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NIPT Plasma Reference Standard

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NIPT plasma reference standard uses gDNA from human cell lines as raw material, which is fragmented and then mixed into human plasma to simulate real clinical samples. This product contains common chromosomal abnormalities, including: aneuploidy of three common chromosomes (21/13/18); two rare chromosomes (9/15); four sex chromosomes, and two common clinical CNV types (22q11 deletion and 15q deletion, etc.). It is suitable for the detection of cell-free DNA (cfDNA) in peripheral blood of pregnant women using the whole genome method (massive-parallel sequencing MPS).
 
  • CBPJ0001-CBPJ0023

  • CBPJ0001-CBPJ0023

Availability:


Intended Use


NIPT plasma reference standard can be used for precision testing, stability testing, and sensitivity testing in non-invasive prenatal testing(NIPT) laboratories. It can monitor the process quality control of sample extraction, library preparation, on-machine sequencing, and data analysis of non-invasive prenatal testing(NIPT) kits.

  • Suitable for performance verification and production quality control of non-invasive prenatal testing (NIPT) test kits.

  • Suitable for indoor quality control of non-invasive prenatal testing (NIPT) tests to monitor the precision of the test process.


Product features

  • Entire workflow quality control

NIPT plasma reference are formulated in human plasma matrix which mimicing patient samples and monitoring the entire workflow from extraction.


  • Compatible with multiple NIPT assay platforms

Matched or simulated maternal-fetal reference standards suit a broad range of NIPT assays such as massively parallel sequencing and single nucleotide polymorphism methods.


  • Comprehensive coverage of variants for workflow performance evaluation

NIPT plasma reference covers common chromosomal abnormalities as well as pathogenic copy number variations ranging from 2Mb to 30 Mb.


  • Flexible portfolio of fetal fraction levels

Fetal DNA ratio can be customised to match your assay and to determine the limit of detection.


Product data display

In the process of detection, quality control products and reference products are indispensable. For NIPT detection, CB-Gene has launched chromosome aneuploidy reference products and quality control products, including autosomes and sex chromosomes, as well as microdeletion and microduplication quality control products and reference products. In the future, chimera reference products will be launched one after another.



Product Name

Chromosomal abnormalities

Catalog ID

Common and Rare Chromosomal Aneuploidy standards

Trisomy 21(47,XX,+21) Reference Standard

Chromosome 21 trisomy standard, female

CBPJ0001

Trisomy 18(47,XX,+18) Reference Standard

Chromosome 18 trisomy standard, female

CBPJ0002

Trisomy 21(47,XY,+21) Reference Standard

Chromosome 21 trisomy standard, male

CBPJ0009

Trisomy 13(47,XY,+13) Reference Standard

Chromosome 13 trisomy standard, male

CBPJ0010

Trisomy 9(47,XY,+9) Reference Standard

Chromosome 9 trisomy standard, male

CBPJ0014

Trisomy 21(47,XY,+21) Reference Standard-2

Chromosome 21 trisomy standard,male

CBPJ0016

Sex Chromosome Aneuploidy Standards

Klinefelter Syndrome (47,XXY) Reference Standard

X chromosome non-global ploidy standard

CBPJ0005

Microdeletion and Microduplication Standards

Trisomy 9 (47,XY,+9, Gain 9p24.3p13.1) Reference Standard

9q11 microdeletion standard, male

CBPJ0003

Angelman syndrome (46,XX,del(15)(q11q13)) Reference Standard

Angelman Syndrome Standards, Female

CBPJ0006

Prader-Willi syndrome (46,XY,del(15)(q11.2q13)) Reference Standard

Prader-Willi syndrome standard, male

CBPJ0007

18P-syndrome (46,XX,del(18)(p11.2)) Reference Standard

18P-syndrome standard, female

CBPJ0008

DiGeorge syndrome (46,XX,del(22)(q11)) Reference Standard

DiGeorge syndrome standard, female

CBPJ0011

18Q-syndrome (46,XX,del(18)(q22)) Reference Standard

18Q-syndrome standard, female

CBPJ0013

11q23.3 del (46,XX,del(11)(q23.3)) Reference Standard

11q23.3 del standard, female

CBPJ0015

Angelman syndrome (46,XY,del(15)(q11.2q13.1)) Reference Standard

Angelman syndrome,male

CBPJ0017

Prader-Willi syndrome (46,XY,del(15)(q11.2q13.1)) Reference StandardPrader-Willi syndrome,maleCBPJ0018

