From Opinion-based to Evidence-based

Evolution of emerging branches under laboratory discipline has made a great difference in the diagnostic market in recent years

Dr GSK Velu

The reliability and versatility of diagnosis has changed from ‘opinion based’ medical care to ‘evidence based’ medicine. Comprehensive range of tests, diagnostic methods and reliability has helped easy diagnosis. International accreditation standards have been adopted by healthcare service providers. With the availability of a large knowledge pool in India and increased awareness of patients and clinicians, preventive care gains priority over therapeutic care. Evolution of emerging branches under laboratory discipline like molecular pathology, molecular genetics, and integration of IT services in laboratory medicine has made a great difference.

Today, the expectations from the diagnostic industry is that of a comprehensive test menu, quality, rapid turn-around-time (point-of-care diagnostics), affordable prices, logistics support for sample pick-up and/or report delivery, easily accessible phlebotomy service, convenient reporting mode, customer friendly pre and post testing telephonic support, honest and transparent approach towards complaints and feedback.

Latest in Diagnostics

Advancing technologies are pushing the healthcare industry to the fore, and the diagnostics industry in particular is emerging as a powerful healthcare player with tremendous potential. Advances in polymerase chain reaction (PCR), multiplexing, sequencing, and other technologies are propelling both new and old companies forward with novel capabilities.

Lab on a Chip using Nanotechnology

Lab-on-a-chip (LOC) is a term for devices that integrate (multiple) laboratory functions on a single chip of only millimeters to a few square centimeters in size and that are capable of handling extremely small fluid volumes down to less than pico liters. This technology utilises a network of channels and wells that are etched onto glass or polymer chips to build mini-labs. Pressure or electrokinetic forces move pico liter volumes in finely controlled manner through the channels. LOC enables sample handling, mixing, dilution, electrophoresis and chromatographic separation, staining and detection on single integrated systems. The main advantages of LOC are ease-of-use, speed of analysis, low sample and reagent consumption and high reproducibility due to standardisation and automation.

The possible areas of application of LOC are:

• Real-time PCR; detect bacteria, viruses and cancers.
• Point of care diagnostics for all common chemistry/ immunoassay parameter, measurement of critical blood analysers such as blood gas analyser, electrolytes and metabolites.
• Immunoassay; detect bacteria, viruses and cancers based on antigen-antibody reactions.
• Dielectrophoresis detecting cancer cells and bacteria.
• Blood sample preparation; can crack cells to extract DNA.
• Cellular lab-on-a-chip for single-cell analysis and Ion channel screening.

Cost Effective Molecular Diagnostics Technology

It's a technology to identify a disease or the predisposition for a disease analysing DNA- or RNA of an organism. For decades, diagnostic labs have relied upon clinical chemistry and immunoassays to detect disease, but with the mapping of the human genome and advances in instrumentation technology, physicians of the future will have access to molecular diagnostic tools that will revolutionise the way medicine is practiced. The molecular diagnostic segment, while only about four per cent of the total in vitro diagnostic market is the fastest growing segment due to new research into the genetics behind microorganisms, disease presence, prevalence, risk factors, and treatment plans. New genetic information has laid the groundwork for the development of clinical laboratory tests and therapies. Also helping the growth of molecular diagnostics has been the invention and mass utilisation of polymerase chain reaction (PCR) 4, a technique widely used to amplify DNA for accurate detection. PCR is the de-facto standard for amplification in the life sciences research market. PCR is beginning to make its way into the molecular diagnostics arena, and can be seen in both FDA approved tests as well as in ‘home brew’ diagnostics tests.

In addition to infectious disease identification, the analysis of single nucleotide polymorphisms (SNPs), which are variations of nucleotide bases that can be related to disease susceptibility, severity, progression and responsiveness to therapy, are fast becoming areas in which molecular tests are being developed. In addition to the expansion into infectious disease testing and genotyping, growth is also expected in areas such as cancer diagnostic and prognostics.

Molecular diagnostics tools will be used in blood bank screening soon through a pooled sera methodology, which will be both accurate and cost effective. In the next coming years, molecular diagnostics will become the most sought after technology for accurate diagnosis of diseases and disorders.

Pre-analytical Automation

In laboratory science, however, a technician-intensive work process has remained commonplace. Some labs are now aggressively catching up. Dwindling reimbursements, evolving technology and the persistent shortage of qualified technologists have stimulated decisions to automate an increasing number of pre-analytic functions or distinct ‘workcell’ areas. Several hundred clinical labs worldwide have even taken the giant stride of converting to total laboratory automation, based on strong evidence that automation not only heightens profitability but also improves quality, timeliness and lab flexibility.

Pre-analytical processing is one of the most labour-intensive aspects of clinical work, occupying up to two-thirds of the total time spent by personnel on clinical laboratory procedures. Many labs are choosing to automate gradually, beginning with this front end of the test cycle-sorting, decapping, barcode labeling, placing sample tubes in racks that may originate from a wide range of manufacturers, aliquoting, and centrifuging.

This pre-analytical unit processes blood specimens through automated specimen sorting, centrifugation, decapping, labeling, aliquoting, and placement of the processed specimen in the analytical rack. Laboratory automation can be classified into three major categories: total laboratory automation (TLA), modular laboratory automation and workcell/workstation automation.

Some of the advantages of preanalytical automation is physical reorganisation, coupled with a well-implemented laboratory management information system (LMIS) performing auto-verification, reflex algorithms, delta checks, and auto-reporting. Automation also helps relieve the stress on the remaining technologists brought about by a continued increase in workload.

The writer is Managing Director Metropolis Health Services (India) Ltd
E-mail: gvelu@metropolis.com