Gebrek aan gevoeligheid van een  IVD

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.

genetique-hum-ulg
genetique-hum-ulg

Human Neuron Specific Enolase ELISA kit

E01N0025-192T 192 tests
EUR 1524
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.

Human Neuron Specific Enolase ELISA kit

E01N0025-48 1 plate of 48 wells
EUR 624
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.

Human Neuron Specific Enolase ELISA kit

E01N0025-96 1 plate of 96 wells
EUR 822
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.

Human Neuron Specific Enolase (NSE) ELISA

LF-EK0169 1×96T
EUR 723.6

Neuron Specific Enolase Protein

abx060902-100ug 100 ug
EUR 1387.2

Neuron Specific Enolase Antibody

F48200-0.4ML 0.4 ml
EUR 322.15
Description: NSE is one of the three enolase isoenzymes found in mammals. This isoenzyme, a homodimer, is found in mature neurons and cells of neuronal origin. A switch from alpha to gamma enolase occurs in neural tissue during development in rats and primates. [Wiki]

Neuron Specific Enolase (NSE)/ENO2

CH23003 100 ul
EUR 214.8

Neuron Specific Enolase (NSE)/ENO2

RA22110 100 ul
EUR 490.8

Human Enolase Neuron Specific ELISA Kit

IHUNSEKT each
EUR 667
Description: Human Enolase Neuron Specific ELISA Kit

Neuron Specific Enolase ELISA Kit

E4703-100 each
EUR 705.6

Human Enolase, Neuron Specific (ENO2) CLIA Kit

20-abx491609
  • EUR 9567.60
  • EUR 5095.20
  • EUR 1177.20
  • 10 × 96 tests
  • 5 × 96 tests
  • 96 tests

Human NSE (Neuron Specific Enolase) ELISA Kit

EKE60659-5x96T 5x96T
EUR 2667.6

Human NSE (Neuron Specific Enolase) ELISA Kit

EKE60659-96T 96T
EUR 561.6

Human Enolase, Neuron Specific (NSE) Protein

20-abx066423
  • EUR 693.60
  • EUR 309.60
  • EUR 2064.00
  • EUR 828.00
  • EUR 510.00
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Human Enolase, Neuron Specific (NSE) Protein

20-abx066426
  • EUR 693.60
  • EUR 309.60
  • EUR 2064.00
  • EUR 828.00
  • EUR 510.00
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Human Neuron Specific Enolase (NSE) ELISA (4X96T)

LF-EK0170 4×96T
EUR 2454

Human Enolase, Neuron Specific (ENO2) ELISA Kit

abx253091-96tests 96 tests
EUR 877.2

Human Enolase, Neuron Specific (ENO2) ELISA Kit

abx573286-96tests 96 tests
EUR 877.2

Human Enolase, Neuron Specific (ENO2) ELISA Kit

20-abx152555
  • EUR 7970.40
  • EUR 4250.40
  • EUR 990.00
  • 10 × 96 tests
  • 5 × 96 tests
  • 96 tests

Neuron Specific Enolase (NSE) Antibody

abx020636-1mg 1 mg
EUR 994.8

Neuron Specific Enolase (NSE) Antibody

abx020637-1mg 1 mg
EUR 994.8

Neuron Specific Enolase (NSE) Antibody

abx020638-1mg 1 mg
EUR 994.8

Neuron Specific Enolase (NSE) Antibody

abx020639-1mg 1 mg
EUR 994.8

Neuron Specific Enolase (NSE) Antibody

abx020640-1mg 1 mg
EUR 994.8

Neuron Specific Enolase (NSE) Antibody

abx020641-1mg 1 mg
EUR 994.8

NSE Antibody / Neuron Specific Enolase

F54038-0.1ML 0.1 ml
EUR 322.15
Description: Neuron Specific Enolase (NSE, Enolase-2) has neurotrophic and neuroprotective properties on a broad spectrum of central nervous system (CNS) neurons. Binds, in a calcium-dependent manner, to cultured neocortical neurons and promotes cell survival.

