What question did this study set out to answer?

To validate the analytical sensitivity, specificity, precision, linearity, and accuracy of the next-generation sequencing-based clonoSEQ assay for identifying measurable residual disease in lymphoid malignancies.

June 30, 2020BMC CancerOpen Access

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

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Authors

TCTravers ChingUniversity of Hawaiʻi at Mānoa MDMegan E. DuncanAdaptive Biotechnologies (United States)TNTera Newman-EerkesAdaptive Biotechnologies (United States)

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Implication

Analytical validation study demonstrates high sensitivity and accuracy in lymphoid malignancies, indicating reliable detection of minimal residual disease down to two malignant cells.

Key Points

To validate the analytical sensitivity, specificity, precision, linearity, and accuracy of the next-generation sequencing-based clonoSEQ assay for identifying measurable residual disease in lymphoid malignancies.
Determined limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) using genomic DNA (gDNA) from 66 patients with multiple myeloma, acute lymphoblastic leukemia, or chronic lymphocytic leukemia, alongside cell lines.
Evaluated precision, linearity, and quantitation accuracy across clinical dilution series by comparing clonoSEQ results against multiparametric flow cytometry.
The assay achieved an LoD of 1.903 malignant cells, an LoQ of 2.390 malignant cells, and an LoB of zero in healthy donor gDNA.
Precision showed a coefficient of variation between 18% at higher DNA inputs and 68% near the LoD, with routine laboratory variations contributing ≤3% CV.

Cite This Study

Ching et al. (2020) studied this question.

synapsesocial.com/papers/6a760e331ce449dc427086ba https://doi.org/10.1186/s12885-020-07077-9

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Implication

Analytical validation study demonstrates high sensitivity and accuracy in lymphoid malignancies, indicating reliable detection of minimal residual disease down to two malignant cells.

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

Discussion

Member takes

Implication

Key Points

Cite This Study

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

Discussion

Member takes

Implication

Key Points

Cite This Study

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