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| Mass Spectrometry in Clinical Laboratory Standardization and Routine Clinical Laboratory Applications |
| Tue 3:00 PM - Session: Regulations and Standards |
| Hubert Vesper |
| For many years, reference measurement procedures used in standardization activities employ mass spectrometry to establish metrological traceability of measurement results. Metrological traceable measurements enable measurement results to be comparable across measurement systems as well as over time and space. Obtaining and maintaining traceability leads to improvements in patient care and disease prevention. Reference measurement procedures are optimized for high precision, accuracy and specificity to meet performance criteria defined by organizations such as ISO, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) or the Joint Committee for Traceability in Laboratory Medicine (JCTLM).
Though reference measurement procedures are important to laboratory medicine, they normally are not intended for clinical diagnostic use. Therefore, they do not need to follow the rules and regulations put in place for clinical diagnostic assays. On the other hand, assays, intended for clinical diagnostic use, may not qualify as reference measurement procedure even though they use the same mass spectrometry technology as the reference measurement procedures. This presentation will provide an overview on traceability in laboratory medicine and will give information on institutions and organizations involved in standardization activities and on rules and standards relevant to clinical and reference measurements. |
| Email: hav2@cdc.gov |