Table 3.

Clonality assessment methods

Assessment method
For CTCL, T-cell clonality can be established by one of the following molecular methods 
 BIOMED-2 or other PCR-based, approved protocol for both  TCR-γ and TCR-β gene rearrangement 
 Next generation sequencing (high-throughput sequencing) 
For CBCL, B-cell clonality can be established by one of the following molecular methods 
 BIOMED-2 protocol or other PCR-approved method for  immunoglobulin heavy chain (IgH) and/or Igκ  rearrangement 
 Surface or cytoplasmic light chains restriction by flow cytometry  (peripheral blood or tissue samples) 
 Monotypic surface light chains restriction by  immunohistochemistry (κ and λ immunostain) 
 Light chains restriction by conventional or RNA-scope  ultrasensitive in situ hybridization 
 IgH rearrangement by next generation sequencing for IgH or  Igκ 
Assessment method
For CTCL, T-cell clonality can be established by one of the following molecular methods 
 BIOMED-2 or other PCR-based, approved protocol for both  TCR-γ and TCR-β gene rearrangement 
 Next generation sequencing (high-throughput sequencing) 
For CBCL, B-cell clonality can be established by one of the following molecular methods 
 BIOMED-2 protocol or other PCR-approved method for  immunoglobulin heavy chain (IgH) and/or Igκ  rearrangement 
 Surface or cytoplasmic light chains restriction by flow cytometry  (peripheral blood or tissue samples) 
 Monotypic surface light chains restriction by  immunohistochemistry (κ and λ immunostain) 
 Light chains restriction by conventional or RNA-scope  ultrasensitive in situ hybridization 
 IgH rearrangement by next generation sequencing for IgH or  Igκ 

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