Development of SNP Matched NIPT Reference Materials for Validation, Proficiency Testing and Quality Control

Plasma-based non-invasive prenatal testing (NIPT) by Next Generation Sequencing (NGS) is being adopted into clinical laboratories. However, obtaining sufficient amounts of patient-derived reference materials for proficiency testing, assay validations, and daily QC remains difficult if not impossible to obtain. Using consistent, high quality and patient-derived reference materials can help with all of these tasks.



Plasma-based non-invasive prenatal testing (NIPT) by Next Generation Sequencing (NGS) is being adopted into clinical laboratories.

However, obtaining sufficient amounts of patient-derived reference materials for proficiency testing, assay validations, and daily QC remains difficult if not impossible to obtain. Using consistent, high quality and patient-derived reference materials can help with all of these tasks.

SeraCare has developed new NIPT materials derived from circulating cell-free DNA (ccfDNA) from pregnant donors. Amplification of ccfDNA from maternal sources allows reference materials to be created that are fetal-maternal matched and maintain fetal-maternal ccfDNA size distribution.

Watch this video to see how SeraCare has developed a technology to generate maternal-fetal matched NIPT reference materials that can be used for validations, proficiency testing, and as daily run controls.

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