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. With LABScreen Single Antigen Beads, you can 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, we can coat each microparticle or bead 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


Antibody monitoring post-transplant

Post-transplant, monitoring for existing and de novo DSA formation with LABScreen Single Antigen is important as a biomarker. DSA post-transplant can lead to rejection episodes, with de novo DSA formation an early indicator of antibody mediated rejection (AMR), requiring increased immunosuppression that can increase the risk of infection and malignancy​.

 

The presence of DSA is associated with significantly lower graft survival and causes both acute and chronic rejection. It is predictive of poor outcomes, demonstrating the need for post-transplant DSA monitoring.

 

The ability to test for and track HLA Class I and Class II antibodies can provide early intervention for ABMR and graft failure. The routine monitoring of DSA in the post-transplant setting can help increase long term graft and patient survival. 

LABScreen Single Antigen allows for precise determination of HLA Class I and Class II antibody profiles

In recent years, the literature has shown the importance of detecting and monitoring for the development of DSA with enhanced sensitivity after transplantation. In a pooled analysis of retrospective cohort studies, the presence of DSA detected by solid-phase assay, even with a negative flow cross-match, demonstrated statistical significance for increased risk for biopsy-proven antibody-mediated rejection (ABMR) and graft failure.1

LABScreen Single Antigen Assays, which are used for both pre- and post-transplant applications, leverage Luminex bead-based multiplexing technology for monitoring DSA in high-PRA patients. This highly sensitive single antigen bead-based assay identifies antibodies against HLA and is a crucial component of a complete patient management system.

In a recent study, both clinical and subclinical de novo DSA (dnDSA) were associated with an increase in graft loss. In the subclinical dnDSA group graft loss was delayed. The authors concluded that the association of dnDSA with subsequent graft loss suggests that screening for DSA post-transplant and early intervention could improve graft outcomes.

Wiebe C, et al. Am J Transplant, 2015

The use of LABScreen Single Antigen Assays as part of a comprehensive monitoring program, identifies changes in existing DSA or the appearance of new specificities which may reveal an early rejection process. This can help clinicians recognise insufficient or non-adherence to immunosuppression and enables early intervention, which reduces the risk of progression to severe acute rejection and graft loss, reducing return to dialysis.

 

Today, ABMR remains a major challenge to graft survival, but monitoring for DSA is the best tool for detecting post-transplant antibody development. Studies have shown that LABScreen Single Antigen Beads are the most sensitive2 and help ensure HLA antibodies are not missed. 

 

Single antigen beads allow for a precise, highly sensitive determination of a patient’s HLA antibody profile. This makes discrimination between donor-specific and non-donor-specific antibodies possible.

 

Interpreting results in HLA Fusion offers comprehensive reporting and tracking features. It includes a built-in patient database or can seamlessly integrate with HistoTrac lab system. Additionally, it allows for export into a laboratory or hospital management system. This facilitates efficient monitoring of antibodies, enabling swift identification of changes and the capacity to promptly address potential consequences.


LABScreen Single Antigen coverage

A Locus
A*01:01 A*26:01  A*36:01
A*02:01 A*29:01 A*43:01
A*02:03 A*29:02 A*66:01
A*02:06 A*30:01 A*66:02
A*03:01 A*30:02 A*68:01
A*11:01 A*31:01 A*68:02
A*11:02 A*32:01 A*69:01
A*23:01 A*33:01  A*74:01
A*24:02 A*34:01 A*80:01
A*24:03 A*34:02 A*33:03
A*25:01    
B Locus
B*27:05 B*15:12 B*40:02 B*50:01 B*58:01
B*07:02 B*15:13 B*41:01 B*51:01 B*59:01
B*08:01 B*15:16 B*42:01 B*51:02 B*67:01
B*13:02 B*18:01 B*44:02 B*52:01 B*73:01
B*14:01 B*27:08 B*44:03 B*53:01 B*78:01
B*14:02 B*35:01 B*45:01 B*54:01 B*81:01
B*15:01 B*37:01 B*49:01 B*55:01 B*82:01
B*15:02 B*38:01 B*47:01 B*56:01 B*13:01
B*15:03 B*39:01 B*48:01 B*57:01 B*15:11
B*15:10 B*40:01 B*46:01 B*57:03 B*40:06
C Locus
C*01:02  C*07:02
C*02:02  C*08:01
C*03:02  C*12:03
C*03:03  C*14:02
C*03:04  C*15:02
C*04:01  C*16:01
C*05:01  C*17:01
C*06:02  C*18:02

