The clinical validation of GeneProof PCR Kits for detection of thrombotic polymorphisms on myCROBE(R) Fully Automated Instrument

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62156489%3A43210%2F22%3A43921482" target="_blank" >RIV/62156489:43210/22:43921482 - isvavai.cz</a>

Výsledek na webu

<a href="https://doi.org/10.1038/s41431-021-01026-1" target="_blank" >https://doi.org/10.1038/s41431-021-01026-1</a>

DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

The clinical validation of GeneProof PCR Kits for detection of thrombotic polymorphisms on myCROBE(R) Fully Automated Instrument

Popis výsledku v původním jazyce

Introduction: Combination of acquired and inherited risk factors can lead to disbalance of coagulation system which is related to many serious disorders. Each assay needs to be detected separately and without automatization, it is a time-consuming process. The aim of this study was to evaluate clinical performance characteristics of the innovated GeneProof PCR assays intended for diagnostics of thrombophilic mutations in myCROBE® Fully Automated Instrument. Materials and Methods: The clinical validation was performed on 842 whole blood samples in total, 184 for Factor II, 186 for Factor V, 111 for Factor XIII, 123 for MTHFR A1298C, 123 for MTHFR C677T and 115 for PAI-1. The samples were extracted, detected, and evaluated in myCROBE® Fully Automated Instrument using innovated GeneProof PCR Kits for myCROBE. The correct genotype was confirmed in collaboration with clinical site at the Unilabs Slovensko, s. r. o. using CE IVD GeneProof PCR Kits with croBEE 201A NA Extraction Kit. Results: Comparison of myCROBE PCR Kits and GeneProof CE IVD PCR Kits demonstrated high reliability which is expressed by Negative percentage agreement (FII, FV, FXIII, PAI-1 - 100 %, MTHFR A1298C - 98.04 %, MTHFR C677T - 96.72 %) and Positive percentage agreement (FII, FV, FXIII, MTHFR A1298C, PAI-1 - 100 %, MTHFR C677T - 96.77 %). Conclusions: The results of clinical validation demonstrate a very good diagnostic parameter of the GeneProof assays and together with myCROBE® Fully Automated Instrument proved to be very convenient and time-saving tool for testing of thrombophilic mutations in clinical routine.

Název v anglickém jazyce

The clinical validation of GeneProof PCR Kits for detection of thrombotic polymorphisms on myCROBE(R) Fully Automated Instrument

Popis výsledku anglicky

Introduction: Combination of acquired and inherited risk factors can lead to disbalance of coagulation system which is related to many serious disorders. Each assay needs to be detected separately and without automatization, it is a time-consuming process. The aim of this study was to evaluate clinical performance characteristics of the innovated GeneProof PCR assays intended for diagnostics of thrombophilic mutations in myCROBE® Fully Automated Instrument. Materials and Methods: The clinical validation was performed on 842 whole blood samples in total, 184 for Factor II, 186 for Factor V, 111 for Factor XIII, 123 for MTHFR A1298C, 123 for MTHFR C677T and 115 for PAI-1. The samples were extracted, detected, and evaluated in myCROBE® Fully Automated Instrument using innovated GeneProof PCR Kits for myCROBE. The correct genotype was confirmed in collaboration with clinical site at the Unilabs Slovensko, s. r. o. using CE IVD GeneProof PCR Kits with croBEE 201A NA Extraction Kit. Results: Comparison of myCROBE PCR Kits and GeneProof CE IVD PCR Kits demonstrated high reliability which is expressed by Negative percentage agreement (FII, FV, FXIII, PAI-1 - 100 %, MTHFR A1298C - 98.04 %, MTHFR C677T - 96.72 %) and Positive percentage agreement (FII, FV, FXIII, MTHFR A1298C, PAI-1 - 100 %, MTHFR C677T - 96.77 %). Conclusions: The results of clinical validation demonstrate a very good diagnostic parameter of the GeneProof assays and together with myCROBE® Fully Automated Instrument proved to be very convenient and time-saving tool for testing of thrombophilic mutations in clinical routine.

Druh

O - Ostatní výsledky

CEP obor

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OECD FORD obor

10608 - Biochemistry and molecular biology

Projekt

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Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů