Title:
DETECTION KIT CAPABLE OF QUANTITATIVELY ASSAYING HUMAN APOLIPOPROTEIN APOC1 AND DETECTION METHOD THEREFOR
Document Type and Number:
WIPO Patent Application WO/2024/055498
Kind Code:
A1
Abstract:
A detection kit and a detection method for quantitative assay of human apolipoprotein APOC1. The kit comprises an enzyme-labeled plate coated with a capture antibody, a calibrator, a negative quality control reagent, a positive quality control reagent, an enzyme-labeled secondary antibody reagent, a chromogenic solution reagent, a termination solution reagent, and a concentrated washing solution reagent. The detection limit of the kit and the detection method therefor is 0.005 μg/mL. For a detection accuracy reference product, the relative deviation of quantitative results is within a range of ±15%; for the detection of samples having concentrations of 6.25 ng/mL-180 ng/mL, the absolute value of the dose-response curve correlation coefficient (r) is not less than 0.99; for the detection of 1 copy of each of a high and a low repeatability reference material, the coefficient of variation (CV) is not higher than 15% (n=10).
Inventors:
ZHANG XUHUI (CN)
HUANG CHEN (CN)
HE JIEKE (CN)
LIU JINGFENG (CN)
ZHANG YANPING (CN)
GAO XIAOTONG (CN)
HUANG CHEN (CN)
HE JIEKE (CN)
LIU JINGFENG (CN)
ZHANG YANPING (CN)
GAO XIAOTONG (CN)
Application Number:
PCT/CN2023/074081
Publication Date:
March 21, 2024
Filing Date:
February 01, 2023
Export Citation:
Assignee:
GUANGDONG CHENHUI BIOMEDICAL TECH CO LTD (CN)
International Classes:
G01N33/68
Foreign References:
| CN115389494A | 2022-11-25 | |||
| CN111487413A | 2020-08-04 | |||
| CN105652019A | 2016-06-08 | |||
| CN111650372A | 2020-09-11 | |||
| CN114047340A | 2022-02-15 | |||
| EP2950102A1 | 2015-12-02 | |||
| KR20210127552A | 2021-10-22 | |||
| US20150168427A1 | 2015-06-18 |
Other References:
YANG JUAN, CHEN YANNI, XIONG XIAOFAN, ZHOU XIAOBO, HAN LIN, NI LEI, WANG WENJING, WANG XIAOFEI, ZHAO LINGYU, SHAO DONGDONG, HUANG : "Peptidome Analysis Reveals Novel Serum Biomarkers for Children with Autism Spectrum Disorder in China", PROTEOMICS CLINICAL APPLICATIONS, WILEY,, DE, vol. 12, no. 5, 1 September 2018 (2018-09-01), DE , pages 1700164, XP093146250, ISSN: 1862-8346, DOI: 10.1002/prca.201700164
MANLUN ZHAO, LI JIAN, ZHOU JINGLIN, LIU JULIN, JIANG LEI, LI JIANZHAI, LI SONGQUANAI, LI SONGQUAN: "Development of anti-apolipoprotein C1 monoclonal antibodies and establishment of assay methods", JOURNAL OF CELLULAR AND MOLECULAR IMMUNOLOGY, vol. 4, 31 December 1993 (1993-12-31), pages 57 - 59, XP093146252
WONG L, ANDERSON P D, GALLAHER W R, ROHEIM P S: "Monoclonal antibodies to rat C apolipoproteins: production and characterization of a unique antibody whose binding to apoC-I is inhibited by nonionic detergents.", JOURNAL OF LIPID RESEARCH, AMERICAN SOCIETY FOR BIOCHEMISTRY AND MOLECULAR BIOLOGY, INC., US, vol. 26, no. 5, 1 May 1985 (1985-05-01), US , pages 528 - 539, XP093146257, ISSN: 0022-2275, DOI: 10.1016/S0022-2275(20)34339-X
