CLSI EP26 Ed.2 ยท 2022 | Author: Dr. Raafat ElShimy
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1 Protocol Setup โ CLSI EP26 Stage 1
Purpose: This tab establishes the protocol parameters for each analyte (one-time setup).
Enter analyte data, then the tool calculates the Rejection Limit (RL) and required sample size (N)
by looking up the embedded CLSI EP26 Appendix A tables (A1, A2, A3) based on CD/SWRL, Sr/SWRL,
and desired statistical power. The output checklist is used for all future lot evaluations.
2 Step 1: Download Input Template
Download and complete the CSV template with your analyte parameters.
Fill one row per analyte concentration level, then import it below.
3 Step 2: Enter or Import Analyte Data
Instructions:
CD: Critical Difference (absolute units or %TEa-based, same units as SWRL)
SWRL: Within-Reagent-Lot imprecision (total, SD)
Sr: Repeatability / within-run SD
Levels: Number of medical decision concentrations being tested (1, 2, or 3 โ selects Table A1, A2, A3)
Power Goal: Desired statistical power (0.80, 0.85, 0.90, or 0.95)
#
Analyte
Conc. Level Label
Target Conc.
Units
CD
SWRL
Sr
No. of Levels
Power Goal
Action
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No analyte data entered yet. Click "Add Analyte Level" or import a CSV file.
4 Step 3: Calculate Protocol Parameters
Calculations use the embedded CLSI EP26 Appendix A tables. The tool computes CD/SWRL and
Sr/SWRL ratios, selects the appropriate table (A1 for 1 level, A2 for 2, A3 for 3),
and returns: Rejection Limit (RL) = k ร CD, Number of Samples (N), and achieved Power.
Analyte
Level
Target Conc.
Units
CD
CD/SWRL
Sr/SWRL
Table Used
Samples (N)
RL (kรCD)
RL Value
Power Achieved
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Click "Calculate All Parameters" after entering analyte data above.
1 Lot Evaluation โ CLSI EP26 Stage 2
Purpose: Enter measured results from the current and candidate reagent lots.
The tool calculates the mean difference for each analyte concentration level and compares it
against the Rejection Limit (RL). A pass/fail conclusion is generated for each level and analyte.
2 Step 1: Load Protocol Parameters
Load the checklist generated in Tab 1, or manually define analytes and their parameters for this evaluation.
Analyte
Level
Target Conc.
Units
N Required
RL
RL Value
Power
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No protocol loaded. Load from Tab 1 or import a checklist CSV.
3 Step 2: Enter Measurement Results
Enter paired measurements for each sample: the result from the Current Lot and
the result from the Candidate Lot. Difference = Candidate โ Current.
Minimum samples per level as specified in the protocol (N required).
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Load protocol parameters first (Step 1 above).
4 Step 3: Evaluation Results & Conclusion
Overall Evaluation Summary
Analyte
Level
Target Conc.
N Tested
Mean Difference
|Mean Diff|
RL (kรCD)
RL Value
CD
Conclusion
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Enter data and click "Calculate & Evaluate" to see results.