PRIMARY EVIDENCE · PEER-REVIEWED
Primary evidence
Guo K, Feng X, Xu L, et al. Evaluation of key analytical performance metrics for reliable lymphocyte subset enumeration using full-spectrum flow cytometry. Clinica Chimica Acta. 2026;591:121096. DOI: 10.1016/j.cca.2026.121096.
What it actually demonstrates
For the evaluated TBNK workflow, most CVs were below 5% and low-abundance subsets generally below 7%. Some B- and NK-cell measurements had 10–15% bias. Fluorescence-parameter linearity was r ≥ 0.9975; this is not a diagnostic accuracy metric. The abstract does not report a patient-sample total.
Evidence boundary
Evidence boundary: this is evidence for analytical performance of a defined full-spectrum TBNK workflow. It should not be extrapolated directly to MRD, high-dimensional leukaemia panels or every spectral platform.
Primary record →Spectral cytometry can expand panel design and exploit full emission information, but clinical adoption depends on much more than colour count. Laboratories need stable reference controls, reproducible unmixing, manageable QC and clinically interpretable outputs.
MRD is a compelling proving ground because additional markers may improve phenotypic resolution while high event counts demand robust acquisition and analysis. Yet every additional dimension also creates another opportunity for technical and interpretive variation.
The transition from research to clinical practice will be defined by standardisation, inter-laboratory reproducibility and evidence that the added complexity produces useful clinical information.
CFCM view
Clinical value depends on reproducibility, transparent limitations and evidence in the intended workflow. Technical novelty is the beginning of validation, not its endpoint.
CFCM is an independent publication. References to manufacturers, instruments, reagents, software or therapies do not constitute endorsement. Technical content should be interpreted in the context of local validation, applicable regulation and manufacturer instructions for use.