Immunoassay Automation: Hands-free platforms change the workflow

Immunoassay Automation: Hands-free platforms set to change the workflow in research labs By Dr John Comley The automation of immunoassays is not a new trend, but one that has already witnessed decades of innovation in diagnostic laboratories. However, in terms of hands-free automated processing of small batches of immunoassays in the research lab, the potential end-user is fortunate to be presented today with an increasing number of choices. These range from the ‘open’ fully configurable traditional automation platforms and benchtop turnkey workstations to the ‘closed’ proprietary cartridge or microfluidic-based systems typically offering miniaturisation, improved sensitivity, multiplexing and unparalleled ease of use.miniaturisation, improved sensitivity, multiplexing and unparalleled ease of use. Hands-free operation has the potential to significantly change workflows and bring productivity gains to immunoassay labs by freeing up operator time. Some of the research lab platforms described in this article are so empowering they are either already available or are being actively developed to run more stringent clinical laboratory tests, and this will facilitate the transitioning of some research-based investigations (eg biomarker analysis) to clinical settings. The automation of immunoassays is not a new trend, but one that has already witnessed decades of innovation in diagnostic laboratories with numerous clinical autoanalyser platforms launched and enhanced over the years. However, most of these are ‘closed’ platforms designed to run a limited repertoire of assays, typically based on the same methodology and/or specific reagent kits/chemistries, with little or no scope to bring on new or optimise alternative assays. Research laboratories, including those in Pharma and Biotech, are seldom familiar with diagnostic instrumentation developments and tend to lag behind their diagnostics counterparts in implementing immunoassay automation. This is partly explained by their differing priorities and objectives (eg drug screening labs typically seek to access ‘open’ modular and scalable platforms capable of processing lots of tests against the same target assay, but with flexibility to rapidly change targets; basic research labs, on the other hand, are less interested in throughput but are heavily constrained by their limited ability to invest in new capital equipment and assay cost per well). In addition, most research labs are much more likely to consider immunoassay automation in terms of enabling microplate-based assays, in automating separate processing steps (eg sample prep, assay assembly, plate washing or plate reading) and predominantly utilise off-theshelf XYZ robotics processing. As a consequence in recent years the biggest innovations in research lab-based immunoassay automation have mainly centred around the exploitation of one-step or nowash homogeneous ELISA protocols (eg PerkinElmer AlphaLISA). In contrast, the majority of biomarker research performed using immunoassay multiplexing systems, such as those based on Luminex xMAP beads or Meso Scale ECL detection of binding events on patterned arrays, are rarely incorporated into fully automated immunoassay platforms and mainly rely on offline feeding of assay plates to detectors. However, some novel ‘closed’ or ‘semi-closed’ immunoassay automation platforms have achieved high levels of sample-to-result automation using their specific technology or novel approach, eg BioScale’s VIBE™ and Gyros GyroLab. These systems have gained traction from potential users striving for simplification in analytical protocols, but mainly attract those seeking major improvements in immunoassay performance criteria (ie increasing sensitivity; reducing assay time; minimising assay volumes and reagent consumption; and improving detection capability in complex samples). In August 2014 HTStec undertook a market survey on immunoassay automation1 predominantly among research labs in academia, pharma and biotech. The main objectives of this survey were to understand the current automation of immunoassays; automation platforms respondents want to access in the future; awareness of emerging platforms; drivers to adoption; and barriers to change that would limit adoption. In this article highlights of this market survey are reported and the findings discussed together with the latest vendor developments in immunoassay automation. Current status of immunoassay automation The majority of survey respondents (39%) have not applied any automation to their immunoassays today (2014), with only 14% having applied full automation to immunoassays today (Figure 1). Survey respondents provided feedback on the specific immunoassay automation instrumentation they had implemented. Most of this involved a plate washer (mainly from BioTek), either