Publications by authors named "S Linko"
Article Synopsis
- The EN ISO 15189:2022 standard updates regulations for medical laboratories, replacing previous versions and aiming for better quality and competence.
- The revision focuses on aligning with ISO/IEC 17025:2017, enhancing patient safety, and providing clearer guidelines while minimizing new requirements.
- A guidance document from the EFLM Committee has been produced to help laboratories and accreditation bodies understand and implement these changes effectively.
APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data.
Clin Chem Lab Med
March 2024
Objectives: According to ISO 15189:2022, analytical performance specifications (APS) should relate to intended clinical use and impact on patient care. Therefore, we aimed to develop a web application for laboratory professionals to calculate APS based on a simulation of the impact of measurement uncertainty (MU) on the outcome using the chosen decision limits, agreement thresholds, and data of the population of interest.
Methods: We developed the "APS Calculator" allowing users to upload and select data of concern, specify decision limits and agreement thresholds, and conduct simulations to determine APS for MU.
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European -Diagnostics Regulation.
Clin Chem Lab Med
March 2023
Article Synopsis
- The EU Diagnostic Device Regulation (IVDR) emphasizes risk-based validation, traceability, and post-market monitoring of diagnostic devices while excluding medical services based on these devices.
- Laboratory-developed tests (LDTs) can be used when commercial devices are unavailable, subjecting them to specific performance and safety guidelines under an ISO 15189-equivalent quality system.
- The IVDR may lead to the disappearance of some commercial tests, necessitating urgent LDT replacements, while raising concerns about the potential loss of niche medical applications and increased costs within healthcare systems.
Background: The biological (CV), preanalytical (CV), and analytical variation (CV) are inherent to clinical laboratory testing and consequently, interpretation of clinical test results.
Methods: The sum of the CV, CV, and CV, called diagnostic variation (CV), was used to derive clinically acceptable analytical performance specifications (CAAPS) for clinical chemistry measurands. The reference change concept was applied to clinically significant differences (CD) between two measurements, with the formula CD = z*√2* CV.
Clinicians trust medical laboratories to provide reliable results on which they rely for clinical decisions. Laboratories fulfil their responsibility for accurate and consistent results by utilizing an arsenal of approaches, ranging from validation and verification experiments to daily quality control procedures. All these procedures verify, on different moments, that the results of a certain examination procedure have analytical performance characteristics (APC) that meet analytical performance specifications (APS) set for a particular intended use.
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