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  Documentary Procedure for Validation & Verification of  examination methods
    

Purpose: Method validation is an important requirement in the practice of an analytical process. One can interpret method validation as the process of defining an analytical requirement, and confirming that the method under consideration has performance capabilities consistent with what the application requires. If the result of a test cannot be trusted then it has little value and the test might as well have not been carried out. Therefore a laboratory and its staff have a clear responsibility to justify that the analytical part of the problem is correct, in other words results have demonstrable “fitness for purpose”.

Responsibility: Laboratory director, Quality manager, Section in charges, Technicians

Procedure:

Validation is the demonstration via objective evidence that a new or modified examination procedure from one’s own working environment (or laboratory) is appropriate for a specific intended use in medical diagnostics, and that it complies with the relevant acceptance criteria as described by the medical laboratory.

A verification is confirming appropriateness of validated examination procedure

The laboratory will select and use examination methods which have been validated for their intended use to assure the clinical accuracy of the examination for patient testing.Preferred methods are those specified in the instructions for use of in vitro diagnostic medical devices or those that have been published in established / authoritative textbooks, peer-reviewed texts, or journals, or in international and national consensus standards or guidelines, or national or regional regulations.

For these validated methods the laboratory will verify the validation performed by the manufacturer that is provided in the kit insert.

The laboratory will validate examination procedures derived from the following sources:

1. non-standard examination procedures
2. laboratory-designed or developed examination procedures
3. validated examination procedures used outside their intended use
4. validated examination procedures subsequently modified
5. If the performance characteristics are either not available or do not meet the acceptance criteria

If an examination procedure is modified, it shall be taken into consideration and documented

• Accuracy:

Obtain reference material from the relevant External Quality Assessment scheme along with the statistical results showing all method mean and method mean, or if available a certified reference material. Run the EQA samples & Calculate SDI. It should be less than 2.SDI= (Lab mean- peer group mean)/ Peer group Standard Deviation.

• Precision:

Precision (in this case meaning Repeatability) is usually stated in terms of Standard Deviation. Perform 10 determinations calculating the standard deviation at 3 concentrations (low, medium and high)

* Limit of Detection (LoD) * Limit of Quantitation (LoQ) * Linearity * Carryover