Laborergebnisse sollen schnell, zuverlässig und von Labor zu Labor vergleichbar sein, damit jeder Patient eine korrekte Diagnose und optimale Therapie erhält. Verordnungen wie die neue IVDR, CEN Standards und ISO Normen tragen hierzu bei, aber auch innovative diagnostische Verfahren wie z.B. NGS für die Erregerdiagnostik bei septischen Patienten.
16:15 Uhr
CEN Spezifikationen und ISO Standards für die Qualität der Präanalytik von Genomanalysen. Wo stehen wir 2022?
U. Oelmüller (Hilden, DE)
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Autor:in:
U. Oelmüller (Hilden, DE)
Molecular in vitro diagnostics and research have allowed great progress in medicine including diagnostics. Further progress is increasingly established by new biomarker tests analyzing specimens’ biomolecule profiles such as nucleic acids, proteins, and metabolites. However, profiles of these molecules can change significantly during specimen collection, transport, storage, and processing including analyte isolation, caused by post collection cellular changes such as gene inductions, gene down regulations, biomolecules modifications or degradation. This can make the outcome from diagnostics or research unreliable or even impossible because the analytical test will not determine the situation in the patient body but an artificial specimen analyte profile generated during the pre-analytical workflow. Preanalytical variables are a major error source for wrong diagnostic test results. High quality specimens with preserved analyte profiles as they were in the patients bodies are therefore crucial for reliable diagnostics, biomedical research and biobanking. Specifying, developing and verifying pre-analytical workflow parameters for diagnostics tests has consequently become a requirement by new European legislation.
The EU SPIDIA Consortium (2008-2013) developed new pre-analytical technologies for preserving molecular profiles in human specimen and generated broad evidence that guidance to laboratories on pre-analytical workflows improves analytical test results. Based on these results, the CEN/TC 140 for “in-vitro diagnostic medical devices” had released first 9 European Technical Specifications for pre-analytical workflows addressing different blood, other body fluids and tissue based molecular applications. In 2018 and 2019 they progressed to International Standards at the ISO/TC 212 for “clinical laboratory testing and in vitro diagnostic test systems”. The successor EU SPIDIA4P consortium project (2017-2021), supported by a large international network, has broadened to a final portfolio of 22 pre-analytical CEN and ISO Standards intending to improve in vitro diagnostics and biomedical research, has developed corresponding External Quality Assurance (EQA) and is driving international implementation. The new standards can serve to fulfill requirements in the new EU In Vitro Diagnostic Regulation 2017/746 (IVDR). The SPIDIA4P project has received several awards including the “CEN-CENELEC Standards+Innovation Project Award 2021” for its important contribution of standardization and innovation to molecular diagnostics.
The SPIDIA project received funding from the EU’s FP7 under grant agreement no. 222916. The SPIDIA4P project received funding from the EU’s Horizon 2020 research and innovation program under grant agreement no. 733112.
16:40 Uhr
Qualitätsgewinn in der Sepsisdiagnostik durch Charakterisierung der Bakteriämie mittels Next Generation Sequencing
K. Sohn (Stuttgart, DE)
17:30 Uhr
P-08-07/FV-07:
Large Performance Differences in Glucose Measurement Devices used in Patient Self-Monitoring
M. Hiepler (Oldenburg, DE)
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Autor:innen:
M. Hiepler (Oldenburg, DE)
F. Gauß (Greifswald, DE)
D. Rosenkranz (Oldenburg, DE)
A. Carl (Oldenburg, DE)
A. Petersmann (Oldenburg, DE)
Background:
Blood glucose systems for patient self-monitoring are not covered by the guideline of the German Medical Association for the quality assurance of laboratory tests. Analytical quality is assessed as part of the approval process but is not mandatory thereafter. Consequently, patients often do not apply and monitor internal quality controls on a regular basis e.g. like in medical laboratories.
Materials and Methods:
In our study we investigate the analytical performance of 13 glucose measurement devices from 7 different manufacturers for patient self-monitoring and compare them with glucose concentrations obtained from a system used in hospital care (Cobas pro, Roche Diagnostics, Mannheim). Two approaches were chosen: a method comparison and an imprecision study. For method comparison, 15 EDTA-whole blood from left over samples were measured on the patient self-monitoring systems. Within 15 min these whole blood samples were centrifuged and the EDTA plasma was used for the determination of the comparison glucose concentration at the Cobas pro platform. Thereafter, the plasma-referenced values of the patient self-monitoring systems were compared to the glucose concentrations from the hospital care platform. For comparison, we calculated correlation coefficients and conducted linear regression analysis.
For determination of imprecision, EDTA plasma pools were prepared from left-over material. The pools encompassed six different glucose concentrations which were measured in duplicates for five consecutive days. Coefficients of variation were calculated for each method.
Results:
The values of the investigated patient self-monitoring systems show good agreement with the laboratory method. Correlation coefficients were ≥0.959. The systematic measurement deviation was below 5 % for eight of the systems examined but above 5 % and up to 14% for the remaining five systems. Nine systems for patient self-monitoring were also comparable with the laboratory method in terms of imprecision < 5%, as recommended by the “Kommission für Labordiagnostik in der Diabetologie (KLD)”. However, four of the systems had a considerably higher imprecision with a coefficient of variation of up to ± 10 %.
Conclusion:
The investigated systems for patient self-monitoring showed variable analytical results, which has to be confirmed in further studies. About one third of the investigated devices for patient self-monitoring showed an unacceptable high imprecision and a clinically relevant systematic measurement deviation. This should be taken into account when such systems are used for patient-self monitoring.