Qualitative Method Verification Report template
A qc sheet in the Method Verification procedure (PR21), mapped to ISO 15189:2022 clause 7.3.2. Fill it in whenever the task occurs. Used by the laboratory team.
Qc sheetISO 15189 · 7.3.2As needed
Calculated automaticallyRed = outside limits
Your LaboratoryQualitative Method Verification Report | YL-LAB-FRM-21-F02b v1.0
Record: Qualitative Method Verification Report — October 2026
ExaminationGlucose
Method / kitGlucose reagent
Comparator method
Plan ref. (PR21-F01b)REF-26-001
2 × 2 Contingency Table (Enter Counts)
True positives (TP)8
False positives (FP)5
False negatives (FN)6
True negatives (TN)10
Results
Positive samples (TP + FN)14
Negative samples (TN + FP)15
Diagnostic sensitivity %57.1
Diagnostic specificity %66.7
Positive predictive value %61.5
Negative predictive value %62.5
Overall agreement %62.1
Cohen's kappa0.24
Sensitivity claim %91.7
Specificity claim %96.6
Sample numbers adequate?Yes
Sensitivity meets claim?No
Specificity meets claim?No
| Discordant results: investigation and resolution |
|---|
Conclusion (method verified for use / not verified)T. Moyo
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Performed by | |||
| Reviewed by (Section Head) | |||
| Approved for use by (Laboratory Director) |
Shaded cells are calculated automatically. Values in red are outside their limits. † marks a corrected value (see Corrections).
Controlled document. Printed copies are uncontrolled unless stamped.Page 1
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What it records
- Examination
- Method / kit
- Comparator method
- Plan ref. (PR21-F01b)
- True positives (TP)
- False positives (FP)
- False negatives (FN)
- True negatives (TN)
- Positive samples (TP + FN)
- Negative samples (TN + FP)
- Diagnostic sensitivity %
- Diagnostic specificity %
- Positive predictive value %
- Negative predictive value %
- Overall agreement %
- Cohen's kappa
- Sensitivity claim %
- Specificity claim %
- Sample numbers adequate?
- Sensitivity meets claim?
- Specificity meets claim?
- Conclusion (method verified for use / not verified)
Sign-off
- Performed by
- Reviewed by (Section Head)
- Approved for use by (Laboratory Director)
Related templates
- Quantitative Method Verification Plan (PR21-F01a)
- Qualitative Method Verification Plan (PR21-F01b)
- Quantitative Method Verification Report (PR21-F02a)
- Precision, Linearity & Accuracy Worksheet (PR21-F03)
- Guide: ISO 15189 documentation checklist
Clause references are to ISO 15189:2022; check them against your licensed copy of the standard.