CHARLOTTE, N.C. and MILFORD, Mass., Nov. 10, 2016 /PRNewswire/ -- SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, is announcing at the 2016 AMP Annual Meeting in Charlotte a collaboration with UK NEQAS, a leading provider of external quality assessment (EQA) schemes. The UK-based provider plans to incorporate these materials into one of the first widespread global NIPT EQA schemes (in collaboration with two other EQA providers; CEQAS and EMQN), and work together with SeraCare toward the implementation of industry-leading NIPT reference materials.
NIPT is the analysis of cell-free DNA (cfDNA) from maternal blood to screen for common prenatal aneuploidies such as Down syndrome (trisomy 21). As such assay services continue to expand globally, it is extremely critical for laboratory managers to ensure that the clinical diagnostic results from NIPT assays are accurate, timely, and consistent. The use of remnant patient samples as controls is not a viable solution as they are often limited in supply, contain unknown levels of fetal cfDNA, or lack sufficient consistency to be used reliably as reference materials. Hence, laboratories performing such tests need reliable, patient-like reference materials for assay development, validation, daily run QC, and to ensure the accuracy and consistency of test results. The Seraseq Aneuploidy Reference Material product line is the industry's first full-process reference material for assessing NIPT performance. They are precise mixtures of fetal DNA derived from trophoblast cells from confirmed trisomies and normal female DNA, fragmented to a size distribution similar to the natural cfDNA size profile, and stabilized and blended into a plasma-like matrix under proprietary technology developed at SeraCare.