In Laboratory Medicine meaningful, accurate and precise routine measurements are essential for diagnosis, risk assessment, treatment and follow-up of patients. To achieve these goals and to improve the quality of their test results diagnostic laboratories are implementing nowadays quality management. Many guidelines for quality management have been published so far. It is generally assumed that with this industrial approach the pre-analytical, the analytical and the post-analytical steps in the diagnostic process will be better organised and more economic. However, in most of these quality management systems the medical, patient related part of laboratory medicine is lacking; the systems are focused on classical, analytical quality assurance and process optimisation.
With the human genome project completed still many questions related to cellular regulation and function will remain unsolved. Diagnosis of diseases will be shifted from investigating body fluids to the examination of cells, the new target for diagnosis. Cell functions triggered and regulated by numerous proteins and mediators, influenced by biochemical and physical stimuli will become key elements for pathophysiology and diagnosis of diseases. Determination of molecular fingerprints will allow risk estimation for a disease or an individual basis. Drugs will be more logically targeted taking the genetic individualism into consideration thus prohibiting toxic side effects. New technologies like flow cytometry and PCR will support this development. Chip-information on cellular functions will be directly communicated to the Clinical Chemist who will integrate these results into the overall report. With these future aspects in mind the professional skills of laboratory staff will be changed towards cellular and genome based laboratory medicine.
Modern computer systems and multi-functionality of new analysers will provide opportunities for improving laboratory organisation, efficiency and communication. By shifting the routine mass analyses to some few work stations with on-line communication to the laboratory information system the work-flow will be structured more efficiently by reducing the number of internal processes, the workload for the laboratory workers, the turnaround time and costs for mass analyses. The free capacities and resources can then be used for implementing new technological innovations expending the diagnostic profile and competence of a clinical laboratory. New concepts for request and use of laboratory tests will be developed in order to compensate higher laboratory expenses when introducing new technologies. The laboratory report (numbers, figures) will contain a written interpretation, which either supports or damages the clinical diagnosis. The integrated computer systems will assist laboratory professionals in interpretation of the more and more complex test results of individual patients.
To reach these new goals and to provide physicians with quality oriented laboratory reports the following points have to be considered or implemented in the overall diagnostic process:
rationale, disease oriented test selection
preparation of the patient
sampling of specimens
preanalytical handling of samples
analytical measurements on highest standards
global standardisation of measurement procedures
implementation of a reference system for new technologies
comparability and commutability of test results
post-analytical handling of test results
reporting process by integrated communication systems
interpretation of test results and accepting responsibility
patient oriented consultation with clinicians
Especially diagnostic areas such as coagulation, drug monitoring, drug interactions, endocrinology, immunophenotyping of cells, inborn errors of metabolism, malignancy monitoring, and virology need data interpretation and support in clinical decision making by the laboratory. Examples of various areas in laboratory medicine will be presented. The interdisciplinary clinical consulting process will expand laboratory obligations nearer to the patient. The personnel in the diagnostic laboratory providing patient care diagnostic expertise will be an adequate partner of the clinicians in the future. With active interactions the diagnostic laboratory will survive in a patient oriented environment that demand interdisciplinary knowledge of the great principles of physiology and pathophysiology as well as readiness to accept the responsibility for made decisions.
Nuclear magnetic resonance (NMR) spectroscopy is well established as a powerful and versatile method of chemical and biochemical analysis, but until now has not been used for routine clinical diagnostic testing. We have developed an automated process which uses NMR spectroscopy to generate detailed lipoprotein subclass profiles (NMR LipoProfiles®) that diagnose cardiovascular disease risk more effectively than the conventional cholesterol and triglyceride risk factors. In a one-minute analysis, simultaneous quantification of 6 VLDL, 4 LDL, and 5 HDL subclasses of different size is achieved. The avoidance of chemical reactions and physical separation of the lipoprotein particles makes the process extremely efficient, accurate, and reproducible. Recent clinical trial data supporting the differential diagnostic value of NMR lipoprotein subclass profiles will be presented, plus a brief survey of other potential clinical analytical applications of NMR.
Szív-specifikus. immunoassay-k, mint a cardiac troponin I es T assay-k, jelentősen hozzájárultak az akut ischemias szívbetegségek gyors diagnózisához. Ugyanezek az assay-k jelentős új információkat is szolgáltattak az akut ischemias szívbetegségek pathomechanizmusára vonatkozólag. A jelenleg az USA-ban számos laboratóriumi marker kipróbálása is folyik azon célból, hogy az akut állapot kialakulását előre lehessen jelezni, illetve a beteg prognózisát fel lehessen becsülni.
Ez az előadás rövid összefoglalót ad az új markerek (mint troponinok, C-reactive protein, glycogen phosphorylase BB és fatty acid binding protein) használhatóságáról. A jelenleg használatban lévő és kipróbálás alatt álló markerek előnyeit és hátrányait klinikai tanulmányok alapján fogjuk megvizsgálni.