CN118050505A - 一种多联检荧光免疫层析检测卡 - Google Patents
一种多联检荧光免疫层析检测卡 Download PDFInfo
- Publication number
- CN118050505A CN118050505A CN202410448775.9A CN202410448775A CN118050505A CN 118050505 A CN118050505 A CN 118050505A CN 202410448775 A CN202410448775 A CN 202410448775A CN 118050505 A CN118050505 A CN 118050505A
- Authority
- CN
- China
- Prior art keywords
- detection
- clone2
- monoclonal antibodies
- tsh
- seq
- 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.)
- Granted
Links
- 238000001514 detection method Methods 0.000 title claims abstract description 62
- 238000003317 immunochromatography Methods 0.000 title claims abstract description 10
- 238000007689 inspection Methods 0.000 title description 3
- 239000000427 antigen Substances 0.000 claims abstract description 29
- 102000036639 antigens Human genes 0.000 claims abstract description 27
- 108091007433 antigens Proteins 0.000 claims abstract description 27
- 239000000020 Nitrocellulose Substances 0.000 claims abstract description 18
- 239000012528 membrane Substances 0.000 claims abstract description 18
- 229920001220 nitrocellulos Polymers 0.000 claims abstract description 18
- 238000012360 testing method Methods 0.000 claims abstract description 15
- 239000002250 absorbent Substances 0.000 claims abstract description 5
- 230000002745 absorbent Effects 0.000 claims abstract description 5
- 239000004005 microsphere Substances 0.000 claims description 21
- 102000011923 Thyrotropin Human genes 0.000 claims description 20
- 108010061174 Thyrotropin Proteins 0.000 claims description 20
- 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 claims description 10
- 239000000126 substance Substances 0.000 claims description 8
- 238000003556 assay Methods 0.000 claims description 7
- 239000000463 material Substances 0.000 claims description 7
- 229940035722 triiodothyronine Drugs 0.000 claims description 7
- 238000003908 quality control method Methods 0.000 claims description 6
- 241000283707 Capra Species 0.000 claims description 3
- 241000287828 Gallus gallus Species 0.000 claims description 3
- 230000002776 aggregation Effects 0.000 claims description 3
- 238000004220 aggregation Methods 0.000 claims description 3
- 238000006243 chemical reaction Methods 0.000 claims description 3
- 230000005284 excitation Effects 0.000 claims description 3
- 239000007850 fluorescent dye Substances 0.000 claims description 3
- 239000004816 latex Substances 0.000 claims description 3
- 229920000126 latex Polymers 0.000 claims description 3
