SMILE

Johns Hopkins University

Baltimore, MD USA

Author: Heidi Hanes Document Number: Pro71-20

Effective (or Post) Date: 17 June 2009
Review History Date of last review: 20 May 2010
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
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.

Qualitative Method Validation SOP Checklist

Qualitative Method Validation SOP Checklist Document 040

Number
Effective Date 17 Jun 2009
Subject Page 1 of 1
CHECKLIST FOR STUDY SITE SOP REQUIRED Supercedes New
ELEMENTS
Qualitative Validation Procedures
Review History Date of last review: 17 Jun 2009
Reviewed by: Heidi Hanes

Version # [0.0] Revision Date Description (notes)

[dd/mm/yy]
Revision
History

407522933.doc Page 1 of 3 SOP Checklist – Method Validation

 SMILE
Johns Hopkins University
Baltimore, MD USA

CHECKLIST FOR STUDY SITE SOP REQUIRED ELEMENTS

Qualitative Validation Procedures

Element
CONTENT-SPECIFIC REQUIRED ELEMENTS
Present
CRITERIA
Procedure identifies requirements for new qualitative methods and equipment to be
validated and approved by the lab director before being place in service.
Comments:

PROCEDURE
Procedure specifies minimum requirements for precision studies:
a.) Note: Not applicable unless the qualitative values are derived from a quantitative
result such as an optical density.
b.) a.) Between day and/or within-in day studies - SMILE recommends performing
both.
b.) Sample requirements
c.) i. Matrix (controls, patient samples, etc)
d.) ii. Levels (number and estimate - i.e., low/high, normal/abnormal)
e.)
c.) Replicate runs per level - SMILE recommends 20
d.) Data evaluation - SMILE recommends using CV, where possible.
e.) Acceptability criteria - SMILE recommends manufacturer’s limits or a
percentage of the total allowable error.
Procedure specifies minimum requirements for accuracy studies:
a.) a.) Acceptable reference or comparison methods - SMILE recommends
previously validated and successful in-house methods be used for
comparison testing.
b.) b.) Sample Requirements
i. Matrix (controls, patient samples, etc.)
ii. Number of samples - SMILE recommends 10 samples for each
expected result.
c.) c.) Testing limitations (i.e., test old and new methods within 2 hours of each
other)
d.) d.) Data evaluation and acceptable criteria – Performance of qualitztive test is
most commonly described in terms of sensitivity and specificity. SMILE
recommends using a decision/truth table. See SMILE Qualitative Validation
Overview Guideline for an example.
Procedure specifies requirements for sensitivity and specificity verification on non-
FDA approved methods.
Procedure specifies minimum requirements for reference range studies:
a.) a.) Requires reference range verification or establishment, as applicable.
b.) b.) Manufacturer’s stated reference ranges may be used.
c.) Data evaluation and acceptable criteria – is the range of test values expected
c.) for a designated population where 95% of the individuals are presumed to be
healthy (or normal).

407522933.doc Page 2 of 3 SOP Checklist – Method Validation

 SMILE
Johns Hopkins University
Baltimore, MD USA

Comments:

DOCUMENTATION
Procedure requires that all data and reports related to the validation be retained
indefinitely and retrievable within 24 hours. SMILE recommends that data be
retained in an organized manner using binders and dividers.
Comments:

References:

 GCLP Workshop and Workbook18-20 May 2008, page 16

 E. Piwowar-Manning, et. al., HIV Prevention Trials Network Microbicide Trials Network Laboratory
Manual, Version 1.0, Release Date: 15 November 2006
 Clinical and Laboratory Standards Institute (CLSI). User Verification of Performance for Precision
and Trueness: Approved Guideline-Second Edition. CLSI document EP15-A2 (ISBN 1-56238-
574-7). Clinical and Laboratory Standards Institutes, 940 West Valley Road, Suite 100, Wayne,
Pennsylvania 19098-1898 USA, 2005.
 NCCLS. (Currently CLSI) Evaluation of Precision Performance of Quantitative Measurement
Methods; Approved Guideline—Second Edition. NCCLS document EP5-A2 (ISBN 1-56238-542-
9). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
 Clinical and Laboratory Standards Institute (CLSI). Method Comparison and Bias Estimation
Using Patient Samples: approved Guidelines- Second Edition. CLSI document EP9-A2 (ISBN 1-
56238-472-4). Clinical and Laboratory Standards Institutes, 940 West Valley Road, Suite 100,
Wayne, Pennsylvania 19098-1898 USA, 2005.
 Clinical and Laboratory Standards Institute (CLSI).Preliminary Evaluation of Quantitative Clinical
Laboratory Measurement Procedure: Approved Guideline – Third Edition. CLSI document EP10-
A3 (ISBN 1-56238-622-0). ). Clinical and Laboratory Standards Institutes, 940 West Valley Road,
Suite 100, Wayne, Pennsylvania 19098-1898 USA, 2005.
 Clinical and Laboratory Standards Institute (CLSI).Estimation of Total analytical Error for Clinical
Laboratory Methods. Approved 2003. CLSI document EP21-A (ISBN 1-56238-502-xX. Clinical
and Laboratory Standards Institutes, 940 West Valley Road, Suite 100, Wayne, Pennsylvania
19098-1898 USA, 2005.
 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, 2005.
 Clinical and Laboratory Standards Institute (CLSI).Defining, Establishing, and Verifying reference
Intervals in the Clinical Laboratory Proposed Guideline-Third Edition, March 2008. CLSI
document C28-P3 (ISBN 1-56238-663-8). Clinical and Laboratory Standards Institutes, 940 West
Valley Road, Suite 100, Wayne, Pennsylvania 19098-1898 USA, 2005.
 James O. Westgard, Online Validation Training, Westgard QC, Inc. www.westgard.com, Module
10: Determining Imprecision.

407522933.doc Page 3 of 3 SOP Checklist – Method Validation