in association with a standalone automated liquid handling systems or in a few cases robotically linked to an automated liquid handling platform. Most liquid handlers were sourced from Agilent, Beckman Coulter, PerkinElmer, Tecan and Thermo Fisher. The median capital cost of immunoassay automation already implemented to date was in the range $40-$60,000. Most wanted immunoassay automation The immunoassay automation survey respondents most want to achieve in the future (2017) was full workflow (walkaway) automation – sample addition, plate washing (if applicable), incubation and detection (44% wanting). This was followed by partial workflow automation – sample addition and plate washing only (27% wanting); sample addition, plate washing (if applicable) and incubation (16% wanting); and sample addition only (13% wanting) (Figure 2). The immunoassay platform that the majority (87%) of survey respondents most want to access is an OPEN generic platform, ie unoptimised and modular automated solution for generic immunoassay applications, typically it can be adapted for future changes in requirements. Only 13% of all respondents preferred a CLOSED platform, ie fully optimised and dedicated automated solution for a specified immunoassay method, typically uses specific assay kits and has limited scope for adaption for future changes in requirements (Figure 3). Only 13% of survey respondents have plans to purchase an automated immunoassay workstation this year (2017). The median likelihood of survey respondents purchasing an automated immunoassay workstation up to end of 2017 was possible (26-50% probability). The median maximum price survey respondents would pay for an automated system that could run their immunoassay requirements hands free was $60,000. Survey respondents rated precision as the factor with the greatest impact on their decision to select an immunoassay automation vendor. This was very closely followed by accuracy, then robustness of assays and sensitivity (Figure 4). Awareness of emerging immunoassay platforms Of new emerging automated immunoassays platforms or alternative technologies survey respondents were most aware of (ranking includes already investigated/implemented) was Luminex microparticle-based flow tests for multiplexed assays. This was followed by PerkinElmer AlphaLISA bead-based homogenous no-wash format; qPCR-based alternative tests; and then MesoScale Discovery ECL MultiArray technology. All respondents were least aware of Douglas Scientific Nexar system optimised for inline homogeneous ELISA processing and Siloam Biosciences Optimiser microfluidic channel ELISA plates (Figure 5). What will motivate future adoption of automated platforms Survey respondents ranked facilitates improved performance/greater sensitivity/better uniformity as their main motivator/driver for adopting a new improved or automated immunoassay platform. This was followed by reduces reagent consumption requirements/cost per sample; flexibility to accommodate range of assays/protocols; and then enhances speed, reduces assay time, enables higher throughput (Figure 6). Survey respondents rated the requirement to invest in new capital equipment as the most important barrier to change that would limit the adoption of a new improved or automated immunoassay platform. This was very closely followed by cost per well (data point); and then ease of transition of existing assays to new format; and availability of a full (diverse) range of kits (Figure 7). Nearly half of survey respondents were either amenable or highly amenable to changing assay buffers and/or protocols to work with a new immunoassay platform with potential to significantly improve performance. Only 4% would not change their assay buffers and/or protocols to work with a new immunoassay platform (Figure 8). Survey respondents ranked improving detection capability in complex samples as the biggest hurdle (limitation) with immunoassays today. This was closely followed by applicability to low abundance targets; and reducing cross reactivity and non-specific binding. Other factors which more related to practicality of running the assay than the optimisation of the biology were ranked less limiting. This shows that any automation platform/strategy must also enable more robust, better quality assays if it is to impact the future of immunoassays (Figure 9). Latest developments in immunoassay automation The key steps of any immunoassay workflow include reagent additions, incubations, wash steps, detection and data management. Automating these steps reduces time, labour and human errors while streamlining manual processes and efficiency in the laboratory. The ability to provide increased productivity and flexibility of throughput using Beckman Coulter’s (www.beckman.com) scalable Biomek SAMI EX Workstation eliminates the need for a technician to manage the critical timing