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Transplant Diagnostics
Helping you build better patient outcomes in all phases of transplantation
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Improve transplant patient outcomes with proven clinical diagnostics
Transplant diagnostics, including human leukocyte antigen (HLA) typing, plays a vital role in determining the compatibility and success of transplant organ recipients and donors. The quality of life in transplant patients and their families can be significantly improved through pre-transplant screening, post-transplant monitoring, transfusion, and companion diagnostics.
Why Thermo Fisher Scientific?
The Transplant Diagnostics business of Thermo Fisher Scientific makes the One Lambda assays that are used by transplant labs around the world and is a recognised and trusted transplant diagnostics solutions provider. Our solutions help transplant labs, and clinical teams provide personalised care across the patient experience.
We offer:
- A comprehensive and reliable line of transplant diagnostic tools, including HLA typing, screening, HLA antibody detection and blood testing products
- All-inclusive HLA software solution to simplify, manage and report all HLA tests
- Support for lab professionals, researchers, and clinicians through every stage of the transplant diagnostic workflow with the ability to provide turnkey solutions
- Global access, local presence – labs can benefit from the extensive customer channel and distribution network of Thermo Fisher Scientific around the world
Transplant diagnostics solutions and tools
Our One Lambda solutions simplify and automate pre- and post-transplant screening, monitoring, research and test evaluations with HLA typing and antibody detection. Transfusion blood screening, blood testing and companion diagnostics are also supported in the suite of transplant diagnostic solutions to help aid transplant care.
Pre-Transplant
Our pre-transplant solutions give laboratory professionals a range of options for HLA typing and antibody detection that help simplify and automate pre-transplant testing and final test evaluation.
Post-Transplant
To support ongoing patient monitoring, we offer assays to help laboratory professionals detect antibodies that can lead to rejection and a service to aid in post-transplant biopsy assessment.
Transfusion
We offer products designed to support the donor screening needs of laboratory professionals through red blood cell and plasma transfusions.
HLA typing
Our broad portfolio of molecular typing products offers low- to high-resolution detection of a range of biomarker antibodies, including assays that revolutionise workflow by putting the most efficient next-generation sequencing method into the hands of laboratory professionals.
Designed to meet the diverse needs of HLA labs, the HLA typing product family includes:
The AllType™ FASTplex™ NGS Assay makes NGS accessible and achievable for any laboratory. The assay’s advanced chemistry and comprehensive coverage is complemented by a streamlined workflow for minimal hands-on time and supported by intuitive software for easy sample auditing and enhanced data integration.
The AllType FASTplex chemistry has been enhanced to improve performance, robustness, and reliability. With the newly added Class II exon 1 primer mix, the AllType FASTplex reagents reduce ambiguities, provide comprehensive coverage across 11 loci, and generate highly concordant results at 99.8% or higher, all in a single PCR reaction.
Our portfolio of AllType™ assays offers a complete next-generation sequencing solution that provides single-tube amplification for all eleven Class I and Class II loci, completely removing the need for amplicon pooling. Samples are transferred directly to library preparation and made ready for sequencing in a single workday. Sequencing analysis and individual allele assignments are automatically generated by our TypeStream™ Visual NGS Analysis Software. Results are delivered in fewer than three days.
LinkSēq™ is a rapid genotyping method with a simple workflow that prevents post-amplification contamination. With a fast turnaround time of only 90 minutes, and minimal hands-on time, your lab’s productivity will greatly increase.
- The LinkSēq HLA Typing Kits provide the most complete solution for high throughput laboratories interested in fast and easy typing of all 11 loci. This product provides low resolution typing for HLA A, B, C, DRB1, DRB345, DQA1, DQB1, DPA1, and DPB1, as well as common null alleles.
- LinkSēq HLA - Specific Genetic Markers kits type specific HLA alleles such as B27 or B*57:01. Each kit types a few specific alleles in strip format. This is the fastest and most cost effective solution for labs looking for specific typing of the alleles included in the strip.
LABType™ products are reverse SSO DNA typing assays that provide superior resolution for HLA A, B, C, DRB1, DRB3, DRB4, DRB5, DQA1, DQB1, DPA1, and DPB1 HLA typing. The multiplex analysis dramatically reduces labour, reagents, reaction-to-reaction inconsistencies, and assay time associated with a multi-well format assay making it a cost-effective solution.