- 239000002096 quantum dot Substances 0.000 claims description 3
- 239000005495 thyroid hormone Substances 0.000 claims description 3
- 229940036555 thyroid hormone Drugs 0.000 claims description 3
- 125000003275 alpha amino acid group Chemical group 0.000 claims 10
- 238000007837 multiplex assay Methods 0.000 claims 4
- 210000001685 thyroid gland Anatomy 0.000 abstract description 7
- 238000013399 early diagnosis Methods 0.000 abstract description 3
- 238000003745 diagnosis Methods 0.000 abstract description 2
- 238000003018 immunoassay Methods 0.000 abstract description 2
- 239000000523 sample Substances 0.000 description 28
- 238000010835 comparative analysis Methods 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 5
- 239000008280 blood Substances 0.000 description 5
- 239000003153 chemical reaction reagent Substances 0.000 description 5
- 238000004458 analytical method Methods 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 206010062767 Hypophysitis Diseases 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 229940088597 hormone Drugs 0.000 description 2
- 239000005556 hormone Substances 0.000 description 2
- 210000003635 pituitary gland Anatomy 0.000 description 2
- 230000035945 sensitivity Effects 0.000 description 2
- 210000002966 serum Anatomy 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
- 238000002965 ELISA Methods 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000012470 diluted sample Substances 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000035484 reaction time Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 239000012898 sample dilution Substances 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 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
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54386—Analytical elements
- G01N33/54387—Immunochromatographic test strips
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
- G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
- G01N21/64—Fluorescence; Phosphorescence
- G01N21/6428—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes"
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
- G01N33/582—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with fluorescent label
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
- G01N33/78—Thyroid gland hormones, e.g. T3, T4, TBH, TBG or their receptors
