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Non-invasive biomarker tests together with the measurement of nuchal translucency (NT) allow the risk assessment of Down’s syndrome without jeopardising the fetus. Especially pregnant women under the age of 35 benefit from this approach. Ten years ago the Fetal Medicine Foundation (FMF) certified the BRAHMS KRYPTOR and took it into clinical routine as the first automated laboratory system for quality-assured combined first trimester screening. Now the compact version of the KRYPTOR follows. Professor Kevin Spencer from the King George Hospital in Essex conducted an evaluation of the first trimester Down’s screening assays Free ßhCG and PAPP-A on the BRAHMS KRYPTOR compact. Based on this study he concluded that results from both systems are interchangeable and screening performance is equally. Thus both platforms will use the same set of medians.
“Medians are established over a long period of time and their stability is important to maintain an effective screening program. Since it has been established - because the KRYPTOR compact and KRYPTOR use exactly the same reagent system - the medians on each machine are interchangeable and therefore any lab wishing to change to compact would not need to re-evaluate medians. This has never been possible with any other analytical platform before,” explained Professor Spencer, who also serves as Director of Biochemical Screening of the Fetal Medicine Foundation (FMF).
Laboratories starting with KRYPTOR compact newly, can expect “that the screening performance using KRYPTOR compact will be equally as good as that which has been achieved with KRYPTOR over the past 10 years”.
Trisomy 21 or Down’s syndrome is one of the most common genetic abnormalities affecting one in every 700 births worldwide. The risk of chromosomal defects like Trisomy 21 increases with maternal age, but decreases with gestational age. Non-invasive testing allows all pregnant women to assess their individual risk without having to submit to invasive testing which is associated with a certain risk of miscarriage of about 1%. Non-invasive risk assessment requires high precision and accuracy in the measurement of the biochemical markers, as well as for the measurement of the nuchal translucency. For the BRAHMS markers Free ßhCG and PAPP-A, KRYPTOR fulfils these requirements in an exceptional way, making KRYPTOR – and now KRYPTOR compact - the instrument of choice for 1st and 2nd trimester screening.
The evaluation was carried out over a six week period from March to April 2009 performed on one KRYPTOR compact and two KRYPTOR classic machines. To assess medians the research team used a group of 400 samples from Caucasian, non smoking women with a singleton pregnancy and with gestations in the range 10+0 to 13+6 weeks. The KRYPTOR compact medians are very close to the current FMF calculated median for KRYPTOR classic and suggest that deriving new medians for the new platform should not be necessary. The clinical utility of KRYPTOR and KRYPTOR compact was compared in a case control study in some 70 cases of known Trisomy 21. Both analytical platforms perform with excellent precision, the medians of KRYPTOR compact highly correlate with those established by the Fetal Medicine Foundation (FMF) using KRYPTOR in their routine from 1998 on.
The BRAHMS Aktiengesellschaft conducts researches, develops, produces and markets innovative diagnostic biomarkers. It is one of the three largest biotechnology companies in Germany. The company sells its products in more than 65 countries via its own subsidiary companies and sales organizations as well as laboratory systems from its own production and globally operating licensees. The headquarter of BRAHMS is at Hennigsdorf / Berlin, where about 220 out of 400 of the world wide employees of the company are posted.
The Fetal Medicine Foundation (FMF) is a Registered Charity that aims to improve the health of pregnant women and their babies through research and training in fetal medicine. The Foundation, with the support of an international group of experts, has introduced an educational programme both for healthcare professionals and parents and a series of certificates of competence in different aspects of fetal medicine. For further information visit www.fetalmedicine.com