FAQ and answers

In what week of pregnancy can you do the Qualified® prenatal test?

Find out why you should decide on the Qualified® test

My name is Milica Kovjenić, Master of Pharmacy - Medical Biochemist. During the last five years of my work at Bio Save Laboratory, my professional interest has been directed solely on prenatal diagnosis. Despite my continuing education and keeping up with the latest global trends in the field, during my pregnancy, I had multiple questions for my gynecologist regarding genetic and developmental abnormalities. By complying with the guidelines and clear recommendations from the experts in this field, noninvasive testing provided all pregnant women, including me, a more comfortable and carefree pregnancy. I will try to answer all of your questions. Should you have any additional questions, besides the ones found on the website, feel free to contact me directly at milica.radovac@biosave.rs. My team and I will be happy to give you clear answers to all of your questions.

Who should take the Qualified® test?

Singleton pregnancy
Twin pregnancy
IVF pregnancy
Donor egg pregnancy

Where is the test done?

The test is done by the Eurofins Genoma Group from Rome, Italy.

How long do I have to wait for the test results?

We will call you with the result in 3 to 5 business days, from the time the sample arrives at the laboratory in Italy.

How accurate is the test?

Using cffDNA-based technology, the Qualified® prenatal test can identify more than 99.9% pregnancies with Down syndrome. Statistical screening tests for Down syndrome (Double marker test, Triple marker test) can miss up to 15% of pregnancies with Down syndrome.

Compared to statistical prenatal tests for Down syndrome, the Qualified® prenatal test gives far less false positive results, meaning there is less need for an invasive test such as amniocentesis.

Qualified® prenatal test is a screening test. Positive test results need to be confirmed with diagnostic tests such as amniocentesis, chorionic villus sampling or cordocentesis.

Is Qualified® safe for me and my baby?

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

How do I know if the Qualified® test is right for me?

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.

Can the Qualified® test be applied to IVF pregnancies?

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

Does a normal test result mean that my baby is completely healthy?

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.

How does Qualified® prenatal testing work?

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.

How is the Qualified® prenatal testing different from any other screening test for Down syndrome?

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%.

Should I consider the Qualified® test if I’m under 35?

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.

When can I take the Qualified® test?

The Qualified® prenatal test can be done as early as the 10th week of pregnancy by a simple venous blood sampling.

I am expecting twins. Can I take the Qualified® prenatal test?

The Qualified® prenatal test can also be taken in twin pregnancies, in the 45, 180 and 360 Qualified® options. In this case, we interpret the sex of the baby as follows. If there is a Y chromosome, it means that at least one baby is male. If there is no Y chromosome, both babies are female.