Infectious Disease & Medical Countermeasures Research
As it is related to infectious disease and chemical, biological, radiological or nuclear (CBRN) threats, Medical Countermeasures (MCM) research* and development is unique and requires specific solutions throughout the process of data capture and analysis.
When studying chemical, biological, radiological or nuclear threats, it is important to understand the effect of the agent itself, but also the potential effects of any therapeutic countermeasure.
The evaluation of physiologic changes often includes assessment of physiologic parameters or biomarkers such as temperature (onset of fever and recovery), respiration (respiration rate, tidal volume), cardiovascular (heart rate, mean pressure) and neurological endpoints (seizure and sleep state).
*FDA U.S. Food & Drug Administration “What are Medical Countermeasures?” February 05, 2018.
Our preclinical solutions are actively used to model the development of COVID-19. With features such as automated fever detection and real-time alarms, researchers are well-equipped to perform natural history, trigger for intervention, and drug efficacy studies for ongoing SARS-CoV-2 research.
In an interview, Brent Barre from Lovelace Biomedical Research Institute explains how he currently works on multiple active SARS-CoV2 studies, using telemetry and plethysmography to look at temperature for onset of fever and respiratory outcomes on various animal models.
Telemetry has become a gold standard in the world of research for the acquisition of wireless, automated and continuous physiological measurements from undisturbed subjects. No matter what signals you’re acquiring (ECG, blood pressure, temperature, etc.), telemetry allows for more natural conditions, minimizing the stressful interactions between researchers and subjects.
As explained by David G Dawson et al , “the incorporation of biotelemetry into the field of infectious disease research has resulted in new insights to pathogenesis and helped to improve the usefulness of animal models, while also resulting in refinements to animal welfare.”
Depending on the needs of your study, emka TECHNOLOGIES offers implantable or non-invasive wireless telemetry systems to acquire multiple physiological endpoints from various sized subjects. Additionally, our non-invasive systems save you to time and expense associated with surgery.
See our implantable systems See our non-invasive systems
Temperature monitoring & automated fever detection
As one of the oldest clinical indicators of disease in mammals, temperature is a crucial parameter to monitor, especially for infectious diseases where an acute fever is one of the first symptoms.
The easyTEL implanted telemetry system monitors and captures in real-time core body temperature and activity from small to large animals (80g to 10kg or more) such as Syrian Hamsters, Rats, Ferrets, Pigs, Dogs, or Primates. Temperature and activity are recorded continuously for up to 150 days in rodents and 285 days in large animals.
When fever or hypothermia is detected, system can send e-mail to preset lists of technicians or directors (for treatment or animal welfare euthanasia criteria), display a flashing warning on monitoring screens and activate a sound alarm on monitoring computers.
In iox2 acquisition software, onset of fever or hypothermia is detected if current temperature exceeds or decreases below preset thereshol. The threshold can use the Standard Deviation or the raw temperature value as the criteria.
Cardiovascular Endpoints and Analysis
Our implantable telemetry systems allow you to transmit desired physiological data (ECG, arterial blood pressure, etc.) from various sized, conscious and freely moving subjects. Whether you’re using rodents or large animals, our compact system allows for continuous data collection for several weeks or months. These systems offer flexibility, allowing you to group house up to 32 subjects as well as reconfigure transmitters after implantation (sampling rate, resolution, gain).
For large animal non-invasive studies, our emkaPACK4G system can collect ECG, activity and more with a transmitter conveniently housed in a jacket worn by the animal. Blood pressure can be acquired using an oscillometric cuff (non-invasive), a vascular access port, or an easyTEL+ implant.
In-depth cardiovascular analysis is performed with ecgAUTO software. Using pioneer shapte recognition technique, ecgAUTO can analyze normal or abnormal ECG morphology from any species and any lead to provide:
- Beat-by-beat calculation of intervals (RR, QRS, QT), amplitude, signal elevation etc.
- Single or multi-lead analysis from any type of cutaneous, subcutaneous or intra-cardiac leads
- Inter- and multi-lead processing
- Automated multi-file analysis
- Predefined/customizable QTc formulas
A range of purpose-built modules can be added for specific analysis of Heart Rate Variability, arrhythmia, conduction abnormalities detection and Isolated P waves detection.
Toxic agents such as chemical warfare agents can cause seizures through various molecular mechanisms and pathways. As shown in the study by Jeffrey et al1., monitoring EEG activity on animals exposed to toxic agents such as agent VX or sarin can help illustrate the neurobiological consequences of these toxins.
Our implantable telemetry systems come in various sizes to accommodate different species and allow for collection of up to 4 EEG or EMG for several weeks or months. These implants are priced for single use and save you the time and hassle of explanting and cleaning.
