When faced with new disease challenges, clinical laboratorians have typically managed to meet the diagnostic test needs for patients. With the emergence of the COVID-19 virus, manufacturers have quickly adapted their analyzers to keep pace with increased testing demands, and they have adopted new approaches that can accommodate changing test requirements.
General analyzer trends
Aside from diagnostic trends that are specific to COVID-19 detection, other rising analyzer trends in the clinical lab industry focus on time-saving and cost-effective features, designed to improve efficiency while increasing test throughput.
Venita Shirley, Director of Marketing, North America Commercial Operations at Instrumentation Laboratory, located in Bedford, MA, reported, “Liquid, ready-to-use reagents with long on-board stabilities have become a requirement in most labs today. With reagents that are ready to use and feature long on-board stability (10 days for PT and APTT) there is less waste, less cost and less time spent on non-testing activities. Plus, incorrect reconstitution of reagents is often the most common issue with out-of-range QC.”
Adding to Shirley’s point about less waste, German Nunez, Marketing Manager, Core Business at Dynex Technologies, located in Chantilly, VA, said, “A trend we’re seeing is multiplexing or getting multiple results from a single-reaction vial.”
Analyzer trends and COVID-19
The COVID-19 virus has created heavy testing demands that require labs to process thousands of swab tests in record turnaround times in order to identify positive cases and stave off additional infections.
At the same time, many existing analyzer features have experienced increased usage because of COVID-19 demands, such as automated ELISA processing, according to Nunez, as well as features related to hemostasis, according to Shirley.
“The most requested feature is to fully automate hemostasis testing through the implementation of hemostasis work cells. With a hemostasis work cell, the sample processing and routing is automatic and standardized, freeing up techs to perform more critical functions. Labs with specific work cells have improved their STAT turn-around-times (TATs) and have standardized the time to result for the rest of the workload. With >99 percent autovalidation, techs can spend their time on the more critical testing performed in the lab,” Shirley elaborated.
She continued, pointing out other analyzer features that also need consideration in times of COVID-19:
- High-specificity D-Dimer is critical to assess severity in COVID-19 patients. Using a high specificity D-Dimer reduces false positive patient results, allowing for a better prognostic evaluation with this biomarker.1
- Anti-Xa is recommended over APTT for the heparin monitoring of these hypercoagulable patients that may present with elevated levels of fibrinogen and factor VIII.2
- On-demand testing of HIT assays is also needed for these hemostatically challenged patients.
Danette Godfrey, Director of IVD Product Marketing at Sysmex America, located in Lincolnshire, IL, added, “The pandemic has stretched and challenged testing personnel and provided new workflows for personnel to adapt to. Automation in analytical laboratory instruments in hematology, urinalysis, flow cytometry and laboratory information solutions continue to improve efficiency and provide time savings for customers. Such improvements are realized through walk-away testing, maintenance, automated rerun/reflex testing and integrated smear preparation and automated smear review. These capabilities improve operational efficiencies, result turnaround times, and overall delivery of patient care. The pairing of these hardware solutions, along with new cloud-based informatics solutions, continue to trend in the industry.”
Training protocols amid pandemic
Prior to the beginning of 2020 and the lab industry’s introduction to COVID-19, lab directors were able to follow an established protocol when training new employees. This training method was subject to change when the same existing rules and regulations were reviewed to ensure they accommodate the specific training and testing demands of COVID-19 for existing and new lab personnel.
Because of new social distancing practices, Nunez noted that lab directors now rely on multimedia options, such as Zoom and Skype meetings, as well as webinars and remote training sessions, to ensure proper instruction is given to all lab employees.
Simon Shorter, Senior Director, IVD Product Marketing at Sysmex America, disclosed, “Our customers have continued to leverage remote learning and analyzer training, which have remained available during the difficult and restrictive travel circumstances. We have been providing certificates and continuing education units (CEUs) to laboratory technicians across the world with Virtual Instructor Led Training (VILT), e-learning and webinars.”
Two areas that still need improvements prior to training are labor and QC issues, according to Shirley. “Today’s instruments should be able to detect under-filled tubes and samples that have unacceptable levels of hemolysis, lipemia and/or icterus. Currently this is a labor drain, or process that may be skipped – with the potential of erroneous results being released.”
She continued, “The other area prone to problems is the execution of the lab’s quality control (QC) policy. With QC material stable up to 24 hours, it may be loaded onto the instrument on first shift. With the auto QC function, the instrument will run QC at the specific time and upon the use of a new vial throughout the day. Should the QC be out, test results will be suppressed until the QC issue is resolved. This is a huge time and labor savings – not only for the tech, but also for the supervisors reviewing QC.”
Lab industry challenges
Among many challenges facing manufacturers of analyzers – especially in the era of COVID-19 – one of the top priorities is to remain flexible and ready for anything that comes along. Whether that is from a large spike in coronavirus cases or a treatment-resistant strain of influenza, the diagnostics industry must remain ready to detect and treat whatever possible next pandemic presents itself in the future.
“The lab industry continues to innovate solutions to combat infection management. The situation lends itself to reliance on the industry’s scientific leaders to find the solutions customers need and remain agile to the changing agents of infection. In doing so, the laboratory industry must remain flexible and responsive to the changing needs of the market and consider novel solutions to address the impact of unforeseen supply chain interruptions to ensure minimal impact to day-to-day operations for laboratories and patients,” said Godfrey of Sysmex America.
Other challenges on the list included standardization, based on Shirley’s comment, “For many vendors, the ability to offer a standardized solution is their challenge,” and space in the lab for analyzers to do their job best, according to Nunez, who said, the “space of analyzers to generate results” is what’s needed in the lab.
Future analyzers forecast
Looking to the future of the analyzers market and the trends the industry can expect to see, Shirley from Instrumentation Laboratory asserted, “Hemostasis is one of the smaller test volumes of the lab and often upgrading or replacing these instruments is not a priority. With on-demand testing for HIT, this smaller area of the lab has become more important to supporting the hospital goals for improving patient care. Also, with the dwindling supply of qualified techs, having instruments that can implement lab policies is more desirable. It is our opinion that the industry forecast for these solutions will continue to grow.”
Nunez from Dynex summarizes a simpler, but more direct, correlation about the future of the analyzers market. He said, “The forecast keeps changing because policies keep changing.”
Commenting on the future forecast, Godfrey suggests medical and lab professionals work together for the greater good of both industries.
“The analyzer market continues to be as impacted as the rest of the lab industry with the uncertainty and unpredictability that ensues with the current state of affairs. While the extent of the impact brings ambiguity, the need for clinical laboratory solutions to support medical professionals remains constant,” she said.
Regardless of what the future holds for the clinical lab analyzers market, the one thing that remains constant is change. And as changes in disease detection and management keep coming, the lab industry and its analyzers will keep meeting the challenges that the new trends present.
- Yao, Y., Cao, J., Wang, Q. et al. D-dimer as a biomarker for disease severity and mortality in COVID-19 patients: a case control study. J Intensive Care.2020; 8, 49. doi: 10.1186/s40560-020-00466-z.
- White D, MacDonald S, Bull T, et al. Heparin resistance in COVID-19 patients in the intensive care unit [published correction appears in J Thromb Thrombolysis. 2020 Jun 22]. J Thromb Thrombolysis. 2020;50(2):287-291. doi:10.1007/s11239-020-02145-0.