In-vitrodiagnostiek voor screening van de bloedvoorziening: de nieuwe Europese verordening voor IVD en het WHO IVD- prekwalificatieprogramma
Bloedtransfusie blijft een routinematige levensreddende medische process die helpt bij het vervangen van bloed dat verloren is gegaan door een operatie, verwonding of ziekte. De kwaliteit van getransfundeerd bloed is cruciaal in dit proces, aangezien bloeddonoren vrij moeten zijn van door transfusie overdraagbare infecties en gedoneerd bloed moet compatibel zijn met dat van de ontvanger. De kwaliteit van gedoneerd bloed kan worden beïnvloed door de kwaliteit van medische hulpmiddelen voor in-vitrodiagnostiek (IVD’s) die bij het screeningproces worden gebruikt.
Als gevolg hiervan ontstaat de behoefte aan hoogwaardige, veilige en goed presterende IVD’s voor gebruik in de transfusiegeneeskunde, samen met de behoefte aan strikte regelgeving op dit gebied. In de Europese Unie vervangt de nieuwe IVD-verordening de bestaande IVD-richtlijn binnen een overgangsperiode van vijf jaar. Fabrikanten van IVD’s zullen naar verwachting tegen 26 mei 2022 volledig voldoen aan de nieuwe verordening.
In deze assessment gaan we in op de belangrijkste verschillen op het gebied van handelsvergunning en testen tussen deze nieuwe verordening en haar voorganger. We presenteren verder de belangrijkste elementen van de prekwalificatiebeoordeling die door de WHO is ingevoerd voor IVD’s , inclusief ziektespecifieke IVD’s voor bloedscreeningslaboratoria.
Gelijktijdige detectie van meerdere mRNA’s en eiwitten in runder- IVD- cellen en weefsel met eencellige resolutie
Doelstellingen: Interacties van cellen met hun buren en invloeden door de omringende extracellulaire matrix (ECM) worden weerspiegeld in een celtranscriptoom en proteoom. In weefsels die bestaan uit heterogene celpopulaties of cellen die afhankelijk zijn van ECM-signaleringsaanwijzingen , zoals die van de tussenwervelschijf (IVD), wordt deze informatie verduisterd of gaat verloren wanneer cellen worden samengevoegd voor de veelgebruikte transcriptieanalyse door middel van kwantitatieve PCR- of RNA-sequencing.
In plaats daarvan hebben deze cellen middelen nodig om RNA-transcriptie en eiwitverdeling op een enkele cel of subcellulair niveau te analyseren om verschillende celtypen en functies te identificeren, zonder ze te verwijderen uit hun omringende signaalaanwijzingen .
Resultaten: We hebben een eenvoudig, sequentieel protocol ontwikkeld dat RNA is situ hybridisatie (RISH) en immunohistochemie (IHC) combineert voor de gelijktijdige analyse van meerdere transcripten naast eiwitten. Hierdoor kan males heterogene celpopulaties karakteriseren op het niveau van een enkele cel in de natuurlijke celomgeving en signaleringscontext, zowel in vivo als in vitro. Dit protocol wordt gedemonstreerd op cellen van het runder-IVD, voor transcripten en eiwitten die betrokken zijn bij mechanotransductie, stamheid en celproliferatie.
Conclusies: Een eenvoudig, sequentieel protocol dat RISH en IHC combineert, wordt gepresenteerd dat gelijktijdige informatie over RNA-transcripten en eiwitten mogelijk maakt om cellen te karakteriseren binnen een heterogene celpopulatie en complexe signaleringsomgevingen zoals die van de IVD.
Description: This monoclonal antibody recognizes a protein of about 50kDa, which is identified as gamma-enolase. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue whereas gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE-gamma is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas.It it be usually employed in combination with other markers such as Synaptophysin,Chromogranin A, and Neurofilament.
Description: This monoclonal antibody recognizes a protein of about 50kDa, which is identified as gamma-enolase. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue whereas gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE-gamma is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas.It it be usually employed in combination with other markers such as Synaptophysin,Chromogranin A, and Neurofilament.
Description: This monoclonal antibody recognizes a protein of about 50kDa, which is identified as gamma-enolase. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue whereas gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE-gamma is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas.It it be usually employed in combination with other markers such as Synaptophysin,Chromogranin A, and Neurofilament.
Description: This monoclonal antibody recognizes a protein of about 50kDa, which is identified as gamma-enolase. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue whereas gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE-gamma is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas.It it be usually employed in combination with other markers such as Synaptophysin,Chromogranin A, and Neurofilament.
Description: This monoclonal antibody recognizes a protein of about 50kDa, which is identified as gamma-enolase. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue whereas gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE-gamma is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas.It it be usually employed in combination with other markers such as Synaptophysin,Chromogranin A, and Neurofilament.
Description: This monoclonal antibody recognizes a protein of about 50kDa, which is identified as gamma-enolase. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue whereas gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE-gamma is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas.It it be usually employed in combination with other markers such as Synaptophysin,Chromogranin A, and Neurofilament.
