IVD Assay Development
Seraseq® Klinefelter Syndrome (XXY) Reference Material
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The Klinefelter Syndrome (XXY) 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 XXY 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 NIPT Reference Materials
Seraseq Klinefelter Syndrome (XXY)
Seraseq Syndrome Non-Requirement Letter
Seraseq Klinefelter Syndrome (XXY) Reference Material
Seraseq Klinefelter Syndrome (XXY)
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