Seraseq® 22q11 Matched Reference Material

Non-invasive prenatal testing (NIPT) continues to expand globally and given the clinical implications, it is extremely critical that NIPT assays report back presence or absence of aneuploidies in an accurate and consistent manner. Matched maternal-fetal reference materials derived from pregnant maternal plasma enable accurate assessment of a broad range of NIPT assays, including those based on counting methods, SNPs, as well as differences in the length of maternal and fetal cfDNA.

The Seraseq 22q11 Male-Matched Reference Material can be used to develop a new test, validate an assay, monitor routine performance, troubleshoot problems across the entire workflow and ensure overall proficiency with the same sustainable product.

• Matched (or related) maternal-fetal 22q11 (or DiGeorge Syndrome) male sample compatible with a broad range of NIPT assay methods
• Microdeletion is at least 2Mb and includes TUPLE1 deletion
• Proprietary method maintains native cfDNA size profile of ~170 bp size distribution and natural maternal-fetal size difference
• Offered in a plasma format capable of assessing the entire workflow from extraction through analysis (similar to clinical samples)
• Fetal fraction levels confirmed to be a high positive to help establish initial baseline (can be customized to lower levels)
• Manufactured in GMP-compliant and ISO 13485-certified facilities

Documents

• Seraseq NIPT Reference Materials (Product Sheet)
• Package Insert for Seraseq 22q11 Male-Matched Reference Material (Package Insert)
• Package Insert for Seraseq 22q11 Female-Matched Reference Material (Package Insert)
• Seraseq Matched Reference Material Non-Requirement Letter (SDS Non-Requirement Letter)
• Seraseq Euploid Reference Material Non-Requirement Letter (SDS Non-Requirement Letter)

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