Clin Chem Lab Med. 2026 Mar 17. doi: 10.1515/cclm-2026-0288. Online ahead of print.
ABSTRACT
OBJECTIVES: European legislation requires detailed performance evaluation of in vitro diagnostic medical devices (IVD-MD) by both commercial manufacturers (through the Conformité Européenne (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 ∼400 analytes (∼15.8 %/∼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.
PMID:41842762 | DOI:10.1515/cclm-2026-0288