NSE Antibody / Neuron Specific Enolase

F54039-0.1ML 0.1 ml
EUR 322.15
Description: Neuron Specific Enolase (NSE, Enolase-2) has neurotrophic and neuroprotective properties on a broad spectrum of central nervous system (CNS) neurons. Binds, in a calcium-dependent manner, to cultured neocortical neurons and promotes cell survival.

Neuron Specific Enolase Antibody (NSE)

F48200-0.08ML 0.08 ml
EUR 140.25
Description: NSE is one of the three enolase isoenzymes found in mammals. This isoenzyme, a homodimer, is found in mature neurons and cells of neuronal origin. A switch from alpha to gamma enolase occurs in neural tissue during development in rats and primates. [Wiki]

Neuron Specific Enolase Antibody (NSE)

F48201-0.08ML 0.08 ml
EUR 140.25
Description: Neuron Specific Enolase, also called Gamma-enolase, and Enolase 2 (ENO2) has neurotrophic and neuroprotective properties on a broad spectrum of central nervous system (CNS) neurons. Binds, in a calcium-dependent manner, to cultured neocortical neurons and promotes cell survival (By similarity). [UniProt]

NSE Antibody / Neuron Specific Enolase

V3398-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V3398-20UG 20 ug
EUR 153.3
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.

NSE Antibody / Neuron Specific Enolase

V3398SAF-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V3400-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V3400-20UG 20 ug
EUR 153.3
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.

NSE Antibody / Neuron Specific Enolase

V3400SAF-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V3498-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V3498-20UG 20 ug
EUR 153.3
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.

NSE Antibody / Neuron Specific Enolase

V3498IHC-7ML 7 ml
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V3498SAF-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V7210-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V7210-20UG 20 ug
EUR 153.3
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.

NSE Antibody / Neuron Specific Enolase

V7210SAF-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

RQ5267 100ul
EUR 356.15
Description: The ENO2 gene encodes one of the three enolase isoenzymes found in mammals. This isoenzyme, a homodimer, is found in mature neurons and cells of neuronal origin. A switch from alpha enolase to gamma enolase occurs in neural tissue during development in rats and primates. [RefSeq]

NSE Antibody / Neuron Specific Enolase

RQ4566 100ug
EUR 356.15
Description: NSE (neuron specific enolase), also known as Enolase 2 (ENO2), is found in elevated concentrations in plasma in certain neoplasias. The enolases catalyze the interconversion of 2-phosphoglycerate to phosphoenolpyruvate in the glycolytic pathway. ENO2 gene contains 12 exons distributed over 9,213 nucleotides. Human neurone-specific enolase is mapped to chromosome 12p13.

Neuron Specific Enolase (NSE) Antibody

E63C00701a 100μg/100μl
EUR 225
Description: Available in various conjugation types.

NSE Antibody / Neuron Specific Enolase

V7731-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V7731-20UG 20 ug
EUR 153.3
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.

NSE Antibody / Neuron Specific Enolase

V7731SAF-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V8361-100UG 100 ug
EUR 349.3
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.

NSE Antibody / Neuron Specific Enolase

V8361-20UG 20 ug
EUR 153.3
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.

NSE Antibody / Neuron Specific Enolase

V8361SAF-100UG 100 ug
EUR 349.3
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.

Human Neuron Specific Enolase (NSE) ELISA (10X96T)

LF-EK0171 10×96T
EUR 5380.8

Human Neuron Specific Enolase (NSE) ELISA (20X96T)

LF-EK0172 20×96T
EUR 9369.6

Enolase, Neuron Specific (ENO2) Antibody

20-abx109806
  • EUR 493.20
  • EUR 2214.00
  • EUR 718.80
  • EUR 218.40
  • EUR 360.00
  • 100 ug
  • 1 mg
  • 200 ug
  • 20 ug
  • 50 ug

Enolase, Neuron Specific (ENO2) Antibody

20-abx109807
  • EUR 493.20
  • EUR 2214.00
  • EUR 718.80
  • EUR 218.40
  • EUR 360.00
  • 100 ug
  • 1 mg
  • 200 ug
  • 20 ug
  • 50 ug

Enolase, Neuron Specific (ENO2) Antibody

20-abx112301
  • EUR 878.40
  • EUR 477.60
  • 150 ul
  • 50 ul

Enolase, Neuron Specific (ENO2) Antibody

abx036140-100ug 100 ug
EUR 469.2

Human Enolase, Neuron Specific (NSE) ELISA Kit

DLR-NSE-Hu-48T 48T
EUR 574.8
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.

