Controls & Reference Materials

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Reproductive Health FAQs

Review the common questions we receive from our customers and the responses we provide.

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NGS Controls & Reference Materials

Reproductive Health

Non-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.

PRODUCT LIST

Product Name	Material Number	Size	Price	Unit	Qty
Seraseq® Trisomy 21 Male - Matched Reference Material (Lyophilized)	0720-1137	1 x lyophilized whit	Please sign in to view pricing.	EA	View Details
Seraseq® Trisomy 18 Female - Matched Reference Material (Lyophilized)	0720-1138	1 x lyophilized whit	Please sign in to view pricing.	EA	View Details
Seraseq® Triple X Syndrome (XXX) Reference Material	0720-1069	1 x 1 mL	Please sign in to view pricing.	EA	View Details
Seraseq® Postpartum T21 Male cfDNA	0720-1101	1 x 25µL	Please sign in to view pricing.	EA	View Details
Seraseq® Postpartum 22q11 Male cfDNA	0720-1103	1 x 25µL	Please sign in to view pricing.	EA	View Details
Seraseq® Euploid Male Twins Matched cfDNA	0720-1117	1 x 25µL	Please sign in to view pricing.	EA	View Details
Seraseq® Euploid Female - Matched Reference Material (Lyophilized)	0720-1136	1 x lyophilized whit	Please sign in to view pricing.	EA	View Details
Seraseq® Antepartum T21 Male cfDNA	0720-1100	1 x 25uL	Please sign in to view pricing.	EA	View Details
Seraseq® Antepartum 22q11 Male cfDNA	0720-1102	1 x 25µL	Please sign in to view pricing.	EA	View Details
Seraseq® 22q11 Male Twins Matched cfDNA	0720-1116	1 x 25µL	Please sign in to view pricing.	EA	View Details

Showing products 1 to 10 out of 10

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