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.
|Product||Order Code||Classification||Clinical Application||Gene/Region|
|Factor V Leiden||04/224||WHO||Thrombosis||F5|
|HLA-DRB1||10/136||CE-marked IVD||HLA Typing||HLA-DRB1|
|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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