About Biogeny Diagnostics

Integrated automation in IVD laboratories

The era of automation in clinical chemistry arrived with the introduction of the autoanalyzer, using continuous flow analysis, and the robotics that automated the traditional manual steps. Successive generations of analyzers increased analytical speed, allowing the testing of high volumes of specimens and providing large assay menus. A diversity developed, with development of immunoassays using a variety of methodologies. ... However, with in last decade, development of integrated systems greatly improved the analytical phase of laboratory testing. Further, automation was developed for pre-analytical procedures, and post-analytical procedures. All phases of testing were ultimately combined in total laboratory automation (TLA) through which all modules are physically linked by some track system, moving samples through the process from beginning- to- end. Another important facet of automation is informatics, including middle-ware, which interfaces the analyzer software to LIS and HIS. This software includes control of the overall operation of TLA and combines analytical results with patient demographic information to provide additional clinically useful information.
A bunch of technologies starting from simple colorimetry up to florescent particle immunoassay (FPIA) and chemiluminesence immunoassay (CLIA) are used in these integrated systems, making them more useful for the purpose for which they are designed. These analyzers use ready-to-use liquid reagents or at times reagents that are reconstituted by the laboratorian upon usage. Again, with development of technology some analyzers also use dry or damp reagents, which are reconstituted with diluent and mixed with specimen directly during testing. Devising this unit dose concept for reagent has helped greatly in avoiding problems like carry overs, residual reagent deterioration, or aerosol effect on reagents.
The integration of chemistry and immunoassay into one system has captured the attention of laboratories and many of them across the globe are showing increasing response for such modular systems. Laboratories are under tremendous pressure for quality, cost, revenue, and speed of output. Hence the drivers for development of modular systems would be quality, TAT, and economy in maintaining them.
Development of modular system has helped to free the laboratorian's time and enhanced menu, upscalability, and improved overall performance are enough to cause revolution in IVD testing.