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Culture Collections

NIBSC Genomic Reference Materials

 

NIBSC

 

The National Institute for Biological Standards and Control (NIBSC) is the only producer of World Health Organization (WHO) international standards for genomic diagnostics, and is the only European producer of human genomic DNA reference materials for in vitro diagnostic use.

NIBSC has utilised cell lines from ECACC as the source of some of their genomic reference materials. These are produced as single, large, well-characterised batches, assuring consistent high quality and highly reproducible performance between samples.

NIBSC produces reference materials for human nucleic acid -based diagnostics where there is strong evidence of need. These control materials are produced as either WHO international standards or as CE-marked reference materials. As higher order materials, WHO international standards are suitable for in vitro diagnostic use worldwide. CE-marked materials are suitable for in vitro diagnostic use in Europe and are available for research use world-wide.

With imminent changes to the IVD directive, it is expected that more diagnostic laboratories will be working towards ISO 15189 accreditation. NIBSC’s CE-marked reference materials and WHO international standards enable laboratories to validate both in-house developed and research-use-only kits, thus facilitating ISO 15189 compliance.

Available standards
Product Order Code Classification Clinical Application Gene/Region
Factor V Leiden 04/224 WHO Thrombosis F5
Prothrombin 05/130 WHO Thrombosis F2
HLA-DRB1 10/136 CE-marked IVD HLA Typing HLA-DRB1
Haemophilia A 08/160 WHO Haemophilia F8
Fragile X Syndrome 08/158 WHO Fragile X Syndrome FMR-1
Prader Willi & Angelman Syndromes 09/140 WHO Prader Willi & Angelman Syndromes 15q11-13/UBE3A
Fetal RhD Status for Non-Invasive Maternal Screening 07/222 WHO Haemolytic Disease of the Newborn RHD
Red Cell Antigen Genotyping 11/214 WHO Red Blood Cell Genotyping Blood group genes
MLH1/MSH2 Exon Copy Number Reference Panel 11/218 CE-marked IVD Hereditary Non-polyposis Colorectal Cancer/Lynch Syndrome MLH1/MSH2
Sensitivity Controls for JAK2 V617F Tumour Genotyping 12/248 CE-marked IVD. WHO reference panel expected late 2016. Myeloproliferative Disorders JAK2

 

For further information click here to visit the NIBSC website.

Materials produced by NIBSC are supplied on a not-for-profit basis.

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