involved in transporting plates to stand alone devices throughout the workflow. The scheduling software, SAMI EX, provides complete control of the entire workflow process enabling pre-verification of the process and consumable supplies on the system, review of critical incubation times and key reagent additions. It maintains the integrity of the planned method while accommodating day to day throughput variations. Data, such as barcode, sample tracking and OD readings, are gathered seamlessly through the software suite (SAMI EX, Biomek, and DART 2.0). A data access point through a web browser enables a technician to check on method status, and provides a quick comparison of results from run to run. The interconnected data stream allows live data decision making within a method and downstream data point connections to drive the process forward across one or multiple islands of automation, QC trending capabilities across instruments and runs, and the ability to create standard Excel reports for their workflow requirements. In addition, Beckman Coulter has partnered with Molecular Devices to expand the range of cost-effective and versatile workflow solutions (Figure 10). The ViBE® platform from BioScale (www.bioscale.com) is a standalone, automated, bench-top immunoassay platform enabling sensitive, homogenous, hands-free assays in microplate format. Powered by the proprietary AMMP® (Acoustic Membrane MicroParticle) technology, the ViBE uniquely integrates magnetic beads with a universal acoustic sensor allowing greater sensitivity in a broader set of matrices as well as improved detection of low affinity interactions as compared to current immunoassay methods and ELISA. The hands-free workflow enables greater productivity in the lab by freeing up to three to seven hours of operator time a day. ViBE assays are similar to current immunoassays in that one can run a sandwich or competitive assay. The difference lies in the workflow. The process starts by pipetting reagents, standards, controls and samples into one of three 96-well microplates – the current on-deck capacity of the instrument. Next the user initiates the instrument and brings up an existing protocol or creates a new protocol using the protocol wizard. Finally, the protocol is started and the instrument will process the microplates by pipetting reagents into samples, standards and controls and run the assay to completion. Hands on time is approximately 45 minutes. The ease of use, low cost per well and hands-free walk-away functionality allow labs and users to significantly increase productivity. A number of recent publications and assays developed by customers are listed on BioScale’s website. These publications cover protein research applications such as pathway analysis, mechanism of action and biomarker studies, and drug development applications such as pharmacokinetic studies and antidrug antibody assays. The platform is currently being developed to run clinical laboratory tests. New enhancements to the platform include an expanded dynamic range protocol and GxP tools such as FDA 21 Part 11 compatibility (Figure 11). One of the most prevalent immunoassay formats in biomedical research is ELISA, using the specificity of antibodies to identify a wide range of analytes from different matrices. The general process of ELISA remains constant with most workflow steps performed manually by technicians, from managing assay timing to physically moving sample microplates between bench top instrumentation. When many samples need to be processed routinely, manual methods are impractical and inefficient. BioTek Instruments (www.biotek.com) offers a wide range of microplate instrumentation for use in such assays. For high throughput settings with workflows necessitating unattended operation, BioTek partners with a number of automation providers including Thermo Scientific. These integrated workstations automate immunoassay processes and in turn free up technician time, allow continuous processing of multiple plates and provide excellent assay performance. At the centre of BioTek/Thermo workstations is an Orbitor™ RS Microplate Mover with BioTek devices such as the MultiFlo™ Dispenser, EL406™ Combination Washer Dispenser and Cytation™ Multi-Mode Reader around the periphery. Stacking the dispenser and washer, these four instruments fit neatly into a compact bench space, with plenty of room for device and plate stack access. Through the use of a compact, simple and robust plate mover with appropriate instrumentation, routine immunoassays can be automated, providing increased productivity without any sacrifice in data integrity (Figure 12). The Multiplier Flex™ Fully-Automated Platform with M2® Technology from Dynex Technologies (www.dynextechnologies.com) unlocks the power of multiplexing and elevates the proven and reliable technique of ELISA to a whole new level. Dynex M2 (Multiplexed Microwells) technology, combined with the Multiplier Flex fully-automated system is a new chemiluminescence-based multiplex technology platform that enables laboratories to easily convert from manual, semi or fully-automated single analyte assays to fully-automated, multi-analyte assays. The easy-to-use M2 technology quickly and cost-effectively automates M2 multiplex assays while delivering fast, sensitive and precise results. M2 Technology supports the use of panels that can be defined and assembled in the laboratory to meet the specific needs for research or LDT applications. M2 Technology and the Multiplier Flex streamlines the front-end preparation and minimises hands-on reagent loading with revolutionary, direct-load SmartKit® reagent packs. Multiplier Flex with SmartKits significantly reduces overall assay times and provides full walk-away freedom, compared to other reader-only multiplex technologies. The innovative M2 technology builds upon proven ELISA methodologies to provide a flexible option for maximising productivity while maintaining sensitivity. Virtually any assay that can be implemented via conventional techniques can be implemented using the M2 Technology and Multiplier Flex Fully- Automated Platform. The Multiplier Flex™ Fully- Automated Platform is for Research Use Only (Figure 13). Gyros (www.gyros.com) manufactures laboratory equipment, software and kits to maximise laboratory productivity by miniaturising and automating immunoassays at nanolitre-scale. Recently, Gyros introduced the Gyrolab xPlore™, a single-CD successor to Gyrolab™ xP workstation. Gyrolab xPlore is a cost-effective tool for companies with moderate throughput requirements. All Gyrolab systems analyse samples in parallel using Gyrolab CDs, which house microstructures that use centrifugal force and capillary action to ensure uniform processing. Gyrolab Bioaffy™ CDs streamline the development of robust nanolitre-scale immunoassays with a broad dynamic range. Several Gyrolab Bioaffy CDs are available for the ideal fit for analyte concentration and assay format. Gyrolab Mixing CD power automated sample pretreatment and is a useful resource for anti-drug antibody analysis. The mixing chamber offers greater flexibility in assay workflows requiring additional incubations for equilibration, acid treatment or enzymatic reactions to occur. Gyrolab xPlore uses proven Gyrolab technology to automate the immunoassay workflow by integrating sample addition, incubation, washing and detection. CDs spin at precise speeds and intervals to ensure optimal reactions. High-sensitivity, laserinduced fluorescence detection yields up to 112 data points per CD, with exceptional reproducibility. If higher throughput is needed, the Gyrolab xP workstation can process up to five CDs in one automated run. First results are obtained within an hour and are automatically evaluated by 21 CFR part 11 compliant Gyrolab software and can easily be exported to an existing LIMS (Figure 14). Hudson Robotics (www.hudsonrobotics.com) offers a workcell that prepares plates for ELISA assays that is inexpensive, easily customised and small enough to fit into a standard hood. At its heart is the SOLO automated pipettor that can be configured to handle sub-microlitre or greater volumes. An extended arm not only moves a multichannel pipette to the nest positions on its deck, but also services an adjacent plate washer and high-speed liquid dispenser. Antigen samples are placed on the dispenser where a dilution series is prepared and transferred to the washer’s nest, along with various antibodies and additional reagents. The system can be customised to support a wide variety of protocols and levels of throughput. For example, multiple assay plates can automatically be prepared by adding a PlateCrane microplate handler equipped with multi-plate stacks for storing samples, assay plates, disposable tips and reagents. The PlateCrane can also feed a wide variety of plate readers creating a fully automated ELISA assay system. Hudson’s SoftLinx lab automation software controls all of these components, as well as many additional accessories, such as heating/cooling nests, bar-code printers and readers and automated incubators. Softlinx includes an intuitive, flow-chart-based designer for creating protocols of all levels of complexity. For example, it would be easy to design an ELISAbased screening system in which samples possessing a particular level of activity are cherry-picked and retested, or examined in a follow-up assay (Figure 15). ELISA is an immunoassay technique that is used extensively to measure individual protein analytes in research and diagnostic applications. While ELISAs have remained a workhorse for decades, its limitations are becoming an impediment, particularly in translational research where the analysis of multiple analytes from small sample volumes with