SeCore™ kits are high-resolution Human Leukocyte Antigens (HLA) typing products based on sequence-based typing. Our kits are designed for ease of use and yield high-quality results. Locus Sequencing Kits provide reagents for amplification, purification, and Sanger sequencing of HLA alleles (variants) from DNA. Sequencing fragments produced using this CE Marked kit are subjected to capillary electrophoresis.
Lambda Monoclonal Trays™, are extremely dependable for determining HLA Class I or Class II antigens. Each tray is comprised exclusively of monoclonal antibodies rather than human anti-serum, has both positive and negative controls, and will accommodate most CDC methods. They are designed for use with both staining techniques−dye exclusion and fluorescence.
Producing consistent, accurate HLA typing of Class I or Class II antigens, this selection of Tissue Typing Trays.is available in a 72-well format. Each tray contains positive and negative controls, accommodating most complement-dependent cytotoxicity (CDC) methods.
Antibody monitoring and detection
The One Lambda integrated solutions help professionals identify and detect anti-human leukocyte antigen (HLA) antibodies which may cause antibody-mediated rejection (ABMR) and graft failure in organ transplant recipients. Our collection of integrated solutions allows for the determination of antibody profiles and expanded antibody coverage to give you robust, reliable PRA (panel reactive antibody) screening results.
The selection of antibody monitoring and detection assays includes:Our broad portfolio of molecular typing products offers low- to high-resolution detection of a range of biomarker antibodies, including assays that revolutionise workflow by putting the most efficient next-generation sequencing method into the hands of laboratory professionals.
Designed to meet the diverse needs of HLA labs, the HLA typing product family includes:
Our selection of reagents for the LABScreen™ line of products are powered by Luminex® xMAP® technology—a microbead platform used to deliver multiplex antibody assays in high-PRA patients. These single antigen-bead based assays allow for precise determination of antibody profiles against HLA, MICA or HNA.
Investigate the role of complement-fixing antibodies with our C1qScreen™ test. The presence of complement binding (C1q) antibodies can be identified and monitored in sera, providing information for building better antibody profiles.
Combining traditional flow cytometry cellular crossmatch testing with the specificity of microbeads technology, the FlowDSA-XM™ test selectively distinguishes leukocyte antibodies, allowing you to obtain selective detection in the first run.
FlowPRA™ screening tests – flow cytometric detection of HLA antibodies and percent PRA in human sera
The FlowPRA™ products offer screening, specific antibody, and single antigen detection assays using flow cytometry. Both the FlowPRA Screening and FlowPRA Specific tests can assign Percent Panel Reactive Antibody (PRA), while FlowPRA Specific tests assign antibody specificity. FlowPRA Single Antigen tests assist in analysing specificities, especially in high PRA sera.
The AT1R and anti-ETAR antibody assays detect biomarker antibodies that form against angiotensin II type 1 receptors (AT1R) and endothelin receptors type A (ETAR). They offer a new approach to transplant research testing at a non-HLA level.
Transfusion Screening
Supporting the screening needs of blood banks and medical laboratory professionals. The One Lambda screening assays for use in the transfusion setting are designed to facilitate blood genotyping and screen for antibodies with products that allow for an efficient workflow, including fast and simple data analysis and reporting.
Instrumentation
Simplify assay workflows and increase testing efficiency in the HLA laboratory. Thermo Fisher Scientific’s One Lambda provides instrumentation solutions such as automated pipettors and dispensers, NGS instruments, and analysers, as well as complete software solutions.
Software Automation
Recent advancements in transplantation have made HLA laboratory software more crucial than ever to the management, reporting, and analysis of data—the critical data that transplant teams rely on to provide patient care.
Imagine if your software could support every step of the transplant diagnostics process? With the HistoTrac™ Software as part of our portfolio, we’re developing the lab of the future.
Learn the latest HLA technical and clinical advancements in transplant diagnostics
Our workshops are geared toward beginner and advanced HLA technicians who want to learn how to troubleshoot and analyse data results. We host webinars or symposia at global transplant societies, including ASHI, EFI, and BSHI where you can interact with industry leaders to discuss the latest techniques and procedures.
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