Imegen-Quimera Screening Multiplex Plus II: Revolutionizing Hematopoietic Chimerism Analysis

Introduction

The analysis of molecular chimerism resulting from allogenic transplantation has become an indispensable tool in monitoring transplant progression. It provides accurate insights into transplant outcomes, enabling timely interventions to anticipate the risks of relapse, rejection, or graft-versus-host disease (GVHD). This approach not only aids in risk assessment but also evaluates responses to various treatment modalities. In this context, the Imegen® Quimera Screening Multiplex Plus II kit emerges as a groundbreaking solution, offering invaluable support to healthcare professionals in the field of molecular biology.

Informative Markers for Transplant Follow-Up

The Imegen® Quimera Screening Multiplex Plus II kit is designed for the precise and simultaneous analysis of 16 insertion/deletion polymorphisms (INDELs) using eight independent multiplexed real-time PCR reactions. Informative markers are crucial for hematopoietic chimerism analysis, and the kit offers a solution for selecting such markers effectively.

Informative polymorphisms are those detected in the transplant recipient but not in the donor, signifying chimerism. The panel includes the RhD marker for cases where Rh information is unavailable and the SRY marker, informative in male recipients without the need for additional molecular analysis.

Technical Advancements

The Imegen® Quimera Screening Multiplex Plus II kit comprises a 16-biomarker genotyping assay that includes null alleles and INDELs, providing a comprehensive view of chimerism. Alongside the previously available Imegen® Quimera Screening Multiplex and the SRY marker on Chromosome Y, it incorporates 33 markers in total. These markers are detected using specific oligonucleotides and fluorescent hydrolysis probes, ensuring accuracy in chimerism assessment.

The kit’s performance has been rigorously validated using genomic DNA from peripheral blood or bone marrow samples, with a limit of detection of 0.01% when genomic DNA is employed. The global cumulative informativity of the panel, combined with the SRY marker, stands at an impressive 99.1%. When the Imegen® Quimera Screening Multiplex Plus panel is analyzed in conjunction, informativity soars to an astounding 99.98%.

Certified Quality

Health in Code is certified against the UNE-EN ISO 13485:2018 standard, affirming the company’s commitment to quality management in the design, development, and production of medical devices for in vitro diagnostic use. The kit is applicable to genetic testing and software for the bioinformatics analysis of genetic data, offering versatility and reliability.

Product Specifications

• Amount of DNA needed: 450 ng of recipient DNA sample (pre-transplant) and 450 ng of donor DNA sample
• Sample type: Peripheral blood or bone marrow
• Number of reactions per recipient sample: 8
• Number of reactions per donor sample: 8
• Number of targets: 16
• Manual working time: 45 min
• Duration of the PCR program: 1h 20 min
• Compatible cyclers: Real-time PCR cycler with FAMTM and VIC® channels

In summary, the Imegen-Quimera Screening Multiplex Plus II kit represents a significant advancement in the field of hematopoietic chimerism analysis. Its innovative design, extensive marker panel, and outstanding performance make it an indispensable tool for healthcare professionals, facilitating precise monitoring of transplant progress and enabling timely interventions to ensure the best possible outcomes for patients.