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HLA Antibody testing is performed to understand the potential risk of a patient before and after organ transplantation from a selected donor. Donor-specific anti-HLA antibodies (DSA) can be developed de-novo after transplantation, transfusion, or pregnancy. Pre-transplant, identification of any DSA can help reduce the incidence of rejection by avoiding matching of donors to recipients with these pre-formed DSAs.
In high PRA patients, antibodies that are reactive to one or more dominant epitopes can mask the presence of additional antibody specificities. LABScreen Single Antigen beads are designed to detect HLA Class I and Class II antibodies that are reactive to one or more dominant epitopes, providing a comprehensive assay to evaluate antigens found frequently in the population.
Utilizing recombinant DNA technology, each microparticle or bead can be coated with a single HLA molecule, providing high sensitivity and specific antigen assignment.
Key features
- HLA antibody detection with purified HLA antigens
- High sensitivity and reproducibility
- Detect allele-specific antibodies
- Identification of antibodies specific for non-self HLA antigen
How does Single Antigen work
HLA antibody detection matters
Detecting antibodies pre-transplant and monitoring donor-specific antibodies (DSAs) after transplant can help identify early immune activation associated with antibody-mediated rejection (ABMR) and graft dysfunction. LABScreen Single Antigen assays support sensitive detection and monitoring of HLA Class I and Class II antibodies to help laboratories and clinicians track changes in antibody profiles over time.
De novo DSA is associated with graft loss
The development of de novo DSA (dnDSA) post-transplant has been associated with increased risk of graft loss, including in patients with subclinical dnDSA. Early identification may support timely clinical decision-making.
Graft survival data. Wiebe C, et al. Am J Transplant, 2015
Allele specific antibody detection may help support assessment of immunologic compatibility
Research has shown that allele-specific anti-HLA antibodies are not uncommon in transplant patients and may occur outside standard SAB panel coverage. Extended antibody detection panels can help identify additional clinically relevant reactivity, particularly in sensitized patients.
These findings reinforce the importance of expanded HLA coverage and high-resolution antibody characterization when assessing donor-recipient compatibility.
Precise antibody characterization
Single antigen bead (SAB) technology enables highly sensitive characterization of HLA Class I and Class II antibody profiles, helping distinguish donor-specific from non-donor-specific antibodies and supporting longitudinal monitoring strategies.
Integrated analysis in HLA Fusion software enables antibody tracking, reporting, and streamlined data management.
LABScreen Single Antigen products and coverage
Table 1. LABScreen Single Antigen products.
| Product | Quantity | Cat. No. |
|---|---|---|
| For In Vitro Diagnostic Use (unless otherwise stated) | ||
| LABScreen Single Antigen Class I | ||
| LABScreen MICA Single Antigen - Group 1 | 25 tests | LSMICA001 |
| LABScreen Single Antigen HLA Class I - Combi | 25 tests | LS1A04 |
| LABScreen Single Antigen HLA Class I Supplement - Group 1 | 25 tests | LS1ASP01 |
| LABScreen Single Antigen Class II | ||
| LABScreen Single Antigen HLA Class II - Group 1 | 25 tests | LS2A01 |
| LABScreen Single Antigen HLA Class II Supplement - Group 1 | 25 tests | LS2ASP01 |
Table 2. Product differentiators.
| Feature | Single Antigen | Supplement | ExPlex |
|---|---|---|---|
| Workflow | Standard | Standard | Combined Well |
| Coverage | Broad | Expanded | Expanded |
| Instrument | LABScan 100/3D | LABScan 100/3D | LABScan3D only |
Table 3. LABScreen Single Antigen Class I coverage.
| Classic kit: 97 single antigen beads (SABs) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| A*01:01 | A*26:01 | A*36:01 | B*27:05 | B*15:10 | B*39:01 | B*47:01 | B*56:01 | C*01:02 | C*07:02 |
| A*02:01 | A*29:01 | A*43:01 | B*07:02 | B*15:11 | B*40:01 | B*48:01 | B*57:01 | C*02:02 | C*08:01 |
| A*02:03 | A*29:02 | A*66:01 | B*08:01 | B*15:12 | B*40:02 | B*49:01 | B*57:03 | C*03:02 | C*12:03 |
| A*02:06 | A*30:01 | A*66:02 | B*13:01 | B*15:13 | B*40:06 | B*50:01 | B*58:01 | C*03:03 | C*14:02 |
| A*03:01 | A*30:02 | A*68:01 | B*13:02 | B*15:16 | B*41:01 | B*51:01 | B*59:01 | C*03:04 | C*15:02 |
| A*11:01 | A*31:01 | A*68:02 | B*14:01 | B*18:01 | B*42:01 | B*51:02 | B*67:01 | C*04:01 | C*16:01 |
| A*11:02 | A*32:01 | A*69:01 | B*14:02 | B*27:08 | B*44:02 | B*52:01 | B*73:01 | C*05:01 | C*17:01 |
| A*23:01 | A*33:01 | A*74:01 | B*15:01 | B*35:01 | B*44:03 | B*53:01 | B*78:01 | C*06:02 | C*18:02 |
| A*24:02 | A*33:03 | A*80:01 | B*15:02 | B*37:01 | B*45:01 | B*54:01 | B*81:01 | ||
| A*24:03 | A*34:01 | B*15:03 | B*38:01 | B*46:01 | B*55:01 | B*82:01 | |||
| A*25:01 | A*34:02 | ||||||||
Table 4. LABScreen Single Antigen Class II coverage.
