Exact, non-invasive prenatal test for trisomy 21, 18 and 13
What to expect from NIPT Classic (Vanadis®)?
The Vanadis test has been optimized to reliably detect trisomies 21, 18 and 13. It is the only NIPT worldwide that uses the ‘rolling circle replication’ method. It is particularly robust because it does not require PCR or DNA sequencing. We analyze approximately 1.8 million DNA fragments from the blood of pregnant women, which originate exclusively from chromosomes 21, 18 and 13. The molecular mechanism is described here: LINK. The large number of data points allows for high test precision. The Vanadis laboratory process is completely automated, eliminating potential sources of error. These technical improvements provide a reliable result and reduce the number of possible test failures* to less than 0.5% [Acta Obstet Gynecol Scand. 2021; 100: 1497-1500]. This allows more pregnant women to receive a result than with other testing methods. Nevertheless, the Vanadis test is currently the cheapest NIPT in Germany for trisomies 21, 18 and 13. The analysis costs 164 EUR, the optional sex determination additionally 15 EUR.
*Test failure: No result even after repeated analysis.
How accurate is the test?
Over 99% of all trisomies 21 and 13 are detected, as well as over 91% of all trisomies 18. The false positive rate is less than 0.2% for each of the three trisomies [package insert Vanadis Kit, version 4]. The accuracy of sex determination, which can be performed upon request, is approximately 99.5%. In less than 0.5 % of all tests, no result can be determined.
What is the testing procedure?
After collection, the blood sample is taken by courier to the Eluthia laboratory in Giessen, where it is analyzed. The result of the test is usually available 3 to 5 days after receipt of the sample and is immediately submitted to the ordering gynecologist. The physician then discusses the result with the pregnant woman.