Non-Invasive Prenatal screening Test – NINALIA (NIPT) - Клініка Стефана Хміля

Non-Invasive Prenatal screening Test – NINALIA (NIPT)

We are pleased to inform you that since October 2017 the Clinic of Professor Stefan Khmil has begun cooperation with the world leader in chromosomal laboratory diagnostics – the company Biomnis in Lyon (France). The Clinic of Professor Stefan Khmil uses only the latest world technologies.

“Patient is the most important for us”, – and we are proud of it.

From now on,  complex laboratory diagnostics available in Ternopil.

Non-Invasive Prenatal screening Test is an innovative genetic test for pregnant women at risk of foetal Patau syndrome (trisomy 13), Edwards’ syndrome (trisomy 18) or Down syndrome (trisomy 21).

It can be performed with a single blood sample obtained from the mother from week 10 of pregnancy.

Rapid, reliable and safe, NIPT is a screening option that enables detection of trisomies 13, 18 and 21 while limiting the required number of invasive tests (amniocentesis…).

How does it work?

Besides maternal DNA, the blood of pregnant women contains foetal DNA originating from the placenta.

The identification of this foetal DNA in the maternal blood, combined with the development of a new technology (Next Generation Sequencing) capable of counting all genetic material sequences in a maternal blood sample, makes it possible to determine whether a trisomy is present in the foetus.

Is Ninalia NIPT reliable?

Since october 2014, Eurofins Biomnis has chosen to collaborate with the company Illumina, a world leader in DNA sequencing, for non-invasive screening for the main chromosomal abnormalities.

The new VeriSeq NIPT method offers the best performance currently available (sensitivity, specificity, detection rate, etc.) for non-invasive prenatal testing.

Over 15,000 Ninalia tests have been performed to date.

This test has the lowest failure rate (0.1%) of any non-invasive prenatal test on the market. This means that it virtually guarantees a result every time.

What are the performance data for Ninalia?

  • Detection rate is greater than 99%
Down Syndrome Edwards’ Syndrome Patau Syndrome
Sensitivity 99.14%* 98.31% 98.15%
Specificity 99.94%* 99.9% 99.95%
Positive predictive value (PPV) 0.9681* 0.863 0.7977
Negative predictive value (NPV) 0.9999* 0.9999 0.9999

*Bhatt et al. Poster presented at the ISPD, 2014 (34,000 patients).

  • The lowest failure rateamong NIPTs: 0.1%*
  • Deeper sequencing: 19 million reads
  • Interpretation software marked

The Ninalia non-invasive prenatal test uses just one tube of maternal blood, eliminating any risk of miscarriage, or other adverse outcomes that are associated with invasive testing procedures such as amniocentesis or chorionic villus sampling (CVS).

Who should avail of the Ninalia screening test?

Eurofins Biomnis follows the International recommendations of the American Congress of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) in relation to the indications for non-invasive prenatal screening for patients at risk.

WHO CAN HAVE THIS TEST:

  • When an ultrasound reveals abnormalities with fetal growth and/or abnormalities
  • Risk greater than 1/1000 according to maternal serum markers
  • Mothers aged ≥ 38 years for patients that did not benefit of the maternal serum markers assay
  • History of pregnancy with foetal aneuploidies
  • Relative is carrier of a Robertsonian translocation involving chromosome 13 or 21
  • Pregnancy with twins
  • 1st line screening

How is the sample collected?

The sample for Ninalia NIPT is based on a single blood collection, which is safe for both you and your foetus.

The blood sample can be collected directly at your physician office or by a Eurofins Biomnis partners.

Then your sample will be sent by your healthcare provider to Eurofins Biomnis, in France for performance of the test.

How are the results returned?

The results are reported directly to the healthcare professional who prescribed the test within a period of 5 business days (Monday-Friday) upon reception at Eurofins Biomnis.

What does a positive result mean?

A positive result indicates a strong suspicion that the foetus is affected by one of the anomalies being investigated (trisomies 13, 18 and 21). Your doctor will tell you which additional tests need to be conducted in order to confirm the diagnosis.

What does a negative result mean?

A negative result indicates a very low risk that the foetus is affected by one of the anomalies being investigated (trisomies 13, 18 and 21). Your doctor will tell you if it is necessary to perform other tests in addition to medical follow-up and “standard” ultrasound monitoring of your pregnancy.

What are the limits of the test?

Eurofins Biomnis follows the International recommendations of the American Congress of Obstetricians and Gynecologists (ACOG) and the Society for Maternal–Fetal Medicine (SMFM).

Apart from trisomies 13, 18 et 21, this test does not investigate the other type of abnormality, such as unbalanced translocations, microdeletions, microduplications, mutations responsible for other diseases, neural tube defects, or triploidy.

This test does not make it possible to predict subsequent complications of pregnancy, such as pre-eclampsia, growth retardation, premature birth, etc.

For additional consultations and passing the NIPT Ninalia test contact the Clinic of Professor Stefan Khmil , where qualified specialists will advise on complicated pregnancy or infertility.

We are grateful that we are trusted everything that is most valuable.

 

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