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One Lambda™ LABType™ sequence-specific oligonucleotide (SSO) tests combine the robustness of reverse-SSO (rSSO) method typing with the Luminex platform, to provide Class I and Class II HLA typing. The assay utilizes bead technology for a streamlined workflow, able to scale the number of samples and target loci per run, delivering accurate results within hours. The multiplex analysis minimizes labor, reagent use, reaction inconsistencies, and assay time compared to a multi-well format, making it a cost-effective solution. The assay is flexible, scalable, with reliable typing and same-day results.
How the assay works
A suspension array platform employs fluorescently coded microspheres as a solid support to immobilize oligonucleotide probes. Target DNA is amplified with biotinylated, locus specific primers. The amplified product is then denatured and hybridized with the oligonucleotide probes. Amplified product hybridized to microsphere-bound oligonucleotide probes are labeled with R-phycoerythrin–conjugated streptavidin (SAPE) and then processed by the LABScan™ system. The assay takes place in a single well of a 96-well PCR plate.
LABType CWD
LABType CWD assays are designed to resolve alleles as defined by the Common, Intermediate and Well Documented catalog. The kits detect HLA alleles defined for CIWD Version 3.0.0 with a broad and global scope of allele frequencies and diversity when analyzed with the Fusion CIWD filter. Loci coverage meets standards for patient HLA Typing, along with requirements for confirmatory HLA typing (HLA-CT) for unrelated donors, and enhanced alignment with LABScreen Single Antigen in determining Donor-Specific Antibody (DSA) identification.
CIWD 3.0.0 allelic resolution: Allelic coverage in alignment with the latest CIWD 3.0.0 catalog and across ethnic allele groups.
Ambiguity resolution: Improved ambiguity resolution across HLA-A, -B, -C and -DRB1 loci.
Alignment with antibody detection: The allele coverage is aligned with the specificity and compatibility of LABScreen products.
- Common and Intermediate alleles comprise > 99.0% of allele frequency distribution on CIWD 3.0.0
- Frequency categories compiled from over 8,000,000 individuals using data from 20 unrelated HSC donor registries
- Alleles represent 7 ancestral populations (ethnic groups), see Table 1
- Reduces ambiguity for Common, Intermediate and Well Documented Null Alleles in the "G1" allele pair group according to CIWD 3.0.0 and regulatory body requirements1,2,3
Table 1. Geographic Regions represented.
| Abbreviation | Region |
|---|---|
| AFA | African / African American |
| API | Asian/Pacific Islands |
| EURO | European / European descent |
| MENA | Middle East / North Africa |
| NAM | Native American |
| HIS | South or Central America / Hispanic / Latino |
| UNK | Unknown / Multi-ancestries |
LABType SSO
With our LABType SSO kits, you get superior resolution and a cost-effective solution for HLA A, B, C, DRB1, DRB345, and DQA1, DQB1, DPA1, DPB1 HLA typing.
Features and benefits
- Reduces labor and processing time with "all-in-one" reaction
- Allows resolution of ambiguities without an additional assay
- Automated data acquisition using flow analysis
- Software-aided data analysis and HLA allele assignment
- Post-hybridization stability for batch processing
- Suitable for both low volume and high throughput laboratories
HLA Fusion Software
HLA Fusion™ software utilizes color-coded filtering functionality* to help you easily identify and define CIWD alleles. Additionally, you can import separate CIWD lists using a dedicated function, providing inclusion of CIWD HLAID alleles and CIWD groups for a more comprehensive analysis.
- Identifies possible allele pair(s) with only CIWD alleles
- Multiple possible allele pairs in G1 group may need to be further resolved if 2-field ambiguities are involved
* Latest version of HLA Fusion should be downloaded for all new tools and capabilities.
References
- Standards for Accredited Laboratories, American Society for Histocompatibility and Immunogenetics, 2021 Revised Standards. 2022:8.
- NMDP Policy for HLA Confirmatory Typing Requirements for Unrelated Adult Donors and HLA Typing Requirement for Patients, 2021:3.
- Standards For Histocompatibility & Immunogenetics Testing, European Federation for Immunogenetics, 2020, V8.0, F1.1.4:33.
LABType SSO, LABType XR/CWD, and HLA Fusion Software are CE marked in the EU and 510k-cleared in the US for in vitro diagnostic use. Availability of products in each country depends on local regulatory marketing authorization status.