The Purpose of Method Validation
The correct answer is C) To ensure the analytical data meets the intended use.
Method validation is fundamentally designed to confirm that an analytical method is suitable for its intended purpose and that the data generated are reliable for clinical decision-making 1. This represents the core principle underlying all validation activities in laboratory medicine.
Why This is the Correct Answer
Method validation ensures that the assay is suitable for its intended use by establishing that it can reliably detect the target analyte and produce accurate, reproducible results 1. The validation process systematically demonstrates that analytical data generated by the method are credible and fit for their specific clinical or research application 2.
Key Validation Objectives
The validation process accomplishes several critical goals:
- Establishes performance specifications including accuracy, precision, analytical sensitivity, analytical specificity, reportable range, and reference range to define test performance 1
- Confirms appropriate detection capabilities by demonstrating that techniques, procedures, equipment, and materials can detect the target at the molecular level in the relevant biological matrix 1
- Reduces potential sources of error through systematic evaluation of all variables that may influence assay performance 1
The Three-Phase Validation Framework
Modern validation follows a structured approach 1:
- Test development phase: Iterative optimization of assay conditions and bioinformatics pipeline settings until standard operating procedures are established 1
- Formal assay validation: Establishment of required performance specifications using appropriate sample diversity and assay conditions 1
- Quality management: Implementation of QC procedures to monitor whether each component functions properly and delivers accurate results 1
Why Other Options Are Incorrect
Option A (To identify the problem) represents a pre-validation activity that occurs during method development, not validation itself 1.
Option B (To select the method) is part of the preliminary method selection process, which precedes validation 1.
Option D (To set minimum requirements) is an outcome of validation rather than its purpose—the validation process establishes what those requirements should be based on intended use 1.
Clinical Significance
It is only acceptable to report laboratory results in clinical diagnostics after the method has been thoroughly validated or verified 1. This requirement exists because effective clinical decision-making depends on reliable analytical data, particularly in time-sensitive situations like sepsis management where analytical accuracy directly influences patient outcomes 1.
The validation must be documented and consider all possible variables that may influence assay performance, with particular attention to critical steps that could lead to false-positive or false-negative results 1.