                

DRB Locus
DRB1*01:01 DRB1*11:01 DRB3*01:01
DRB1*01:02 DRB1*11:04 DRB3*02:02
DRB1*01:03 DRB1*12:01 DRB3*03:01
DRB1*03:01 DRB1*12:02 DRB4*01:01
DRB1*03:02 DRB1*13:01 DRB4*01:03
DRB1*04:01 DRB1*13:03 DRB5*01:01
DRB1*04:02 DRB1*14:01 DRB5*02:02
DRB1*04:04 DRB1*14:02  
DRB1*04:05 DRB1*14:54  
DRB1*07:01 DRB1*15:01  
DRB1*04:03 DRB1*15:02  
DRB1*08:01 DRB1*15:03  
DRB1*09:01 DRB1*16:01  
DRB1*09:02 DRB1*16:01  
DRB1*10:01
   

                

DQ Locus
DQB1*02:01 
DQA1*02:01
DQB1*06:03 
DQA1*01:03
DQB1*02:01 
DQA1*03:01
DQB1*06:04 
DQA1*01:02
DQB1*02:01 
DQA1*04:01
DQB1*06:09 
DQA1*01:02
DQB1*02:01 
DQA1*05:01
DQB1*03:01 
DQA1*03:01
DQB1*04:01 
DQA1*02:01
DQB1*03:01 
DQA1*05:03
DQB1*04:01 
DQA1*03:03
DQB1*03:01 
DQA1*05:05
DQB1*04:02 
DQA1*02:01
DQB1*03:01 
DQA1*06:01
DQB1*04:02 
DQA1*04:01
DQB1*03:02 
DQA1*02:01
DQB1*05:01 
DQA1*01:01
DQB1*03:02 
DQA1*03:01
DQB1*05:02 
DQA1*01:02
DQB1*03:02 
DQA1*03:02
DQB1*06:01 
DQA1*01:03
DQB1*03:03 
DQA1*02:01
DQB1*06:02 
DQA1*01:02
DQB1*03:03 
DQA1*03:01
DQB1*06:02 
DQA1*01:01
DQB1*03:03 
DQA1*03:02

                

DP Locus
DPB1*01:01 
DPA1*01:03
DPB1*13:01 
DPA1*02:01
DPB1*01:01 
DPA1*02:01
DPB1*13:01 
DPA1*02:02
DPB1*02:01 
DPA1*01:03
DPB1*13:01 
DPA1*03:01
DPB1*05:01 
DPA1*02:02
DPB1*14:01 
DPA1*02:01
DPB1*03:01 
DPA1*01:03
DPB1*15:01 
DPA1*02:01
DPB1*03:01 
DPA1*01:05
DPB1*17:01 
DPA1*02:01
DPB1*03:01 
DPA1*02:01
DPB1*18:01 
DPA1*02:01
DPB1*04:01 
DPA1*01:03
DPB1*18:01 
DPA1*01:05
DPB1*04:02 
DPA1*01:03
DPB1*18:01 
DPA1*01:04
DPB1*05:01 
DPA1*02:01
DPB1*19:01 
DPA1*01:03
DPB1*06:01 
DPA1*02:01
DPB1*20:01 
DPA1*03:01
DPB1*06:01 
DPA1*01:03
DPB1*23:01 
DPA1*01:03
DPB1*09:01 
DPA1*02:01
DPB1*28:01 
DPA1*01:05
DPB1*10:01 
DPA1*02:02
DPB1*28:01 
DPA1*04:01
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.


References

  1. Mohan S, et al. J Am Soc Nephrol, 2012.
  2. Bertrand, D. et al. PLoS One 16, 2021.