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Nativa is a Non Invasive Prenatal Test (NIPT). It is a screening test for the presence of chromosomal anomalies of the fetus. Nativa analyzes DNA fragments originating from placental trophoblasts that freely circulate in the mother’s bloodstream and identify the subjects that should undergoes further analysis, such as Amniocentesis or chorionic villus sampling test.

What does NATIVA analyze?

Nativa analyze the presence of trisomy 21, 18 or 13, sexual chromosomes aneuploidy and the sex of the unborn.

Nativa can analyze the presence of the following chromosomal anomalies:

  • Down’s syndrome (trisomy 21)
  • Jacobs’ syndrome (XYY)
  • Turner’s syndrome (X monosomy)
  • X chromosome Trisomy
  • Klinefelter’s syndrome (47XXY)
  • Patau’s syndrome (trisomy 13)
  • Edwards’ syndrome (trisomy 18)

NATIVA IS CE-IVD MARKED

The whole Nativa workflow is CE-IVD marked (In-Vitro Diagnostic) and is performed into the SmeL accredited (Lombardy Region Clinical Laboratory Services) BioRep laboratory, located at the San Raffaele Hospital Scientific Park in Milan. European Community certify that NATIVA is conformed to the European standards and performance levels for medical devices. The CE-IVD mark is issued only if the product is compliance to the 98/79/CE legislation and it’s a guarantee of quality.

NATIVA

  • From 10th week of gestation 
  • Results available in 5 days
  • Nativa is not dependent on fetal fraction amount, and deliver results even when very low.
  • Sensibility >99,9% to identify anomalies-> avoid false negative
  • Sensitivity >99,9% to exclude anomalies-> avoid false positive

 

How can have NATIVA?

Nativa is suitable for every pregnant woman that want to avoid the miscarriage risks from invasive diagnosis. Nativa can be performed from the 10th week of gestation.

Nativa is suited also for:

  • Twin pregnancies,
  • Donor Egg pregnancies,
  • IVF pregnancies,
  • Solid Organ Transplant or Bone Marrow Transplant.

Nativa is particularly suited in case of:

  • Mother age over 35;
  • Positive first trimester combined screening test or maternal serum screening test;
  • Pregnancy at risk of spontaneous miscarriage;
  • Placental detachment;
  • Evidence of aneuploidies;
  • Family history suggests chromosomal abnormalities

LIMITS of the TEST

In case of twin pregnancies NATIVA:

  • Can only indicate if one of the Analyze trisomy is observed.
  • Can assess if both child are female or at least one is male.
  • Do not analyze Sexual Aneuploidy.

Nativa cannot be used in case of multiple pregnancies with more than 2 fetus.

How Nativa works?

  • The test need only a small blood sample.
  • BioRep has specialized nurses available for blood drawing.
  • The blood Sample is shipped to BioRep Laboratories in Milan by express courier.
  • Results are ready within 5 days from the receipt of the sample in the lab.