Microbiology as a science has expanded by leaps and bounds in the past few decades due to advancements in sophisticated instrumentation and recombinant DNA technology, which added new dimension and revealed the understanding of the subject at molecular level. Now, the latest buzz in the clinical laboratory is automated specimen processing and digital microbiology
The landscape of microbiology is rapidly changing from one of heavy manual procedures and multiday 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 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.
There is no denying that the ability to respond quickly to the ever-changing clinical needs of patients today can be achieved quite eloquently by modern molecular diagnostic methods. While molecular diagnostics and next-generation sequencing are still in their relative infancy and currently cannot replace bacterial cell culture in full, the benefits of the early generations of these technologies are apparent. Most importantly, they have given clinical microbiologists the tools to view their world from a new vantage point and contribute to the well-being of patients in a way that is simply not possible using culture techniques.
The Indian microbiology analysers and reagents market in 2014 is estimated at `255 crore. The reagents at `204 crore dominate the market with 80 percent market share.
There is an increase in the demand for laboratory automation, also it is of utmost priority to educate healthcare practitioners to better understand the quality and accuracy of their systems, follow recommended guidelines, implement best practices, accreditations, and improve the turnaround time for all laboratories, making it easier for the clinician to start his targeted therapy and better patient healthcare management.Indian Market The Indian microbiology analysers and reagents market in 2014 is estimated at `255 crore. The reagents at `204 crore dominate the market with 80 percent market share.
The key drivers for the growing market remain the need for user-friendly compact systems and PoCs, which bring about early initiation of goal directed therapy in the management of infectious diseases. The risk of healthcareassociated infections from invasive monitoring techniques, opportunistic infections due to immunosuppressive therapy, emerging drug resistance among microbes (bacteria, viruses, fungi, and parasites) are factors that have driven clinical microbiology into the fastest growing laboratory sciences in the last decade. The challenge remains in achieving quicker and faster diagnosis.
The global clinical microbiology market is expected to reach US$ 12,411 million in 2019 from US$ 6,727 million in 2014, at a CAGR of 13.03 percent between 2014 and 2019.
The microbiology testing market is segmented on the basis of applications into clinical, energy, environment, food, manufacturing, and pharmaceuticals. The pharmaceuticals application segment accounted for the largest share of the microbiology market in 2014. Each of these market segments is further divided into multiple product segments and subsegments. The microbiology testing consumables market consists of two sub-segments, namely, kits and reagents. The kits segment accounted for the largest share of the microbiology testing consumables market in 2014 and is expected to grow at the highest CAGR between 2014 and 2019.
The microbiology testing instruments market is subsegmented into automated microbiology instruments, laboratory instruments, and microbiology analyzers. The laboratory instruments accounted for the largest share of the microbiology testing instruments market in 2014, whereas the automated microbiology instruments segment is expected to grow at the highest CAGR between 2014 and 2019. The laboratory instruments are further categorized into anaerobic gas systems, automated gram stainers, automated petri dish fillers, autoclave sterilizers, bacterial colony counters, incubators, microbial air samplers, and other laboratory instruments. The microbiology analyzers are further categorised into mass spectrometers, microscopes, and molecular diagnostic instruments.
Increasing incidences of infectious diseases will be an important growth driver for the market. Furthermore, increased healthcare funding along with growing burden of new diseases will aid the growth of this market.
Microbiology as a science has expanded by leaps and bounds in t.he past few decades due to advancements in sophisticated instrumentation and recombinant DNA technology, which added new dimension and revealed the understanding of the subject at molecular level. Now, the latest buzz in the clinical laboratory is automated specimen processing and digital microbiology.
Laboratory automation and digital microbiology are trending topics high on a lot of laboratoriesâ€™ list. During 2014, different manufacturersâ€™ systems of the new generation of full laboratory automation and digital microbiology were installed in North American laboratories. The modular and open full laboratory automation systems for microbiology consist of front-end specimen processors that automatically seed cultures, prepare Gram slides for staining, and inoculate broths, with a conveyor track connecting the processors to smart incubators which include image acquisition stations that gather the images needed for downstream digital microbiology analysis. So, what are some of the early benefits and process improvements that these automated lines are bringing to laboratories across the globe?