JIAN LI, JIAN LEI, ZHAO MAN-CANG, CHEN WEN XIANG, LI JIAN-ZHAI: "Isolation and Purification of Human Serum Apolipoprotein CⅠ,CⅢ and Preparation of Their Monoclonal Antibodies", CHINESE JOURNAL OF ARTERIOSC LEROSIS, vol. 3, no. 4, 25 December 1995 (1995-12-25), pages 325 - 329, XP093146261
HUI XU, YAN YU-QIN; ZHAO LIN-NA: "Study on the diagnostic value of serum APOC1 level detection in acute upper respiratory tract infection", JOURNAL OF LOGISTICS UNIVERSITY OF PAP(MEDICAL SCIENCES, vol. 30, no. 11, 30 November 2021 (2021-11-30), pages 144 - 145, 187, XP093146263, DOI: 10.16548/j.2095-3720.2021.11.042
YI JIE, REN LIWEN, WU JIE, LI WAN, ZHENG XIANGJIN, DU GUANHUA, WANG JINHUA: "Apolipoprotein C1 (APOC1) as a novel diagnostic and prognostic biomarker for gastric cancer", ANNALS OF TRANSLATIONAL MEDICINE, AME PUBLISHING COMPANY, US, vol. 7, no. 16, 1 August 2019 (2019-08-01), US , pages 380 - 380, XP093146265, ISSN: 2305-5839, DOI: 10.21037/atm.2019.07.59
MANLUN ZHAO, LI JIAN, ZHOU JINGLIN, LIU JULIN, JIANG LEI, LI JIANZHAI, LI SONGQUANAI, LI SONGQUAN: "Development of anti-apolipoprotein C1 monoclonal antibodies and establishment of assay methods", JOURNAL OF CELLULAR AND MOLECULAR IMMUNOLOGY, vol. 4, 31 December 1993 (1993-12-31), pages 57 - 59, XP093146252
WONG L, ANDERSON P D, GALLAHER W R, ROHEIM P S: "Monoclonal antibodies to rat C apolipoproteins: production and characterization of a unique antibody whose binding to apoC-I is inhibited by nonionic detergents.", JOURNAL OF LIPID RESEARCH, AMERICAN SOCIETY FOR BIOCHEMISTRY AND MOLECULAR BIOLOGY, INC., US, vol. 26, no. 5, 1 May 1985 (1985-05-01), US , pages 528 - 539, XP093146257, ISSN: 0022-2275, DOI: 10.1016/S0022-2275(20)34339-X
JIAN LI, JIAN LEI, ZHAO MAN-CANG, CHEN WEN XIANG, LI JIAN-ZHAI: "Isolation and Purification of Human Serum Apolipoprotein CⅠ,CⅢ and Preparation of Their Monoclonal Antibodies", CHINESE JOURNAL OF ARTERIOSC LEROSIS, vol. 3, no. 4, 25 December 1995 (1995-12-25), pages 325 - 329, XP093146261
HUI XU, YAN YU-QIN; ZHAO LIN-NA: "Study on the diagnostic value of serum APOC1 level detection in acute upper respiratory tract infection", JOURNAL OF LOGISTICS UNIVERSITY OF PAP(MEDICAL SCIENCES, vol. 30, no. 11, 30 November 2021 (2021-11-30), pages 144 - 145, 187, XP093146263, DOI: 10.16548/j.2095-3720.2021.11.042
YI JIE, REN LIWEN, WU JIE, LI WAN, ZHENG XIANGJIN, DU GUANHUA, WANG JINHUA: "Apolipoprotein C1 (APOC1) as a novel diagnostic and prognostic biomarker for gastric cancer", ANNALS OF TRANSLATIONAL MEDICINE, AME PUBLISHING COMPANY, US, vol. 7, no. 16, 1 August 2019 (2019-08-01), US , pages 380 - 380, XP093146265, ISSN: 2305-5839, DOI: 10.21037/atm.2019.07.59
Attorney, Agent or Firm:
BEIJING ZHIXING YANGGUANG INTELLECTUAL PROPERTY AGENCY OFFICE (ORDINARY PARTNERSHIP) (CN)
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