high degrees of precision and accuracy is required. Furthermore, as biomarker analysis transitions from research environments to clinical settings, a robust and standardised platform is needed. To address these challenges, ProteinSimple (www.proteinsimple.com) has developed a fully automated, hands-free immunoassay platform. The Simple Plex platform retains the specificity of single-analyte ELISAs, but provides multi-analyte analysis while avoiding the constraints of high sample volume requirements, relatively slow reaction rates, and intensive labour needs. The Ella system includes a self-contained disposable microfluidic cartridge integrated with a simple desktop analyser. The assay protocol is extremely easy: the user scans a bar code on the test cartridge, adds sample and buffer to the appropriate ports, inserts the cartridge into the analyser and initiates the test. A single Ella cartridge enables the simultaneous quantification of four analytes from 16 individual samples in an hour, with hands-on time of approximately five minutes. A key feature of the Ella cartridge is that each sample is analysed within a unique microfluidic circuit consisting of four channels, with each channel containing an immunoassay for a specific analyte. The hands-free approach not only offers unparalleled ease of use but also contributes to enhanced performance thereby making Simple Plex a very powerful immunoassay platform in research and diagnostics (Figure 16). Quanterix (www.quanterix.com) has developed an ultra-sensitive platform capable of measuring individual proteins at concentrations 1,000 times lower than the best immunoassays available today. The Single Molecule Array (Simoa™) technology at the heart of this platform enables the detection and quantification of biomarkers previously difficult or impossible to measure, opening up new applications to address significant unmet needs in life science research, biopharma and in vitro diagnostics. The ultrasensitivity of Simoa assays sets it apart from all other immunoassays available today, offering PCR-like limits of detection with both existing and novel protein biomarkers. This sensitivity is made possible by obtaining digital measurements of bound immunocomplexes. Because the signal generation volume in a Simoa assay is 2 billion times smaller than the conventional ELISA, a single target molecule in a sealed microwell quickly generates enough fluorophores to be measured using conventional fluorescence imaging. When concentrations of the target analyte reach levels above which digital calculations are meaningful, the system’s proprietary algorithm converts to an analogue measurement, ensuring accuracy across a wide dynamic range (>4 logs). Simoa provides multiplexing options up to a 10- plex on a variety of analyte panels with sensitivity comparable to single-plex assays, while also maintaining excellent precision across a broad dynamic range. The Simoa HD-1 Analyzer has been designed to provide users with a completely automated experience to ensure consistent results and the greatest sensitivity possible. A robust menu of ultrasensitive assays is available for proteins important in a variety of applications including inflammation, metabolism, neurology, oncology and cardiovascular disease. The HD-1 platform was launched in 2013 for commercialisation into the life science research market. By partnering with the diagnostics company bioMerieux, Quanterix has ensured a product continuum for the Simoa technology, from research use only (RUO) to the in vitro diagnostic (IVD) markets (Figure 17). The research use only Erenna® immunoassay system, powered by Singulex’s (www.singulex.com) proprietary single molecule counting technology, provides a versatile high-precision solution to researchers seeking truly quantitative biomarker and bioanalytical measurements. The Erenna system combines a familiar immunoassay workflow with SMC™ digital detection technology to achieve femtogram/mL analyte quantification, often several orders of magnitude greater sensitivity over traditional technologies. Erenna SMC immunoassays may be configured in plate or bead formats, allowing researchers to select the format best suited for them depending on their quantification requirements for a specific analyte or experiment, balanced against cost, ease of operation and sample volume availability. By utilising the Erenna Immunoassay Development kits, a researcher may take a known antibody pair from a less sensitive ELISA and easily transition to a plate or bead SMC assay to achieve quantitative improvements. If the analyte of interest does not require the ultimate sensitivity of a bead-based SMC assay, the researcher may choose a plate-based format, enabling precise sample measurement with costs at or below the less sensitive ELISA assay. The Erenna SMC plate-based or bead-based immunoassay workflow may be further