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Product Manual FetoGnost® Kit Control Download PDF
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Background:  Rhesus factor D (RhD) or RhD antigen is the most common of the five main Rhesus antigens (C, c, D, E, and e) out of a variety of antigens on the surface of red blood cells. The dominantly inherited RHD gene determines whether a person is RhD-positive or -negative. Most of the population is RhD-positive. In a RhD-negative status, a complete deletion of the RHD gene is usually present. Less commonly, minor genetic alterations (e.g. point mutations, insertions, deletions, and gene rearrange-ments) result in non-functional or weak RhD antigen. Prediction of the fetal RhD status is significant for the prevention of fetal hemolytic disease, where a RhD- negative mother becomes sensitized to an RhD-positive fetus causing a maternal immune response to produce IgG anti-D antibodies, which damage the fetus in a subsequent pregnancy. For analysis of the fetal RhD-status, proper fetal DNA extraction is essential. Evaluating the extraction of cffDNA can prove difficult, as maternal DNA drowns out the signal of cffDNA. By initial, selective re-striction digest and subsequent PCR, FetoGnost® Kit Control allows evaluation of extraction methodology by isolating fetal DNA.

Description:  FetoGnost® Kit Control is a non-automated real-time PCR test for the qualitative detection of cell-free fetal DNA (cffDNA) in maternal plasma samples of pregnant women. This test is suitable for women of all ages from the 12th week of pregnancy (gestational age ≥ 11+0) with singleton or multiple pregnancies. The test can be used both in the first pregnancy and in subsequent pregnancies. The test is for research use only and is exclusively intended for the validation of suitable extraction meth-ods for the purification of cffDNA from maternal plasma. The test is thus suitable for validating the extraction and for verification of the amount of cffDNA from hu-man maternal plasma. FetoGnost® Kit Control can be used with FetoGnost® Kit RHD in one PCR run.

  • Not suitable for samples taken before gestational age ≥ 11+0.
  • This test is for research use only and cannot be used for clinical testing.
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 Maternal / Fetal Marker
For research use only
Shipping Temperature: -20 °C to +4 °C
Product Features:
  • Amplification and detection: 1 maternal and 2 fetal DNA markers
  • 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 with NED-channel
  • Harmonized thermal profiles to run simultaneously with FetoGnost® Kit RHD

PCR platforms: FetoGnost® Control was developed for the ABI® 7500 instrument and QuantStudio™ 7 Pro (Thermo Fisher Scientific) - fast cycle parameters are not supported by this test. It is also compatible with other real-time PCR in-struments which detect and differentiate fluorescence in FAM, VIC, NED, and ROX channels. When using PCR-platforms not tested by Ingenetix, an evaluation of the multiplex-PCR should be done. Keep in mind that some PCR-platforms first must be calibrated with the corresponding dye before per-forming multiplex-PCR.

FetoGnost® Kits run with the same thermal cycling conditions.