SMILE

JohnsHopkinsUniversity

Baltimore, MDUSA

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 Number / 040
Effective Date / 17 Jun 2009
Subject
CHECKLIST FOR STUDY SITE SOP REQUIRED ELEMENTS
Qualitative Validation Procedures / Page / 1 of 1
Supercedes / New
Review History / Date of last review: / 17 Jun 2009
Reviewed by: / Heidi Hanes
Revision History / Version # [0.0] / Revision Date [dd/mm/yy] / Description (notes)

CHECKLIST FOR STUDY SITE SOP REQUIRED ELEMENTS

Qualitative Validation Procedures

Element
Present / CONTENT-SPECIFIC REQUIRED ELEMENTS
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
a.)
b.)
c.)
d.)
e.) / Procedure specifies minimum requirements for precision studies:
Note: Not applicable unless the qualitative values are derived from a quantitative result such as an optical density.
a.)Between day and/or within-in day studies - SMILE recommends performing both.
b.)Sample requirements
  1. Matrix (controls, patient samples, etc)
  2. Levels (number and estimate - i.e., low/high, normal/abnormal)
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.
a.)
b.)
c.)
d.) / Procedure specifies minimum requirements for accuracy studies:
a.)Acceptable reference or comparison methods- SMILE recommends previously validated and successful in-house methods be used for comparison testing.
b.)Sample Requirements
  1. Matrix (controls, patient samples, etc.)
  2. Number of samples - SMILE recommends 10 samples for each expected result.
c.)Testing limitations (i.e., test old and new methods within 2 hours of each other)
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.
a.)
b.)
c.) / Procedure specifies minimum requirements for reference range studies:
a.)Requires reference range verification or establishment, as applicable.
b.)Manufacturer’s stated reference ranges may be used.
c.)Data evaluation and acceptable criteria –is the range of test values expected for a designated population where 95% of the individuals are presumed to be healthy (or normal).
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, Pennsylvania19098-1898USA, 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, Pennsylvania19087-1898USA, 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, Pennsylvania19098-1898USA, 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, Pennsylvania19098-1898USA, 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, Pennsylvania19098-1898USA, 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, Pennsylvania19098-1898USA, 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, Pennsylvania19098-1898USA, 2005.
  • James O. Westgard, Online Validation Training, Westgard QC, Inc. Module 10: Determining Imprecision.

040_ SOP Checklist -Qualitative Method Validation v. 1.0.docPage 1 of 3SOP Checklist – Method Validation