Limitations of the Qualified® test
In a very small number of cases, the Qualified® test cannot be successfully administered. This usually occurs when the quantity of the fetal DNA (cffDNA) is too small to give a result. Other reasons for the failure of the test are the client’s failure to inform us of the presence of a donated egg, the presence of a vanishing twin, and previously undiagnosed (usually benign) chromosomal abnormalities in the mother.
In those cases, we recommend that the mother's venous blood be re-sampled at a slightly later stage of pregnancy, in order to repeat the Qualified® test. Most cases were successfully processed after a re-sampling of the blood. If the test is not successfully performed after repeated sampling, the client will be refunded in full.
24 hours must pass from the last administration of low-molecular-weight heparin therapy.
Mosaics, partial trisomies and translocations
No NIPT method based on cffDNA testing is able to determine chromosomal mosaicism, partial trisomy, or translocations.
Multiple pregnancies
Qualified® cannot be used to test for chromosomal abnormalities in 3 or more fetuses. In cases of triplet and multiple pregnancies, invasive methods are recommended.