Relationships between accredited laboratories and laboratories in the process of accreditation and their suppliers often fail because of the documentation requirement. This is because foreign suppliers in particular find it difficult to understand the requirements placed on them by the laboratories. Our whitepaper “Key points of ISO/IEC 17025” helps to improve the laboratory-supplier relationship. [...]
In addition to cell number, differential cell image, glucose-lactate total protein determination and the Reiber diagrams for albumin, IgG, IgA and IgM, the diagnosis of oligoclonal bands (OKB) is one of the central analytical methods in liquor diagnostics. The qualitatively reliable detection of oligoclonal IgG bands in CSF by means of isoelectric focusing (IEF) [...]
“Quick action is necessary”, says an article on the effects of the IVDR regulation on medical laboratories by Dipl. Biol. Ulrich Hafen in edition 3/2019 of the journal Trillium Diagnostik. Medical laboratories that use their own “laboratory developed tests” (LDT), including their own software, are just as affected by the new IVDR regulation, which [...]
