Concepto-NIPT
The most advanced and safe Non-Invasive Prenatal Test in the UK
Concepto NIPT is a safe and non-invasive screening test that uses cell free DNA (cf DNA) found in maternal blood to detect prenatal chromosomal anomalies accurately, starting from WEEK 10 of pregnancy
- Concepto NIPT is powered by Illumina (VeriSeq NIPT Solution v2)
- Optional gender test included (worth £149)
- Results in up to 5 working days
- 99.9% accuracy for Down syndrome, Edwards syndrome, and Patau syndrome
- 0.1% false positive rate
- Illumina's whole-genome sequencing allows for reporting NIPT results with confidence, even at low fetal fraction
Concepto-NIPT - The most advanced and safe Non-Invasive Prenatal Test in the UK
Concepto NIPT is a safe and non-invasive screening test that uses cell free DNA (cf DNA) found in maternal blood to detect prenatal chromosomal anomalies accurately, starting from WEEK 10 of pregnancy
- Concepto NIPT is powered by Illumina (VeriSeq NIPT Solution v2)
- Optional gender test included (worth £149)
- Results in up to 5 working days
- 99.9% accuracy for Down syndrome, Edwards syndrome, and Patau syndrome
- 0.1% false positive rate
- Illumina's whole-genome sequencing allows for reporting NIPT results with confidence, even at low fetal fraction
How accurate is NIPT?
- Concepto NIPT has >99% detection rate for aneuploidies.
- NIPT provides fewer false-positive and false-negative results than combined first trimester screening for trisomy 21, 18 and 13.
| Accuracy (T21, T18, T13) | Sensitivity | False-Positive rate* |
|---|---|---|
| Combined first trimister screening | 82% | 1 in 26 |
| NIPT | > 99% | < 1 in 1,000 |
*Proportion fetuses with trisomy correctly idnetified by the test as high probability of disorder.
*Proportion of normal fetuses incorrectly identified by the test as high probability of disorder.
NIPT Performance data in a general screening population
| Detection/Sensitivity | Specificity | |
|---|---|---|
| Trisomy 21 | > 99.9% (95% CI:97.1%) | > 99.90% (95% CI:99.63%) |
| Trisomy 18 | > 99.9% (95% CI:91.4%) | > 99.90% (99.64% CI:97.1%) |
| Trisomy 13 | > 99.9% (95% CI:87.1%) | > 99.90% (95% CI:99.64%) |
What are the limitations of NIPT?
Concepto-NIPT is not suitable for patients with:
- Recent maternal blood transfusion
- Maternal mosaicism
- Maternal prior organ transplant/ stem cell transplant
- Maternal copy number variations
- Maternal autoimmune disease
- Fetoplacental mosaicism / confined placental mosaicism
- Maternal neoplasms (benign and malignant)
- Fetal demise/ vanishing twin
- Sex chromosome anomalies cannot be reported for twin pregnancies.
- The VeriSeq NIPT Solution v2 is not validated for use in pregnancies with more than two fetuses, demised or vanishing fetus, mosaicism, partial chromosome aneuploidy, triploidy, translocations, maternal aneuploidy, transplant or malignancy. VeriSeq NIPT Solution v2 does not detect neural tube defects.
- Twin pregnancy limitations: For twin pregnancies, HIGH PROBABILITY test results apply to at least one fetus; male test results apply to one or both fetuses; female test results apply to both fetuses.
Safe and simple, single blood draw.
>99% accuracy.
Optional gender detection
As early as week 10.
What is a Concepto-NIPT?
Concepto-NIPT helps in identifying if your baby is likely to have a chromosomal anomaly.
Who can take the test?
All pregnant women, irrespective of age or risk, who are 10 weeks or over into their pregnancy. (NIPT is endorsed by American College of Obstetricians and Gynaecologists (ACOG) /Society for Maternal-Fetal Medicine (SMFM) for all pregnant mothers regardless of age or risk).
