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1. CN109633189 - Fluorescent standard card and test method for calibration and quality control of fluorescent immunoassay analyzer

Office
Chine
Numéro de la demande 201910104547.9
Date de la demande 01.02.2019
Numéro de publication 109633189
Date de publication 16.04.2019
Type de publication A
CIB
G01N 35/00
GPHYSIQUE
01MÉTROLOGIE; TESTS
NRECHERCHE OU ANALYSE DES MATÉRIAUX PAR DÉTERMINATION DE LEURS PROPRIÉTÉS CHIMIQUES OU PHYSIQUES
35Analyse automatique non limitée à des procédés ou à des matériaux spécifiés dans un seul des groupes G01N1/-G01N33/153; Manipulation de matériaux à cet effet
G01N 21/64
GPHYSIQUE
01MÉTROLOGIE; TESTS
NRECHERCHE OU ANALYSE DES MATÉRIAUX PAR DÉTERMINATION DE LEURS PROPRIÉTÉS CHIMIQUES OU PHYSIQUES
21Recherche ou analyse des matériaux par l'utilisation de moyens optiques, c. à d. en utilisant des rayons infrarouges, visibles ou ultraviolets
62Systèmes dans lesquels le matériau analysé est excité de façon à ce qu'il émette de la lumière ou qu'il produise un changement de la longueur d'onde de la lumière incidente
63excité optiquement
64Fluorescence; Phosphorescence
CPC
G01N 21/64
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
21Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
63optically excited
64Fluorescence; Phosphorescence
G01N 35/00623
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
35Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
00584Control arrangements for automatic analysers
00594Quality control, including calibration or testing of components of the analyser
00613Quality control
00623of instruments
G01N 35/00693
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
35Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
00584Control arrangements for automatic analysers
00594Quality control, including calibration or testing of components of the analyser
00693Calibration
G01N 2021/6497
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
21Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
63optically excited
64Fluorescence; Phosphorescence
6497Miscellaneous applications
G01N 2035/00633
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
35Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
00584Control arrangements for automatic analysers
00594Quality control, including calibration or testing of components of the analyser
00613Quality control
00623of instruments
00633logging process history of individual samples
G01N 2035/00702
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
35Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
00584Control arrangements for automatic analysers
00594Quality control, including calibration or testing of components of the analyser
00693Calibration
00702Curve-fitting; Parameter matching; Calibration constants
Déposants SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO., LTD.
深圳市金准生物医学工程有限公司
Inventeurs ZHAO RUIXIONG
招睿雄
JIANG TINGYAN
蒋庭彦
DU PEISHEN
杜沛深
WANG JIONG
王炯
LI HAOBO
李浩勃
ZHANG ERYING
张二盈
ZHANG GUOJIAN
章国建
Mandataires 深圳市精英专利事务所 44242
Titre
(EN) Fluorescent standard card and test method for calibration and quality control of fluorescent immunoassay analyzer
(ZH) 用于荧光免疫分析仪校准和质控的荧光标准卡及测试方法
Abrégé
(EN)
The invention discloses a fluorescent standard card for calibration and quality control of a fluorescent immunoassay analyzer. The fluorescent standard card comprises a fluorescent standard card bodyand a fluorescent detecting unit. The fluorescent detecting unit is made of a fluorescent solution, a photocurable fluorescent material, fluorescent printing ink or fluorescent ink. Compared with theuse of a quality control product, reference product or standard product, the fluorescent standard card has the characteristics of stable luminescent properties, being not easy to decay with time, highline width precision, uniform spatial distribution of fluorescent substances, linearity of fluorescent substance amount and fluorescent intensity and great preparation consistency. The invention further discloses a test method. The method and parameters of a fluorescent standard card evaluation device are established. The method has the advantages of complete evaluation content and easy operation, is a systematic measurement and evaluation scheme, is beneficial for calibration and quality control of the fluorescent immunoassay analyzer, and improves the detection accuracy of the fluorescent immunoassay analyzer. The traceability scheme of each method can reliably ensure that the properties of the fluorescent standard card are strictly controlled during production and use.

(ZH)
本发明公开了一种用于荧光免疫分析仪校准和质控的荧光标准卡,包括荧光标准卡本体和荧光检测单元,荧光检测单元由荧光溶液、光固化荧光材料、荧光油墨或荧光墨水制得。所述荧光标准卡与使用质控品、参考品或标准品相比,具有发光性质稳定、不易随时间衰减,线宽精度高、荧光物质空间分布均匀,荧光物质的量和荧光强度呈线性以及制备一致性好的特点。还公开了一种测试方法,建立了一种荧光标准卡评估设备的方法和参数,该方法评估内容完整、易于操作,是一套系统的测量评估方案,有利于对荧光免疫分析仪进行校准和质控,提高了荧光免疫分析仪的检测准确性,以及各方法的溯源方案,能够可靠保证荧光标准卡在制作和使用过程中本身的属性严谨受控。

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