What is the clinical purpose of the FetoGnost® Kit RHD?

The kit enables non-invasive prenatal determination of the fetal RHD status in RhD-negative pregnant women by detecting fetal RHD DNA in maternal plasma using real-time PCR.

Which gene targets does the FetoGnost® Kit RHD detect?

The test specifically detects exons 5, 7, and 10 of the RHD gene, allowing confirmation of fetal RhD positivity.

When can the test be used during pregnancy?

The test is validated for use from gestational week 12 (week 11+0) onward and is suitable for both singleton and multiple pregnancies.

What is the significance of using triplicates in this test?

Each sample is tested in triplicates for each exon to ensure accuracy and reduce the risk of false-negative results.

How does the kit ensure specificity for fetal DNA?

The detection is based on real-time PCR using fluorescent probes specific to fetal RHD DNA, minimizing maternal background interference.

What role does the internal positive control (IPC) play in the test?

The IPC monitors both DNA extraction and potential PCR inhibition, ensuring reliability of negative results.

What is the minimum plasma volume recommended for reliable testing?

At least 0.5 ml of plasma per sample is recommended for extraction.

Can rare RHD variants affect test results?

Yes, rare maternal or fetal RHD variants may lead to detection of only some exons or unusually low Cq values, which must be interpreted with caution.

FetoGnost® Kit RHD – Real-Time PCR for the non-invasive detection of the fetal Rhesus factor D (RHD) gene

Name: FetoGnost® Kit RHD – Real-Time PCR for the non-invasive detection of the fetal Rhesus factor D (RHD) gene
Brand: ingenetix GmbH
SKU: HUFG100
Rating: 5.0 (1 reviews)

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Product Manual FetoGnost^® Kit RHD	Download PDF
Material Safety Data Sheet FetoGnost^® Kit RHD	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. Since the intended purpose explicitly states that only RhD negative women are to be tested with FetoGnost^® Kit RHD no interference of detection of exons of the fetus occurs. 60 % of fetuses are RhD-positive while 40 % are negative. 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.

Description: FetoGnost^®Kit RHD is a non-automated IVD real-time PCR test for the qualitative detection of fetal RHD DNA from cell free DNA extracted from maternal plasma of RhD-negative pregnant women (non-invasive prenatal determination of fetal RhD status, NIPD-RhD). The test detects exons 5, 7 and 10 of the RHD gene.

The clinical function of the test is the prediction of the fetal RhD status. It allows targeted anti-D prophy-laxis in non-immunized RhD-negative 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 a first pregnancy and subsequent pregnancies.

The test is intended for professional use and is limited to qualified personnel instructed in the procedures of real-time PCR and in vitro diagnostic procedures.

FetoGnost^® Kit RHD

Order Number	Reactions	Channel Pathogen	Channel IPC	Target
HUFG100	100	FAM, VIC, NED	Cy5	RHD Exon 5, 7, 10
HUFG500	500	FAM, VIC, NED	Cy5	RHD Exon 5, 7, 10

For in vitro diagnostic use
Shipping Temperature: -20 °C to +4 °C

Product Features:

CE-IVDR Real-Time PCR
Amplification and detection: human RHD gene Exon 5 (VIC), 7 (FAM), 10 (NED)
Internal Positive Control System (IPC): control for DNA extraction, exclusion of false-negative results, Cy5 channel
Rapid hot-start Taq DNA polymerase
ROX™ dye as passive reference
Optimized to handle PCR inhibitors
HUFG100: analysis of up to 30 plasma samples in triplicates (incl. controls)
HUFG500: analysis of up to 150 plasma samples in triplicates (incl. controls)

PCR platforms: FetoGnost^® Kit RHD has been validated with the ABI^® 7500 Fast instrument and QuantStudio™ 5, 6 and 7 Pro (Thermo Fisher Scientific) (fast cycle parameters are not supported by this test).

With FetoGnost^® Kit RHD, laboratories achieve fast, sensitive and non-invasive fetal RHD genotyping, reducing the need for unnecessary anti-D prophylaxis in RhD-negative pregnancies.

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