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Table 2 LoD and LoQ of the clonoSEQ Assay by MRD cell counts and MRD frequency

From: Analytical evaluation of the clonoSEQ Assay for establishing measurable (minimal) residual disease in acute lymphoblastic leukemia, chronic lymphocytic leukemia, and multiple myeloma

Measure

Malignant cellsa (95% CI)

500 ng DNA input frequency (95% CI)

20 μg DNA input frequency (95% CI)

LoD

1.903 (1.75–2.07)

2.26 × 10− 5

(2.01 × 10− 5–2.53 × 10− 5)

6.77 × 10− 7

(6.02 × 10− 7–7.61 × 10− 7)

LoQ

2.390 (1.90–9.14)

2.39 × 10−5

(2.26 × 10− 5–7.01 × 10− 5)

1.76 × 10−6

(6.77 × 10−7–4.09 × 10− 6)

  1. CI confidence interval, LoD limit of detection, LoQ limit of quantitation, MRD minimal residual disease
  2. aCalculated from samples with 500 ng and 20 μg of DNA input