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Equ51-05 - Linearity - RQMT - Chem

This document provides guidelines for performing linearity testing on a chemistry analyzer. It outlines the sample criteria, testing procedures, and data evaluation requirements. A minimum of 5 samples covering the reportable range should be tested in duplicate. Data is plotted and analyzed using linear regression to calculate slope, intercept, predicted values, and systematic error. The method is considered linear if the systematic error is less than 50% of the total allowable error for each sample point.

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84 views3 pages

Equ51-05 - Linearity - RQMT - Chem

This document provides guidelines for performing linearity testing on a chemistry analyzer. It outlines the sample criteria, testing procedures, and data evaluation requirements. A minimum of 5 samples covering the reportable range should be tested in duplicate. Data is plotted and analyzed using linear regression to calculate slope, intercept, predicted values, and systematic error. The method is considered linear if the systematic error is less than 50% of the total allowable error for each sample point.

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benchmark Innovation
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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SMILE

Johns Hopkins University


Baltimore, MD USA

SMILE Linearity Requirements-Chemistry

Author: Validation Committee Document Number: Equ51-05

Effective (or Post) 23-Mar-11


Date:

Review History Date of last review: 13-Feb-2020

Reviewed by: Heidi Hanes

SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s
specific processes and/or specific protocol requirements. Users are encouraged to ensure compliance with local laws and
study protocol policies when considering the application of this document. If you have any questions contact SMILE.

SMILE Linearity Requirements-Chemistry Document Number 230

Effective Date 19 Dec 2008

Subject Page 1 of 1

Guidelines for performing linearity testing on a chemistry analyzer Supersedes New

Author(s) Name, Title Date

Mark Swartz, Heidi Hanes, Jo Shim, Penny Dec 2008


Stevens, Anne Sholander
Approved by Name, Title Date

SMILE Validation Committee Dec 2008

Review History Date of last review: 11 Mar 2011

Reviewed by: Anne Sholander

Version # [0.0] Revision Date Description (notes)


[dd/mm/yy]

Revision
1.1 03/11/11 Updated to acceptability criteria to remove reference to “pass or fail”.
History

640375978.doc Page 1 of 3
SMILE
Johns Hopkins University
Baltimore, MD USA

SMILE Chemistry Linearity Guidelines

A quantitative analytical method is said to be LINEAR when measured results from a series
of sample solutions are directly proportional to the concentration or activity in the test
specimens. This means that a straight line can be used to characterize the relationship
between measured results and the concentrations or activity levels of an analyte for some
stated range of analyte values.

I. Linearity
A. Sample Criteria
1. A minimum of 5 samples that cover the reportable range of the
method.
2. When plotted, the values should ideally be equidistant from each
other.
3. Quality control, calibrators or commercial linearity standards should
be used.
B. Testing
1. At a minimum, run each sample in duplicate.
2. Data should be plotted immediately to identify and correct any
outliers.
C. Evaluation of data:
1. Plot the data in regression analysis program. The SMILE Linearity
spreadsheet (Appendix 1) performs all necessary calculations.
a. Plot the known values of the standards on the X-axis
b. Plot the mean of the measured values on the Y-axis.
c. Calculate slope and intercept using linear regression. This can
be done using the Excel SLOPE and INTERCEPT functions or
from the website
http://tools.westgard.com/cgi-bin/westgard/comp_calc.cgi?
header=http:/www.westgard.com/images/headtoolkit.gif
d. Using slope and intercept, calculate a predicted Y value for
each X value.
e. Plot the predicted Y values versus the corresponding known X
values on the same graph mentioned in a and b above. Draw
a straight line to connect all the predicted Y points on the
graph.
f. Subtract each measured Y value from the associated
predicted Y value. This difference is the systematic error due
to non-linearity.
g. Compare that systematic error to 50% of the total error. The
systematic error must be less than 50% of the total error.

640375978.doc Page 2 of 3
SMILE
Johns Hopkins University
Baltimore, MD USA

2. Alternatively, plot the data in EP Evaluator Linearity Module or


similar regression analysis program. If using EP follow the steps
below. (See Appendix 2 for an example EP Linearity Report).
a. Under the Linearity parameters select Confirm Linearity.
b. Enter the Allowable Total Error (TEa) concentration and
percent. Refer to SMILE Chemistry TE Limits table (Appendix
3).
c. Enter 50% for Systematic Error.
d. Select edit and enter the assigned values of your standards.
e. Enter each replicate of your test data.
D. Acceptability criteria
The method is linear if the difference between the predicted Y value
and the measured Y value is less than the allowable error for each
specimen point.
II. References
A. GCLP Guidelines, Standard for Performance Specifications.
B. Clinical and Laboratory Standards Institute (CLSI). Evaluation of the Linearity
of Quantitative Measurement Approved Guideline-Second Edition, CLSI
document EP6-A (ISBN 1-56238-498-8) Clinical and Laboratory Standards
Institutes, 940 West Valley Road, Suite 100, Wayne, Pennsylvania 19098-
1898 USA.
C. EP Evaluator Release 8, David G. Rhoads Associates Inc.,
www.dgrhoads.com.
D. James O. Westgard, Online Validation Training, Westgard QC, Inc.
www.westgard.com, Sections 9-Determining Reportable Range.

640375978.doc Page 3 of 3

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