How do I validate my new instrument?
You must verify that the test's performance in your laboratory is similar to the manufacturer's claims of accuracy, precision and reportable range. All related forms, printouts, control inserts, and reports will be maintained for the life of the system plus 2 years.
- Accuracy is determined by performing a multiple-point linearity study.
Linearity study must meet the minimum standards:
Slope = 1.0 +/- 15% (0.85 - 1.15)
R2 > 0.95
- Precision is determined by evaluating 15 level 1 or normal control results.
Precision study must meet the minimum standards:
Control mean +/- 2SD
CV < 2.0% or as otherwise noted on the worksheet.
- Reportable Range is determined by demonstrating accuracy at a low, mid, and high point. Use data from Linearity Study.
- Verification of manufacturer's normal values is determined by comparing 5 non-patient results against the manufacturer's normal values.