Description: Recognizes a protein of about 50kDa, which is identified as gamma-enolase/neuron specific enolase/enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: Recognizes a protein of about 50kDa, which is identified as gamma-enolase/neuron specific enolase/enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: Recognizes a protein of about 50kDa, which is identified as gamma-enolase/neuron specific enolase/enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: Recognizes a protein of about 50kDa, which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: Recognizes a protein of about 50kDa, which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: Recognizes a protein of about 50kDa, which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: Recognizes a protein of about 50kDa, which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: Recognizes a protein of about 50kDa, which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: Recognizes a protein of about 50kDa, which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: This mAb recognizes a protein of about 50 kDa which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: This mAb recognizes a protein of about 50 kDa which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: This mAb recognizes a protein of about 50 kDa which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: This mAb recognizes a protein of about 50 kDa which is identified as gamma-Enolase/Neuron Specific Enolase/Enolase 2. Three isoenzymes of enolases are identified, alpha, beta and gamma. Alpha-isoform is expressed in most tissues, whereas beta-form is expressed predominantly in muscle tissue and gamma-enolase is found only in nervous tissue. These isoforms exist as both homodimers and heterodimers, and they play a role in converting phosphoglyceric acid to phosphenolpyruvic acid in the glycolytic pathway. NSE is a useful marker to identify peripheral nerves and tumors of neuro-endocrine origins, such as pheochromocytomas. It it be usually employed in combination with other markers such as Synaptophysin, Chromogranin A, and Neurofilament.
Description: A competitive ELISA for quantitative measurement of Human Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Human Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Human Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Goat Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Goat Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Goat Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Canine Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Canine Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Canine Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Rat Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Rat Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Rat Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Mouse Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Mouse Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Mouse Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Rabbit Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Rabbit Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Rabbit Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Porcine Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Porcine Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Porcine Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A polyclonal antibody raised in Rabbit that recognizes and binds to Human Neuron Specific Enolase (NSE) . This antibody is tested and proven to work in the following applications:
Description: A polyclonal antibody raised in Chicken that recognizes and binds to Human Neuron-Specific Enolase (NSE) . This antibody is tested and proven to work in the following applications:
Description: A competitive ELISA for quantitative measurement of Monkey Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Monkey Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: A competitive ELISA for quantitative measurement of Monkey Neuron Specific Enolase in samples from blood, plasma, serum, cell culture supernatant and other biological fluids. This is a high quality ELISA kit developped for optimal performance with samples from the particular species.
Description: Quantitative sandwich ELISA kit for measuring Human Neuron-specific enolase, NSE in samples from serum, plasma, tissue homogenates. A new trial version of the kit, which allows you to test the kit in your application at a reasonable price.
Description: Quantitative sandwich ELISA kit for measuring Human Neuron-specific enolase, NSE in samples from serum, plasma, tissue homogenates. Now available in a cost efficient pack of 5 plates of 96 wells each, conveniently packed along with the other reagents in 5 separate kits.
Description: A sandwich quantitative ELISA assay kit for detection of Human Enolase, Neuron Specific (NSE) in samples from serum, plasma, tissue homogenates, cell lysates, cell culture supernates or other biological fluids.
Description: A sandwich quantitative ELISA assay kit for detection of Human Enolase, Neuron Specific (NSE) in samples from serum, plasma, tissue homogenates, cell lysates, cell culture supernates or other biological fluids.
De nieuwe IVD- verordening 2017/746: een casestudy in een groot universitair ziekenhuislaboratorium in België toont aan dat er behoefte is aan verduidelijking over de vrijheidsgraden die laboratoria moeten gebruiken om in het laboratorium ontwikkelde checks te gebruiken om de patiëntenzorg te verbeteren
Doelstellingen De nieuwe Europese In Vitro Diagnostic (IVD) Verordening 2017/746 (IVDR) beperkt het gebruik van in het laboratorium ontwikkelde checks (LDT) na 26 mei 2022. Er zijn geen gegevens over de impression van de IVDR op laboratoria in de Europese Unie. Methoden De laboratoriumtests die in UZ Leuven werden uitgevoerd, werden onderverdeeld in vier groepen: kernlaboratorium, immunologie, speciale chemie en moleculaire microbiologische checks.
Elke check werd geclassificeerd als Conformité Européenne (CE) -IVD, gemodificeerd / off-label CE-IVD, Business Analysis Use Solely (RUO) of LDT . Elke matrix werd als een afzonderlijke check beschouwd. Resultaten We ontdekten dat 97,6% van de meer dan 11,5 miljoen resultaten / jaar werd gegenereerd met een CE-IVD-methode. Van de 922 verschillende laboratoriumtests waren echter slechts 41,8% CE-IVD, 10,8% gemodificeerd / off-label CE-IVD, 0,3% RUO en 47,1% LDT. Off-label CE-IVD werd voornamelijk gebruikt om alternatieve matrices te testen die niet onder de declare van de fabrikant vallen (bijv. Pleurale of peritoneale vloeistof). LDT’s werden voornamelijk gebruikt voor speciale chemie, flowcytometrie en moleculaire testen.
