In addition to other methods, the PrenaTest® offers the possibility of testing for the existence of trisomy 21, 18 and 13 in your child in more detail. This website should provide you with general information on the PrenaTest™ and serve as preparation for a further talk with your physician. Whether the PrenaTest® is suitable for you personally or not can only be clarified together with your physician. Do not hesitate to address any questions that may arise about your personal situation or the test to your physician.
The PrenaTest® is the only non-invasive blood test for the determination of fetal trisomies which is exclusively performed in Germany and in strict adherence to the high quality standards persuant to the European In Vitro Diagnostic Directive.
When is it sensible to carry out the PrenaTest®?
Carrying out the PrenaTest® is optional. Doing so makes sense if you belong to a risk group or if one of the mentioned trisomies is suspected in your unborn child based on ultrasound findings or previous blood tests. Please consult your physician about how high your personal risk is that your unborn child carries a trisomy 13, 18 or 21.
How is the PrenaTest® carried out?
Your physician takes 20 ml blood from you, after you were informed in detail and subjected to genetic counselling by your physician and have signed the declaration of consent for the PrenaTest®. This blood is sent to the LifeCodexx diagnostics laboratory. The analysis generally takes 10 working days (Mon.–Fri.) resp. two weeks. With the new PrenaTest®express (available in Germany starting Oct. 7, 2013) the test result will be provided in up to six working days guaranteed (Mon - Fri). Your physician then receives a letter with the result and will inform you about the outcome of the analysis.
The expenses for the PrenaTest® and the related medical services are not covered by health insurance. Thus, you have to pay these expenses yourself. However, several statutory as well as private health insurance funds in several countries already covered the costs for the analysis in individual cases.
What will happen in case of a negative test result?
A negative test result means that the existence of a trisomy 21, 18 or 13 in the unborn child can be excluded with a high degree of certainty. Depending on the medical reason which caused the PrenaTest® to be performed, your responsible physician will nevertheless track the course of your pregnancy with special attention and advise further examinations, if necessary.
What will happen in the event of a positive test result?
A positive test result means that your child is almost certainly carrying the respective trisomy. Then it is strongly recommended that you undergo genetic counselling and clarify the result of the PrenaTest® further diagnostically by means of an invasive examination, an amniocentesis in most cases. This further examination is necessary to diagnose a genetic reason for the trisomy.
Limits of the test
A healthy child is born in the majority of pregnancies. This is, however, not the case for a minority of pregnancies. Today it is possible to search specifically for many diseases in the course of pregnancy. But under no circumstances is it possible to exclude all conceivable diseases. Nobody can guarantee you a healthy child.
Standard trisomies 21, 18 and 13 can be detected by the PrenaTest® with a high degree of certainty. In the context of clinical studies to evaluate the PrenaTest® more than 99% of all blood samples were correctly classified. In only one sample was an existing trisomy 21 not detected (false-negative), in one other sample there was a trisomy 18 indicated although in reality this was not present in the unborn child (false-positive).
No other chromosomal defects are detected by the PrenaTest® so that no statements can be made based on the test results. You should also be aware that certain rare forms of the mentioned trisomies cannot be detected with certainty using the PrenaTest®. This is true for very few cases, in which only parts of the respective chromosome exist in triplicate or if only parts of the child’s body show the respective chromosome in triplicate. These rare occurrences cannot be detected reliably using the PrenaTest®. In addition the PrenaTest® is currently not suitable for multiple pregnancies. No test result or an unclear test result may occur despite careful implementation in very rare cases. Thus, it may become necessary to repeat the test and also to request a new blood sample if required.
Please consider the following:
Most prenatal examinations do not show any abnormalities and this helps to reduce fears and ensures an undisturbed course of pregnancy. However, if one examination shows medical findings, this can often lead in part to great un - certainty and a situation of conflict. Your physician will provide you with comprehensive information and support. In addition, psychosocial counselling is recommended in such situations. Your physician will also inform you about that in detail