NGS Controls & Reference Materials
Reproductive Health
SHOP PRODUCTSNon-invasive prenatal testing (NIPT) based on circulating cell-free DNA (ccfDNA) in the maternal blood is one of the fastest growing test methods for screening pregnancies due to its superior sensitivity, and it is being widely adopted by clinical laboratories around the world. Thanks to continuous sequencing technology advancement, it allows screening for not only the most common fetal aneuploidies such as trisomy 21 (Down Syndrome), but also other autosomal and sex chromosome aneuploidies as well as some microdeletions, large copy number variants, and monogenic disorders.
Common problems with fertility and conception are leading to an increased use of assisted reproductive technology and subsequent preimplantation genetic testing (PGT) to improve the odds of a successful pregnancy.
SeraCare offers a unique portfolio of patient-derived reproductive health reference materials for NIPT assay development, validation, and routine run QC. In addition to the wide selection of readily available Seraseq® NIPT reference materials, we also provide custom solutions for NIPT as well as PGT-A applications.
Features & Benefits
- SNP-matched NIPT reference materials sustainably derived from clinical samples
- Compatible with all NGS NIPT assays on the market including SNP-based methods
- Preserving the patient ccfDNA size profile and fetal fraction
- Full process controls supplied in synthetic plasma allow monitoring of entire NIPT workflow
- Long term stability due to a patented encapsulation process
- Manufactured in GMP-compliant and ISO 13485-certified facilities
- Common aneuploidies (trisomy 13, 18 and 21), sex chromosome aneuploidies (SCA), microdeletion and euploid samples
Seraseq NIPT reference materials help expedite assay development, validation and performance monitoring
- Provide increased confidence in clinical results
- Test and optimize the entire NIPT workflow
- Determine assay sensitivity and specificity
- Ensure compliance with regulatory guidelines
- Proactively monitor assay and instrument performance
- Expedite troubleshooting
- Train staff, validate new reagent lots or protocol changes
With nearly 40 years providing quality control reagents to IVD developers and clinical laboratories worldwide, SeraCare helps solve assay development challenges. We can produce sophisticated, high quality aneuploid, euploid and microdeletion reference materials tailored to your specifications with regard to concentration, fetal fraction and format.
With our custom services, you have a high degree of flexibility, access to our technical and scientific experts, and a rapid turnaround time to support a new platform and consumable launch, ensure reliable QC testing or provide in-kit controls.
