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Validation and maintaining laboratory developed molecular tests compliant with ISO15189 for diagnosis of intestinal
1Microvida Laboratory for Medical Microbiology and Immunology, ElisabethTweesteden Hospital, Tilburg, The Netherlands.
Introduction:
Although, in the past few decades molecular diagnostics of parasitic infections have been accepted as first-line diagnostics, laboratories tend to be reluctant of introducing nucleic acid based tests as they dread the validation of laboratory developed tests (LDTs) compliant with ISO1589.
Areas Covered:
This paper describes how to set tailor-made performance characteristics for the validation of laboratory developed tests (LDTs) for the molecular diagnosis of intestinal parasitic infections complying with the ISO 15189 guidelines. Then, just as important, maintaining these tests by daily monitoring, external quality assessment schemes, and reassessment of the test set-up.
Expert Opinion:
Tailoring performance characteristics for the validation of LDTs defining criteria that make sense and actually leading to a process of continuous quality improvement in the day-to-day practice of a diagnostic laboratory. It is essential or even obligatory to modify these characteristics, skip, or to add additional characteristics based on personal or changing insights fitted for a specific setting.
Insights
This study details setting custom performance standards for validating laboratory-developed tests (LDTs) for intestinal parasitic infections, ensuring ISO 15189 compliance and continuous quality improvement in diagnostics.
Area of Science:
- Clinical diagnostics
- Molecular parasitology
- Laboratory quality management
Background:
- Molecular diagnostics are established for parasitic infections, but labs hesitate to adopt nucleic acid-based tests due to validation challenges.
- Implementing laboratory-developed tests (LDTs) requires rigorous validation to meet international standards like ISO 15189.
Purpose of the Study:
- To provide a framework for setting tailor-made performance characteristics for LDT validation in molecular parasitology.
- To ensure compliance with ISO 15189 guidelines for diagnostic laboratory tests.
- To guide the continuous quality improvement of molecular diagnostic testing.
Main Methods:
- Describing the process of defining and tailoring performance characteristics for LDT validation.
- Emphasizing the importance of daily monitoring, external quality assessment, and reassessment for test maintenance.
- Highlighting the flexibility to adapt validation criteria based on specific laboratory needs and evolving insights.
Main Results:
- A practical approach to validating LDTs for intestinal parasitic infections according to ISO 15189.
- Demonstration of how tailored validation leads to enhanced quality control and continuous improvement.
- Establishment of methods for ongoing maintenance and reassessment of molecular diagnostic tests.
Conclusions:
- Tailored validation of LDTs is crucial for molecular diagnostics of parasitic infections.
- ISO 15189 compliance can be achieved through customized validation strategies.
- Continuous quality improvement is facilitated by adaptable performance characteristics and ongoing monitoring.
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