Diagnostics › Method comparison

Detection capability (LoB/LoD/LoQ)

Estimates the lowest concentrations an assay can reliably distinguish from a blank (LoB), detect (LoD), and quantify (LoQ), from blank and low-level replicate measurements.

What is Detection capability (LoB/LoD/LoQ)?

Near zero, an assay's noise can masquerade as signal. Three limits pin down how low it can go. The Limit of Blank (LoB) is the highest reading you'd plausibly see from a true-zero sample — the 95th percentile of blank replicates. The Limit of Detection (LoD) is the lowest true concentration that reliably reads above the LoB, adding the low-level material's own scatter. The Limit of Quantitation (LoQ) is the lowest concentration you can report with acceptable precision (a target CV or total-error goal).

The parametric estimate uses LoB = mean_blank + c·SD_blank and LoD = LoB + c·SD_low, with c = 1.645 (5% error) corrected for the finite number of replicates; a non-parametric LoB (rank-based 95th percentile) is reported alongside for robustness. This follows the classical CLSI EP17 detection-capability approach.

When should I use Detection capability (LoB/LoD/LoQ)?

  • Characterizing an assay's low-end performance during method validation.
  • Establishing or verifying claimed LoB / LoD / LoQ.
  • Comparing the analytical sensitivity of competing assays.

What data does it need?

A column of blank (zero-concentration) replicate measurements and a column of low-level replicate measurements, in concentration units. Optionally a target CV% for the LoQ.

What does it report?

LoB (parametric and 95th-percentile), LoD, and an LoQ estimate, plus the blank/low means, SDs, and the low-level CV.

What does it assume?

  • Measurements are expressed in concentration units (not raw signal).
  • Blank and low-level replicates are representative and roughly normally distributed.
  • The low-level material sits near the expected LoD.

Formula

LoB = mean_blank + c·SD_blank (c = 1.645, finite-sample corrected)
LoD = LoB + c·SD_low
LoQ = lowest level meeting the target CV / total-error goal

How do I interpret the result?

Report a numeric result below the LoQ as "< LoQ", not as a number — its imprecision is too large to quantify. Results between LoB and LoD are "detected but not quantifiable". LoB/LoD/LoQ should be re-established whenever reagents, calibrators, or instruments change.

See also

References

  • CLSI EP17-A2. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.
  • Armbruster & Pry (2008). Limit of Blank, Limit of Detection and Limit of Quantitation. Clin Biochem Rev 29(Suppl 1).