The Dr. Giovanni Di Piazza Medical Testing Laboratory carries out the Harmony Prenatal Test, a very precise test that analyses the foetal DNA in the mother’s blood to verify the risk of Down’s Syndrome, i.e. Trisomy 21, and two other genetic pathologies, trisomy 18, or Edwards syndrome, and trisomy 13, or Patau syndrome. The tests also detect the aneuploid of the sexual chromosomes X and Y, and the 22q11.2 deletion syndrome. Compared to the bio-chemical screenings that might not detect Down’s Syndrome in 15% of pregnant women, Harmony offers a more specific screening for Down’s Syndrome in women of any age and risk group. It is, in fact, a new generation test, based on the research for foetal DNA, which has been amply tested for trisomy 21 in women between 18 and 50 years of age. Laboratory tests have shown that Harmony is capable of identifying the risk of Down’s Syndrome in 99% of the cases, with a rate of false positives of 0.1%. One of the main advantages of Harmony is that it reduces the risk of invasive tests to a minimum thanks to its precision and the low rate of false positives compared to traditional tests.
|Comparing Harmony and traditional biochemical Down’s Syndrome tests|
|FALSE POSITIVE RATE*||RELIABILITY RATING**|
1 out of 1.000
99 out of 100
first trimester screening
|1 out of 20|
85 out of 100
* Detects an elevated risk of Down’s Syndrome when there is actually none
** Correctly detects an elevated risk of Down’s Syndrome when it truly exists
How does it work?
Harmony Prenatal Test consists in one single blood sample that can be taken beginning in the tenth week of pregnancy at the Dr. Giovanni Di Piazza Medical Testing Laboratory, having booked an appointment via phone or email. The results will be available in two weeks and an estimate can be requested over the phone or through the contact box.
Who can take the test?
- Pregnant women from the 10th week of pregnancy
- Single or Twin pregnancies
- Pregnancies obtained with IVF (homologous or heterologous insemination)
In twin pregnancies a single result will be offered for both embryos (high or low risk for both). The test will also reveal the sex of the foetus.
The test does not detect the risk of mosaic, partial trisomy or genetic translocations regarding chromosomes which are not the object of the test, and conditions of all the other chromosomes which are not the object of the test.
The test CANNOT be carried out on women with transplants, transfusions, tumours or vanishing twin documented with the first ultrasound.
The Harmony Prenatal Test will be carried out at the TOMA Advanced Biomedical Assays S.p.A. Laboratory, accredited and recognized by the National Health System, accredited ISO 9001:2008, Quality in Laboratory Medicine (rev. 2013) and SIGUCERT 2013 (quality certificate of the Italian Society for Human Genetics)
Please note that the test is NOT diagnostic and is NOT a substitute for prenatal invasive diagnosis, i.e. obtained by amniocentesis or chorionic villus sampling (CVS).
Click here to download the brochure.