Human Enolase, Neuron Specific (NSE) ELISA Kit

DLR-NSE-Hu-96T 96T
EUR 745.2
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.

Human Enolase, Neuron Specific ELISA Kit (NSE)

RK01966 96 Tests
EUR 625.2

Human Enolase, Neuron Specific (NSE) ELISA Kit

RD-NSE-Hu-48Tests 48 Tests
EUR 573.6

Human Enolase, Neuron Specific (NSE) ELISA Kit

RD-NSE-Hu-96Tests 96 Tests
EUR 794.4

Human Enolase, Neuron Specific (NSE) ELISA Kit

RDR-NSE-Hu-48Tests 48 Tests
EUR 600

Human Enolase, Neuron Specific (NSE) ELISA Kit

RDR-NSE-Hu-96Tests 96 Tests
EUR 830.4

Human Enolase, Neuron Specific (NSE) ELISA Kit

DL-NSE-Hu 96T
EUR 402
Description: serum, plasma, tissue homogenates, cell lysates, cell culture supernates or other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

DLR-NSE-Hu 96T
EUR 422
Description: serum, plasma, tissue homogenates, cell lysates, cell culture supernates or other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

RDR-NSE-Hu-48T 48T
EUR 432.39
Description: serum, plasma, tissue homogenates, cell lysates, cell culture supernatants and other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

RDR-NSE-Hu-96T 96T
EUR 617.72
Description: serum, plasma, tissue homogenates, cell lysates, cell culture supernatants and other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

RD-NSE-Hu-48T 48T
EUR 411.8
Description: serum, plasma, tissue homogenates, cell lysates, cell culture supernatants and other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

RD-NSE-Hu-96T 96T
EUR 588.3
Description: serum, plasma, tissue homogenates, cell lysates, cell culture supernatants and other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

SEA537Hu-10x96wellstestplate 10x96-wells test plate
EUR 5128.02
Description: This is Double-antibody Sandwich Enzyme-linked immunosorbent assay for detection of Human Enolase, Neuron Specific (NSE) in serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

SEA537Hu-1x48wellstestplate 1x48-wells test plate
EUR 527.48
Description: This is Double-antibody Sandwich Enzyme-linked immunosorbent assay for detection of Human Enolase, Neuron Specific (NSE) in serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

SEA537Hu-1x96wellstestplate 1x96-wells test plate
EUR 702.12
Description: This is Double-antibody Sandwich Enzyme-linked immunosorbent assay for detection of Human Enolase, Neuron Specific (NSE) in serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

SEA537Hu-5x96wellstestplate 5x96-wells test plate
EUR 2799.54
Description: This is Double-antibody Sandwich Enzyme-linked immunosorbent assay for detection of Human Enolase, Neuron Specific (NSE) in serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids.

Human Enolase, Neuron Specific (NSE) ELISA Kit

4-SEA537Hu
  • EUR 5188.80
  • EUR 2739.60
  • EUR 703.20
  • 10 plates of 96 wells
  • 5 plates of 96 wells
  • 1 plate of 96 wells
Description: Enzyme-linked immunosorbent assay based on the Double-antibody Sandwich method for detection of Human Enolase, Neuron Specific (NSE) in samples from serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids with no significant corss-reactivity with analogues from other species.