Met uitzondering van flowcytometrie, waren de belangrijkste redenen voor het gebruik van 377 LDT ’s het ontbreken van een CE-IVD-methode (71,9%), analytische vereisten (14,3%) en het feit dat de LDT in gebruik was voordat CE-IVD beschikbaar was (11,9%) . Conclusies Hoewel de overgrote meerderheid van de resultaten (97,6%) werd gegenereerd met een CE-IVD-methode, was slechts 41,8% van de laboratoriumtests CE-IVD. Momenteel is er geen alternatief op de markt voor 71,5% van de 537 in ons laboratorium uitgevoerde LDT’s die niet onder de huidige IVD-richtlijn (IVDD) vallen. Naleving van de IVDR zal een grote investering in tijd en moeite vergen.
Gebrek aan gevoeligheid van een IVD / CE-gelabelde package gericht op het S-gen voor detectie van SARS-CoV-2
Doelstellingen: Nieuwe moleculaire checks voor SARS-CoV-2 worden snel gelanceerd als reactie op de COVID-19-pandemie. Het doel van deze studie was om de analytische en klinische prestaties van de VIASURE SARS-CoV-2 S gen RT-PCR Equipment op het BD Max ™ -systeem te evalueren en om de resultaten te vergelijken met die verkregen met de cobas® SARS-CoV-2 check op het cobas® 6800-systeem.
Methoden: Voor het testen van de analytische prestaties is referentiemateriaal gebruikt. Klinische monsters (n = 101) verkregen van patiënten met symptomen die compatibel zijn met COVID-19 werden bestudeerd. Oro- en nasofaryngeale uitstrijkjes werden verzameld met behulp van ESwab ™ of UTM ™ verzamelsystemen.
Resultaten: Toen de analytische prestaties werden geëvalueerd, testte het monster met de laagste SARS-CoV-2-concentratie negatief met de VIASURE-test, terwijl de resultaten verkregen met de cobas®-test overeenkwamen met de verwachte resultaten. Zes van de 101 klinische monsters (5,9%) vertoonden een remming met de VIASURE-test. Bij het analyseren van de resterende 95 klinische monsters bleken er 27 negatief te zijn bij beide assays. Van 68 monsters die positief waren met de cobas®-test, miste de VIASURE-test 21 (30,9%) monsters. Al die 21 monsters vertoonden Ct-waarden ≥ 31 met het cobas® 6800-systeem. Geen van de monsters testte positief met de VIASURE-test en negatief met de cobas®-test.
Conclusies: De VIASURE-test werd gehinderd door een gebrek aan gevoeligheid en een relatief hoog aantal ongeldige resultaten. Bij gebruik van de VIASURE-test voor routinetests zou een aanzienlijk aantal COVID-19-positieve monsters zijn gemist.
Huidige stand van ontwikkeling van methylatiebiomarkers voor in vitro diagnostische IVD- toepassingen
Een aanzienlijk deel van het onderzoek toont duidelijk aan dat ziektegerelateerde methyleringsveranderingen kunnen worden gebruikt als biomarkers in alle stadia van klinisch ziektebeheer, inclusief risicobeoordeling en predispositiescreening door middel van vroege diagnostiek tot personalisatie van patiëntenzorg en monitoring van terugval en chronische ziekte. Ziektegerelateerde methyleringsveranderingen zijn dus een aantrekkelijke bron van de biomarkers die een aanzienlijke impression kunnen hebben op de precisiegeneeskunde. De vertaling van de onderzoeksresultaten op het gebied van methylatiebiomarkers naar de klinische praktijk is echter op zijn minst niet bevredigend. Dat komt voornamelijk omdat het bewijs dat is gegenereerd in onderzoeksstudies die het nut van de ziektegerelateerde methyleringsverandering om de klinische uitkomst te voorspellen, binnen ishet merendeel van de gevallen is niet voldoende om het diagnostische gebruik van de biomarker te postuleren.
De onderzoeksstudies moeten worden gevolgd door goed opgezette en systematische onderzoeken van klinisch nut van de biomarker die gegevens opleveren van voldoende kwaliteit om te voldoen aan de wettelijke goedkeuring van de check om te worden gebruikt om een klinisch geldige beslissing te nemen. In deze assessment beschrijven we op methylatie gebaseerde IVD-tests die momenteel zijn goedgekeurd voor IVD-gebruik of in de gevorderde stadia van de ontwikkeling voor diagnostisch gebruik.
Voor elk van deze checks analyseren we de technologieën die de check gebruikt voor methylatiedetectie en beschrijven we de soorten klinische onderzoeken die zijn uitgevoerd om de klinische validiteit van de check aan te tonen en om goedkeuring door de regelgevende instanties te rechtvaardigen. De voorbeelden die hier worden besproken, zouden moeten helpen bij het plannen van klinische onderzoeken en het leveren van het vereiste klinische bewijs voor de goedkeuring van potentiële IVD-tests op foundation van methylatiebiomarkers.