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What does Concepto-NIPT test for?
Concepto-NIPT tests for
- Down Syndrome (Trisomy 21)
- Edwards Syndrome (Trisomy 18)
- Patau Syndrome (Trisomy 13)
- Gender- Male (XY) Female (XX)
- Sex chromosome anomalies: X(O) -Turners Syndrome; XXY - Klinefelter's syndrome; XYY- Jacob's syndrome; XXX- Triple X syndrome.
Non-invasive Prenatal Testing Results Explained
What does a low-risk result mean?
A low risk means - no anomaly detected for that specific condition which is under study. A LOW-RISK result does not guarantee that a fetus is unaffected by a chromosomal or genetic condition as False Negatives are possible, though the probability is quite low with Concepto-NIPT (VeriSeq NIPT Solution v2)
What does a high-risk result mean?
A high risk means - An anomaly is detected for that specific condition which is under study. Some non-aneuploid fetuses may have HIGH PROBABILITY results i.e., false positives may occur, though the probability of this occurrence is very low. In the event of a HIGH-RISK result and/or other clinical indications of a chromosomal condition, confirmatory testing is necessary for diagnosis.
What is fetal fraction?
Cell-free DNA (cfDNA) in the peripheral blood of pregnant women consists of maternal DNA and a small portion of DNA from the fetus (which is placentally derived). The percentage of DNA in the maternal blood sample that comes from the placenta is known as the fetal fraction (FF). Factors that impact FF include gestational age, multiple gestations, maternal BMI, fetal aneuploidy, maternal disease, and medication.
Illumina’s NIPT performance at lower fetal fraction
Illumina’s VeriSeq NIPT Solution v2 approach allows samples with low fetal fraction to be reported, reducing NIPT failures. This method uses paired-end sequencing to measure fragment length, adding to FF estimation.
Non-invasive Prenatal Testing Results Explained
What does a low-risk result mean?
A low risk means - no anomaly detected for that specific condition which is under study. A LOW-RISK result does not guarantee that a fetus is unaffected by a chromosomal or genetic condition as False Negatives are possible, though the probability is quite low with Concepto-NIPT (VeriSeq NIPT Solution v2)
What does a high-risk result mean?
A high risk means - An anomaly is detected for that specific condition which is under study. Some non-aneuploid fetuses may have HIGH PROBABILITY results i.e., false positives may occur, though the probability of this occurrence is very low. In the event of a HIGH-RISK result and/or other clinical indications of a chromosomal condition, confirmatory testing is necessary for diagnosis.
What is fetal fraction?
Cell-free DNA (cfDNA) in the peripheral blood of pregnant women consists of maternal DNA and a small portion of DNA from the fetus (which is placentally derived). The percentage of DNA in the maternal blood sample that comes from the placenta is known as the fetal fraction (FF). Factors that impact FF include gestational age, multiple gestations, maternal BMI, fetal aneuploidy, maternal disease, and medication.
Illumina’s NIPT performance at lower fetal fraction
Illumina’s VeriSeq NIPT Solution v2 approach allows samples with low fetal fraction to be reported, reducing NIPT failures. This method uses paired-end sequencing to measure fragment length, adding to FF estimation.
What is a trisomy
Normally, all cells in the human body have 46 chromosomes, made up of 23 pairs of chromosomes. These 23 pairs of chromosomes contain all of the DNA to determine the health of the baby. Certain genetic anomalies can occur when a baby develops three copies of a particular chromosome instead of two. The risk of having a chromosomal condition increases as the mother gets older.
Is it safe for mother and child
It involves a simple and safe blood draw from the arm of the expectant mother. Being non-invasive, it is completely safe for mother and baby
How do I take this test
Fill in your details, book your appointment and visit our clinic for sample collection.
What are sex chromosome aneuploidies?
