Newborn screening (NBS) is an analytical or physical screening process used to test neonates for inherited or congenital disorders related to inborn errors of metabolism (IEM). IEMs are caused by the deficiency, absence, or alteration of specific enzymatic reactions. The goal of NBS is to detect metabolic errors at the earliest stage of development, such that treatment can be initiated and irreversible damage to the central nervous system can ultimately be avoided. To help facilitate IEM screens (e.g., for phenylketonuria, maple syrup urine disease, medium-chain and very long-chain acyl-CoA dehydrogenase deficiencies), CIL is pleased to offer two types of CE-marked IVD medical devices: amino acid reference standards (NSK-A-CE) and carnitine/acylcarnitine reference standards (NSK-B-CE). These devices have been manufactured according to the quality system requirements outlined by ISO 13485 and rigorously characterized toward fit-for-purpose implementation.

NSK-A-CE Newborn Screening
The NSK-A-CE reference standard is composed of a dry mixture (packaged as 10 vials per box) of 12 stable isotope-labeled amino acids.