Human Enolase, Neuron Specific (NSE) ELISA Kit

EKN45014-48T 48T
EUR 341.04

Human Enolase, Neuron Specific (NSE) ELISA Kit

EKN45014-5x96T 5x96T
EUR 2314.2

Human Enolase, Neuron Specific (NSE) ELISA Kit

EKN45014-96T 96T
EUR 487.2

Human Enolase, Neuron Specific (NSE) ELISA Kit

EKU03903-48T 48T
EUR 500.5

Human Enolase, Neuron Specific (NSE) ELISA Kit

EKU03903-5x96T 5x96T
EUR 3396.25

Human Enolase, Neuron Specific (NSE) ELISA Kit

EKU03903-96T 96T
EUR 715

Rat Neuron Specific Enolase ELISA kit

E02N0025-192T 192 tests
EUR 1524
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.

Rat Neuron Specific Enolase ELISA kit

E02N0025-48 1 plate of 48 wells
EUR 624
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.

Rat Neuron Specific Enolase ELISA kit

E02N0025-96 1 plate of 96 wells
EUR 822
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.

Pig Neuron Specific Enolase ELISA kit

E07N0025-192T 192 tests
EUR 1524
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.

Pig Neuron Specific Enolase ELISA kit

E07N0025-48 1 plate of 48 wells
EUR 624
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.

Pig Neuron Specific Enolase ELISA kit

E07N0025-96 1 plate of 96 wells
EUR 822
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.

Dog Neuron Specific Enolase ELISA kit

E08N0025-192T 192 tests
EUR 1524
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.

Dog Neuron Specific Enolase ELISA kit

E08N0025-48 1 plate of 48 wells
EUR 624
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.

Dog Neuron Specific Enolase ELISA kit

E08N0025-96 1 plate of 96 wells
EUR 822
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.

ELISA kit for Human NSE (Neuron Specific Enolase)

E-EL-H1047 1 plate of 96 wells
EUR 452.4
Description: A sandwich ELISA kit for quantitative measurement of Human NSE (Neuron Specific Enolase) in samples from Serum, Plasma, Cell supernatant

Enolase, Neuron Specific (NSE) Antibody

20-abx270247
  • EUR 560.40
  • EUR 644.40
  • EUR 326.40
  • EUR 978.00
  • EUR 427.20
  • 100 tests
  • 200 tests
  • 25 tests
  • 500 tests
  • 50 tests

Enolase, Neuron Specific (NSE) Antibody

20-abx172246
  • EUR 1011.60
  • EUR 526.80
  • 1 mg
  • 200 ug

Enolase, Neuron Specific (NSE) Antibody

20-abx172247
  • EUR 1011.60
  • EUR 526.80
  • 1 mg
  • 200 ug

Enolase, Neuron Specific (NSE) Antibody

20-abx102347
  • EUR 477.60
  • EUR 159.60
  • EUR 1328.40
  • EUR 644.40
  • EUR 376.80
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody

20-abx102348
  • EUR 477.60
  • EUR 159.60
  • EUR 1328.40
  • EUR 644.40
  • EUR 376.80
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody

20-abx102349
  • EUR 493.20
  • EUR 159.60
  • EUR 1362.00
  • EUR 661.20
  • EUR 376.80
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody

20-abx102350
  • EUR 510.00
  • EUR 159.60
  • EUR 1412.40
  • EUR 693.60
  • EUR 393.60
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody

20-abx129524
  • EUR 493.20
  • EUR 159.60
  • EUR 1362.00
  • EUR 661.20
  • EUR 376.80
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Goat Neuron Specific Enolase ELISA kit

E06N0025-192T 192 tests
EUR 1524
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.

Goat Neuron Specific Enolase ELISA kit

E06N0025-48 1 plate of 48 wells
EUR 624
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.

Goat Neuron Specific Enolase ELISA kit

E06N0025-96 1 plate of 96 wells
EUR 822
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.

Mouse Neuron Specific Enolase ELISA kit

E03N0025-192T 192 tests
EUR 1524
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.

Mouse Neuron Specific Enolase ELISA kit

E03N0025-48 1 plate of 48 wells
EUR 624
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.

Mouse Neuron Specific Enolase ELISA kit

E03N0025-96 1 plate of 96 wells
EUR 822
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.

