The Future of the Laboratory

Today's laboratory is under pressure on many fronts: staffing deficiencies, demand for round-the-clock results and low profitability.1 Lab managers looking to hire and retain skilled technicians to complete the complex molecular diagnostic tests demanded by healthcare today are hampered by smaller budgets and a shortage of trained laboratory workers.2 The problem has serious national and global implications as the industry struggles to find prospective employees entering the field, increase reimbursement and educate the healthcare world about the important role the laboratory plays in healthcare delivery.3 Critical to solving this problem will be the advancement of the laboratory itself, specifically in the field of automating molecular diagnostic testing. With the spread of infectious diseases, the need for molecular diagnostic testing continues to grow exponentially. Polymerase chain reaction (PCR) testing and its real-time fluorescence-based detection is the current method of choice, however, PCR testing is multifaceted and requires a significant time investment from the laboratory technician. It is also vulnerable to sample impurities and cross-contamination. Due to sensitivities intrinsic to molecular diagnostics, these tests are considered highly complex by the Clinical Lab Improvement Amendments and are subject to more rigorous standards. Such a rating requires that the testing only be performed by technicians with specific certifications and advanced training, and generally staff the lab during the day shift. New Technology Creates Alternative for Complex Testing While a number of companies have recently entered the market with automated analyzers with inexpensive cartridges for specific routine lab tests such as blood lipid, creatine, and electrolyte levels and others, none provide PCR-level molecular diagnostics. Now entering the market is the next wave of automated laboratory analyzers with the innovation to offer an alternative to PCR-based testing and allow less experienced technicians to perform the test. The first generation tests came with a higher cost, but these new products answer the call for a lower cost thus increasing profit margins for the laboratory. "Labs can improve reimbursement and reduce time-to-delivery with automated molecular diagnostic testing." The model system will perform at or above the sensitivity level of the PCR test, but at a decreased cost and significantly lower complexity. The new platforms in the market combine automated sample preparation with isothermal amplification and chip-based visual detection systems to create a molecular platform that is fast, offers disruptive economics, and is highly versatile. The simple process begins with the loading of a small sample onto a disposable test cartridge by a laboratory technician. The cartridge is then placed in the analyzer before the technician starts the machine and, within an hour, can return to comprehensible results. Faster Results Create Clear Benefits The overall simplification of the system will create immediate and important benefits for the laboratory. A key change will be seen in the overall staffing of the laboratory. Previously, complex testing required a high dedication of hours and a certain level of skill. Now, with the automated system, less experienced technicians can perform the test. This directly impacts the employee structure within the laboratory, as the need for specialists can remain low and the automated testing can be performed during every shift. Costs incurred by hospitals will also be reduced by the automated system's ability to quickly identify infectious diseases. Clinical outcomes and treatment decisions are a direct result of the time between a patient presenting with symptoms and the delivery of test results. The automation of molecular diagnostics presents a cost-break to hospitals, as the time to diagnose, treatAir Zoom Vomero 14