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

Neuron Specific Enolase Protein

abx060902-100ug 100 ug
EUR 1387.2

Neuron Specific Enolase Antibody

F48200-0.4ML 0.4 ml
EUR 379

Neuron Specific Enolase (NSE)/ENO2

CH23003 100 ul
EUR 214.8

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 (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

Neuron-Specific Enolase (ENO2) Antibody

20-abx159487
  • EUR 326.40
  • EUR 276.00
  • 100 ug
  • 50 ug

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

Neuron-Specific Enolase (ENO2) Antibody

20-abx131861
  • EUR 376.80
  • EUR 944.40
  • EUR 493.20
  • EUR 184.80
  • EUR 309.60
  • 100 ug
  • 1 mg
  • 200 ug
  • 20 ug
  • 50 ug

Neuron-Specific Enolase (ENO2) Antibody

20-abx131862
  • EUR 360.00
  • EUR 861.60
  • EUR 427.20
  • EUR 184.80
  • EUR 292.80
  • 100 ug
  • 1 mg
  • 200 ug
  • 20 ug
  • 50 ug

Neuron-Specific Enolase (ENO2) Antibody

20-abx125813
  • EUR 493.20
  • EUR 710.40
  • EUR 218.40
  • EUR 376.80
  • 100 ul
  • 200 ul
  • 20 ul
  • 50 ul

Neuron-Specific Enolase (ENO2) Antibody

20-abx126897
  • EUR 493.20
  • EUR 710.40
  • 100 ul
  • 200 ul

Enolase, Neuron Specific (ENO2) Antibody

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

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

Neuron-Specific Enolase (ENO2) Antibody

20-abx002239
  • EUR 493.20
  • EUR 710.40
  • EUR 218.40
  • EUR 376.80
  • 100 ul
  • 200 ul
  • 20 ul
  • 50 ul

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

Neuron-Specific Enolase (ENO2) Antibody

abx012133-100ug 100 ug
EUR 493.2

Neuron-Specific Enolase (ENO2) Antibody

20-abx013157
  • EUR 376.80
  • EUR 117.60
  • EUR 477.60
  • EUR 594.00
  • 100 ug
  • 10 ug
  • 200 ug
  • 300 µg

Neuron-Specific Enolase (NSE) Antibody

abx037802-100ug 100 ug
EUR 469.2

Enolase, Neuron Specific (ENO2) Antibody

abx036140-100ug 100 ug
EUR 469.2

Neuron-Specific Enolase (NSE) Antibody

abx037440-100ug 100 ug
EUR 469.2

Neuron-Specific Enolase (ENO2) Antibody

abx031704-400ul 400 ul
EUR 627.6

Neuron-Specific Enolase (ENO2) Antibody

abx031704-80l 80 µl
EUR 343.2

Neuron-Specific Enolase (ENO2) Antibody

abx031705-400ul 400 ul
EUR 627.6

Neuron-Specific Enolase (ENO2) Antibody

abx031705-80l 80 µl
EUR 343.2

Neuron-Specific Enolase (ENO2) Antibody

20-abx210136
  • EUR 526.80
  • EUR 393.60
  • 100 ug
  • 50 ug

Neuron-Specific Enolase (ENO2) Antibody

20-abx329234
  • EUR 376.80
  • EUR 292.80
  • 100 ug
  • 50 ug

Neuron-Specific Enolase (ENO2) Antibody

abx331441-100ul 100 ul
EUR 510

Neuron-Specific Enolase (ENO2) Antibody

abx331504-100ul 100 ul
EUR 510

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

Neuron-Specific Enolase (NSE) Antibody

abx411075-02mg 0.2 mg
EUR 678

Neuron-Specific Enolase (NSE) Antibody

abx411512-02mg 0.2 mg
EUR 678

Neuron-Specific Enolase (ENO2) Antibody

20-abx241083
  • EUR 493.20
  • EUR 360.00
  • 100 ul
  • 50 ul

Neuron-Specific Enolase (ENO2) Antibody

20-abx241084
  • EUR 493.20
  • EUR 360.00
  • 100 ul
  • 50 ul

Neuron-Specific Enolase (NSE) Antibody

abx235865-100ug 100 ug
EUR 577.2

Neuron-Specific Enolase (NSE) Antibody

abx235866-100ug 100 ug
EUR 577.2

Neuron-Specific Enolase (NSE) Antibody

abx235867-100ug 100 ug
EUR 610.8

Neuron Specific Enolase ELISA Kit

E4703-100
EUR 705.6

Neuron Specific Enolase (NSE)/ENO2

RA22110 100 ul
EUR 490.8

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-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)

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

Neuron Specific Enolase Antibody (NSE)

F48200-0.08ML 0.08 ml
EUR 165

Neuron Specific Enolase Antibody (NSE)

F48201-0.08ML 0.08 ml
EUR 165

NSE Antibody / Neuron Specific Enolase

F54038-0.1ML 0.1 ml
EUR 379

NSE Antibody / Neuron Specific Enolase

F54039-0.1ML 0.1 ml
EUR 379

NSE Antibody / Neuron Specific Enolase

RQ4566 100ug
EUR 419

NSE Antibody / Neuron Specific Enolase

RQ5267 100ul
EUR 419

NSE Antibody / Neuron Specific Enolase

V3398-100UG 100 ug
EUR 499
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 219
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 499
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 499
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 219
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 499
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 499
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 219
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 499
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 499
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 499
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 219
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 499
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

V7731-100UG 100 ug
EUR 499
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 219
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 499
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 499
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 219
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 499
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 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 Recombinant Neuron-Specific Enolase (NSE)

6362-100
EUR 548.4

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) Protein

abx670067-50ug 50 ug
EUR 360

Human Neuron Specific Enolase (NSE) ELISA

LF-EK0169 1×96T
EUR 723.6

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.