Negative control

Normal Karyotype (46,XY) Reference Standard

Normal Karyotype,male

CBPJ0004



Product features


  • Entire workflow quality control

NIPT plasma reference are formulated in human plasma matrix which mimicing patient samples and monitoring the entire workflow from extraction.


  • Compatible with multiple NIPT assay platforms

Matched or simulated maternal-fetal reference standards suit a broad range of NIPT assays such as massively parallel sequencing and single nucleotide polymorphism methods.


  • Comprehensive coverage of variants for workflow performance evaluation

NIPT plasma reference covers common chromosomal abnormalities as well as pathogenic copy number variations ranging from 2Mb to 30 Mb.


  • Flexible portfolio of fetal fraction levels

Fetal DNA ratio can be customised to match your assay and to determine the limit of detection.

Product data display

In the process of detection, quality control products and reference products are indispensable. For NIPT detection, CB-Gene has launched chromosome aneuploidy reference products and quality control products, including autosomes and sex chromosomes, as well as microdeletion and microduplication quality control products and reference products. In the future, chimera reference products will be launched one after another.



Product Name

Chromosomal abnormalities

Catalog ID

Common and Rare Chromosomal Aneuploidy standards

Trisomy 21(47,XX,+21) Reference Standard

Chromosome 21 trisomy standard, female

CBPJ0001

Trisomy 18(47,XX,+18) Reference Standard

Chromosome 18 trisomy standard, female

CBPJ0002

Trisomy 21(47,XY,+21) Reference Standard

Chromosome 21 trisomy standard, male

CBPJ0009

Trisomy 13(47,XY,+13) Reference Standard

Chromosome 13 trisomy standard, male

CBPJ0010

Trisomy 9(47,XY,+9) Reference Standard

Chromosome 9 trisomy standard, male

CBPJ0014

Trisomy 21(47,XY,+21) Reference Standard-2

Chromosome 21 trisomy standard,male

CBPJ0016

Sex Chromosome Aneuploidy Standards

Klinefelter Syndrome (47,XXY) Reference Standard

X chromosome non-global ploidy standard

CBPJ0005

Microdeletion and Microduplication Standards

Trisomy 9 (47,XY,+9, Gain 9p24.3p13.1) Reference Standard

9q11 microdeletion standard, male

CBPJ0003

Angelman syndrome (46,XX,del(15)(q11q13)) Reference Standard

Angelman Syndrome Standards, Female

CBPJ0006

Prader-Willi syndrome (46,XY,del(15)(q11.2q13)) Reference Standard

Prader-Willi syndrome standard, male

CBPJ0007

18P-syndrome (46,XX,del(18)(p11.2)) Reference Standard

18P-syndrome standard, female

CBPJ0008

DiGeorge syndrome (46,XX,del(22)(q11)) Reference Standard

DiGeorge syndrome standard, female

CBPJ0011

18Q-syndrome (46,XX,del(18)(q22)) Reference Standard

18Q-syndrome standard, female

CBPJ0013

11q23.3 del (46,XX,del(11)(q23.3)) Reference Standard

11q23.3 del standard, female

CBPJ0015

Angelman syndrome (46,XY,del(15)(q11.2q13.1)) Reference Standard

Angelman syndrome,male

CBPJ0017

Prader-Willi syndrome (46,XY,del(15)(q11.2q13.1)) Reference StandardPrader-Willi syndrome,maleCBPJ0018

Negative control

Normal Karyotype (46,XY) Reference Standard

Normal Karyotype,male

CBPJ0004



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