FAQ and answers

• Singleton pregnancy
• Twin pregnancy 
• IVF pregnancy 
• Donor egg pregnancy

The Qualified® Test is performed in Italy at a state-of-the-art genetic laboratory in Turin.

Qualified® test results are available within 2–3 business days after the sample is received by the laboratory.

Using technology based on cell-free fetal DNA (cffDNA), the Qualified® Prenatal Test can identify more than 99.9% of pregnancies affected by Down syndrome. In comparison, traditional statistical screening tests for Down syndrome (double and triple tests) may fail to detect up to 15% of affected pregnancies.

Compared with conventional prenatal screening tests for Down syndrome, the Qualified® Prenatal Test produces significantly fewer false-positive results, reducing the need for invasive diagnostic procedures such as amniocentesis.

The Qualified® Prenatal Test is a screening test. Any positive result should be confirmed by a diagnostic procedure such as amniocentesis, chorionic villus sampling (CVS), or cordocentesis.

Yes, it involves only a simple blood draw at any time of day, regardless of the food, drink or supplements.

Noninvasive prenatal testing is required for all pregnant women who will be 35 or older at the time of child delivery. It is also recommended for pregnant women who had a miscarriage or a fetus with a genetic abnormality in their previous pregnancy. In addition, it may be done by pregnant women who are afraid of invasive procedures such as amniocentesis or chorionic villus sampling.

Yes, the Qualified® test may also be applied to pregnancies achieved by in vitro fertilization.

There is no test that can guarantee that your baby will be completely healthy. Also, there is no single test that can test all genetic abnormalities that may occur in a fetus. Genetic counseling is required before and after testing, in addition to a mandatory regular ultrasound examination by your gynecologist.

While you are pregnant, parts of the developing placental DNA can be found in your blood, besides your DNA. Qualified® prenatal test analyzes this very fetal fraction to determine genetic health of the baby and to rule out, with high certainty, the probability for Down syndrome, Edwards syndrome and Patau syndrome, as well as other chromosomal abnormalities, microdeletions and duplications.

The Qualified® prenatal test gives clear answers as early as in the first trimester after a simple blood draw. Other screening tests for Down syndrome are performed later in the pregnancy and require several visits to the doctor. The risk is assessed by a combination of several non-specific parameters. Some of these parameters are the age of the pregnant woman, specific ultrasound examinations, free beta hCG and PAPP. Statistical screening tests during the 1st trimester are associated with a false positive rate of up to 5%. 

The Qualified® prenatal test uses a unique method of a targeted DNA analysis combined with quality control thus achieving over 99% detection rate and a false positive rate of less than 0.1%. 

Yes. Professional societies’ guidelines support the option of noninvasive prenatal testing for the general population. The Qualified® prenatal test has been thoroughly tested in women under and over 35. Most babies with Down syndrome are born to pregnant women under the age of 35, even though the risk for Down syndrome is higher for pregnant women over 35. 

The Qualified® Prenatal Test can also be performed in twin pregnancies through the TWIN BASIC, TWIN 360°, and VANISHING TWIN options. In twin pregnancies, fetal sex is interpreted as follows: if a Y chromosome is detected, at least one of the babies is male; if no Y chromosome is detected, both babies are female.