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How to verify and validate a clinical microbiology test before it can be used in routine diagnostics: a practical
Erlangga Yusuf1, Maarten J Schijffelen2, Mariska Leeflang3
1Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands.
Background:
Before a new test can be routinely used in your laboratory, its reliability must be established in the laboratory where it will be used. International standards demand validation and verification procedures for new tests. The International Organization for Standardization (ISO) 15189 was recently updated, and the European Commission's In Vitro Diagnostic Regulation (IVDR) came into effect. These events will likely increase the need for validation and verification procedures.
Objectives:
This paper aims to provide practical guidance in validating or verifying microbiology tests, including antimicrobial susceptibility tests in a clinical microbiology laboratory.
Sources:
It summarizes and interprets certain parts of standards such as ISO 15189:2022, and regulations, such as IVDR 2017/746 regarding validation or verification of a new test in a routine clinical microbiology laboratory.
Content:
The reasons for choosing a new test and the outline of the validation and verification plan are discussed. Furthermore, the following topics are touched upon: the choice of reference standard, number of samples, testing procedures, how to solve the discrepancies between results from new test and reference standard, and acceptance criteria. Arguments for selecting certain parameters (such as reference standard and sample size) and examples are given.
Implications:
With the expected increase in validation and verification procedures because of the implementation of IVDR, this paper may aid in planning and executing these procedures.
Insights
This guide offers practical advice for validating and verifying microbiology tests, crucial for clinical labs adopting new methods under updated ISO 15189 and In Vitro Diagnostic Regulation (IVDR) standards.
Area of Science:
- Clinical Microbiology
- Laboratory Science
- Diagnostic Testing
Background:
- International standards like ISO 15189 and the In Vitro Diagnostic Regulation (IVDR) necessitate rigorous validation and verification of new laboratory tests.
- Recent updates to ISO 15189 and the implementation of IVDR are expected to increase the demand for these essential procedures.
Purpose of the Study:
- To provide practical guidance on validating and verifying microbiology tests, specifically including antimicrobial susceptibility tests.
- To assist clinical microbiology laboratories in navigating the complexities of new test implementation.
Main Methods:
- Summarizes and interprets key aspects of ISO 15189:2022 and IVDR 2017/746 relevant to test validation and verification.
- Discusses the rationale for selecting new tests and outlines the structure of validation and verification plans.
Main Results:
- Addresses critical elements of the validation/verification process, including reference standard selection, sample size determination, testing procedures, discrepancy resolution, and acceptance criteria.
- Provides arguments and examples for choosing specific parameters like reference standards and sample sizes.
Conclusions:
- This paper serves as a resource to aid laboratories in planning and executing validation and verification procedures.
- Anticipates that the guidance will be particularly valuable given the anticipated rise in validation needs due to IVDR implementation.
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