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.

Description

When studying chemical, biological, radiological or nuclear threatsit 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.

Using telemetry

Telemetry has become a gold standard in the world of research for the acquisition of wireless, automated and continuous physiological measurements from undisturbed subjectsNo 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.  

TheeasyTEL 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 cutaneoussubcutaneous 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. 

 

 

Seizure 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 monthsThese implants are priced for single use and save you the time and hassle of explanting and cleaning. 

For rats and larger subjectsour 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 animalsour 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 verificationFrom 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. 

Inhalation and respiratory assessment

The respiratory system is often affected due to the inhaled nature of chemical threats.

For  large animals, our non-invasive emkaPACK4G system uses 1 or 2 belts to record lung volume for respiration measurements by Inductive Plethysmography (RIP). This technique provides tidal volume, minute volume and accumulated volume as well as phase angle.

In rodents, the vivoFlow whole-body plethysmograph tracks changes in ventilatory parameters throughout the progression of a respiratory infection. This technique provides continuous high-fidelity respiratory recording including measures of respiratory rate, estimated tidal volumes and minute ventilation. To additionally obtain accumulated volume assessment, a head-out plethysmograph must be used. Each animal can be assessed for the dose it specifically receives via an inhalation route.

The flexiVent has been 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 feature permit unique and novel insights into inflammatory responses and evolution of lung injury throughout the progression of an exposure.

The inExpose administers drugs and novel therapeutic carriers through the inhalation pathway, a preffered route for preclinical models.It standardizes experimental conditions providing reproducible and relevant animal models.

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

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