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Newborn Screening

NSK-B-CE Newborn Screening

NSK-A-CE and NSK-B-CE Amino Acid and Free Carnitine/Acylcarnitine Reference Standards


  • NSK-A-CE and NSK-B-CE Amino Acid and Free Carnitine/Acylcarnitine Reference Standards

The NSK-B-CE reference standard is composed of a dry mixture (packaged as 10 vials per box) of eight stable isotope-labeled standards (free carnitine and eight acylcarnitines). When used as directed (see instructions in product flyer), this product provides a solution to quantitatively measure these target analytes in a range of neonate biosamples (e.g., dried blood spot, urine) using a variety of MS-based techniques. These screens can be used toward the detection of organic acidemias (e.g., methylmalonic acidemia, propionic acidemia) and fatty acid oxidation disorders (e.g., carnitine uptake defect, medium-chain and very long-chain acyl-CoA dehydrogenase deficiencies).


For sale in European Economic Area (EEA) – EU and EFTA – only.
For professional use only.
In the US, CIL products are labeled “For research use only. Not for use in diagnostic procedures.”


Resources 

  NSK-A-CE and NSK-B-CE

 

Frequently Asked Questions 

What is the difference between NSK-B and NSK-B-CE?

The regulated NSK-B-CE product is designed for use as a calibrator in screening, diagnosis, and monitoring procedures of organic acidemias and fatty acid oxidation disorders. This is a CE-marked IVD medical device (manufactured according to ISO 13485:2016) that is available only in the European Economic Area (EU and EFTA). The nonregulated NSK-B product, in contrast, is not designed for specific metabolic assessment procedures and is globally available for research applications.

What QC tests are performed on NSK-B-CE?

The analyte concentrations of NSK-B-CE are based on HPLC analysis of the reconstituted product against a traceable standard. The mean and standard deviations of the analyzed measurements, together with the target and prepared concentrations, are reported in the product CoAs.  Isotopic enrichments (≥98%, via LC-MS) and chemical purity (1H NMR) are based on tests of the starting materials.

What is the recommended protocol for reconstituting this isotope-labeled mix?

The guidelines for reconstitution are detailed in the product flyer.

What is the storage and shelf life of this isotope-labeled mix?

The details of storage and shelf life are tabulated in the product flyer. This reflects both before and after mix reconstitution.

Where are these CE products available?

These are available only in the European Economic Area – EU and EFTA.  The applicable countries are tabulated below:

Austria

Germany

Luxembourg

Slovenia

Belgium

Greece

Malta

Spain

Bulgaria

Hungary

Netherlands

Sweden

Cyprus

Iceland

Norway

Switzerland

Denmark

Ireland

Poland

Turkey

Finland

Italy

Portugal

United Kingdom

France

Liechtenstein

 

 

 

Krista Backiel

Krista Backiel

Marketing Manager and Metabolomics Manager

Krista Backiel is responsible for managing and promoting products that are utilized in metabolomics and clinical/diagnostic MS. She spends a lot of her time developing new products to assist customers in their diverse research efforts.

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Andrew Percy, PhD

Andrew Percy, PhD

Senior Applications Chemist – Mass Spectrometry

Dr. Andrew Percy is the Senior Applications Chemist for Mass Spectrometry. His responsibilities minimally involve overseeing product development, identifying new product market opportunities, assisting in the analysis of products for MS ‘omics applications, and providing technical support to customers.

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To view the instructions for use of this CE Mark product click here.