simplified through integration with a variety of automated solutions, including plate washers, liquid handling platforms and LIMs for fully integrated data management, suitable for GLP environment as required. Several laboratories, including Singulex’s own CLIA accredited and CAP-certified clinical laboratory, have fully automated the Erenna assay workflow by integrating an on-board incubator and plate washers into a liquid handling automation system, offering a completely hands-off approach to the assay processing (Figure 18). Full automation immunoassay workstations have evolved to meet the demands of the ever-changing laboratory environments. The clinical environments value ease of operation and greater walkaway time while the research environments echo these with the addition of simplicity of programming and flexibility. To meet these requirements Tecan (www.tecan.com) offers two platforms for full automation of ELISA: 1) The Freedom Evolyzer is designed for the clinical market enabling completely unattended processing to free valuable resources in the lab. This platform provides a user interface that calculates the plates, reagents and consumables necessary for a run and then guides the operator through the process of loading and preparing the instrument for a run. The Freedom Evolyzer maximises walkaway time so that laboratory professionals can focus on higher value adding activities 2) The Freedom Evo platform is a flexible platform that can be configured to the specific needs of immunoassay processing in a research environment. The flexibility allows choosing the specific incubation, washing and reading technologies to meet the user’s requirements. To control the system the robust and proven Freedom EVOware Plus software is utilised providing a drag-and-drop graphical user interface for simplicity of programming. The system is further simplified at run time by using TouchTools which is a touch screen optimised software for guiding the user interaction with the instrument. With both the Freedom Evolyzer and Freedom Evo platforms, Tecan has the immunoassay solutions necessary to meet the challenges of tomorrow’s laboratory (Figure 19). The Thermo Scientific (www.thermoscientific.com/automate) ELISA WorkStation™ is a turnkey benchtop automation solution specifically designed to simplify the running of ELISA assays. Featuring the new Thermo Scientific Spinnaker™ robot, this ELISA automation platform delivers an extremely friendly user-experience. Utilising its built-in vision system and specialised teach jig, included with all Spinnaker movers, teaching locations on a system is a quick and painless process. The vision system is also equipped with a location verification procedure that inspects all nest locations prior to a run and will automatically correct minor location discrepancies (position healing). The integrated camera on Spinnaker also acts as a barcode reader, enabling automatic confirmation of sample IDs and robust sample tracking. With four degrees of movement, the Spinnaker is ideally suited for tight configurations as well as instruments and storage in arrayed configurations. All these Spinnaker features have been seamlessly integrated into the Thermo Scientific Momentum™ 4 laboratory automation workflow and scheduling software. Momentum enables users to run multiple ELISA processes as well as multiple batches. Momentum further enhances the user experience by offering enhanced workflow capabilities such as the ability to pool instruments and the capability to take instruments online/offline readily to replenish reagents or reorder the sequence in which ELISA microplates are processed. Now, more than ever, the combined hardware and software capabilities enable even the most novice automation user to design, set up and execute ELISA assays quickly (Figure 20). Titertek-Berthold (www.titertek-berthold.com) presents a new platform for the automation of micro-plate-based assays: The most popular assay platform is ELISA. It is most often performed in 96-well microplates. The ELISA process is based on the binding of specific antibodies to biomolecules, and the quantification via enzyme label after a bound-free separation process. An automation solution requires the dispensing of two or more reagents, sample incubation, often at 37°C, removal of unbound label by ‘washing’ (addition of wash buffer and its aspiration), as well as absorption reading at a certain wavelength. Common automation solutions are ‘deck-based’ and use pipettors. They can be very flexible, but they are complicated to set up and the pipetting steps are slow. Titertek-Berthold chose a different approach: The new Crocodile uses minimal bench space to perform all of the above functions autonomously: The microplate is moved on one rail to the functional subunit (dispenser, washer, shaker, incubator, reader). The dispensing is performed by a