Background:  Cell-free fetal DNA (cffDNA) is highly fragmented genetic material of the fetus (< 300 bp), that crosses the placenta and circulates in the maternal blood. DNA from fetal sources comprises only a small portion of total circulating cell-free DNA (ccfDNA) rising from 3 % in early to 12 % in late pregnancy. In plasma samples taken during the second trimester of pregnancy the concentration of cffDNA can range from 50–200 genome equivalents of cffDNA/ml of blood. Methods in molecular biology enable the detection of minute amounts of circulating cffDNA.

Description:  FetoGnost® Kit Control is a real-time PCR test for the detection of cell-free fetal DNA (cffDNA) in maternal plasma samples of pregnant women. The test is exclusively intended for the validation of suitable extraction methods for the purification of cffDNA from maternal plasma. This test is suitable for women of all ages with gestation age ≥11+0 with singleton or multiple pregnancies. The test can be used both in a first pregnancy and in subsequent pregnancies. Contraindication

  • The test is not suitable for samples taken before gestation age 11+0.
FetoGnost® Kit Control allows the non-invasive detection of cffDNA in samples purified from maternal plasma of pregnant women, based on real-time PCR technology. It serves as a control to ensure that enough cffDNA can be detected in extracted maternal plasma. The sampling shall be after gestation age ≥11+0. The detection of cffDNA by FetoGnost® Kit Control depends on a restriction enzyme digest of an aliquot of sample eluate to remove maternal DNA. The digested DNA sample is subsequently tested with real-time PCR. Probe-specific amplification curves in fluorescence channels for VIC, FAM and NED detect the amplification of two fetal markers, a maternal marker serves as an additional control. When testing plasma samples in triplicates and controls in duplicates, the content of one kit allows the analysis of 15 plasma samples.

FetoGnost® Kit Control
Order Number Reactions Channel Pathogen Channel IPC Target
HUFG050 50 FAM, VIC, NED Maternaler, Fetaler Marker
Shipping Temperature: -20 °C to +4 °C
Product Features:
  • Amplification and detection: one maternal marker and two fetal DNA marker
  • Real-time PCR with rapid hot-start Taq DNA polymerase
  • ROX™ dye as passive reference
  • Optimized to handle PCR inhibitors
  • PCR- platforms: runs on all established standard real-time PCR- platforms

PCR platforms: FetoGnost® Kit Control has been developed for the ABI® 7500 instrument (Thermo Fisher Scientific), but is also compatible with other real-time PCR instruments, which detect and differentiate fluorescence in FAM, VIC and NED channels. When using PCR-platforms not tested by ingenetix, an evaluation of the multiplex-PCR is recommended.

BactoReal® , MycoReal® , ParoReal ® and ViroReal® Kits run with the same thermal cycling conditions.