Download Validation Plan for Cobas Integra 400 for ALT

SMILE
Johns Hopkins University
Baltimore, MD USA
Verification Plan for New Mycobacteriology Drug Susceptibility Testing
Method
Author: Peggy Coulter
Review History
Document
Number:
Effective (or Post)
Date:
Date of last
review:
Reviewed by:
Equ35-L-05
7-July-11
13-Feb-12
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.
SMILE Document
Mycobacteriology Testing Verification Template
27 June 2011
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Verification Plan for New Mycobacteriology Drug Susceptibility Testing
Method
Method being verified: The verification will be conducted on the insert method. This
is a qualitative mycobacteriology method.
Preparation
I.
SOP Development: Include target dates for the development, review and
implementation of SOP for the new mycobacteriology method.
An SOP that outlines the procedure for the insert method being verified will be
prepared and reviewed by insert target date.
II.
Training and Competency: Include a timeline for staff training and
competency assessment of staff members performing the verification.
 Training must be complete before evaluation data is collected.
 Proficiency must be demonstrated in sample handling and storage, proper
test protocol and, interpretation of results and quality control of the system.
 Competency must be determined initially for responsible staff performing
the verification procedures and interpreting the results.
Training and competency will be performed and assessed by (describe how
training will be performed and how competency will be assessed). Training and
competency assessment will be completed by insert target date.
Verification
I.
Selection of specimens
Specimen Options: Cover the spectrum of organisms expected to be
encountered.
• Materials with assigned values (EQA events)
• Patient specimens
a. Shared with another accredited laboratory.
b. Shared with a reference laboratory
c. Shared between two in-house methods
d. Saved from previously identified cultures
• Outside sources
a. ATCC strains
b. National programs
II.
Number of specimens:
 A minimum of 5 isolates using the new method for precision of each
antimycobacterial agent.
 A minimum of 30 specimens for categorical agreement as compared to the
reference method on each antimycobacterial agent
Verification will be performed using (include number of specimens and selected
sample options).
SMILE Document
Culture Verification Template
3 June 2011
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Calculations
I.
Precision (Reproducibility) - the agreement of the measurements of
replicate runs of the same sample. It is the process of determining the range
of random error.
Precision will be determined by testing a minimum of 5 isolates in triplicate for
3 days for each antimycobacterial agent.
Precision Calculation:
Precision % = number of repeated results in agreement/ total number of
results X 100
II.
Categorical Agreement (CA) %- agreement with interpretive results of
sensitive, intermediate and resistant (S/I/R), as applicable.
Categorical Agreement Calculation:
Categorical agreement % = number of categorical results/matches/ total
number tested X 100
Criteria for acceptability

Acceptable precision results must be >95%.

Categorical agreement must be > 90%. All categorical errors must be
investigated.
If the precision or categorical agreement of the new test does not satisfy the
verification requirements, the test will be considered unverified and corrective
action must be taken by the manufacturer, the laboratory, or both. Following
corrective action the new or revised test will be run again in parallel with the
reference method and interpreted.

Method Approval
The final decision on methodology verification and acceptance is made after a careful
review of all the studies performed as part of the complete process. The Laboratory
Director shall make the ultimate decision on method verification. 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.
Conclusion
SMILE Document
Culture Verification Template
3 June 2011
Insert Lab Header here
Include full name and address of Lab
Include a brief conclusion for additional notes on the process and statistical
calculations to justify final approval of the new method.
References
SMILE Document
Culture Verification Template
3 June 2011