Frequently asked questions

Here you can find out more about the PrenaTest®:

 

What can the PrenaTest® detect?

The PrenaTest® is known as a non-invasive prenatal test (NIPT). From maternal blood, it can detect the following changes in the genetic material of your unborn child, known as chromosomal disorders:

  • Trisomy 21 (Down syndrome)
  • Trisomy 18 (Edwards syndrome)
  • Trisomy 13 (Patau syndrome)
  • Maldistributions of the sex chromosomes X and Y (Turner, triple X, Klinefelter and XYY syndrome)
  • Monosomies 21,18 and 13
  • Monosomies and trisomies of all other chromosomes 1-12, 14-17,19, 20 and 22
  • 22q11.2 microdeletion (DiGeorge syndrome)

If desired, you can also learn whether you are expecting a girl or a boy. In Germany, in accordance with statutory provisions, your doctor will tell you the sex of your child starting from the twelfth week of pregnancy post-conception. National regulations in other countries may vary.

 

How safe is the PrenaTest®?

The high accuracy of the PrenaTest® has been proven in clinical studies. Test accuracies of more than 99% were achieved, depending on the chromosomal disorder tested. This number means that out of 100 pregnant women whose unborn child is affected by a chromosomal disorder, 99 will be determined correctly. In addition, the probability that an abnormal (that is, positive) test result is not correct is very low. This is indicated by the so-called false-positive rate of 0.1%. This value implies that in a group of 1000 unaffected pregnant women, one pregnant woman will receive an abnormal (that is, positive) test result, although her unborn child is in fact not affected by a chromosome disorder. It is important for you to know that 100% test accuracy should not be expected when non-invasive prenatal tests are used. In rare cases, there may be no or an unclear test result. However, this does not reveal anything about the health of your child. You may then repeat the PrenaTest® at no additional cost. The waiting time for the test result will be accordingly prolonged. Please have your doctor explain to you which level of accuracy the PrenaTest® can offer you and how.

 

Should I have the PrenaTest® performed?

In principle, the PrenaTest® is suitable for all pregnant women. You and your doctor can discuss together whether the test is also appropriate for you. Many women choose to undergo the PrenaTest® because of their age or because they are concerned about prior abnormal test results. Talk to your doctor about which of the test option is advisable for you in your personal situation.

 

When can i have PrenaTest® performed?

You can undergo the PrenaTest® after the ninth week of pregnancy has been completed (week 9 + 0 since LMP). Discuss with your doctor when the test would be most advisable for you personally.

 

I would like to have the PrenaTest® performed. What’s the next step?

Information, counseling, blood sampling
First your doctor will provide you with comprehensive and unbiased counseling and information in accordance with national regulations. After you provide your written consent for the genetic testing, blood will be drawn from a vein in your arm.

Laboratory analysis
The analysis begins once the blood sample is received by the laboratory and after it has successfully undergone a quality control inspection.

Test result
Your doctor will be informed of the test result immediately after the analysis is completed. He or she will then explain the result to you and discuss the next step with you.

 

When do i receive the test result and how should I enterpret it?

The test result will be sent to your doctor within a few business days. If the measured analysis values of the chromosome examined in each case are within normal limits, this means that it is highly likely that the corresponding chromosomal disorder is not present in your unborn child (negative test result). Nonetheless, your doctor will track the rest of your pregnancy closely. If the measured analysis values of the chromosome examined in each case are outside of normal limits, this means that it is highly likely that your unborn child has the chromosomal disorder in question (positive test result). Based on your doctor’s recommendation,the test result should then be diagnostically clarified further.

 

 

PrenaTest® – Information for expectant mothers

 

 

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