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.

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.

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.

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.

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.

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

Mouse Enolase, Neuron Specific (NSE) Protein

20-abx066424
  • 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

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

Enolase, Neuron Specific (ENO2) Antibody (Biotin)

20-abx105440
  • 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 (Biotin)

20-abx105441
  • 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-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

Mouse Enolase, Neuron Specific (NSE) Protein

20-abx167196
  • 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

Enolase, Neuron Specific (ENO2) Antibody Pair

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

Enolase, Neuron Specific (NSE) Antibody Pair

20-abx370057
  • EUR 1914.00
  • EUR 1228.80
  • 10 × 96 tests
  • 5 × 96 tests

Rabbit Enolase, Neuron Specific (NSE) Protein

20-abx653280
  • EUR 777.60
  • EUR 326.40
  • EUR 2397.60
  • EUR 927.60
  • EUR 560.40
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody (Biotin)

20-abx273178
  • EUR 543.60
  • EUR 292.80
  • EUR 1545.60
  • EUR 744.00
  • EUR 410.40
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody (FITC)

20-abx273791
  • EUR 543.60
  • EUR 292.80
  • EUR 1545.60
  • EUR 744.00
  • EUR 410.40
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody (FITC)

20-abx274000
  • EUR 543.60
  • EUR 292.80
  • EUR 1579.20
  • EUR 760.80
  • EUR 410.40
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody (FITC)

20-abx274136
  • EUR 560.40
  • EUR 292.80
  • EUR 1663.20
  • EUR 777.60
  • EUR 427.20
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody (Biotin)

20-abx271998
  • EUR 510.00
  • EUR 276.00
  • EUR 1429.20
  • EUR 693.60
  • EUR 393.60
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody (Biotin)

20-abx272702
  • EUR 510.00
  • EUR 276.00
  • EUR 1462.80
  • EUR 710.40
  • EUR 393.60
  • 100 ug
  • 10 ug
  • 1 mg
  • 200 ug
  • 50 ug

Enolase, Neuron Specific (NSE) Antibody (APC)

20-abx176282
  • EUR 1412.40
  • EUR 693.60
  • 1 mg
  • 200 ug

Polyclonal Neuron Specific Enolase (NSE) Antibody

APR08718G 0.1ml
EUR 580.8
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:

Polyclonal Neuron-Specific Enolase (NSE) Antibody

APR08719G 0.1mg
EUR 633.6
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:

Anti-Neuron Specific Enolase (NSE) Antibody

M02930-2 100ul
EUR 476.4
Description: Rabbit Polyclonal Neuron Specific Enolase (NSE) Antibody. Validated in IF, IHC, ICC, WB and tested in Human, Mouse, Rat.

Rabbit Neuron- specific enolase ELISA Kit

ELA-E0537Rb 96 Tests
EUR 1113.6

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.

Anti-NSE (Neuron specific enolase) antibody

STJ120175 100 µl
EUR 562.8

Neuron Specific Enolase Antibody (phospho-Y236)

F48585-0.08ML 0.08 ml
EUR 165

Human Neuron-specific enolase, NSE ELISA Kit

CSB-E07961h-24T 1 plate of 24 wells
EUR 198
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.

Human Neuron-specific enolase, NSE ELISA Kit

1-CSB-E07961h
  • EUR 843.60
  • EUR 5811.60
  • EUR 3084.00
  • 1 plate of 96 wells
  • 10 plates of 96 wells each
  • 5 plates of 96 wells each
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.

Human Neuron-specific enolase,NSE ELISA Kit

CN-03318H1 96T
EUR 546

Human Neuron-specific enolase,NSE ELISA Kit

CN-03318H2 48T
EUR 364.8

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 (ENO2) ELISA Kit

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

Human Neuron-Specific Enolase (NSE) CLIA Kit

abx195569-96tests 96 tests
EUR 990

Human Enolase, Neuron Specific (ENO2) ELISA Kit

abx573286-96tests 96 tests
EUR 877.2

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 Enolase, Neuron Specific (ENO2) ELISA Kit

abx253091-96tests 96 tests
EUR 877.2

Human Neuron-specific enolase,NSE ELISA Kit

201-12-0938 96 tests
EUR 528
Description: A quantitative ELISA kit for measuring Human in samples from biological fluids.

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

LF-EK0170 4×96T
EUR 2454

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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