Chimerism Multiplex Plus II Kit
The Chimerism Multiplex Plus II Kit analyses 16 biomarkers, comprising null alleles and INDELs, in eight multiplexed real-time PCR reactions per sample, to identify informative markers for chimerism follow-up after allogeneic transplantation. The panel includes the RhD marker and the SRY marker on chromosome Y. Together with the earlier Chimerism Multiplex Plus panel and SRY it covers 33 markers in total, with a limit of detection of 0.01 per cent. CE marked for in vitro diagnostic use.
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This kit in detail
- 16 biomarkers with null alleles and INDELs, in eight multiplexed reactions per sample
- 33 markers in total in combination with the Chimerism Multiplex Plus panel and SRY
- RhD marker for cases without Rh information, SRY marker for male recipients
- Limit of detection 0.01 per cent on genomic DNA
- Cumulative informativity 99.1 per cent with SRY, 99.98 per cent combined with Multiplex Plus
- 450 ng of recipient DNA and 450 ng of donor DNA, blood or bone marrow
- 45 minutes hands-on, 1 hour 20 minutes PCR, FAM and VIC channels
The Chimerism Multiplex Plus II Kit is used to select informative markers for the follow-up of molecular chimerism after allogeneic transplantation. Chimerism analysis provides a basis for anticipating relapse, rejection and graft-versus-host disease, and for assessing the response to treatment.
Informative markers
An informative polymorphism is one that is detected in the recipient but not in the donor; that difference is what makes chimerism measurable. This kit genotypes 16 biomarkers, comprising null alleles and insertion and deletion polymorphisms, using specific oligonucleotides and fluorescent hydrolysis probes. The panel also includes the RhD marker, for cases where Rh information is not available, and the SRY marker on chromosome Y, which is informative in male recipients without further analysis.
Marker count and informativity
Together with the previously available Chimerism Multiplex Plus panel and the SRY marker, 33 markers are covered in total. Cumulative informativity of this panel with SRY is 99.1 per cent, and rises to 99.98 per cent when the Chimerism Multiplex Plus panel is analysed alongside it.
Performance and samples
Performance was validated on genomic DNA from peripheral blood and from bone marrow, with a limit of detection of 0.01 per cent. Each analysis requires 450 ng of recipient DNA taken before transplantation and 450 ng of donor DNA, and uses eight reactions per sample.
Workflow
Hands-on time is approximately 45 minutes and the PCR run takes 1 hour and 20 minutes. The assay runs on real-time PCR instruments with FAM and VIC channels.
Quality and regulatory status
The manufacturer, Health in Code, is certified against UNE-EN ISO 13485:2018 for quality management. This kit is CE marked for in vitro diagnostic use.
PCR reagents for amplification, Oligonucleotides and hydrolysis probes for marker detection, Genomic DNA samples (recipient and donor), Real-time PCR cycler compatible with FAMTM and VIC® channels and Quality control materials for validation.
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Instructions for Use
Imegen-Quimera Screening Multiplex Plus II
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