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Representation and performance of CE-marked and in-house in vitro diagnostic tests for routine laboratory parameters in external quality assessment programmes
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DOI：10.1515/cclm-2026-0288.png)
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Abstract
En 中文
Objectives European legislation requires detailed performance evaluation of in vitro diagnostic medical devices (IVD-MD) by both commercial manufacturers (through the Conformit & eacute; Europ & eacute;enne (CE) mark) and in-house (IH) IVDs. Little information is currently available on how CE- and IH-IVDs are mapped in laboratory routine operations with respect to spectrum, frequency and performance.Methods External quality assessment (EQA) providers routinely collect information from participants in connection with test results on the IVD-MDs and combinations used. Using data from a national EQA provider, we compared frequencies and performances of commercial and non-commercial laboratory tests reported by laboratories participating in the programmes of an EQA provider. Due to differing, but equally tenable, interpretations regarding the distinction between CE- and IH-IVDs, two possibilities were considered in data analysis.Results Depending on the applied definition of IH-IVDs, a total of 59 or 13/1,763 laboratories (3.5 %/0.74 %) used 170 or 21/5,488 (3.1 %/0.4 %) IH-IVD systems to produce a total of 263 or 21/32845 (0.8 %/0.1 %) results for 63 or 18 of similar to 400 analytes (similar to 15.8 %/similar to 4.5 %). The EQA performance of IH-IVDs was essentially the same as that of CE-IVDs.Conclusions IH-IVDs accounted for only a minimal proportion of tests. EQA results obtained with them showed no inferiority to those obtained with CE-IVDs. Furthermore, our findings show that EQA data are a useful tool for examining the analytical landscape, possibly even beyond the national level. Studies on the use and performance of IH-IVDs should be conducted based on EQA programmes for laboratory diagnostic areas where their proportion is likely to be higher.
Keywords:
in-house IVD
CE-IVD
laboratory developed test
validation
verification
performance
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