学附属北京朝阳医院 | 一种癌胚抗原参考物质准确赋值的方法 |
CN114200139B (zh) * | 2021-12-01 | 2024-06-11 | 首都医科大学附属北京朝阳医院 | 一种癌胚抗原参考物质准确赋值的方法 |
CN115831382A (zh) * | 2022-12-26 | 2023-03-21 | 北京大学第三医院(北京大学第三临床医学院) | 激素检测数据的转换方法和*** |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN112684189A (zh) | 改进tsh检测结果一致性的定标方法、tsh候选标准物质及其制备方法 | |
AU694144B2 (en) | Cytological screening method | |
Sánchez-Carbayo et al. | Analytical and clinical evaluation of TSH and thyroid hormones by electrochemiluminescent immunoassays | |
McClelland et al. | A multicentre study into the reliability of steroid receptor immunocytochemical assay quantification | |
CA2596204C (en) | Method and system for determining an optimal dilution of a reagent | |
US8417002B2 (en) | Method for analyzing image data relating to agglutination assays | |
US11808765B2 (en) | Method and device for detecting excessive antigen concentration and storage medium | |
CN108613977A (zh) | 一种n末端脑钠肽前体检测试剂盒及其检测方法 | |
CN113219182B (zh) | 一种利用室间质量评价数据分析tsh多***可比性的方法 | |
CN112014577B (zh) | 一种提高gpc3检测灵敏度的试剂盒及其制备方法 | |
CN109297953A (zh) | 一种血清中c-肽含量的化学发光法测定试剂盒及检测方法 | |
CN108362892B (zh) | 一种降钙素原胶体金免疫比浊法检测试剂 | |
CN102288604A (zh) | 一种***锌浓度定量检测试剂盒及其应用 | |
CN109324192A (zh) | 快速定量检测抗核抗体含量的检测方法 | |
CN111308079B (zh) | 一种提高胶体金免疫层析平台定量分析准确度的方法 | |
CN107516014B (zh) | 定性和定量测量数据的计量学处理方法 | |
Dessauer | Analytical requirements for biochemical bone marker assays | |
CN114496293A (zh) | Covid-19患者重症风险预测模型的构建方法和构建*** | |
CN112326956A (zh) | 一种肿瘤特异性生长因子胶乳增强免疫比浊法检测试剂盒及其制备方法 | |
CN113740523A (zh) | 一种基于量值溯源的tsh多***赋值方法 | |
Hölzel | Analytical variation in immunoassays and its importance for medical decision making | |
CN113063947B (zh) | 一种检测血清淀粉样蛋白a的试剂盒、***及方法 | |
CN113337348B (zh) | 一种吖啶脂化学发光清洗液 | |
CN116837142B (zh) | 一种断裂点簇集区艾贝尔逊白血病病毒校准品及其制备方法和应用 | |
CN115856279A (zh) | 免疫检测主曲线的校准方法 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
CB03 | Change of inventor or designer information | ||
CB03 | Change of inventor or designer information |
Inventor after: Zhang Shunli Inventor after: Yin Hongyi Inventor after: Zhang Rui Inventor after: Cui Ruifang Inventor after: Sang Lu Inventor after: Yue Yuhong Inventor after: Wang Qingtao Inventor after: Cheng Fei Inventor after: Mo Yu Inventor after: Wang Hua Inventor after: Gao Ruifeng Inventor after: Jia Tingting Inventor after: Wang Mo Inventor before: Zhang Shunli Inventor before: Yin Hongyi Inventor before: Zhang Rui Inventor before: Yue Yuhong Inventor before: Cui Ruifang Inventor before: Sang Lu Inventor before: Wang Qingtao Inventor before: Wei Xing Inventor before: Cheng Fei Inventor before: Mo Yu Inventor before: Wang Hua Inventor before: Gao Ruifeng Inventor before: Jia Tingting Inventor before: Wang Mo |
|
TA01 | Transfer of patent application right | ||
TA01 | Transfer of patent application right |
Effective date of registration: 20231120 Address after: 100020 laboratory b305, 3rd floor, outpatient building, Beijing Chaoyang Hospital, 8 Gongti South Road, Chaoyang District, Beijing Applicant after: BEIJING CHAO-YANG HOSPITAL, CAPITAL MEDICAL University Applicant after: BEIJING CENTER FOR CLINICAL LABORATORY Address before: 100020 laboratory b305, 3rd floor, outpatient building, Beijing Chaoyang Hospital, 8 Gongti South Road, Chaoyang District, Beijing Applicant before: BEIJING CHAO-YANG HOSPITAL, CAPITAL MEDICAL University Applicant before: BEIJING CENTER FOR CLINICAL LABORATORY Applicant before: BEIJING HUANUO AOMEI GENE BIOTECHNOLOGY CO.,LTD. |