For rats and larger subjects, our rodentPACK head-mounted system offers an interesting alternative for high-quality and noise-free EEG acquisition. This cost-effective system allows you to reuse transmitters across cohorts and is ideal for obtaining up to 4 EEG or EMG’s from small animals. The non-invasive rodentPACK system can be used for seizure assessment in large animal models as well.
For large animals, our non-invasive emkaPACK4G system can be used in combination with our easyTEL+ implants to attain neurological endpoints, core body temperature and more.
Our EEG analysis module allows the analysis of EEG morphology with time-synchronized video for behavioral verification. From the EEG signal, the seizure detection module automatically detectcs seizures, combining multiple user adjusted criteria and logical modes:
- All detected seizures are logged in a table
- Invalid seizures can be deleted
- Undetected seizures can be created
- Valid seizures can be exported to text or xls files
Researchers can generate FFT power spectrums or heat map/spectrograms for further visualization.
1 Addition of ketamine to standard-of-care countermeasures for acute organophosphate poisoning improves neurobiological outcomes (Jeffrey David Lewine et al, NeuroToxicology, 2018).
Percutaneous exposure to the nerve agent VX: Efficacy of combined atropine, obidoxime and diazepam treatment, Marloes J.A Joosen et al, Chemico-Biological Interactions, 2010
Prophylaxis with human serum butyrylcholinesterase protects Göttingen minipigs exposed to a lethal high-dose of sarin vapor, Ashima Saxena et al, Chemico-Biological Interactions, 2015
Inhalation and respiratory assessment
The respiratory system is often affected by CBRN agents. Our telemetry, plethysmography, and exposure systems are currently used in medical countermeasures research and many other applications.
emkaPACK4G non-invasive telemetry for large animals uses 1 or 2 RIP* bands to assess changes in frequency, tidal volume, and minute volume. The use of 2 RIP bands produces additional measures including phase angle, an assessment of abdominal and thoracic asynchrony and a surrogate for bronchoconstriction. This modular system, currently being used in BSL-3 labs, offers temperature, ECG, blood pressure, and activity as optional endpoints. Real-time email alerts based on user-defined thresholds assist with trigger for intervention studies, while ecgAUTO and its integrated modules serve as a single platform for pulmonary, cardiovascular, and neurological analysis needs.
Whole body plethysmography permits a continuous and non-invasive assessment of breathing patterns in conscious subjects. Measurements of respiratory rate, estimated tidal volume, and minute ventilation provide valuable insights into the subject’s conscious response to a vesicant induced lung injury.
The flexiVent is used in a wide range of applications focused on vesicant induced lung injury (chlorine, sarin, mustard, etc.). Its unique ability to measure central vs. peripheral airways, combined with delivered dose estimators and automated dose-response features permit novel insights into inflammatory responses and evolution of lung injury throughout the progression of an exposure.
The inExpose is a compact, customizable inhalation exposure system, which provides a reproducible method of exposing animals to a test atmosphere, creating relevant and practical animal models. It is specifically designed for targeted aerosol delivery by controlling air flow rates and aerosol generation devices. The inExpose’s ability to minimize the ingestion with the nose-only tower, or minimize stress using the whole-body chamber, provides control over the experimental conditions beyond the typical inhalant parameters and offers a unique testing environment for therapeutics.
For more information on current BSL-3 and non BSL-3 models of coronavirus, and more details on respiratory solutions available, please click here.
*Respiratory inductance plethysmography
Mark R. Perry et al. A novel sulfur mustard (HD) vapor inhalation exposure model of pulmonary toxicity for the efficacy evaluation of candidate medical countermeasures. Inhalation Toxicology Vol 0, No 0 (2021)
Palipane, M. et al. Macrophage CD14 impacts immune defenses against influenza virus in allergic hosts. Microbial Pathogenesis Volume 127, February 2019, Pages 212-219.
Dumm, R. E. et al. Non-lytic clearance of influenza B virus from infected cells preseves epithelial epithelial barrier function. Nature Communications. 10(1), p. 779. (2019).
McGraw, M. D. et al. Bronchiolitis obliterans and pulmonary fibrosis after sulfur mustard inhalation in rats – American Journal of Respiratory Cell and Molecular Biology, 58(6), pp. 696–705. 2018.
GLP compliant solutions
Introducing a new software application into an organization working in a regulated environment, especially in biosafety containment structures, involves many complex business processes and can be tedious and time-consuming.
To comply with regulatory requirements, optional GLP modules can be activated with each emka TECHNOLOGIES’ software.
Furthermore, our dedicated validation specialists can provide full service, or à la carte validation of our systems. We can help you lower validation costs using methods such as risk analysis, gap analysis and impact assessment in relation to the relevant GLP guidelines. As the system provider, we are knowledgeable on how the systems operate, thus, we can provide effective validation assistance through our validation support service packages:
- Support to customer and/or third-party package
- Sample plan and test script models package
- Tailored models package
- Full validation process package