Laboratory Automation in Diagnostic Microbiology:
Dr T.V.Rao. MD
Infectious diseases are now the world's biggest killer of children, young and aged, however effective diagnosis and treatment SAVE many in the world. In recent years, conventional methods of culturing for bacterial infections are found to be slow and the physicians lose vital time to take effective decisions, depending only traditional methods, which were more than many decades old, delays in effective decision in treating patients, are now being replaced by automated methods for identification and culturing, of bacterial and fungal pathogens. On average routine diagnostics can take anywhere from 48-72 hours. This delay can result in incorrect empirical antibiotic therapy, prevents early targeted therapy and can promote nosocomial infections and generate Multidrug resistant bacterial pathogens. Why has it taken until only recently for the microbiology laboratory to move towards total laboratory automation? Frankly change is hard and due to the complexity of testing, cost, and the need for the human factors, needing training of work force The historical perspective has been that, automating microbiology was too much of a challenge to undertake. However, times are changing and there is a quiet revolution afoot in microbiology. With progress of time Automation is replacing the many traditional methods owing to reduced time for culture and ease of laboratory work using machines and helping in higher isolation rate than conventional methods. Automation is not new as Automation has steadily spread throughout the clinical chemistry and clinical hematology areas of diagnostic laboratories, clinical microbiology laboratories have not been upgraded in the same pace, as microbiology is too complex to automate. In comparison to chemistry and hematology, microbiology specimens are much more complex and need better understanding as much of human surfaces and mucosal membranes are associated with normal flora. The great challenge still remain which is a true pathogen or just a normal Human flora, The newer developments in automation wish to address the challenges and cut short in turnaround time for prompt decisions for practice of evidence based medicine. WHAT DELAY IN MICROBIOLOGY REPORTS MEAN IN PATIENT CARE ?
Microbiological delays in isolation identification and antibiotic sensitivity testing will lead to empirical over treatment or inappropriate antibiotic use, a true concern to medical profession with emergence of Multi drug resistant bacterial and fungal pathogens, The increase in resistance can lead to increased acuity of patient presentation, which increases the length of stay and costs of health care, and Automation enables workflow optimization, removing unnecessary delays and better utilizing the skills of trained lab professionals ADVANCES IN PATIENT CARE NEED BETTER FASTER MICROBIOLOGY REPORTS - Many clinical specialties invested much in critical and multi specialty care and most complex procedures are done , driven by a variety of factors, we believe that the level and degree of automation in clinical microbiology laboratories are poised for dramatic change the modern laboratories equipped with newer equipment bringing in automation to the advantages of the timely decision making in critical and advanced care of the patients. The key drivers for growth of the clinical microbiology market are availability of automation, outbreaks caused by novel organisms (Swine flu virus, Ebola virus), the growing menace of antimicrobial drug resistance, the need for performing research to understand re-emerging pathogens, and identifying drugs to combat them. These factors have led to increased public-private partnerships and better funding to conduct research to develop kits for specific pathogen
TRENDS OF CHANGE IN DIAGNOSTIC MICROBIOLOGY - However, systems are emerging for the clinical microbiology laboratory with the potential to automate almost all areas of testing, including inoculation of primary culture plates, detection of growth on culture media, identification of microorganisms, susceptibility testing, and extraction and detection of nucleic acids in clinical samples. As a result, the workflow in the microbiology laboratory is changing at a rapid pace and microbiologists have the challenge of selecting the most appropriate, clinically useful, and cost-effective automation for their laboratories.
NEWER AUTOMATION IN MICROBIOLOGY BACTEC blood culture system - Since the mid-1970s there has been many advances in blood culture practices and technology; these advances have been based largely on well-designed controlled clinical evaluations of blood culture systems and media. Thus, a sound scientific basis for the fundamental principles of blood culturing now exists Instrumented blood culture systems. Until recently, the BACTEC instrumented systems were the only products commercially available in the United States; these systems were initially equipped with radiometric instruments and media, followed in the mid-1980s by the non-radiometric instruments and media. Both systems (as well as in the newer BACTEC and BacT/Alert continuous-monitoring devices) are based on the utilization of carbohydrate substrates in the culture media and subsequent production of CO2 by growing microorganisms, for the radiometric system, the instrument detects 14C02 in the bottle head space, and for the non radiometric system, CO2 is detected by infrared spectrophotometry.