Rat Enolase, Neuron Specific (ENO2) Protein

20-abx066425
  • EUR 744.00
  • EUR 326.40
  • EUR 2230.80
  • EUR 878.40
  • EUR 543.60
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Rabbit Neuron Specific Enolase ELISA kit

E04N0025-192T 192 tests
EUR 1524
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.

Rabbit Neuron Specific Enolase ELISA kit

E04N0025-48 1 plate of 48 wells
EUR 624
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.

Rabbit Neuron Specific Enolase ELISA kit

E04N0025-96 1 plate of 96 wells
EUR 822
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.

Monkey Neuron Specific Enolase ELISA kit

E09N0025-192T 192 tests
EUR 1524
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.

Monkey Neuron Specific Enolase ELISA kit

E09N0025-48 1 plate of 48 wells
EUR 624
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.

Monkey Neuron Specific Enolase ELISA kit

E09N0025-96 1 plate of 96 wells
EUR 822
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.

Rabbit Neuron- specific enolase ELISA Kit

ELA-E0537Rb 96 Tests
EUR 1113.6

Recombinant Enolase, Neuron Specific (NSE)

4-RPA537Hu01
  • EUR 496.32
  • EUR 256.80
  • EUR 1531.20
  • EUR 590.40
  • EUR 1060.80
  • EUR 408.00
  • EUR 3648.00
  • 100 ug
  • 10ug
  • 1 mg
  • 200 ug
  • 500 ug
  • 50ug
  • 5 mg
Description: Recombinant Human Enolase, Neuron Specific expressed in: E.coli

Recombinant Enolase, Neuron Specific (NSE)

4-RPA537Hu02
  • EUR 496.32
  • EUR 256.80
  • EUR 1531.20
  • EUR 590.40
  • EUR 1060.80
  • EUR 408.00
  • EUR 3648.00
  • 100 ug
  • 10ug
  • 1 mg
  • 200 ug
  • 500 ug
  • 50ug
  • 5 mg
Description: Recombinant Human Enolase, Neuron Specific expressed in: E.coli

Recombinant Enolase, Neuron Specific (NSE)

4-RPA537Mu02
  • EUR 528.58
  • EUR 265.20
  • EUR 1652.16
  • EUR 630.72
  • EUR 1141.44
  • EUR 429.60
  • EUR 3950.40
  • 100 ug
  • 10ug
  • 1 mg
  • 200 ug
  • 500 ug
  • 50ug
  • 5 mg
Description: Recombinant Mouse Enolase, Neuron Specific expressed in: E.coli

Recombinant Enolase, Neuron Specific (NSE)

4-RPA537Ra01
  • EUR 528.58
  • EUR 265.20
  • EUR 1652.16
  • EUR 630.72
  • EUR 1141.44
  • EUR 429.60
  • EUR 3950.40
  • 100 ug
  • 10ug
  • 1 mg
  • 200 ug
  • 500 ug
  • 50ug
  • 5 mg
Description: Recombinant Rat Enolase, Neuron Specific expressed in: E.coli

Recombinant Enolase, Neuron Specific (NSE)

4-RPA537Mu01
  • EUR 528.58
  • EUR 265.20
  • EUR 1652.16
  • EUR 630.72
  • EUR 1141.44
  • EUR 429.60
  • EUR 3950.40
  • 100 ug
  • 10ug
  • 1 mg
  • 200 ug
  • 500 ug
  • 50ug
  • 5 mg
Description: Recombinant Mouse Enolase, Neuron Specific expressed in: E.coli

Recombinant Enolase, Neuron Specific (NSE)

RPU41280-100ug 100ug
EUR 431.2

Recombinant Enolase, Neuron Specific (NSE)

RPU41280-1mg 1mg
EUR 1911

Recombinant Enolase, Neuron Specific (NSE)

RPU41280-50ug 50ug
EUR 346.5

Recombinant Enolase, Neuron Specific (NSE)

