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  Prenatal Screening  
   
   
  Trisomy 21 or Down’s Syndrome is one of the most common genetic abnormalities affecting 1 in every 700 births worldwide. In modern western societies, the average age at which a woman has her first child is on the increase (29.7 years). The risk of chromosomal defects like Trisomy 21 increases with maternal age, but decreases with gestational age, since fetuses with chromosomal defects are more likely to die in utero than unaffected fetuses. The risk of having a child with Trisomy 21 is also increased if the couple has already produced a child with Trisomy 21 before.  
     
  Invasive testing for chromosomal abnormalities and fetal karyotyping is associated with a risk of miscarriage of about 1 %. Therefore these tests should only be carried out in pregnancies considered to be at high risk for chromosomal defects. To assess the individual risk of a pregnancy being affected only the most accurate and precise method should be used, to allow the parents to make an informed decision for or against invasive testing. Non-invasive testing allows also the group of mothers under the age of 35 years—usually considered to be at low risk—to assess their individual risk without having to submit to invasive testing. Non-invasive testing in the 1st Trimester of pregnancy identifies an increased risk not only for Trisomy 21, but also for Trisomy 18, Trisomy 13 and Triploidy. In the 2nd Trimester of pregnancy it identifies also the risk of NTD (neural tube defects).  
     
  Serum markers for the Prenatal screening in the 1st Trimester  
     
  BRAMHS serum markers for prenatal screening and BRAHMS Kryptor Systems fulfill the high quality standards of the FMF (Fetal medical foundation) in an exceptional way. For the most precise and accurate determination of the individual risk, the precision of the biochemical markers is of utmost importance.  
     
  BRAHMS Kryptor Free βhCG  
 
  • Clinical use: Prenatal screening for chromosomal abnormalities in the 1st and 2nd Trimester of pregnancy and the diagnosis and follow up of trophoblastic tumors of ovarian, placental or testicular origin
  • TRACE technology (Time resolved amplified cryptate emission)
  • Sample matrix: Serum
  • Diluent included in kit
  • Sample volume: 26 µl
  • Incubation time: 19 min
  • Direct measuring range: 0.16 - 150 IU/L
  • Range with automated dilution: 0.16 – 50 000 IU/L
  • Detection Limit: 0.16 IU/L
  • Intra – assay and Inter-assay coefficients of variation are 2.72 – 3.69 % and 2.78 – 3.94 % , respectively
 
  BRAHMS Kryptor PAPP-A  
 
  • Clinical use: Prenatal screening for chromosomal abnormalities in the 1st Trimester of pregnancy
  • TRACE technology (Time resolved amplified cryptate emission)
  • Sample matrix: Serum, heparin plasma
  • Diluent included in kit
  • Sample volume: 50 µl
  • Incubation time: 19 min
  • Direct measuring range: 0.004 - 6 IU/L
  • Range with automated dilution: 0.004 - 90 IU/L
  • Detection Limit: 0.004 IU/L
  • Intra – assay and Inter-assay coefficients of variation are 2.19 – 2.3 % and 2.43 – 2.78 % , respectively
 
 
Product code Product name Method Kit Size Sample Type
866.075 BRAHMS PAPP-A KRYPTOR TRACE Technology 75 test kit Serum, heparin plasma
809.075 BRAHMS free βhCG KRYPTOR TRACE Technology 75 test kit Serum
  BRAHMS ADAM 12 KRYPTOR TRACE Technology Under development
 
     
 
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  Serum markers for the Prenatal screening in the 2nd Trimester  
     
  For screening of the 2nd Trimester of pregnancy, the serum markers alpha-fetoprotein (AFP), total human chorionic gonadotropin + β subunit (hCG + β), free β subunit of hCG (free hCG) and unconjugated estriol (uE3) are the most commonly used.  
     
 

Double tests                                                               Triple Test

AFP + hCG + β                                                            AFP + uE3 + hCG + β

AFP + free βhCG                                                        AFP + uE3 + free βhCG

 

  
  Free βhCG is the marker of choice in combination with AFP and maternal age. At a false positive rate unconjugated add noting further to the detection rate compared with the use of AFP and free βhCG alone.  
     
  Your best option for the 2nd Trimester screening: AFP and + free βhCG on BRAHMS Kryptor  
     
  BRAHMS Kryptor hCG + β  
 
  • Clinical use: Total hCG is used for the diagnosing and monitoring of early pregnancy and Down’s Syndrome screening in the 1st and 2nd Trimester of pregnancy. Total hCG is also used for the diagnosis, follow-up and therapy monitoring of germ cell tumor
  • TRACE technology (Time resolved amplified cryptate emission)
  • Sample matrix: Serum
  • Diluent included in kit
  • Sample volume: 26 µl
  • Incubation time: 14 min
  • Direct measuring range: 2 – 2000 IU/L
  • Range with automated dilution: 2 – 1000 000 IU/L
  • Detection Limit: 2 IU/L
  • Intra – assay and Inter-assay coefficients of variation are 0.5 – 0.9 % and 2.43 – 1.9 – 4.5 % , respectively
 
  BRAHMS Kryptor AFP  
 
  • Clinical use: AFP is used for the Prenatal screening for chromosomal abnormalities and fetal neural tube defects (NTD) in the 2nd Trimester of pregnancy . AFP is also used for the diagnosis , therapy control and follow-up of hepatocellular carcinomas and germ cell tumors
  • TRACE technology (Time resolved amplified cryptate emission)
  • Sample matrix: Serum, plasma (EDTA/heparin), amniotic Fluid
  • Diluent included in kit
  • Sample volume: 14 µl
  • Incubation time: 9 min
  • Direct measuring range: 0.23 – 700 ng/ml
  • Range with automated dilution: 0.23 – 500 000 ng/ml
  • Detection Limit: 0.23 ng/ml
  • Intra – assay and Inter-assay coefficients of variation are 2,54 – 4.63 % and 2.81 – 5.22 % , respectively
 
 
Product code Product name Method Kit Size Sample Type
809.075 BRAHMS free βhCG KRYPTOR TRACE Technology 75 test kit Serum
841.050 BRAHMS hCG + β KRYPTOR TRACE Technology 50 test kit Serum
816.075 BRAHMS AFP KRYPTOR TRACE Technology 75 test kit Serum, plasma (heparin/EDTA) Amniotic Fluid
 
     
 

LINKS

http://www.brahms.de/

  
 
   
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