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Physics & Mathematics (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Biotechnology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Endocrinology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Optics & Photonics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Peptides Or Proteins (AREA)
Abstract
本发明公开了一种多联检荧光免疫层析检测卡,检测卡内含试纸条,试纸条包括样品垫、结合垫、硝酸纤维素膜载体以及吸水纸,硝酸纤维素膜载体上设有三条检测线,检测线上分别包被有甲功三项单克隆抗体一或抗原,甲功三项单克隆抗体一为FT3‑Clone1、TSH‑Clone1,抗原为FT4抗原;结合垫上有甲功三项单克隆抗体二,甲功三项单克隆抗体二为FT3‑Clone2、FT4‑Clone2、TSH‑Clone2。本发明用于制备甲功三项的荧光免疫法联合检测试剂盒,能一次性对三个指标测试,提高甲状腺功能的早期诊断率,避免漏诊,又可以减少误诊,省时且高效。
Description
技术领域
本发明涉及一种检测卡,具体涉及一种多联检荧光免疫层析检测卡。
背景技术
甲功三项:主要是指TSH(促甲状腺激素)、FT3(游离三碘甲状腺原氨酸)和FT4(游离甲状腺素)。根据这三个指标能够查看甲状腺功能的基本情况。TSH是由垂体分泌的一种激素,它能够刺激甲状腺合成和释放FT3和FT4。由甲状腺分泌FT3和FT4激素,它们能够调节身体的各种生理功能。当血液中的FT3和FT4水平过低或过高时,垂体也会相应地调节TSH的分泌,以便维持平衡。因此,通过检测TSH、FT3和FT4的水平,就能够判断出甲状腺功能是否正常。
现有的甲功三项检测方法都存在一定的缺陷,如酶联免疫法反应时间长且自动化程度低,基层应用不便;化学发光法灵敏度高,但是需要昂贵的化学发光仪器,不能检测全血样本,均为项目单检检测耗时,不适于常规临床应用。
而荧光免疫层析法稳定性好、操作简单、响应快速、灵敏度高,可以实现样本的快速和高通量检测,但目前荧光免疫层析法存在试剂盒均为单项检测、抗体特异性差、易受背景干扰、检测样本类型受限等问题。
发明内容
为解决现有荧光免疫层析法存在试剂盒为单项检测、抗体特异性差的问题,本发明提供一种多联检荧光免疫层析检测卡,其在多个检测线上分别包被不同单克隆抗体或抗原,实现多种目标物同时检测的目的。
本发明提供如下技术方案:
一种多联检荧光免疫层析检测卡,检测卡内含试纸条,试纸条包括样品垫、结合垫、硝酸纤维素膜载体以及吸水纸,所述样品垫的一端为加样端,所述样品垫的另一端与结合垫的一端搭接,所述结合垫的另一端与硝酸纤维素膜载体搭接,所述硝酸纤维素膜载体的另一端与吸水纸搭接,所述硝酸纤维素膜载体上设有三条检测线,三条检测线是T1线、T2线、T3线,检测线上分别包被有甲功三项单克隆抗体一和抗原,甲功三项单克隆抗体一分别为FT3-Clone1、TSH-Clone1,抗原是FT4抗原;所述结合垫上有甲功三项单克隆抗体二,甲功三项单克隆抗体二为FT3-Clone2、FT4-Clone2、TSH-Clone2。
FT4抗原:C15H11I4NO4 - BSA
FT3-Clone1-Heavy chain VH
QVTLKESGPGILKPSQTLSLTCSFSGFGLSTGGTGVGWIRQPSGKGLEWLAHIWWDDDRDYNPGLRGQLTISKDTSRNQVFLKITSVDTADTATYYCARGVPTSPFAYWGQGTLVTVS
FT3-Clone1-Light chain VL
DIVMTQSQKFMSTSVGDRVSVTCRAGQNVSTDVAWYQHKPGQSPKALIFGASYRYGGVPDRFIGSGSGTDFTLTISNVQSEDLAEYFCQYYMTYGTFGGGTKLEIK
TSH-Clone1-Heavy chain VH
DVQLQESGPDLVKPSQSLSLTCTVTGYPLTSGYTWHWIRQFPGNCLEWMGYMHYNGSTNYNPSLKSRLSITRDTSKNQFFLQLNSVTTEDTATYYCALLIYYMDYWGQGTSVTVSS
TSH-Clone1-Light chain VL
DVVMTQTPLTLSVTIGQPASISCKSSQSLIDSDGRTYLNWLLQRPGQSPKRLIYIVSKLDSGVPDRFTGSGSGTDFLLKISRVEAEDLGVYYCWQGTSFPQTFGGGTKLEIK
FT3-Clone2-Heavy chain VH
QIQLVQSGPELKNPGETVNISCKTSGYTFTNSGMNWVKQAPGKGLKWMGWINTNTGKPTYADDFKGRFAFSLETSASTAFLQINNLRNEDTATYFCARSGPYYGLYFYTMDYWGQGTSVTVSS
FT3-Clone2-Light chain VL
DILMTQTTSSLSASLGDRVTISCRASQDINNFLNWYQQKPDGTVKFLIYYTSRLHSGVPSRFSGSGSGTDYSLTISNLEQEDIATYFCQQGSSLPWTFGGGTKLDIK
FT4-Clone2-Heavy chain VH
QVQLQQSGTVLARPGASVKLSCTTSGSTFTSYdMHWVKQRPGQGLEWIGTSYPGNGDASYNQRFRDKAKLTAVTSASTAYMELNSLTNEDSAVYYCAREFLVRDYWGQGTTLTVSS
FT4-Clone2-Light chain VL
DIQMTQTTSSLSASLGDRVTISCKASQDIENYLMWFQQKPDGTFKLLIYTTSRLGSGVPSRFSGSGSGTDYSLTITNLEEEDVATYFCQYGDVLPATFGSGTKLEIK
