The role of technology in the clinical laboratory of the future.

Advances in automation and informatics will drive the implementation of new technology as we enter the 21st century. Five technologies which will have the greatest impact on the practice of laboratory medicine during the next decade include molecular diagnostics, near patient testing, image analysis, robotics, and information management. The list of molecular pathology tests with potential clinical utility expands daily. Some, such as tests for human immune deficiency virus (HIV) and hepatitis C virus, already are available as commercial kits. Quality assessment and proficiency testing programs still are evolving. DNA tests in oncology, such as T- and B-cell gene rearrangements and t(9;22) translocation, have proven useful in detecting small numbers of tumor cells and have demonstrated clinical utility in some circumstances. Tests for monogenetic diseases, such as sickle cell disease, are useful in planning antenatal management of mothers at risk. Screening tests for the genetic predisposition for certain forms of colon and breast cancer and Alzheimer's Disease are now possible. This suggests the potential for large scale screening of populations at risk. Continued improvements in biosensor technology and miniaturization will increase the ability to test for many analytes at or near the patient. The generally increased cost per test must be reconciled with the potential to decrease the overall cost of care by improved turnaround time. Computerized image analysis will radically change, and in some cases eliminate, manual clinical microscopy in urinalysis, hematology, immunohistochemistry, and cytology. Robotics will greatly decrease personnel requirements for repetitive tasks, such as specimen transport, processing, and aliquoting. We will process many specimens from start to finish without human intervention. Image management systems will allow archiving of diagnostic gross and microscopic images along with the traditional text descriptions and diagnosis. Telepathology will link smaller centers with expert consultants in tertiary centers. Voice recognition systems will obviate the need for transcriptionists. Modern database architectures will allow the clinical laboratory to measure performance effectiveness and clinical outcomes and will place laboratorians at the forefront of outcomes research. Hand-held devices will allow physicians to conveniently order laboratory tests and retrieve results, further decreasing the functional turnaround time for laboratory testing. All of these technologies will be expensive to implement, but well-planned deployment will both decrease cost and improve the quality of medical care.