MATTERS INFLUENCING THE NEED FOR AUTOMATION IN MICROBIOLOGY
increasing testing volumes
improved health care/access
Ageing population
Emerging diseases / HIV AIDS produced great challenges to Medical profession Many opportunistic emerging and reemerging infections entering the immunosuppressed patients need testing innovations, certainly created necessity for many innovations in rapid, automated and molecular methods
Infection control demands growing challenges resulting from detection and identification of multidrug-resistant microorganisms
The trend toward increasingly shorter lengths of stay for hospital inpatients has led to increased demand for more rapid turnaround times for infectious disease assays thereby improving patient care The(24/7) with microbiology laboratories support is becoming much more common, and automation that can shorten turnaround time is being viewed more favorably, and certainly greater need of the future
AUTOMATION – IN SEPTIC AND LIFE THREATING CONDITONS – it is utmost priority to save many with critical condition as happens in septic condition, blood culturing is the top priority and culturing the specimens of CSF, ventilator associated pneumonia and surgical site infections as every hour of delay account to faster death and higher morbidity and increasing costs in treating with empirical treatment, and necessities the Automation.
NEWER AUTOMATION METHODS -Although continuous-monitoring blood culture systems, automated microbial identiļ¬cation, and automated antimicrobial susceptibility testing systems are widely utilized in microbiology laboratories, microbiology specimen
BACTEC blood culture system supported with VITEK® 2:
VITEK® 2: Healthcare Optimizing Collection to Care
The VITEK® 2 system has everything the healthcare laboratories need for fast, accurate microbial identification, and antibiotic susceptibility testing.
The innovative VITEK® 2 microbial identification system includes an expanded identification database, the most automated platform available, rapid results, improved confidence, with minimal training time.
The VITEK® 2 system next-generation platform provides greater automation while increasing safety and eliminating repetitive manual operations. The rapid response time means results can be provided more quickly than with manual microbial identification techniques.
Total laboratory automation systems currently are available to handle specimens, streak plates, incubate, and digitally image cultures. “That’s one of the great things about microbiology at the moment, THE WORLD OF AUTOMATION IS PROGRESSING WITH
Automated urine analyzers
• Plate streakers
• Blood cultures
• Automated ID
• Automated susceptibility testing
• Automated molecular platforms. Gene Xpert
MALDI-TOF
Recently the availability of new technologies such as identification by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF), the utilization of liquid-based transport devices and laboratory consolidation have triggered the development of automated solutions designed for microbiology. MALDI/TOF spectra are used for the identification of micro-organisms such as bacteria or fungi. A portion of a colony of the microbe in question is placed onto the sample target and overlaid with matrix. The mass spectra generated are analyzed by dedicated software and compared with stored profiles. Species diagnosis by this procedure is much faster, more accurate and cheaper than other procedures based on immunological or biochemical tests. MALDI/TOF is becoming a standard method for species identification in medical microbiological laboratories. The technology has been readily imbibed by microbiologists who have reported usage of MALDI-TOF MS for several purposes like, microbial identification and strain typing, epidemiological studies, detection of biological warfare agents, detection of water- and food-borne pathogens, detection of antibiotic resistance and detection of blood and urinary tract pathogens etc. The first automated modules to be launched on the market were automated specimen processors. The first generations were developed more than 20 years ago, but only third-generation instruments allowing high-throughput and accurate inoculation were successfully introduced into routine diagnostic laboratories. Many working with MALDI-TOF MS experience it has become a valuable tool for a microbiological laboratory, which might potentially replace molecular identification techniques in near future.