TSH-Clone2-Heavy chain VH
EVQVQQSGAELVRSGTSVKLSCTASGFNDKDYYFHWVIQRPEQGLEWIGWLDAGNGATEYAPKFQVKATMTADTSSNTAYLQLTSLTSEDTAVYFCNARKYAGYYTMDKWGQGTSVTVSS
TSH-Clone2-Light chain VL
QIVLSQSPAILSASPGEKVTMTCRASSSLSYMYWYQQKAGSSPKTWIYATDNLASGVPVRFSGSGSGTSYSLTISRVEAEDAATYYCQSWSSNPYTFGGGTRLEIK
进一步的,单克隆抗体二上偶联的检测信标物质不同,检测信标物质为荧光染料、荧光微球、胶乳微球、量子点微球、聚集诱导发光材料、上转换发光材料中的一种或几种。
进一步的,所述检测线上的多个特异性单抗或抗原,单抗为鼠抗人促甲状腺激素单抗一(TSH-Clone1)、鼠抗人三碘甲状腺原氨酸单抗一(FT3-Clone1),抗原为甲状腺激素重组抗原(FT4抗原);
所述结合垫上的标记单抗为鼠抗人促甲状腺激素单抗二(TSH-Clone2)-荧光微球偶联物、鼠抗人三碘甲状腺原氨酸单抗二(FT3-Clone2)-荧光微球偶联物、鼠抗人甲状腺激素单抗二(FT4-Clone2)-荧光微球偶联物。
进一步的,所述硝酸纤维素膜载体上设有质控线,质控线上设有独立抗体羊抗鸡IgY;结合垫上设有标记鸡IgY抗体-荧光微球偶联物。
进一步的,所述检测信标物质的激发光波长为365nm。
与现有技术相比,本发明的有益效果是:本申请用于制备甲功三项(FT3/FT4/TSH)的荧光免疫法联合检测试剂盒优势,
可实现一次性对三个指标测试,提高甲状腺功能的早期诊断率,避免漏诊,又可以减少误诊,省时且高效;
可以减少操作次数,降低人为操作失误率;
生成的数据量更少,更易管理,因而分析起来更加轻松;
样本类型同时支持血清/血浆/全血/指尖血,满足不同场景需求。
附图说明
图1为本发明检测卡结构示意图。
图2为本发明结构示意图。
图3为试剂盒检测样本中FT3的线性范围检测结果图。
图4为试剂盒检测样本中FT4的线性范围检测结果图。
图5为试剂盒检测样本中TSH的线性范围检测结果图。
图6为TSH临床样本对比分析图。
图7为FT3临床样本对比分析图。
图8为FT4临床样本对比分析图。
图中:1、样品垫;2、结合垫;3、硝酸纤维素膜载体;4、吸水纸;5、加样端。
实施方式
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
请参阅图1-2,本发明的一种多联检荧光免疫层析检测卡,检测卡内含试纸条,试纸条包括样品垫1、结合垫2、硝酸纤维素膜载体3以及吸水纸4,样品垫1的一端为加样端5,样品垫1的另一端与结合垫2的一端搭接,结合垫2的另一端与硝酸纤维素膜载体3搭接,硝酸纤维素膜载体3的另一端与吸水纸4搭接,硝酸纤维素膜载体3上设有三条检测线,三条检测线是T1线、T2线、T3线,检测线上分别包被有甲功三项单克隆抗体一或抗原,甲功三项单克隆抗体一分别为FT3-Clone1、TSH-Clone1,抗原为FT4抗原;结合垫上有甲功三项单克隆抗体二,甲功三项单克隆抗体二为FT3-Clone2、FT4-Clone2、TSH-Clone2。
各种单克隆抗体二上偶联的检测信标物质不同。检测信标物质为荧光染料、荧光微球、胶乳微球、量子点微球、聚集诱导发光材料、上转换发光材料中的一种或几种。
检测线上的多个特异性单抗或抗原,单抗为鼠抗人促甲状腺激素单抗一(TSH-Clone1)、鼠抗人三碘甲状腺原氨酸单抗一(FT3-Clone1),抗原为甲状腺激素重组抗原(FT4抗原);
结合垫上的标记单抗为鼠抗人促甲状腺激素单抗二(TSH-Clone2)-荧光微球偶联物、鼠抗人三碘甲状腺原氨酸单抗二(FT3-Clone2)-荧光微球偶联物、鼠抗人甲状腺激素单抗二(FT4-Clone2)-荧光微球偶联物。
硝酸纤维素膜载体上设有质控线,质控线上设有独立抗体羊抗鸡IgY;结合垫上设有标记鸡IgY抗体-荧光微球偶联物。
检测信标物质的激发光波长为365nm。
图3为试剂盒检测样本中FT3的线性范围检测结果图,结果显示试剂盒FT3的检测线性范围为1.5-50pmol/L。
图4为试剂盒检测样本中FT4的线性范围检测结果图,结果显示试剂盒FT4的检测线性范围为6.4-77.2pmol/L。
图5为试剂盒检测样本中TSH的线性范围检测结果图,结果显示试剂盒FT4的检测线性范围为0.1-100μIU/mL。
检测方法:
(1)准备:使用前将试剂条、样本恢复至室温,从铝箔包装袋中取出检测卡,将其置于一水平、干燥的平面上;
(2)录入试剂参数:点击“录入试剂参数”,扫描试剂盒上的二维码,录入试剂名称和试剂批次;
(3)样本稀释:吸取50μL血清、血浆或全血至0.1mL稀释液中,混匀后加样;
(4)加样:选择样本类型,将检测卡插入展板仓后,在检测卡的样本孔上垂直滴加100μL稀释后的样本。
(5)测量:将反应后的检测卡插入检测设备,按仪器说明书进行测试,并确认结果。
表一40份TSH临床样本检测结果分析表(μIU/mL):
表二40份FT3临床样本检测结果分析表(pmol/L):
表三40份FT4临床样本检测结果分析表(pmol/L):
图6为TSH临床样本对比分析图,图7为FT3临床样本对比分析图,图8为FT4临床样本对比分析图。实验证明:本发明的多联检荧光免疫层析检测卡,在多个检测线上分别包被不同单克隆抗体或抗原,实现多种目标物同时检测的目的,对甲功三项(FT3/FT4/TSH)进行检测,可实现一次性对三个指标测试,抗体特异性好、不受背景干扰,提高甲状腺功能的早期诊断率。
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限定。
Claims (5)