RPU41281-100ug 100ug
EUR 468.6

Recombinant Enolase, Neuron Specific (NSE)

RPU41281-1mg 1mg
EUR 2074.8

Recombinant Enolase, Neuron Specific (NSE)

RPU41281-50ug 50ug
EUR 376.2

Recombinant Enolase, Neuron Specific (NSE)

RPU41282-100ug 100ug
EUR 468.6

Recombinant Enolase, Neuron Specific (NSE)

RPU41282-1mg 1mg
EUR 2074.8

Recombinant Enolase, Neuron Specific (NSE)

RPU41282-50ug 50ug
EUR 376.2

Recombinant Enolase, Neuron Specific (NSE)

RPU41283-100ug 100ug
EUR 431.2

Recombinant Enolase, Neuron Specific (NSE)

RPU41283-1mg 1mg
EUR 1911

Recombinant Enolase, Neuron Specific (NSE)

RPU41283-50ug 50ug
EUR 346.5

Recombinant Enolase, Neuron Specific (NSE)

RPU51141-100ug 100ug
EUR 468.6

Recombinant Enolase, Neuron Specific (NSE)

RPU51141-1mg 1mg
EUR 2074.8

Recombinant Enolase, Neuron Specific (NSE)

RPU51141-50ug 50ug
EUR 376.2

Enolase, Neuron Specific (ENO2) Antibody (HRP)

20-abx108279
  • EUR 493.20
  • EUR 2214.00
  • EUR 718.80
  • EUR 218.40
  • EUR 360.00
  • 100 ug
  • 1 mg
  • 200 ug
  • 20 ug
  • 50 ug

Enolase, Neuron Specific (ENO2) Antibody (HRP)

20-abx108280
  • EUR 493.20
  • EUR 2214.00
  • EUR 718.80
  • EUR 218.40
  • EUR 360.00
  • 100 ug
  • 1 mg
  • 200 ug
  • 20 ug
  • 50 ug

Rat Enolase Neuron Specific ELISA Kit

IRTNSEKT each
EUR 718
Description: Rat Enolase Neuron Specific ELISA Kit

Enolase, Neuron Specific (ENO2) Antibody (FITC)

20-abx106859
  • EUR 493.20
  • EUR 2214.00
  • EUR 718.80
  • EUR 218.40
  • EUR 360.00
  • 100 ug
  • 1 mg
  • 200 ug
  • 20 ug
  • 50 ug

Enolase, Neuron Specific (ENO2) Antibody (FITC)

20-abx106860
  • EUR 493.20
  • EUR 2214.00
  • EUR 718.80
  • EUR 218.40
  • EUR 360.00
  • 100 ug
  • 1 mg
  • 200 ug
  • 20 ug
  • 50 ug

Enolase, Neuron Specific (ENO2) Antibody Pair

abx117504-1pair5x96wellplates 1 pair (5x96 well plates)
EUR 1212

Neuron Specific Enolase (NSE) Antibody-HRP

E63C00702a 100μg/100μl
EUR 275
Description: Available in various conjugation types.

ELISA kit for Human NSE (Enolase, Neuron Specific)

ELK2587 1 plate of 96 wells
EUR 518.4
Description: A sandwich ELISA kit for detection of Enolase, Neuron Specific from Human in samples from blood, serum, plasma, cell culture fluid and other biological fluids.

Anti-NSE (Neuron specific enolase) antibody

STJ120175 100 µl
EUR 562.8

Rat Enolase, Neuron Specific (ENO2) CLIA Kit

abx197337-96tests 96 tests
EUR 990

Rat Enolase, Neuron Specific (ENO2) CLIA Kit

20-abx491611
  • EUR 10282.80
  • EUR 5472.00
  • EUR 1262.40
  • 10 × 96 tests
  • 5 × 96 tests
  • 96 tests

Rat NSE(Neuron Specific Enolase) ELISA Kit

ER1200 96T
EUR 571.5
Description: Method of detection: Double Antibody, Sandwich ELISA;Reacts with: Rattus;Sensitivity: 0.188 ng/ml

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.

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