What does the future hold for Microbiology?

The latest buzz in the clinical laboratory is automated specimen processing and digital microbiology. In recent years digital microbiology has been adopted in Europe but remained an unexplored area in North America. However, the North American interest in this field is growing at a fast rate. Automated specimen processors plant and streak samples onto culture plates, prepare Gram slides and subculture broths, and apply Kirby-Bauer and ID discs. The specimen processors are connected to conveyor belts that take the processed culture plates to smart incubators. In the smart incubators, high-quality images of the plates are captured, using different lighting, at different time intervals, to replicate what humans see at the bench. The plate images are used for digital image analysis. High volume simple cultures, such as urines or nosocomial cultures, have high negativity rates. Despite high negativity rates, these high-volume cultures require manual interaction for reading and reporting. By reading the cultures on a computer, instead of traditional benches, laboratories can save time by discarding all negative cultures without having to touch the plates. Laboratory professionals can focus on handling only the positive cultures, streamlining their workflow for faster turnaround times.

— Gabriela Franco, Director of Marketing
Copan Diagnostics, Inc.
Maker of WASP and WASPLab

In clinical microbiology, we are seeing molecular-based multiplex assays becoming more widely used because of the superior specificity and sensitivity they offer. This paradigm shift toward rapid, multiple-pathogen detection technologies is driving the need for more advanced biological controls to meet CLIA requirements for validating, verifying, and monitoring these complex systems. While individual live culture controls are necessary for growth-based testing and testing of individual targets, modern molecular technologies do not rely on culturing microorganisms prior to testing.

Inactivated microorganisms, genomic extracts, and synthetic materials are a few examples of the innovative controls entering the market for quality control testing of molecular instruments. Pooled controls take this a step further and are necessary for effective and efficient QC of multiplex panels. Specialized biomaterial producers have the expertise to develop highly stable tittered controls containing multiple analytes to support users of multiplex assays. As regulatory agencies continue to place increasing emphasis on using reference materials from accredited manufacturers, laboratories should be looking for controls that carry the Medical In Vitro Diagnostic (IVD) or CE Mark designations.

— Brian Beck, PhD
VP of Molecular Products and Services
Microbiologics, Inc.
Provider of Helix Elite Molecular Standards

While culture-based methods have been recognized as the gold standard in clinical microbiology for more than 100 years, the recent emergence of multiplexed molecular technologies has enabled labs to test for broad panels of pathogens with high sensitivity and specificity in a matter of a few hours instead of a few days. These comprehensive molecular panels have been associated with improved patient outcomes, reduced hospital costs, and improved antimicrobial stewardship.

However, as the number of targets available on each panel continues to increase, so does the cost, begging the question of whether a one-size-fits-all diagnostic approach is appropriate for patients whose presentations do not warrant testing for all targets on the panel. This poses a problem in an era when labs are being asked to be more efficient and cost-effective, while at the same time healthcare is pushing for more personalized patient care.

I believe that the future of microbiology is in the development of broad molecular panels that offer laboratories the ability to respond to clinician ordering patterns based on their unique patient populations and treatment algorithms, and report and ultimately pay only for the subsets of targets that are relevant for each patient. Such tests would enable platform consolidation and provide a flexible solution to meet the laboratory’s workflow and cost needs while satisfying the physician’s requirement for timely, accurate, cost-effective results.

— Michael McGarrity, President & CEO
Nanosphere, Inc., developer of the Verigene System,
a multiplex molecular diagnostic platform

The landscape of microbiology is rapidly changing from one of heavy manual procedures and multi-day processing times to one of robotic automation and rapid results. Robotics automates plating and incubation to improve accuracy, consistency, and safety by reducing direct handling of plates or specimens.

Clinical laboratories are greatly investing in molecular platforms that detect and quantify infectious disease agents. PCR-based tests have replaced culture for some organisms, reducing turnaround times from days to hours. Mass spectrometry (MS) provides identification at the species, genus, and family level in only minutes. The ability to report the organism to a clinician in a shorter time reduces assumptions and allows for more effective treatment by getting the right drug the first time.

Sequencing is a powerful application platform that will revolutionize microbiology. The complexity of data interpretation requires a larger investment than automation, PCR, or MS techniques, however; eventually, molecular and sequence-based genetic testing may surpass culture to the degree that the desire to invest in sequencing eclipses that for plating and culture automation.

— Megan Schmidt, BS
Senior Product Manager,
Sunquest Information Systems
Creator of Sunquest Laboratory

What does the future hold for Microbiology?

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