1.一种多联检荧光免疫层析检测卡,其特征在于:检测卡内含试纸条,试纸条包括样品垫(1)、结合垫(2)、硝酸纤维素膜载体(3)以及吸水纸(4),所述样品垫(1)的一端为加样端(5),所述样品垫(1)的另一端与结合垫(2)的一端搭接,所述结合垫(2)的另一端与硝酸纤维素膜载体(3)搭接,所述硝酸纤维素膜载体(3)的另一端与吸水纸(4)搭接,所述硝酸纤维素膜载体(3)上设有三条检测线,三条检测线是T1线、T2线、T3线,检测线上分别包被有甲功三项单克隆抗体一或抗原,甲功三项单克隆抗体一分别为FT3-Clone1、TSH-Clone1,抗原为FT4抗原;所述结合垫上有甲功三项单克隆抗体二,甲功三项单克隆抗体二为FT3-Clone2、FT4-Clone2、TSH-Clone2;
所述FT4抗原的分子式为C15H11I4NO4 - BSA;
所述FT3-Clone1的重链可变区氨基酸序列如SEQ ID NO.1所示,所述FT3-Clone1的轻链可变区氨基酸序列如SEQ ID NO.2所示;
所述TSH-Clone1的重链可变区氨基酸序列如SEQ ID NO.3所示,所述TSH-Clone1的轻链可变区氨基酸序列如SEQ ID NO.4所示;
所述FT3-Clone2的重链可变区氨基酸序列如SEQ ID NO.5所示,所述FT3-Clone2的轻链可变区氨基酸序列如SEQ ID NO.6所示;
所述FT4-Clone2的重链可变区氨基酸序列如SEQ ID NO.7所示,所述FT4-Clone2的轻链可变区氨基酸序列如SEQ ID NO.8所示;
所述TSH-Clone2的重链可变区氨基酸序列如SEQ ID NO.9所示,所述TSH-Clone2的轻链可变区氨基酸序列如SEQ ID NO.10所示。
2.根据权利要求1所述的一种多联检荧光免疫层析检测卡,其特征在于:各种单克隆抗体二上偶联的检测信标物质不同,检测信标物质为荧光染料、荧光微球、胶乳微球、量子点微球、聚集诱导发光材料、上转换发光材料中的一种或几种。
3.根据权利要求1所述的一种多联检荧光免疫层析检测卡,其特征在于:所述检测线上的多个特异性单抗或抗原,单抗为鼠抗人促甲状腺激素单抗一、鼠抗人三碘甲状腺原氨酸单抗一,抗原为甲状腺激素重组抗原;所述结合垫上的标记单抗为鼠抗人促甲状腺激素单抗二-荧光微球偶联物、鼠抗人三碘甲状腺原氨酸单抗二-荧光微球偶联物、鼠抗人甲状腺激素单抗二-荧光微球偶联物。
4.根据权利要求1所述的一种多联检荧光免疫层析检测卡,其特征在于:所述硝酸纤维素膜载体上设有质控线,质控线上设有独立抗体羊抗鸡IgY;结合垫上设有标记鸡IgY抗体-荧光微球偶联物。
5.根据权利要求1所述的一种多联检荧光免疫层析检测卡,其特征在于:所述检测信标物质的激发光波长为365nm。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202410448775.9A CN118050505B (zh) | 2024-04-15 | 2024-04-15 | 一种多联检荧光免疫层析检测卡 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202410448775.9A CN118050505B (zh) | 2024-04-15 | 2024-04-15 | 一种多联检荧光免疫层析检测卡 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN118050505A true CN118050505A (zh) | 2024-05-17 |
CN118050505B CN118050505B (zh) | 2024-06-21 |
Family
ID=91046894
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202410448775.9A Active CN118050505B (zh) | 2024-04-15 | 2024-04-15 | 一种多联检荧光免疫层析检测卡 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN118050505B (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN118243918A (zh) * | 2024-05-28 | 2024-06-25 | 南京佰抗生物科技有限公司 | 一种用于干式荧光免疫检测的光路模块 |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108084263A (zh) * | 2016-12-16 | 2018-05-29 | 苏州旭光科星生物技术有限公司 | 一种抗人cd25嵌合单克隆抗体及其制备方法和应用 |
KR20190112299A (ko) * | 2017-01-27 | 2019-10-04 | 울트라휴먼 원 리미티드 | 결합제 |
CN110749738A (zh) * | 2019-10-30 | 2020-02-04 | 南京佰抗生物科技有限公司 | 一种检测胃泌素-17的试剂盒及其制备方法 |
CN215116313U (zh) * | 2021-05-21 | 2021-12-10 | 北京易斯威特生物科技股份有限公司 | 一种甲状腺功能联合检测试剂盒 |
WO2023103827A1 (zh) * | 2021-12-07 | 2023-06-15 | 郑州安图生物工程股份有限公司 | 一种促甲状腺激素受体抗原试剂及促甲状腺激素受体抗体定量检测试剂盒 |
CN116413444A (zh) * | 2021-12-29 | 2023-07-11 | 广州达安基因股份有限公司 | 一种检测总三碘甲状腺原氨酸含量的试剂盒及其检测方法 |
