As the non-invasive prenatal testing (NIPT) market continues to expand, there is a growing need for reliable reference materials to ensure the accuracy of results. SeraCare’s reproductive health product line fulfills that need by providing precisely formulated and consistent reference materials. This is especially critical as labs scale up their operations and need to develop, optimize, validate, and monitor ongoing assay performance.
Often labs resort to remnant patient samples or development of their own homebrew controls to perform NIPT, however, those approaches are not robust, reliable or sustainable in the long run, especially in an environment of growing regulatory requirement for the use of robust QC materials.
Seraseq NGS reference materials for NIPT assays
In order to alleviate the sourcing challenges and inherent variability in creating homebrew controls, SeraCare has created the Seraseq line of biosynthetic aneuploidy reference materials. Seraseq aneuploidy products can be used as a QA reference material for NIPT assays that screen for trisomy 21, 18, and 13 using next-generation sequencing (NGS) platforms.
Seraseq Aneuploidy Reference Materials can be used in a single trisomy or multi-analyte format to save time and money in the testing process. As a key component in NGS quality control practices, this product provides a consistent, reliable source of control material that mimics a positive trisomy patient sample at varying fetal fractions to assess performance across the entire workflow.
- Seraseq™ Trisomy 21, 18 and 13 Multi-Analyte Aneuploidy Reference Material
- Seraseq™ Trisomy 21 Aneuploidy Linearity Panel (1-8% Fetal Fraction)
- Seraseq™ Trisomy 21 Aneuploidy Reference Material
- Seraseq™ Trisomy 18 Aneuploidy Reference Material
- Seraseq™ Trisomy 13 Aneuploidy Reference Material
- Seraseq™ Aneuploidy Negative (Euploid) Reference Material
Provides confidence in your test results
The NIPT results delivered to clinicians have an important impact on their patients and management of their pregnancy. Utilizing a full-process reference material provides an added level of confidence in the performance of your NIPT assay, as well as the results which are interpreted and reported to your clinicians.