Detection needs a definition
A limit-of-detection assessment depends on the assay, target, sample matrix and definition of a positive result. The study should describe the conditions under which detection was evaluated.
Look beyond sequencing depth
More sequencing reads cannot restore molecules that were absent from the original sample. Input quantity, specimen quality and the number of independent molecules are therefore relevant when interpreting sensitivity claims.
Ask how the estimate was obtained
Review the concentration levels tested, the number of replicates and the observed detection rates. A model-derived estimate should be identified as such and considered alongside direct experimental observations.
Match the evidence to the application
For a practical review, ask whether the study represents the material, variant types and quality range expected in routine testing. Identify where additional experiments would provide the most useful evidence.
References and further reading
U.S. Food and Drug Administration. Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests — Guidance for Industry and FDA Staff. March 2007.