Laboratory automation and digital microbiology are trending topics high on a lot of laboratoriesâ€™ list
A key component of the new full laboratory automation in microbiology is the use of smart incubators, which place each individual plate on its own shelf. The initial rationale for individual shelves inside the smart incubators is mainly for random and faster retrieval when the laboratory professional wishes to access a particular plate. However, one interesting benefit of the smart incubators is that cultures grow faster in them as compared to traditional incubators, and therefore cultures are ready to be read sooner. The reason for the faster growth is that each culture plate is placed on its own shelf inside the incubator, which provides for a homogeneous atmosphere and efficient thermal conductivity in the incubator to bring the culture plate up to optimal conditions faster. Because the smart incubators are not constantly being opened, they are able to maintain those optimal conditions uninterruptedly. As this incubation technology is implemented, microbiologists and clinicians will be able to work together to select the optimal reading time to benefit from faster growth with faster turnaround times for reports.
Digital microbiology allows the laboratory to share the image of a culture plate and/or of the Gram stain with the physician, who may be in a remote location. This is a practice currently used in some laboratories that have adopted full lab automation of the microbiology laboratory. Laboratory personnel can provide key patient information and consultation to clinicians faster to expedite patient treatment and improve care.
Standardisation and rationalisation A downstream indirect benefit of full laboratory automation in microbiology is the standardisation and rationalisation of sample containers. The adoption of automated specimen processing technology, however, is driving laboratories to standardise and rationalise the containers they receive to optimise the use of the automated processors. When laboratories adopt full laboratory automation they define, which specimens are to be included and stratify which have the highest priority, to be able to roll out the implementation in stages starting from the highest sample volume with the highest negativity rates.
As more and more laboratories embrace technologies, the benefits in terms of faster TAT, better patient care, and the relevance of traditional culture will be substantial
Automated specimen processors are able to handle non-liquid samples, but in order to maximize the use of the processors, microbiology laboratories are optimising workflow by standardising containers, such as vacuum tubes for urines, elution swabs, and sputum liquefying containers, among others. Standardisation of sample collection devices benefits clinicians by simplifying and reducing the number of specimen containers needed at specimen collection sites. In fact, liquid-based microbiology allows clinical specimen optimisation and has several important advantages: cost reduction (due to the smaller number of different devices used), time savings for medical or nursing staff (less confusion in collection device selection and fewer samples being collected), time savings for laboratory staff (fewer samples to access and handle for individual investigations), and patient comfort improvement (multiple sample collection can be avoided). Faster colony growth, grouping culture plates by estimated number of colonies for streamlined analysis, providing clinicians with digital patient records with images of cultures and Gram stains for clinical actionable results faster, and laboratory standardisation are early buzz-worthy benefits of full laboratory automation and digital microbiology. As more and more laboratories embrace this new technology, the benefits in terms of faster turnaround times, better patient care, and the relevance of traditional culture will be substantial.
The image acquisition stations built into the full laboratory automation systems use highly sophisticated cameras and versatile lighting systems to obtain sharp, unparalleled high-resolution images. The high quality of the images acquired by the system enables laboratorians to zoom in on the culture plates and to detect even small colonies that could be obscured or potentially be hard to see. One manufacturer has pioneered discriminative image analysis software that uses the plate image taken at time 0, and compares it to the images taken after incubation. The software is able to discriminate artifacts present on the plate at time 0, focus on the growth, and recognise even small colonies. The software groups the plates according to the estimated number of colonies, and the system then sorts the plates from most estimated colonies to least estimated colonies and presents them to the laboratory professional for interpretation and analysis. The laboratorians can then decide which plates represent significant growth and choose to work these up first.
According to Gabriela Franco, Director of Marketing, Copan Diagnostics, this new technology helps speed up the workup of positive cultures, by presenting them to the operator first, and leaving the nogrowth cultures for last. In the case of no-growth cultures, the laboratory professional, after reviewing the plates, can result them in groups, without having to manually discard the plates. It is important to emphasize that the new systems do not make the decisions for the laboratory personnel; the software simplifies and groups culture plates for faster interpretation and increased operational efficiencies.