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Harmony prenatal test to screen for chromosomal abnormalities

During pregnancy, as part of pregnant care, the gynaecologist recommends performing various screening tests to assess the health status of the unborn child. As part of this, the specialist also offers the possibility of screening for rare chromosomal abnormalities (Down syndrome, Edwards syndrome, Patau syndrome) that affect both the physical and mental development of the foetus.

Why is screening for Down syndrome recommended?

Some genetic disorders are inherited within the family, while others, such as Down syndrome, are typically non-hereditary diseases. It can occur in any pregnancy.

Although the risk of developing Down’s disease increases with age, the majority of children with Down syndrome are born to women under the age of 35.

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What can I learn with the help of the Harmony test?

A genetic test of foetal DNA from maternal blood can be performed on a pregnant woman of any age or at risk. The test results are more accurate and the rate of false-positive results is extremely low compared to common tests. In negative cases, no further testing (genetic testing from amniotic fluid) is required.

The prenatal genetic test available at Medicover shows 3 non-hereditary chromosomal abnormalities affecting the baby’s intellectual and physical development, which can also be tested in case of twin pregnancies:

  • Down syndrome (chromosome 21 trisomy)
  • Edwards syndrome (chromosome 18 trisomy)
  • Patau syndrome (chromosome 13 trisomy)

In addition to these three chromosome defects, the test also includes a numerical abnormality (M. Turner, M. Klinfelter) of the sex chromosomes (X and Y chromosomes). This difference cannot be tested when it comes to twin pregnancies.

How is Harmony different from other tests used to screen for Down syndrome?

During pregnancy, fragments of the child’s DNA enter the mother’s blood. The Harmony Prenatal Test is a new type of screening test that analyses these DNA fragments from a maternal blood sample to detect the risk of Down syndrome and other genetic disorders, Edwards syndrome, and Patau syndrome.

It gives more accurate results

Clinical trials have shown that it detects Down syndrome with greater than 99% accuracy, while the rate of false-positive results is less than 0.1%.

A clear result even at an early stage

The Harmony Prenatal Test requires only a single blood sample, which can be done from the 9th week of pregnancy. The examination is performed by a laboratory in Sweden, and the results are available to the patient in English and Hungarian on the 9th working day.

It minimizes the need for additional pregnancy tests

Since the Harmony test gives an accurate result and the rate of false-positive results is extremely low, there is minimal chance that additional tests will need to be performed – as opposed to common tests. This is important because further tests may require invasive procedures such as amniocentesis.

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How does Harmony work?

The screening test is based on a proprietary, targeted DNA-based technology (DANSR ™ and FORTE ™). Since fragments of foetal DNA enter the mother’s blood during pregnancy, the test is able to analyse fragments of certain chromosomes instead of all chromosomes, distinguishing between maternal and foetal DNA, the latter being quantified. Unlike other tests, which randomly arrange non-cell DNA, Harmony focuses on the non-cell DNA of the chromosomes in question, thus providing more accurate results.

Thanks to the microarray technology used in prenatal genetic diagnostic procedures, which gives a multitude of functional and structural information while significantly increasing the number of genes analysed at the same time, Harmony shows the differences faster and more efficiently.

The test accurately distinguishes between high- and low-risk results, combines maternal risk factors and accurate foetal DNA measurements, providing individual probability scores for each person.

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Other information about the test

By taking the test, if you ask specifically, it is also possible to find out the gender of the child.

After receiving the results of the Harmony test, you can discuss further pregnancy care with your doctor.

The Harmony test does not examine partial trisomy, mosaicism, and translocation genetic differences. Some biological conditions may affect the accuracy of the test. Rarely, there may be few sex chromosome aberrations in donor eggs and twin pregnancies. In twin pregnancies, the boy result may refer to one or both foetuses, the girl result refers to the sex of both foetuses.

The test does not examine all possible trisomies. Some foetal trisomies present a low risk, or there may be non-trisomic foetal abnormalities that present a high risk. False negative and false positive results can occur. The Harmony test provides a risk estimate and does not make a diagnosis. The result should be evaluated with the results of other clinical tests.

If the result is high risk or a chromosomal abnormality is suspected, karyotyping of a foetal sample by amniocentesis is recommended.

How do I prepare for the test?

Having an empty stomach is not required for the Harmony Prenatal test.

When is the result expected?

On the 9th working day following the examination.

Price of the Harmony Prenatal laboratory test

Price of sampling, sending samples and testing: 168 000 HUF

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