CAP calibration verification
Run low, middle and high materials with independently assigned values or target ranges, check accuracy against your limits, and show that the materials cover the range you report.
Checklist requirements
Calibration verification shows that the current calibration still gives accurate results across the range you report. 42 CFR 493.1255 sets out the materials, your acceptance criteria, low, middle and high coverage, a check at least every six months and the events that call for an earlier one.
For chemistry AMR, CHM.13550 covers the materials and CHM.13600 covers the verification itself and its schedule. To satisfy both, the study has to show acceptable accuracy and that your materials cover the range you claim.
Based on the CAP checklists dated 9 December 2025.
Before you start
- Suitable low, middle and high materials covering the claimed range, with independent assigned values or target ranges for this method and unit.
- The kit or material lot and preparation instructions. For dilution or admixture work, use independently assigned anchor concentrations.
- Enough material for three measurements at each level in one run on one day. Add levels around important decision concentrations or across a wider range.
If you make dilutions or admixtures, keep the anchor values and the fractions you used. To check whether the response is a straight line using measured anchors, run a Linearity study.
Samples and acceptance limits
Suggested starting design: 3 material levels × 1 day × 1 run × 3 replicates; 9 results.
The low, middle and high design follows the calibration-verification framework in 42 CFR 493.1255.
Calculation minimum: Point accuracy checks need 3 different target concentrations with at least 1 result each. SD, confidence intervals and the optional precision index need at least 2 replicates per level.
LabRuns starts the mean-bias allowance at 50% of the total allowable error and the optional precision index at 25%, and you can change either to your laboratory's figures. If you leave the endpoint proximity allowance blank, LabRuns uses 10%.
Running it in LabRuns
- Choose New study → Calibration verification and enter the analyte and unit.
- On Set up → Calibration materials, choose whether your materials have assigned values or target ranges, then enter each material's value or range under Material levels.
- For assigned values, enter the total allowable error and the mean-bias share under Accuracy limits. Under Claimed range, enter both ends of the range you report and the endpoint proximity allowance.
- On Data, enter or import the replicates using the same level names. Save and calculate, then read Accuracy and Range coverage, which get separate outcomes.
Download the example CSV to see the columns, then replace the example results and IDs with your own.
Checking the results
Check that the collection is complete, then look at each replicate and each material mean against the accuracy limits, and at whether the low and high materials land inside their endpoint windows with a middle material in between. A target range gives inclusive lower and upper limits with no single assigned value, so there is no bias to calculate. Switch on the optional linearity check only when you have independently assigned concentrations and a separate deviation limit.
For a Not met or Undecided result, follow the study's troubleshooting steps.
Records to keep
Once the study is calculated, download the PDF from Report. The table shows which parts of the report answer each checklist item and what your laboratory keeps alongside it; each number is ringed on page 1 of the example report beside it.
| Checklist item | In the LabRuns report | From your lab |
|---|---|---|
| CHM.13550 |
| Material suitability and preparation instructions |
| CHM.13600 |
| AMR schedule and applicable event records |
Alongside the report, keep the assignments or target ranges, why the materials were suitable and how they were prepared, and the calibration and QC records for the day you ran it. Your endpoint criteria, any event assessment and what you did after a failure belong with them too.
To put several studies together for an inspection, open Reports → Binders, choose Create binder, pick the studies and report versions, group them by analyte or analyzer and choose Build binder. You get one PDF with a CAP evidence index, plus an archive of the reports, saved calculations, result CSVs and the imports you kept, with a checksum for every file. How to build a binder.
Schedule the next study
Plan around the six-month interval, and check earlier after the events that call for it: a relevant reagent change, major service, replacement of a critical part, or QC problems you can't resolve.
In Recurring work, choose Add schedule, pick the saved study and the rule that applies, and set the next due date. When the work comes due, Create next study copies the setup and limits. Afterwards, Record performed work links the calculated study to the event with the date you ran the measurements. How scheduling works.
Sources
42 CFR 493.1255: calibration and calibration verification is the CLIA regulation itself. CAP: calibration verification and linearity explains how the two evaluations relate, and CAP: CHM.13600 Q&A (updated November 2023) goes into materials, individual instruments and how close to the endpoints your materials need to be.
Calibration verification bench guide · Settings, acceptance rules and calculations.