| Classic kit: 95 SABs | ||||||
|---|---|---|---|---|---|---|
| DRB1*01:01 | DRB1*11:01 | DRB3*01:01 | DQB1*02:01 DQA1*02:01 | DQB1*06:03 DQA1*01:03 | DPB1*01:01 DPA1*01:03 | DPB1*13:01 DPA1*02:01 |
| DRB1*01:02 | DRB1*11:04 | DRB3*02:02 | DQB1*02:01 DQA1*03:01 | DQB1*06:04 DQA1*01:02 | DPB1*01:01 DPA1*02:01 | DPB1*13:01 DPA1*02:02 |
| DRB1*01:03 | DRB1*12:01 | DRB3*03:01 | DQB1*02:01 DQA1*04:01 | DQB1*06:09 DQA1*01:02 | DPB1*02:01 DPA1*01:03 | DPB1*13:01 DPA1*03:01 |
| DRB1*03:01 | DRB1*12:02 | DRB4*01:01 | DQB1*02:01 DQA1*05:01 | DQB1*03:01 DQA1*03:01 | DPB1*05:01 DPA1*02:02 | DPB1*14:01 DPA1*02:01 |
| DRB1*03:02 | DRB1*13:01 | DRB4*01:03 | DQB1*02:02 DQA1*02:01 | DQB1*03:01 DQA1*02:01 | DPB1*03:01 DPA1*01:03 | DPB1*15:01 DPA1*02:01 |
| DRB1*04:01 | DRB1*13:03 | DRB5*01:01 | DQB1*04:01 DQA1*02:01 | DQB1*03:01 DQA1*05:03 | DPB1*03:01 DPA1*01:05 | DPB1*17:01 DPA1*02:01 |
| DRB1*04:02 | DRB1*14:01 | DRB5*02:02 | DQB1*04:01 DQA1*03:03 | DQB1*03:01 DQA1*05:05 | DPB1*03:01 DPA1*02:01 | DPB1*18:01 DPA1*02:01 |
| DRB1*04:03 | DRB1*14:02 | DQB1*04:02 DQA1*02:01 | DQB1*03:01 DQA1*06:01 | DPB1*04:01 DPA1*01:03 | DPB1*18:01 DPA1*01:05 | |
| DRB1*04:04 | DRB1*14:54 | DQB1*04:02 DQA1*04:01 | DQB1*03:02 DQA1*02:01 | DPB1*04:02 DPA1*01:03 | DPB1*18:01 DPA1*01:04 | |
| DRB1*04:05 | DRB1*15:01 | DQB1*05:01 DQA1*01:01 | DQB1*03:02 DQA1*03:01 | DPB1*05:01 DPA1*02:01 | DPB1*19:01 DPA1*01:03 | |
| DRB1*07:01 | DRB1*15:02 | DQB1*05:02 DQA1*01:02 | DQB1*03:02 DQA1*03:03 | DPB1*06:01 DPA1*02:01 | DPB1*20:01 DPA1*03:01 | |
| DRB1*08:01 | DRB1*15:03 | DQB1*06:01 DQA1*01:03 | DQB1*03:03 DQA1*02:01 | DPB1*06:01 DPA1*01:03 | DPB1*23:01 DPA1*01:05 | |
| DRB1*09:01 | DRB1*16:01 | DQB1*06:02 DQA1*01:02 | DQB1*03:03 DQA1*03:01 | DPB1*09:01 DPA1*02:01 | DPB1*28:01 DPA1*01:05 | |
| DRB1*09:02 | DRB1*16:02 | DQB1*06:02 DQA1*01:01 | DQB1*03:03 DQA1*03:02 | DPB1*10:01 DPA1*02:02 | DPB1*28:01 DPA1*04:01 | |
| DRB1*10:01 | DPB1*11:01 DPA1*01:03 | DPB1*11:01 DPA1*02:02 | ||||
| DPB1*28:01 DPA1*01:03 | ||||||
LABScreen Single Antigen Supplement
LABScreen Single Antigen Supplemental kits were designed to provide further antigen coverage to the classic LABScreen single antigen kits. As antigen representation is limited to 100 analytes or beads on the LABScan 100 Luminex, and each bead represented a single antigen, additional panels were needed to increase testing options and provide more specificities for varying populations. These are available for Class I and II antigens.
LABScreen MICA Single Antigen
MHC Class I related Chain A (MICA) is a gene located in MHC Class I region expressed in cells that that play a role in rejection both pre and post-transplant. LABScreen MICA Single Antigen can assign specificities, as an antigen is coated on a separate bead population utilizing Luminex xMAP technology. The panel consists of 10 MICA antigens found frequently in the population.
Resources
Not all products are CE marked or have 510(k) clearance for sale in the U.S. Availability of products in each country depends on local regulatory marketing authorization status.