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.
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, treat and cure the infection is reduced.5 In diagnosing MRSA, an automated molecular diagnostic test could be used to determine the exact strain and antibiotic-resistance profile directly from the patient’s GPCC-positive blood culture. The test could be designed such that time-to-results would be 40 to 60 minutes. Additionally, minimal handling would be required by a laboratory technician, very low costs would be incurred, and the process could be run on demand during any shift, day or night.
New Age for Molecular Diagnostic Testing
Molecular diagnostic testing has brought with it many benefits, but the time has come to take greater advantage of this innovation with automated molecular diagnostic solutions. At its core, this innovation will equip the lab to perform at its best, with more flexible staffing, lower costs and quicker diagnoses. Automated solutions are the future of the lab.
References
1. Hospital-Acquired Infections in Pennsylvania. A report by the Pennsylvania Health Care Cost Containment Council 2008, www.phc4.org.
2. Alarm Sounded Again Over Shrinking Supply of Lab Personnel. National Intelligence Report 2008; 29:4-6.
3. Shortage. Critical Values Newsletter, American Society for Clinical Pathology 2008; 1(4)
4. Berens, MJ, Armstrong, K. MRSA: Patients revolt against hospital secrecy. Seattle Times 2008
5. Cunningham, R, Jenks, P, Northwood, J, Wallis, M, Ferguson, S, Hunt, S. Effect on MRSA
transmission of rapid PCR testing of patients admitted to critical care. J Hosp Infect 2007; 65:24-