Table 1. Characteristics of common MRD... | American Society of Hematology

Table 1.

Characteristics of common MRD assays for ALL

Method	Specimen	Sensitivity	Advantages	Disadvantages
MFC for “difference from normal”	Fresh viable cells	∼1 × 10⁻⁴	Fast Relatively inexpensive Does not require pretreatment specimen	Lower sensitivity than other available MRD assays May fail to identify phenotypic shifts Interlaboratory variability
PCR for IG/TR gene rearrangements	DNA	∼1 × 10⁻⁴ to 10⁻⁵	Specific for leukemic sequences	Time-consuming and labor intensive Requires standardization (not done within the United States) Requires pretreatment specimen to identify leukemia clonotype Does not provide information about antigen expression
RT-PCR for BCR::ABL1	RNA	∼1 × 10⁻⁴ to 1 × 10⁻⁵	Relatively simple to perform Uses standard primers used for diagnostic purposes	Applicable only to Ph-positive ALL (∼1/3 of ALL cases) Not optimal for MRD assessment of multilineage Ph-positive ALL Does not provide information about antigen expression
NGS for IG/TR gene rearrangements	DNA	∼1 × 10⁻⁶	More sensitive than other available MRD assays Specific for leukemic sequences Only FDA-cleared assay for MRD in B-cell ALL (ie, clonoSEQ)	Relatively expensive (vs MFC or RT-PCR for BCR::ABL1) Requires pretreatment specimen to identify leukemia clonotype Does not provide information about antigen expression

Method	Specimen	Sensitivity	Advantages	Disadvantages
MFC for “difference from normal”	Fresh viable cells	∼1 × 10⁻⁴	Fast Relatively inexpensive Does not require pretreatment specimen	Lower sensitivity than other available MRD assays May fail to identify phenotypic shifts Interlaboratory variability
PCR for IG/TR gene rearrangements	DNA	∼1 × 10⁻⁴ to 10⁻⁵	Specific for leukemic sequences	Time-consuming and labor intensive Requires standardization (not done within the United States) Requires pretreatment specimen to identify leukemia clonotype Does not provide information about antigen expression
RT-PCR for BCR::ABL1	RNA	∼1 × 10⁻⁴ to 1 × 10⁻⁵	Relatively simple to perform Uses standard primers used for diagnostic purposes	Applicable only to Ph-positive ALL (∼1/3 of ALL cases) Not optimal for MRD assessment of multilineage Ph-positive ALL Does not provide information about antigen expression
NGS for IG/TR gene rearrangements	DNA	∼1 × 10⁻⁶	More sensitive than other available MRD assays Specific for leukemic sequences Only FDA-cleared assay for MRD in B-cell ALL (ie, clonoSEQ)	Relatively expensive (vs MFC or RT-PCR for BCR::ABL1) Requires pretreatment specimen to identify leukemia clonotype Does not provide information about antigen expression

FDA, US Food and Drug Administration.