-
2024
- 2024-04-15 CN CN202410448775.9A patent/CN118050505B/zh active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108084263A (zh) * | 2016-12-16 | 2018-05-29 | 苏州旭光科星生物技术有限公司 | 一种抗人cd25嵌合单克隆抗体及其制备方法和应用 |
KR20190112299A (ko) * | 2017-01-27 | 2019-10-04 | 울트라휴먼 원 리미티드 | 결합제 |
CN110749738A (zh) * | 2019-10-30 | 2020-02-04 | 南京佰抗生物科技有限公司 | 一种检测胃泌素-17的试剂盒及其制备方法 |
CN215116313U (zh) * | 2021-05-21 | 2021-12-10 | 北京易斯威特生物科技股份有限公司 | 一种甲状腺功能联合检测试剂盒 |
WO2023103827A1 (zh) * | 2021-12-07 | 2023-06-15 | 郑州安图生物工程股份有限公司 | 一种促甲状腺激素受体抗原试剂及促甲状腺激素受体抗体定量检测试剂盒 |
CN116413444A (zh) * | 2021-12-29 | 2023-07-11 | 广州达安基因股份有限公司 | 一种检测总三碘甲状腺原氨酸含量的试剂盒及其检测方法 |
Non-Patent Citations (1)
Title |
---|
KAZEROUNI F 等: "Performance characteristics of three automated immunoassays for thyroid hormones", CASPIAN J INTERN MED, vol. 3, no. 2, 31 December 2012 (2012-12-31), pages 400 - 404 * |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN118243918A (zh) * | 2024-05-28 | 2024-06-25 | 南京佰抗生物科技有限公司 | 一种用于干式荧光免疫检测的光路模块 |
Also Published As
Publication number | Publication date |
---|---|
CN118050505B (zh) | 2024-06-21 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN118050505B (zh) | 一种多联检荧光免疫层析检测卡 | |
KR970007079B1 (ko) | 주변 분석물의 농도 측정 방법 | |
EP1965212B1 (en) | Non-liquid phase type chemiluminescent enzyme immunoassay method and assay kit | |
CN105403698A (zh) | 采用内部校正系统的诊断性试验试剂盒 | |
CN105891508A (zh) | 一种快速定量检测h-fabp的时间分辨荧光免疫层析试剂及制备方法 | |
CN106706926A (zh) | 血清淀粉样蛋白a测定试剂盒及制作方法 | |
CN108333344A (zh) | 高灵敏度的化学发光免疫分析试剂盒及其制备方法和应用 | |
CN108593919A (zh) | 一种胶体金免疫层析试纸及其制备方法和应用 | |
CN108318690A (zh) | 一种免疫荧光层析试纸及其制备方法和应用 | |
CN114324901B (zh) | 一种扩展定量检测范围的试剂盒及检测方法 | |
CN106959372A (zh) | 血清淀粉样蛋白a和c‑反应蛋白二合一测定试剂盒及制法 | |
CN208367017U (zh) | 血清淀粉样蛋白a免疫层析定量检测试纸条 | |
CN109239326A (zh) | 基于磁颗粒纳米酶的微流控免疫芯片分析方法及应用 | |
JP2007064766A (ja) | 被検物質の検出方法、増感剤及びイムノクロマトグラフィー用キット | |
CN107656048A (zh) | 一种半定量检测抗原或抗体的免疫层析试纸条及其应用 | |
CN113740543A (zh) | 一种快速检测糖化血红蛋白比例的试剂盒及其制备方法 | |
CN106771264A (zh) | 促甲状腺激素测定试剂盒及制作方法 | |
CN106198964A (zh) | 一种卡式蛋白芯片及其应用 | |
CN109884294B (zh) | 一种具有高精密度的荧光免疫试纸条制备方法 | |
CN205049575U (zh) | 一种降钙素原(pct)定量检测试剂盒 | |
CN205049578U (zh) | N末端脑钠肽(NT-proBNP)定量检测试剂盒 | |
US20080166740A1 (en) | Multiple immunochemistry assays on an element | |
CN113466450B (zh) | 一种多联检免疫层析试剂卡以及多联检免疫层析检测方法 | |
CN207396501U (zh) | 一种半定量检测抗原或抗体的免疫层析试纸条 | |
CN110488024A (zh) | 采用荧光技术检测多种待检测物质的方法及荧光检测产品 |
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 | ||
GR01 | Patent grant | ||
GR01 | Patent grant |