Method Validation Plan

Test Name:

Method:

Department:

Prepared by:

Date:

Method Performance Characteristic Summary

Accuracy/Method Comparison

Verify or establish the accuracy of the method.

Number of samples:_____________________

Reference method:______________________

Sample type:__________________________

Other information:______________________

Include a copy of regression statistics from a statistical

evaluation program.

Achieved performance - include summarized data for

reference and comparison methods. Brief description of

number of samples, sample type, how samples were

chosen, brief description of comparative method/name

of comparative method. This should include regression

statistics. Use of reference materials with known

concentrations is suggested in establishing or verifying

accuracy.

Analytical Precision

Verify or establish the precison of the method

Number of samples:____________________

Concentrations tested:__________________

Sample type:_________________________

Include a copy of statistics including mean, SD, and CV

from a statistical evaluation program.

Achieved performance - include summarized pertinent

data for all levels. Analytic precision can be established

by making measurements on a series of aliquots of the

same test sample within a specified period of time.

There should be a minimum of 10 data points for each

precision check. Precision should be checked at 2 or 3

concentrations whenever possible. Use concentrations

as close as possible to the medical decision level for

the analyte.

Analytic Sensitivity

Verify or establish the analytic sensitivity of the method.

Include a copy of the calculated mean and SD

statistics.

Include a brief description of how the data was

obtained. The method should be sensitive enough to

detect differences in the level of the analyte, especially

at the decision point level. Run material of known lowest

concentration such as linearity material to determine

analytic sensitivity at that range.

Method Validation Plan

Instructions:

Summarize the method performance characteristics in the table below. Attach all supporting documentation to

this plan. The number of samples and sample type is determined by the clinical laboratory and approved by the

medical director prior to initiation of the validation.

Master Series Webinar. © CAP 2013

Please note this is a sample form only.

Use is not required and will not guarantee that your facility is compliant.

VAL 002

49886-10

Interferences

Verify or establish interferences for the method. Include

brief description of the manufacturer information

reviewed and substances tested. Include data results

for interferences if tested.

Brief description of how data was obtained. May include

manufacturer information. Analytical system should be

evaluated for cross reactivity or interferences by

compounds known to be similar in chemical structure,

or known to be interfering substances. This

investigation should also focus on substances that are

unique to the population being served.

Reportable Range/AMR

Determine the analytical measurement range for the

method. Verify or establish AMR for the method.

Include copy of statistical evaluation from a statistical

evalaution program.

Achieved performance - include summarized results for

samples tested. Materials of appropriate matrix with

known target values must be used. In order for a test of

linearity, five analyte concentrations must be utilized.

Replicate samples must be run. (Minimum duplicate

analysis.)

Reference Intervals

Reporting of results with reference intervals.

Achieved performance - summary of data obtained.

Include a brief description of how data was obtained.

This may include the number of subjects, criteria for

inclusion, composition of patient pool, number of

assays, etc. The minimum number of values is 20; 100

values are recommended.

Other Method Performance Characteristics

Describe: Summary of assessment:

(Specimen stability studies) (description here)

(Specimen type comparisons)

(Carryover studies)

Include documentation of evaluation or manufacturers

literature summary review.

This validation study has been reviewed and the performance of the method is

considered acceptable for patient testing.

Laboratory Medical Director Approval:_____________________________________

Date:______________________________

Please note this is a sample form only.

Use is not required and will not guarantee that your facility is compliant.

VAL 002

49886-10