flow-through system, which results in very fast dispensing of the required reagent. Setting up assays is intuitive and transparent on the windows-based software. The results are presented as a comprehensive report which lists all steps, together with the actual temperature while they were performed. Optical Density (OD) data can be exported or interfaced with existing evaluation software packages. Two versions of the product have been realised to date: One for complete ELISA automation ‘5-in-one’ including reader. Other microplate assays (FIA, LIA, Assays based on arrays in 96-well microplates) use the ‘4- in-one’ version, which does not include the reader (Figure 21). Discussion In terms of hands-free automated systems for processing immunoassays, the potential end-user is fortunate to be presented today with a variety of empowering options. At one extreme we have the fully configurable open automation platforms that feature pipettors and deck-based robotic plate movers (Beckman, Tecan). Slightly smaller and simpler in design are the benchtop turnkey workstations, made up of only those peripherals devices (ie dispenser, washer, reader) needed to run immunoassays, seamlessly linked together by the latest space saving robots (BioTek, Thermo Scientific). Then comes a workcell that uses microplate handlers to move plates between peripherals and can, for example, prepare plates for ELISA assays (Hudson). All these systems have one thing in common – they rely on increasingly-sophisticated automation scheduling software, typically with enhanced workflow capabilities enabling novice automation users to design, set up and execute ELISA assays quickly. Titertek has taken a different approach to immunoassay automation. Its workstation is based on rail to move the microplate to the functional assay step (ie dispensing, washing, shaking, incubation and detection) and uses minimal bench space to perform all these functions autonomously. All the offerings so far described are ‘open’ and generic in that they support a wide range of traditional ELISA and immunoassay chemistries and are mostly washer-based approaches. The remaining offerings reviewed in the article typically utilise proprietary, high-precision measuring solutions and alternative, often cartridge or microfluidic-based, approaches to sample preparation. The resulting systems are for the most part ‘closed’ platforms, but several also have wider applicability and support reconfiguration of immunoassays previously developed by conventional techniques. Highlights of the capabilities offered include: improved detection of low affinity interactions and hands-free, walk-away functionality (BioScale); the attainment of ultra-low levels of sensitivity and single molecule detection (Quanterix, Singulex); multiplexing options at a sensitivity and speed comparable to single-plex assays (Dynex, ProteinSimple, Quanterix); unparalleled ease of use and enhanced performance in a fully automated, hands-free multi-analyte immunoassay platform (ProteinSimple); streamlined front-end preparation and minimised handson time with direct-load reagent packs (Dynex); maximised laboratory productivity by miniaturising and automating immunoassay workflow at the nanolitre-scale (Gyros); and enhanced flexibility by enabling the transition between traditional platebased or high sensitivity bead-based immunoassay workflows allowing researchers to select the format best suited for them depending on their quantification requirements for a specific analyte or experiment, balanced against cost, ease of operation and sample volume availability (Singulex). To conclude, it would not be overstating the case to suggest that the future of immunoassay automation in research labs already exists in some of the new solutions presented in this article, and this is further evidenced by the fact that variants of some of the platforms described are available or are being actively developed to run more stringent clinical laboratory tests. DDW --- This article originally featured in the DDW Winter 2014 Issue --- Dr John Comley is Managing Director of HTStec Limited, an independent market research consultancy whose focus is on assisting clients delivering novel enabling platform technologies (liquid handling, laboratory automation, detection instrumentation; assay methodologies and reagent offerings) to drug discovery and the life sciences. Since its formation 11 years ago, HTStec has published more than 110 market reports on enabling technologies and Dr Comley has authored 52 review articles in Drug Discovery World. Please contact info@htstec.com for more information about HTStec reports. Reference 1 Automated Immunoassays Trends 2014, published by HTStec Limited, Cambridge, UK, August 2014. More on this subject... Enzyme-linked Immunosorbent Assays (ELISA): Recent Innovations Take Analyte Detection To New Levels READ MORE