Validation Plan for Cobas Integra 400 for ALT

SMILE Johns Hopkins University Baltimore, MD USA

I. Validation Plan for HIV Western Blot Author: Document Number: Equ35-K-01 Validation Committee Effective (or Post) 4 March 2011 Date: Review History Date of last review: NA 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. Validation Plan for HIV Western Blot Document Number 1310 Effective Date 1 Dec 2009 Subject Page 1 of 1 Template validation plan for HIV Western Blot Supersedes V. 1.0 Author(s) Name, Title Date Anne Sholander, MT(ASCP) October 2009 Heidi Hanes, MT(ASCP), SH Approved by Name, Title Date Heidi Hanes, MT(ASCP), SH 23 Oct 2009

Review History Date of last review: 15 February 2011

Reviewed by: Anne Sholander

Version # Revision Date Description (notes) [0.0] [dd/mm/yy]

Revision 1.1 2/15/2011 Updated terminology in Diagnostic Sensitivity and Specificity section. History

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Validation Plan for HIV Western Blot

I. Overview A. Precision B. Accuracy C. Linearity D. Sensitivity E. Specificity F. Reference Range G. Method Approval

II. Plan: The validation will be conducted on the HIV Western Blot method using the insert name of kit. This is a qualitative method.

A. Precision—not applicable for qualitative methods unless described by the manufacturer. B. Accuracy/Correlation 1. Accuracy is the true value of a substance being measured. Verification of accuracy is the process of determining that the test system is producing true, valid results. This can be verified by: a) Assaying materials with assigned values b) Comparing patient specimen results with a method of long standing use c) Verifying results from inter-laboratory survey specimens d) Splitting specimens with another sufficiently accredited laboratory The results must demonstrate the system is accurate enough to provide clinically valid patient results. Limits of acceptability should be set by the Laboratory Director.

2. Accuracy: a) Accuracy will be demonstrated by insert details of accuracy determination b) Acceptability criteria: diagnostic sensitivity (true positive rate) and diagnostic specificity (true negative rate) must meet or exceed manufacturer’s stated claims.

C. Linearity/Reportable range--not applicable for qualitative methods.

D. Analytical Sensitivity is the lowest concentration of an analyte that can be measured (Lower Limit of Detection). For an FDA approved unmodified method the manufacturer’s stated sensitivity will be used.

E. Analytical Specificity is the determination of the affect of interfering substances. For an FDA approved unmodified method the manufacturer’s stated specificity will be used.

F. Verification of Expected Values/Reference Ranges Not applicable. Normal (expected)=HIV negative, Abnormal=HIV positive

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G. Method Approval The final decision on methodology validation and acceptance is made after a careful review of all the studies performed as part of the complete method validation process. The Laboratory Director shall make the ultimate decision on method validation. Method acceptance is based on the results from the above studies plus an evaluation of the new method’s cost effectiveness, turn-around-time, laboratory staff training needs, and any other relevant operational considerations

H. References 1. NCCLS EP9-A2 Vol.22 No.19 (Method Comparison and Bias Estimation Using Patient Samples), Sep 2002. 2. NCCLS C28-A Vol. 15 No. 4 (How to Define and Determine Reference Intervals in the Clinical Laboratory), Jun 2000. 3. NCCLS C10-A2 Vol. 22 No. 29 (Preliminary Evaluation of Quantitative Clinical Laboratory Methods), Dec 2002. 4. NCCLS C6-A Vol. 23 No. 16 (Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach), April 2003. 5. NCCLS C5-A2 Vol. 24 No. 25 (Evaluation of Precision Performance of Quantitative Measurement Methods), Aug 2004. 6. NCCLS EP21-A Vol. 23 No. 20 (Estimation of Total Analytical Error for Clinical Laboratory Methods), Apr 2003. 7. CAP Commission on Laboratory Accreditation, Laboratory General Checklist, 2007. 8. HPTN-MTN Lab Manual, Version 1.0, 15 November 2006 9. EP Evaluator, www.dgrhoads.com

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