IVD Assay Development
Seraseq® Trisomy 18 Male-Matched Reference Material
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Non-invasive prenatal testing (NIPT) continues to expand globally, and given the clinical implicatons, 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 Trisomy 18 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 Trisomy 18 (or Edwards Syndrome) male sample compatible with a broad range of NIPT assay methods
- 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 (identical to clinical samples
- Fetal fraction levels confirmed to be moderate-high positive to help establish initial baseline (can be customized to lower levels)
- Manufactured in GMP-compliant and ISO 13485-certified facilities
Seraseq Trisomy 18 Male Matched Reference Material
Seraseq Trisomy 18 Male-Matched Reference Material
Seraseq NIPT Reference Materials
Seraseq Matched Reference Material Non-Requirement Letter
Package Insert for Seraseq Trisomy 18 Male Matched Reference Material
Seraseq Trisomy 18 Male-Matched Reference Material
Reproductive Health FAQs
Review the common questions we receive from our customers and the responses we provide.