NIMoTest® Fetal RHD qPCR kit is a kit for determining the fetal RHD genotype from maternal plasma. It is intended for the monitoring of RhD-negative pregnant women to guide anti-RhD immunoprophylaxis and adapt the monitoring of immunised women.
Detailed description
The kit is designed for duplex quantitative PCR (pPCR) amplification of exons 5 and 7 of the RHD gene in circulating cell-free fetal DNA (cffDNA) samples obtained from the maternal plasma of non-immunised RhD-negative pregnant women. Results are interpreted by analysing the Ct curves using NIMoSoft® software.
Operating principle
The kit is designed to amplify specific regions of exons 5 and 7 of the RHD gene by pPCR, with a duration of approximately 1 hour from the extraction of the cffDNA (cell-free fetal DNA) present in maternal plasma.
It includes a small extraction control (EC) that must be added to the plasma before lysis to validate the extraction process and verify the absence of PCR inhibitors.
Results are interpreted using NIMoSoft® analysis software.
Clinical applications
It is intended for determining the fetal RHD genotype from the maternal plasma of non-immunised RhD-negative pregnant women as part of non-invasive biological prenatal diagnosis.
It supports decisions regarding the administration of anti-D prophylaxis only in pregnancies with an RhD-positive fetus to control the risk of fetal and neonatal haemolytic disease associated with anti-RhD.
Indicated for use from week 11 of pregnancy.
Key aspects and benefits
Multiplex detection of exons 5 and 7 of the RhD gene with ready-to-use reagents.
Includes an extraction control (small DNA fragment) to validate extraction and the absence of inhibitors.
Provides a simplified workflow.
Includes NIMoSoft analysis software for complete traceability, validation, interpretation and LIMS integration.
Enables results to be obtained in approximately 1 hour from DNA extraction.
Technology used
Validated with QuantStudio 7, LightCycler 480 II, M2000rt and qTower3 instruments.
Validated with extraction methods including MagNAPure 96, MagNA Pure 24, MagPurix, LabTurbo-24 and Chemagic 360d.
Intended users
Immunohaematology laboratories, blood banks and transfusion services interested in fetal RhD genotyping in non-immunised RhD-negative pregnant women.
Additional considerations
DNA extraction is critical due to the low concentration of cffDNA in maternal plasma.
The test is only suitable from week 11 of pregnancy.
Heparin may inhibit PCR; the validated starting material is plasma obtained from EDTA blood.
Presentation details
Kit size: 21 samples per 96-reaction kit to allow testing in triplicate and the extraction control.
Reference number: NIMRHDQ96.
Includes a positive control, negative control and extraction control.
