Reproductive Health
Seraseq Discordant Twins Matched cfDNA T21 Female Euploid Male Lyophilized
Details
Specifications
Frequently Asked Questions
The Seraseq® Discordant Twins – Matched cfDNA (T21 Female / Euploid Male) (Lyophilized) reference material is designed to support the development, validation, verification, monitoring of test performance and quality control of Non-Invasive Prenatal Testing/Screening (NIPT/NIPS). These assays analyses circulating cell-free DNA in the maternal bloodstream to detect fetal chromosomal aneuploidies, such as Trisomy 21 (also known as Down syndrome).
This product is derived from a naturally occurring mixture of matched (or related) maternal and fetal circulating cell-free DNA, obtained from the blood sample of a twin pregnancy donor whose female twin has been diagnosed with a trisomy 21, and the male fetus euploid.
This reference material is ideal for use by clinical laboratories, diagnostic assay developers and proficiency testing providers. It can help ensure consistent and reliable assay performance across multiple sequencing runs, operators, instruments, and laboratory conditions.
Supplied as lyophilized plasma.
-> Clinically sourced: derived from naturally occurring cfDNA from a twin gestation, accurately reflecting the challenges and complexities of these cases.
-> The only reference material compatible with a broad range of NIPT methods, including SNP-based NIPT assays.
-> Proprietary method preserves native cfDNA characteristics such as size profile of ~170 bp, SNP content and natural maternal-fetal size difference. This ensures the material behaves like patient samples.
-> High-quality Quality Assured 3rd party control: lot-to-lot consistency with materials manufactured in GMP-compliant and ISO 13485-certified facilities under strict quality controls.
-> Easy to use & highly stable: supplied as lyophilized plasma with a 2 years shelf-life.
Important Notice: For Research Use Only (RUO). Not for use in diagnostic procedures. This product is not intended for patient diagnosis, treatment, management, or therapeutic procedures, and should only be handled by trained laboratory personnel.
| Product Specifications | |
| CLINICAL INFORMATION | |
| Source/Origine: | Patient-derived (antepartum blood drawn at 31 weeks gestation) |
| Pregnancy type:: | Dichorionic-diamniotic twin gestation |
| Fetal condition:: | Trisomy 21 (female) and Euploid (male) |
| PRODUCT INFORMATION | |
| Format: | Cell-free DNA (cfDNA) |
| Fetal fraction (%): | Typically observed between 5.63% – 29%(assay-dependent; see Technical Product Report in the Resource tab. for lot-specific data) |
| Fetal gender: | Female and Male |
| Format: | 1x vial. ≥10 ng per vial is provided as a powder lyophilised from 1 mL synthetic plasma (SeraCon™ Matribase (Cat no.1800-0005) with 5 mM EDTA) |
| Fragment size: | ~170bp (100-200 bp range) |
| Expected DNA yield /Concentration: | ≥120 ng/mL after extraction (based on extracted cfDNA recovered from QIAGEN’s QIAamp® ccfDNA extraction kit (Cat no. 55184) - see Batch-specific Technical Product Report in the Resource tab |
| Shipping condition: | Ambient |
| Storage condition: | Ambient |
| Stability: | 24 months from the date of manufacture - See Technical Product Report in the Resource tab |
| Hazardous: | No - see Safety Data Sheet (Non-Requirement Letter) |
| Country of manufacture: | USA |
| Manufacturing standards: | ISO 13485, GMP-compliant |
| QUALITY CONTROL | |
| Quantification: | Qubit™ dsDNA BR Assay (Cat No. Q32850, Q32853) |
| Fragmentation size assay: | Agilent 2100 bioanalyzer |
| Fetal allelic ratio and fetal gender: | External clinical laboratory using a commercial NIPT assay. See Batch-specific Technical Product Report in the Resource tab |
| Intended use: | This reference material is for research use only. Not for use in diagnostic procedures. |
| COMPATIBILITY & PERFORMANCE ADVANTAGES | |
| NIPT ccompatibility: | Platform Agnostic (Fully compatible with sequencing-based, SNP-based, and chromosome counting NIPT/NIPS assays) |
| Advantages over cell line standards | True Patient-Derived Biological Material: Unlike artificial or cell-line-derived alternatives, this naturally occurring maternal-fetal mix provides a more authentic biological representation of complex twin gestation clinical samples. |
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