WO2023092234 - QUALITY CONTROL MATERIALS FOR CARDIAC TROPONIN TESTING FIELD
National phase entry:
Publication Number
WO/2023/092234
Publication Date
01.06.2023
International Application No.
PCT/CA2022/051733
International Filing Date
25.11.2022
Title **
[English]
QUALITY CONTROL MATERIALS FOR CARDIAC TROPONIN TESTING FIELD
[French]
SUBSTANCES DE CONTRÔLE QUALITÉ POUR CHAMP D'ANALYSE DE TROPONINE CARDIAQUE
Applicants **
MCMASTER UNIVERSITY
Inventors
KAVSAK, Peter
CLARK, Lorna
Priority Data
63/283,366
26.11.2021
US
Application details
| Total Number of Claims/PCT | * |
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International Searching Authority |
CIPO
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| Recordal of a Change of the Applicant's Name/Address |
Change of Applicant's Name and Address
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| Type of Assignment |
The Standard Agent's Assignment
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| Applicant's Legal Status |
Legal Entity
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| Entry into National Phase under |
Chapter I
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| Patent Delivery |
Send the Letters Patent by Courier
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| Translation |
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Quotation for National Phase entry
| Country | Stages | Total | |
|---|---|---|---|
| China | Filing, Examination, Granting | 2360 | |
| EPO | Filing, Examination, Granting | 16206 | |
| Japan | Filing, Examination, Granting | 2450 | |
| South Korea | Filing, Examination, Granting | 2717 | |
| USA | Filing, Examination, Granting | 5540 |
Total:
29,273
The term for entry into the National Phase has expired. This quotation is for informational purposes only
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Abstract[English]
A method for the preparation of a cardiac troponin quality control sample of a mammal to determine the accuracy and/or precision of a cardiac troponin assay over time is provided. The method comprises the steps of: i) preparing a cardiac troponin concentrate from a pool of biological samples obtained from a population of the mammal having a troponin concentration of greater than 75% of an upper analytical limit of the assay; ii) obtaining a cardiac troponin base material comprising whole blood, plasma or serum of the mammal which is interference-free and disease-free; and iii) combining a quantity of the troponin concentrate with the base material to yield a quality control sample having a target concentration. Quality control samples may be provided in kits which provide a set of samples having particular concentrations which essentially correspond with lower detectable limits of an assay, upper limits of normal, as well as concentrations which define risk stratification cutoffs and other diagnostic cutoffs.[French]
L'invention concerne un procédé de préparation d'un échantillon de contrôle qualité de la troponine cardiaque chez un mammifère pour déterminer l'exactitude et/ou la précision d'un dosage de troponine cardiaque dans le temps. Le procédé comprend les étapes suivantes : i) la préparation d'un concentré de troponine cardiaque provenant d'un ensemble d'échantillons biologiques obtenus à partir d'une population de mammifères ayant une concentration de troponine supérieure à 75 % d'une limite analytique supérieure du dosage ; ii) l'obtention d'une substance de base de troponine cardiaque comprenant du sang total, du plasma ou du sérum du mammifère sans interférence et sans maladie ; et iii) la combinaison d'une quantité du concentré de troponine avec la substance de base pour obtenir un échantillon de contrôle qualité ayant une concentration cible. Les échantillons de contrôle qualité peuvent être fournis dans des trousses qui proposent un ensemble d'échantillons ayant des concentrations particulières qui correspondent essentiellement aux limites inférieures détectables d'un dosage, aux limites supérieures de la normale, ainsi qu'aux concentrations qui définissent les seuils de stratification du risque et d'autres seuils diagnostiques.