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1. (WO2019007868) AUTOMATED CLINICAL DIAGNOSTIC SYSTEM AND METHOD
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Pub. No.: WO/2019/007868 International Application No.: PCT/EP2018/067739
Publication Date: 10.01.2019 International Filing Date: 02.07.2018
IPC:
G01N 1/40 (2006.01) ,G01N 35/00 (2006.01) ,G01N 30/72 (2006.01) ,G01N 30/88 (2006.01)
G PHYSICS
01
MEASURING; TESTING
N
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
1
Sampling; Preparing specimens for investigation
28
Preparing specimens for investigation
40
Concentrating samples
G PHYSICS
01
MEASURING; TESTING
N
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
35
Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/-G01N33/148; Handling materials therefor
G PHYSICS
01
MEASURING; TESTING
N
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
30
Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography
02
Column chromatography
62
Detectors specially adapted therefor
72
Mass spectrometers
G PHYSICS
01
MEASURING; TESTING
N
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
30
Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography
02
Column chromatography
88
Integrated analysis systems specially adapted therefor, not covered by a single one of groups G01N30/04-G01N30/86146
Applicants:
F. HOFFMANN-LA ROCHE AG [CH/CH]; Grenzacherstrasse 124 4070 Basel, CH (AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BE, BF, BG, BH, BJ, BN, BR, BW, BY, BZ, CA, CF, CG, CH, CI, CL, CM, CN, CO, CR, CU, CY, CZ, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GD, GE, GH, GM, GN, GQ, GR, GT, GW, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KG, KH, KM, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MC, MD, ME, MG, MK, ML, MN, MR, MT, MW, MX, MY, MZ, NA, NE, NG, NI, NL, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SI, SK, SL, SM, SN, ST, SV, SY, SZ, TD, TG, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, UZ, VC, VN, ZA, ZM, ZW)
ROCHE DIAGNOSTICS GMBH [DE/DE]; Sandhofer Straße 116 68305 Mannheim, DE (DE)
ROCHE DIAGNOSTICS OPERATIONS, INC. [US/US]; Intellectual Property Law Dept. 9115 Hague Road Indianapolis, Indiana 46250-0457, US (US)
Inventors:
KOBOLD, Uwe; DE
PAUL, Hubert; DE
REMPT, Martin; DE
Agent:
CURCIO, Mario; CH
Priority Data:
17179534.704.07.2017EP
Title (EN) AUTOMATED CLINICAL DIAGNOSTIC SYSTEM AND METHOD
(FR) SYSTÈME ET PROCÉDÉ DE DIAGNOSTIC CLINIQUE AUTOMATISÉ
Abstract:
(EN) A clinical diagnostic system (100), a clinical diagnostic method and an interconnected laboratory system (200) comprising a plurality of clinical diagnostic systems (100, 100') are herein introduced. The clinical diagnostic system (100) comprises a sample preparation module (20) for the automated preparation of samples, a liquid chromatography (LC) separation module (30) coupled to the sample preparation module via a sample preparation/LC interface (40), a mass spectrometer (MS) module (50) coupled to the LC separation module (30) via an LC/MS interface (60), and a result calculation module (70) for identifying and/or quantifying analytes or substances of interest contained in the samples and passed through the LC separation module (30) and the MS module (50). The clinical diagnostic system (100) further comprises a controller (80). The controller (80) is programmed to monitor a predetermined set of operational parameters (1-n) indicative of a performance status of the clinical diagnostic system (100). The controller (80) is further programmed to trigger a quality control procedure and/or a maintenance procedure whenever one or more parameters (1-n) of the predetermined set of operational parameters (1-n) is out of specification and to minimize the quality control and/or maintenance procedures as long as the set of operational parameters (1-n) remains within specification.
(FR) La présente invention concerne un système de diagnostic clinique (100), un procédé de diagnostic clinique et un système de laboratoire interconnecté (200) comprenant une pluralité de systèmes de diagnostic clinique (100, 100’). Le système de diagnostic clinique (100) comprend un module de préparation d’échantillon (20) pour la préparation automatisée d’échantillons, un module de séparation de chromatographie en phase liquide (LC) (30) couplé au module de préparation d’échantillon par l’intermédiaire d’une interface de préparation d’échantillon/LC (40), un module de spectromètre de masse (MS) (50) couplé au module de séparation LC (30) par l’intermédiaire d’une interface LC/MS (60), et un module de calcul de résultat (70) pour identifier et/ou quantifier des analytes ou des substances d’intérêt contenues dans les échantillons et ayant traversé le module de séparation LC (30) et le module MS (50). Le système de diagnostic clinique (100) comprend en outre un dispositif de commande (80). Le dispositif de commande (80) est programmé pour surveiller un ensemble prédéterminé de paramètres de fonctionnement (1-n) indicatifs d’un état de performance du système de diagnostic clinique (100). Le dispositif de commande (80) est en outre programmé pour déclencher une procédure de contrôle de qualité et/ou une procédure de maintenance chaque fois qu’un ou plusieurs paramètres (1-n) de l’ensemble prédéterminé de paramètres opérationnels (1-n) sont en dehors de la spécification et pour réduire au minimum les procédures de contrôle de qualité et/ou de maintenance dans la mesure où l’ensemble de paramètres opérationnels (1-n) reste dans la spécification.
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Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)