SYNDROME BASED APPROACH IN DIAGNOSIS OF INFECTIOUS DISEASES – Till recently our approach to infectious disease with identification of individual microbial infections, as we are aware a patient can get infected in many ways with many unknown pathogens, to fulfill the desired goal multiple testing are needed, needing many resources and much with the help of the technological staff spending many working hours, and yet the results are difficult to analyze which is true of the identification the problem can be solved with newer methods and Film Array® a emerging technology
The Film Array® Blood Culture Identification (BCID) Panel tests for a comprehensive set of 24 gram positive, gram negative and yeast pathogens and 3 antibiotic resistance genes associated with bloodstream infections. The BCID Panel detects and identifies the most common causes of bloodstream infections. Quickly identifying the cause of sepsis may help clinicians more rapidly and appropriately manage septic patient therapy. Rapid identification of bloodstream pathogens may help reduce the time to appropriate antimicrobial therapy and positively impact patient survival. The FilmArray® Respiratory Panel detects 20 viral and bacterial pathogens known to cause respiratory tract infections. Test results are automatically reported in about an hour. The FilmArray® Trend is a cloud based epidemiology network that exports de-identified results from participating sites across the United States. Data displayed here aggregate results from hundreds of thousands of tests and the graphs are updated daily. Known quality control tests are removed prior to display. There are more than 20 sites contributing data to the FilmArray Trend, about half of the sites are in the East, 20% are in the Midwest and West and 10% are in the South. A manuscript describing the FilmArray Trend project is in preparation
BAR CODING THE LABORATORY SPECIMENS - Accurate identification of patients, their specimens and laboratory test results linked to them is essential in all healthcare settings for providing effective, safe, timely, efficient, equitable and patient-centered healthcare Bar coding is effective for reducing patient specimen and laboratory testing identification errors in diverse hospital settings and is recommended as an evidence-based “best practice.” The overall strength of evidence rating is high and the effect size rating is substantial. Unpublished studies made an important contribution comprising almost half of the body of evidence.
TELE BACTERIOLOGY
Telebacteriology is the use of digital imaging and file storage for on-screen reading and decision making. The laboratory has access to a library of digitally recorded images that can be electronically shared between consultants located at different sites; they may also be used as an educational tool. Thus, diagnostic laboratories can create ‘reading rooms,’ which may offer a comfortable working environment for the reading of the digitalized images. However, such an organization requires a separation of the reading and the downstream applications (i.e. subculture, ID, AST), which should be performed by different technicians for optimized laboratory workflows.
MAN, VERSUS MACHINE- Despite many arguments and counter arguments, no machine can replace a human in the microbiology laboratory. A long-standing mantra is that humans are generally considered capable of performing tasks faster than machines and that machines cannot think. The perception that machines cannot exercise the critical decision-making skills required to process microbiology specimens has persisted. Specifically, human observation of organism growth on agar plates is still considered essential by many. While machines are programmable, humans are more flexible. However, with progress of technological advances, we are entering an age of monumental change for clinical microbiology laboratories. While a precise assessment of the full impact of these changes is in its infancy, there is no doubt in our minds that the benefits of automation on laboratory efficiency and indirectly on clinical care will be profound, Automation in clinical microbiology will also have some impact on patient care by improving trace ability, reproducible, and quality and certainly reduce the morbidity and mortality, Finally, while quality of the diagnostic results was mainly based on the experience and expertise of the microbiology staff in the past, in the course of automation it will much more depend on the method or apparatus used, It is certain that next generation of Doctors dependent on Automation as everybody needs faster delivery of laboratory results helping the evidence based Medicine a true reality
References –
1 Automation in Clinical Microbiology Paul P. Bourbeaua and Nathan A. Ledeboerb, J. Clin. Microbiol. June 2013 vol. 51 no. 6 1658-1665
2 Automation and the Future of Microbiology Laboratories Labs Weigh Upfront Investment Against Faster Throughput Author: Julie Kirkwood // Date: MAR.1.2017 // Source: Clinical Laboratory News AACC
3 Laboratory automations in clinical bacteriology: what system to choose? Croxatto A1, Prod'hom G1, Faverjon F2, Rochais Y3, Greub G4. Clin Microbiol Infect. 2016 Mar;22(3):217-35
4 Automation in the Clinical Microbiology Laboratory Carey-Ann D. Burnham, W. Michael Dunne, Gilbert Greub, Susan M. Novak, Robin Patel Published November 2013 CLINICAL CHEMISTRY
5 Seng, P.; Drancourt, M.; Gouriet, F.; La Scola, B.; Fournier, P. E.; Rolain, J. M.; Raoult, D. (2009). "Ongoing revolution in bacteriology: routine identification of bacteria by matrix-assisted laser desorption ionization time-of-flight mass spectrometry". Clinical Infectious Diseases. 49 (4): 552–3. PMID 19583519
Dr.T.V.Rao MD
Email; doctortvrao@gmail.com
Formulated for web resources in Infectious diseases