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Tuberculosis Mycobacteria in Air

#3713


Development of Device for M. Tuberculosis Hygienic Monitoring in Indoor Air

Tech Area / Field

  • MED-DID/Diagnostics & Devices/Medicine
  • MED-OTH/Other/Medicine
  • INS-MEA/Measuring Instruments/Instrumentation

Status
3 Approved without Funding

Registration date
14.03.2007

Leading Institute
Research Center of Toxicology and Hygienic Regulation of Biopreparations, Russia, Moscow reg., Serpukhov

Supporting institutes

  • State Research Center for Applied Microbiology and Biotechnology, Russia, Moscow reg., Obolensk

Collaborators

  • Centers for Disease Control, USA, WV, Morgantown\nLovelace Respiratory Research Institute, USA, NM, Albuquerque

Project summary

The project objective is to develop an experimental model of a portable device for hygienic monitoring of M. tuberculosis in indoor air.

The choice of M.tuberculosis (Tb) as a target agent is motivated by the fact that nowadays the problem of tuberculosis is extremely urgent in many countries worldwide. According to the WHO data, about 30% of the globe population (~5.7 bln people) is infected with tuberculosis, which rapidly becomes a pandemic infection. Despite 40-year expertise in anti-tuberculosis chemotherapy, 8 mln cases of infection and 2.9 mln. lethal cases are annually registered in the world. Existing methods for control of air contamination for Tb including plating on medium and identification of the grown colonies using microscopy take about 30 days; besides, they are low sensitive. Therefore, it is urgent to develop a device for direct and rapid detection of airborne mycobacteria. Such device will provide a manual and automatic monitoring of air contamination with mycobacteria and taking appropriate sanitary-epidemiological measures for anti-tuberculosis prophylaxis.

The proposed hygienic monitoring device (HMD) is intended for express detection of Tb in indoor air in the presence of other physical and biological contaminants. Besides, it makes it possible to give quantitative assessment of Tb in the air (Tb concentration per unit of air volume), i.å. evaluation of personnel infection risk in test working area. The device can also be used for analysis of liquid samples from water supplies and food for Tb presence. Multifunctionality of the device will help find wide application in different spheres of industrial activities, in health care and sanitary-epidemiological monitoring systems, in microbiological industry and related scientific institutions conducting studies on mycobacteria as well as on development and production of protective means against Tb.

The device must meet the following requirements:

  1. HMD is a self-contained portable device with add-in vacuum booster and software programmable units for sampling, transportation and sample analysis;
  2. The device must be of small size and weight (under 5 kg);
  3. HMD must be easy to use for non-trained personnel;
  4. The device must be cost effective and commercially profitable.

The device consists of 2 basic units – aerosol sampler and Tb detector - and each of them should meet its own specific requirements.

Aerosol sampler:

  1. volume air sampling rate –100-300 l/min (will be specified at the stage of designing);
  2. aerodynamic resistance – up to 10 kPa;
  3. bottom cut-point, d50 – 0.7 - 0.8 µm;
  4. time of continuous operating - up to 30 min;
  5. volume of adsorptive liquid in sampler –up to 10 ml;
  6. dimensions and mass –minimal possible.

Tb analyzer:
  1. target infectious agent - M. tuberculosis
  2. is based on a variant of Tb immunochemical analysis;
  3. sensitivity limit - 102 - 103 microbial cells/ml;
  4. analysis duration – no more than 10-15 min;
  5. simple and fast change of preparation and analysis cycles.

The project research will be carried out considering the above-mentioned criteria for HMD designing.

SFES RCT&HRB of FMBA of RF is a leading Russian scientific institution in the field of aerobiological research and aerosol engineering. In 2006, ISTC #1487p Project “Sampler for detection and express-identification of airborne microorganisms” financed by DTRA (USA) was successfully completed. In the course of the Project, a series of bioaerosol samplers for different purposes was developed, for which 2 RF patent applications were submitted. Based on the conducted studies in the field of methodology for detection and express-identification of target microorganisms analyzers-biosensors immunochromatographic and metabolic tests were developed and served a basis for designing automatic control system for detection and express-identification of target airborne microorganisms including Tb. Study results are published in a scientific journal “Aerosol Science & Technology” (2006, #40 (5), p.293-308) and presented at 12 International conferences. At present, a number of articles and patent applications on novel modified aerosol samplers are under preparation. The proposed project is a continuation of the efforts made on #1487p Project. Within the project it is planned to optimize the developed designs of bioaerosol samplers and Tb analyzers with the purpose to enhance their sensitivity and improve reliability of assessment. In addition, bringing the project developments up to the commercial level and initiating an industrial production of the developed devices is of importance for the project authors.

The role of FSES SRC AMB as a participating institution is methodological support of the processes of detection and identification of M. tuberculosis based on perspective trends of immunochemical studies. Reliable detection of Tb in vivo needs maximal sensitivity of the used methods. In our opinion, the most promising in this respect is immunofluorescence and PCR methods. Earlier conducted studies demonstrated that using a refined technique of fluorescence signal scanning on analytical surface sensitivity of detection achieves 102 CFU/ml. The obtained level of sensitivity is compatible with PCR, the most sensitive present-day method for analysis of microorganisms, at that, technical implementation of this immunofluorescence-based device is simpler and does not include expensive components compared to the PCR-analyzers.


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