Diagnostics › Method comparison

Interference test

Tests whether a suspected interferent shifts an assay's result, from paired measurements of test (spiked) versus control samples, against an allowable-bias limit.

What is Interference test?

Substances like hemolysis, lipemia, bilirubin, or drugs can bias an assay. An interference study measures the same pool with and without the added interferent and looks at the paired difference. Because the samples are paired, the analysis is a paired comparison — far more sensitive than comparing two independent groups.

The engine reports the mean interference bias with a paired-t 95% confidence interval and its p-value. If you supply an allowable bias, it flags interference when the confidence interval breaches that limit — the clinically relevant question is not just "is there a bias?" but "is it large enough to matter?".

When should I use Interference test?

  • Screening a candidate interferent during assay validation.
  • Confirming or ruling out a suspected interference from a QC failure investigation.

What data does it need?

A test-sample column (with interferent) and a paired control-sample column. Optionally an allowable bias limit.

What does it report?

The mean interference bias, its 95% CI, t/p, and — if an allowable bias is given — an interference / no-interference verdict.

What does it assume?

  • Test and control samples are truly paired (same base pool, split).
  • Differences are approximately normally distributed.

Formula

bias = mean(test − control)
interference flagged when the 95% CI of the bias exceeds the allowable limit

How do I interpret the result?

A statistically significant bias that stays within the allowable limit is not clinically important. Conversely, a non-significant bias whose CI still reaches the allowable limit means the study was underpowered — collect more replicates before concluding "no interference".

See also

References

  • CLSI EP07. Interference Testing in Clinical Chemistry.