Sex chromosome anomalies (SCA) occur when there is a missing, extra or partial/incomplete sex chromosome (X or Y).
The Concepto-NIPT looks for SCAs such as:
X(O) - Turners Syndrome A condition affecting females, due to partially or completely missing sex chromosome. Most of them can lead a normal life with regular medical care.
XXY - Klinefelter's syndrome is an aneuploid genetic condition where a male has an additional copy of the X chromosome. The primary features are infertility and small, poorly functioning testicles
XYY- Jacob's syndrome is a genetic condition having an extra copy of the Y chromosome in each of a male's cells, the chromosomal change sometimes causes no unusual physical features
XXX- Triple X syndrome A genetic disorder characterized by the presence of an additional X chromosome in female children. They are often taller than average girls.
| Fetal Sex Classification | Phenotype from the Physical Exam | Cytogenetic Results | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Detected | Karyotype | Female | Male | XX | XY | XO | XXX | XXY | Other |
| Anomoly Not Detected | XX | 997 | 0 | 21 | 0 | 2 | 0 | 0 | 0 |
| Anomoly Not Detected | XY | 0 | 966 | 0 | 15 | 0 | 0 | 0 | 0 |
| Anomoly Detected | XO | 0 | 0 | 0 | 0 | 19 | 0 | 0 | 1 |
| Anomoly Detected | XXX | 0 | 0 | 0 | 0 | 0 | 17 | 0 | 0 |
| Anomoly Detected | XXY | 0 | 0 | 0 | 0 | 0 | 0 | 23 | 0 |
| Anomoly Detected | XYY | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 11 |
| Total | 997 | 966 | 21 | 15 | 21 | 17 | 23 | 12 | |
| Percent Concordant | 100 | 100 | 100 | 100 | 90.5 | 100 | 100 | 91.7 | |
*Five twin pregnancy were correctly classified as presence of Y. Two pregnencies were correctly classified as no presence of Y.
**Other Cytogenetic results were XXXXX and XXYY
Services offered
Concepto-NIPT Advance
T21, T18 and T13, gender detection and sex chromosome anomalies.
£319.00
FAQs
Resources
Scientific Validation Studies
- DNA Sequencing versus Standard Prenatal Aneuploidy Screening
- Genome_Wide_Fetal_Aneuploidy_Detection_by_Maternal
- Number Variation and False Positive Prenatal Screening Results
Clinical Experience Studies
- Prenatal Diagnosis - 2016 - Taneja - Noninvasive prenatal testing in the general obstetric population clinical performance
- Ultrasound in Obstet Gyne - 2016 - Fosler - Aneuploidy screening by noninvasive prenatal testing in twin pregnancy
VeriSeq NIPT Solution V2 Publications
- Analysis of cell-free DNA in a consecutive series of 13,607 routine cases for the detection of fetal chromosomal aneuploidies in a single center in Germany
- Performance of a Paired-End Sequencing-Based Noninvasive Prenatal Screening Test in the Detection of Genome-Wide Fetal Chromosomal Anomalies
Genome-Wide Publications
- Clinical experience with noninvasive prenatal testing in Germany Analysis of over 500 high-risk cases for trisomy 21, 18, 13 and monosomy X
- Clinical impact of additional findings detected by genome-wide noninvasive prenatal testing- Follow-up results of the TRIDENT-2 study
- Genome-wide cell-free DNA screening a focus on copy-number variants
- Initial Clinical Experience with NIPT for Rare Autosomal Aneuploidies and Large Copy Number Variations
- Origin and clinical relevance of chromosomal aberrations other than the common trisomies detected by genome-wide NIPS- results of the TRIDENT study
- Outcome of publicly funded nationwide first-tier noninvasive prenatal screening
- Prenatal Diagnosis - 2018 - Scott - Rare autosomal trisomies Important and not so rare
- Three years of clinical experience with a genome-wide cfDNA screening test for aneuploidies and copy-number variants
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