Table 1 Methodology for MRD detection... | American Society of Hematology

Table 1

Methodology for MRD detection

Method	Sensitivity	Quantitative (range)	Standardized	Sample requirements	Influences on assay performance⁹
FLC CD5/19 κ/λ^2,6,22	10⁻²	No	No	Live leukocytes*	Number of benign B cells
Quantitative 4-color FLC^7,8,27	10⁻⁴-10⁻⁵	Yes, to 10⁻⁴	Yes⁷	≥10⁷ live leukocytes*	Number of available leukocytes; sensitivity reduced in paucicellular specimens
Consensus IGHV PCR²⁷	∼10⁻³	No	Yes	∼10⁶ total leukocytes†	Number of benign B cells, clone
ASO IGHV RQ-PCR^33-35	10⁻⁵	Yes, to 10⁻⁴	Yes³⁵	∼10⁶ total leukocytes†	Clone (CDR3 region)
Nested ASO IGHV PCR³⁶	10⁻⁶	No	No	∼10⁶ total leukocytes†	Clone (CDR3 region)
Consensus IGHV PCR using HTS^37,38	10⁻⁶	Yes, to 10⁻⁵	No	1 μg DNA for baseline sample, 6-60 μg for follow-up†	Specific sequences may amplify poorly in mutated CLL

Method	Sensitivity	Quantitative (range)	Standardized	Sample requirements	Influences on assay performance⁹
FLC CD5/19 κ/λ^2,6,22	10⁻²	No	No	Live leukocytes*	Number of benign B cells
Quantitative 4-color FLC^7,8,27	10⁻⁴-10⁻⁵	Yes, to 10⁻⁴	Yes⁷	≥10⁷ live leukocytes*	Number of available leukocytes; sensitivity reduced in paucicellular specimens
Consensus IGHV PCR²⁷	∼10⁻³	No	Yes	∼10⁶ total leukocytes†	Number of benign B cells, clone
ASO IGHV RQ-PCR^33-35	10⁻⁵	Yes, to 10⁻⁴	Yes³⁵	∼10⁶ total leukocytes†	Clone (CDR3 region)
Nested ASO IGHV PCR³⁶	10⁻⁶	No	No	∼10⁶ total leukocytes†	Clone (CDR3 region)
Consensus IGHV PCR using HTS^37,38	10⁻⁶	Yes, to 10⁻⁵	No	1 μg DNA for baseline sample, 6-60 μg for follow-up†	Specific sequences may amplify poorly in mutated CLL

Fresh, tested within 48 hours of collection or cryopreserved in liquid nitrogen. Live cells with intact membrane required.

†

DNA is stable at room temperature for prolonged periods of time, allowing these tests to be performed on historical samples. Live cells are not required.

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