Immunoassays, as a technology, have a dominant presence in clinical lab diagnostics. Traditionally, enzyme linked immunoassays or ELISAs have presented challenges for clinical adoption, due to the number of liquid exchanges and imaging optimization steps, among other complexities. Well-to-well and plate-to-plate precision has presented limitations as well, holding ELISA and other complex immunoassays back from more widespread adoption and approval for clinical chemistry workflows.
Repeatability and reproducibility are different but not mutually exclusive parameters of an experimental method workflow. Repeatability is a measure of the similarity of results performed on the same day with the same methods and batch reagents – expressed as standard deviation. Reproducibility is a measure of the similarity of results performed on different reagents preparations using exclusive experimental setups – expressed as coefficient of variation or %CV. Both are measures of precision and each are tests of a methods robustness, reliability, and competence to produce an actionable result. ELISAs and other complex immunoassays have traditionally been challenged by these measures, partly due to the multiple steps requiring pipetting and liquid exchange.
New technologies are focused on automation of the method to allow not only better precision, but higher-throughput and multiplexing abilities.
These multiplex immunoassay technologies may be a prelude of what is to come in more routine and widespread clinical diagnostics.
Another trend that is gaining momentum is the use of microfluidic technologies for clinical applications. Such areas primarily involve point of care diagnostics, although a growing number of companies are focused in the areas of design fabrication for custom applications as well.
Microfluidics, as a technology, address major pain points in the typical diagnostic workflow.
These benefits have been harnessed in immunoassay applications including ELISA where reagents use and time-to-result are critical. Applications where traditional lateral flow devices are common are now being enhanced by microfluidics as well. Molecular detection by techniques such as isothermal assay is now better realized by multi-channel and modular optical features.
An area that is often overlooked but is becoming more and more important in lab operations is the concept of sustainability. Reagent and consumables usage have traditionally been closely linked with liquid handling methods and applications. Advances in multiplexing and microfluidics and other refinements have helped reduce waste and foster the practice of sustainability. Certain consumables, however, are a necessity for automated liquid handling systems and other high-throughput devices – and as such, no obvious way around their use exists.
An emerging trend is focusing on minimizing the throughput of consumables such as pipetting tips by washing and regenerating their useful life. Plastic pipette tips are traditionally disposed of after a single use and incinerated with biohazard waste. It is clear, well beyond the lab, that single use plastics present a problem for our environment, not to mention the expenses associated with production and disposal.
Although a tall order, a successful platform for liquid handling tips recycling and reuse may involve several key metrics.
The three trends above are moving the automated liquid handling industry forward. The application of these advancements to better and more refined clinical diagnostics is a reality that is approaching with accelerating speed. It will continue to be interesting to see what new technologies appear along the way towards the future of clinical lab medicine.
Updated July 2022