IVD Assay Development

Seraseq® Trisomy 21 Male-Matched Reference Material

Material Number 0720-0167
Size 1 x 1 mL
Inventory Status In Stock
Unit EA

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 Trisomy 21 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 21 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 21 Male - Matched Reference Material

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq NIPT Reference Materials

Doc type
Product Sheet

Seraseq Trisomy 21 Male - Matched Reference Material

Doc type
Product Report
Lot #
10494994

Seraseq Trisomy 21 Male - Matched Reference Material

Doc type
Technical Product Report
Lot #
10597141

Seraseq Trisomy 21 Male - Matched Reference Materia

Doc type
Technical Product Report
Lot #
10680182

Seraseq Trisomy 21 Male - Matched Reference Material

Doc type
Package Insert
Lot #
-

Seraseq Matched Reference Material Non-Requirement Letter

Doc type
Safety Data Sheet (Non-Requirement Letter)

Seraseq Trisomy 21 Male - Matched Reference Material

Doc type
Product Report
Lot #
10417417

Seraseq Trisomy 21 Male - Matched Reference Materia

Doc type
Technical Product Report
Lot #
10690465

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