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Company news

21 September 2011

Test kits for prenatal screening of Down's syndrome, Alkor Bio latest elaboration, had got the registration certificate

Latest elaborations of biotechnological group Alkor Bio – reagents kits “EIA-PAPP-A” & “GonadotropinEIA – free – hCG”, aimed for prenatal screening for Down’s syndrome in the 1 trimester of pregnancy, got the registration certificate of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation.

 It is important to mention that nowadays doctors in Russia stand for the transfer of prenatal diagnostics from the late gestational age to the earlier - to the first trimester in particular. Following the latest trends of organization of biochemical prenatal screening Saint-Petersburg biotechnical company Alkor Bio developed “GonadotropinEIA – free – hCG” for the determination of the β-subunit of HCG & “EIA-PAPP-A” for the quantitative determination of PAPP-A (associated with pregnancy protein A of blood plasma) in the human serum by the means of enzymatic immunoassay analysis.  

The use of the diagnostic kits “GonadotropinEIA – free – hCG” & “EIA-PAPP-A” can be considered relevant & prospective for the reason that it will significantly widen the potential of diagnostics of fetus chromosomal defects at the early gestational age. The detection of Down’s syndrome in the first trimester of pregnancy by means of complex screening using the ultrasound investigation indexes – nuchal translucency (NT) together with biochemical indexes PAPP-A & β-hCG – reaches 90%. At the same time the detection of Down’s syndrome as the result of the prenatal screening made in the second trimester doesn’t exceed 75%. 

Before the development of the named diagnostic kits for prenatal screeningmade in the first trimester, Alkor Bio has developed the diagnostic kits for the examination of pregnant women made in the second trimester together with the Prenatal Risk Assessment Software «Isida». Thus the complete complex for prenatal screening of Down’s syndrome, Edward’s syndrome, Neural Tube’s defects & puerilism is developed by the Alkor Bio company.