What results can you expect from the Qualified® test?

What results can you expect from the Qualified® test?

The risk of Down syndrome in pregnant women aged 35 is 1:360

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There are three possible Qualified® prenatal test results:

A high-risk result. This means that the probability of a chromosomal abnormality is higher than usual. Then additional testing is recommended. 

A low-risk result. This means that the risk of chromosomal abnormalities is low for the tested abnormalities. The usual course of pregnancy management is recommended. 

No result. In a small percentage of cases, the Qualified® test cannot produce a result. Additional blood sampling and retesting or diagnostic testing may be recommended. The probability that the Qualified® test can be performed successfully depends greatly on how much cell free fetal DNA (cffDNA) is found in the mother’s blood. The percentage of cffDNA also depends on the length of pregnancy (the earlier the pregnancy, the lower the percentage of cffDNA), as well as on the mother’s weight (the higher the mother’s weight, the less baby’s cffDNA will be isolated).

Negative (normal) test result

The Qualified® test determines the risk of trisomy 21, 18, and 13, and upon request, the risk of numerical changes in the sex chromosomes X and Y, as well as other chromosomes. In the event of a negative test result with no pathological ultrasound findings, the presence of the tested disorders in your baby can be excluded with a high level of accuracy.

All NIPT methods have limitations when it comes to determining mosaicism and changes in chromosome structure. The Qualified® test examines the most common chromosomal disorders, so it cannot identify physical disorders in the baby; therefore, a negative (normal) test result cannot exclude the possibility of other disorders in the fetus. A large number of these disorders can be identified by a precise ultrasound examination, most commonly from the 12th week of pregnancy. Genetic testing, such as the Qualified® test, can never replace an ultrasound examination.

Positive (abnormal) test result 

If the Qualified® test shows a positive (abnormal) result, there is a high probability that the fetus has one of the tested chromosomal abnormalities. However, since the test can give a false positive result, the positive (abnormal) result must always be confirmed by another diagnostic method, an invasive method (chorionic villus sampling, amniocentesis, or cordocentesis).

Additional chromosomal analysis of these samples can then provide a definite diagnostic result. As part of the information process, the Bio Save Lab's medical associate will explain to you all the possible effects of the chromosomal disorder and provide you with the information on further diagnostic testing options. Also, in the event of a positive test result, Bio Save Lab will cover the costs of the invasive method.

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