CHAUDHRY MUHAMMAD AKRAM

TEACHING & RESEARCH HOSPITAL

Policy & Procedure for Protocol Validation

 CHAUDHRY MUHAMMAD AKRAM TEACHING &
RESEARCH HOSPITAL
Department Name: Molecular Pathology Document Number: CMA/MP-01/003
Version Number: MP-001-A
Title of the Policy & Procedure: SOP of Protocol Validation
Effective Date: 22-FEB-2021

1. PURPOSE

1.1. The primary goal of method validation in the molecular diagnostics laboratory is to
ensure the accuracy of the reported results. To reach that goal, each step of the testing
process must be carefully evaluated and monitored to document the appropriateness of
the method for the test being performed and to compare the results to another standard
testing method.

2. DEFINITIONS AND ABBREVIATIONS

2.1. Validation:
Objective evidence that requirements for a specific intended use can be fulfilled
consistently
2.2. Verification:
Objective evidence that requirements have been fulfilled.
2.3. Bias:
Difference between results.
3. PROCEDURE
3.1. Select random samples of difference concentration almost 30 samples.
3.2. Check the quantity and sample conditioned.
3.3. Centrifuge the samples at 4000 rpm for 10 minutes.
3.4. Run parallel samples on two different analyzers
3.5. Compare the results with each other.
3.6. Evaluate the bias between the results of both instruments
3.7. Also check the precision & Accuracy.
4. RELATED REFERENCES
4.1. Clinical significance - leads to accurate medical decisions •

Required by CLIA*, CAP, and The Joint Commission (*Clinical Laboratory Improvements
Amendments of 1988)
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 CHAUDHRY MUHAMMAD AKRAM TEACHING &
RESEARCH HOSPITAL
Department Name: Molecular Pathology Document Number: CMA/MP-01/003
Version Number: MP-001-A
Title of the Policy & Procedure: SOP of Protocol Validation
Effective Date: 22-FEB-2021

Prepared by: Danish Ahmad Molecular Biologist

Name Title Signature & Employee Date

ID

Reviewed by: Dr. Sadia Ikram Lab Incharge

Name Title Signature & Employee Date

ID
Prof. Dr. Mulazim
Approved By: HOD Pathology
Hussain Bukhari

Name Title Signature & Employee Date

ID

Date Reviewed: ___________________ Next Review Date: ________________

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