Mobile Diagnostics

MobiLab | The lab-to-go for fast and mobile on-site molecular diagnostics of biological pathogens

The demands for a molecular pathogen diagnostic under ield conditions and the associated robust and fast analytic are increasing. Currently available pathogen detections require proof testing of samples in a qualiied laboratory by trained personnel, whereby manpower, time and money are enormous. In order to reduce waiting times and to enable a low-cost sample analysis in the field, Analytik Jena has developed a device platform that meets these re-quirements. The overall system is very easy to use which makes the operation for laymen possible and as well reliable. The system also provides state-of-the- art, highly speciic pathogen detection in less than one hour.

Ultramodern instrument platform: MobiLab

The MobiLab is designed so that even non-special ists will be guided step by step through a computerized manual from beginning of the sampl ing to the specific pathogen detection. This can be done easily and quickly, as the MobiLab combines nucleic acid extraction, thermal mixer and rapidPCR cycler in an expedient way. On the basis of an integrated high performance battery and supply in a robust case the system allows very flexible applications – future-oriented in the field.

Due to the external power supply the MobiLab can be operated indoor on a surface of a sheet of DIN A4 paper to replace an entire laboratory. On the position, where normally one lap-top finds its place, now two fully equipped workplaces can be established. The over-all concept offers enormous variety and is therefore suitable for different applications. Both the robust housing and the soft-touch control panel are optimized for the outdoor use and realize an easy and thorough cleaning and disinfecting.

To meet the requirements of every user and various applications the MobiLab is available in two versions. Both devices combine an entire laboratory, including extraction, thermal mixer and PCR thermal cycler in a suitcase. If a simple Yes/No statement of a single sample or a sample pool is needed the MobiLab One is the right choice. With its removable Blocksystem Combi it allows easy storage and building up at lowest place. If samples should be analyzed under ield conditions or even in a wet-wet environment the MobiLab Case is the best system. The operation takes place by a 5.7’’ touchscreen and an integrated Windows CE computer.

Mature technology for on-site analyses

This is the f irst ever mobi le system for nucleic acid isolation followed by targeted rapidPCR amplification and inal detection.Yet another highl ight : the system saves an enormous amount of time. The full process is typical ly completed in less than 60 minutes. The MobiLab system includes an integrated thermal shaker for ef fective sample lysis of dif ferent star ting materials. DNA/RNA extraction is based on patented

DC technology and proceeds by binding the nucleic acids to magnet ic particles. A specially designed magnetic trap rapidly separates bound nucleic acids from other cellular components. The device also includes a rapidPCR thermal cycler in which the sequence of interest is quickly ampliied using RAH-(Rapid Amplification and Hybridization) technology and then hybridized in the same reaction.

Redefining pathogen detection

Ready-to-use kits, containing all of the reagents and consumables needed to detect different pathogens, have been perfectly adapted to the MobiLab system. Kits include, among other materials, sampling vessels and materials (such as swabs), reagents for nucleic acid extraction and PCR components in a preformulated and storable form.Novel reaction cartridges, in which the entire amplification and detection process takes place, are also included. This closed system reduces operating errors and contamination to an absolute minimum. Final pathogen detection is highly sensitive and is performed on a Lateral Flow Strip (LFS) containing an additional conjugate control to verify the reaction.

• Identification and quantification of toxins and pathogens
  
• Fully automated, stable, electrochemical detection on microarrays
  
• Plug & play operation using disposable one way chipsticks
  
• User-friendly operation and data analysis, incl. alarm feature
  
• Robust housing for mobile NBC detection systems such as those found in emergency management vehicles or for stationary monitoring systems used in public buildings
  
• In-house production of monoclonal antibodies for quantification (BoNT-A, -B, -F, SEB, ricin) and detection (BoNT-F, SEB and ricin)
  
• Samples are easy to handle
  
• Short measurement times (approx. 20 minutes for toxins/proteins; approx. 10 minutes for DNA/RNA)
  
• Limit of detection = approx. 0.5 ng/mL

Detection principle

The principle of Chip-detection with the ePaTOX II is based on an electrochemical reaction. The process utilizes chips with extremely fine, nanoscale electrode structures produced using the state of the art silicon semiconductor technology. A biochip of this kind includes 16 measuring positions which are then loaded with various receptor molecules specific to the application. Depending on how the biochip is configured, this allows scientists to detect multiple toxins or pathogens in parallel on a single chip. The sample to be studied is automatically pumped across the chip during the detection process, allowing the target molecules in the sample to bind to their complementary receptor molecules (e.g., antibodies, oligonucleotides), which are immobilized on the surface of the chip.

This step is followed by enzyme marking. Fixed on the chip in this way, the enzyme then converts a substrate that can be detected in an electrochemical reaction. The electrode structures on the chip make it possible to measure an electrical signal — the size of the signal is directly proportional to the concentration of the target molecules in the sample. This electrochemical detection principle makes it possible to achieve high analytical sensitivity, and the resulting detection system is immune to the effects of turbidity and other sources of optical interference.

Clearly structured and intuitive

The ePaTOX II is particularly easy to use: its fully automated, userfriendly software controls the analytical process, provides the user with necessary instructions and analyzes the test results. The system also displays important notes for error-free routines. A simple syringe filtration step is used for preparing protein or toxin samples. Appropriate, ready-to-use kits are also available. The ePaTOX II is ideal for integration into mobile ABC systems and for the monitoring systems used in public buildings such as airports, harbors and subways or laboratories.

The system offers extensive, group-specific detection options for toxins and/or pathogens. Toxins detected include ricin, staphylococcus enterotoxin B and botulinum toxin A, B and E. The system can detect the following pathogens after appropriate DNA extraction and PCR: Bacillus anthracis, Yersinia pestis, Francisella tularensis and Orthopoxvirus. One special feature of the system is its high tolerance to a variety of different sample matrices (such as water, milk, starch, flour, juice, soil, aerosols, etc.)

Array-based test format

Simultaneous analysis of multiple electrode positions is the test principle underlying an array-based, electrical biochip. For detection to occur, the target molecules must bind to the specific receptor molecules immobilized on the chip. To this end, each of the 16 mea-suring positions have been modified with corresponding receptor oligonucleotides and/or antibodies, thereby enabling detection of multiple biomolecules in parallel within a single sample. Because an exceptionally wide variety of receptor molecules can be immobilized on the chip, a considerable number of solid-phase-bound detection systems (such as ELISA, i.e., enzyme-linked immunosorbent assay“) can be transferred to the biochip.

Target and detection limits:

ePaTOX Toxin Kit I

• Botulinum toxin A: 2 ng/mL (30 ng/mL complex)
• Botulinum toxin B: 2 ng/mL (20 ng/mL complex)
  
• Botulinum toxin E: 5 ng/mL (50 ng/mL complex)
  
• SEB: 0.5 ng/mL
  
• Ricin: 2 ng/mL

ePaTOX Pathogen DNA Kit I

• Bacillus anthracis
  
• Yersinia pestis
  
• Francisella tularensis
  
• Orthopoxvirus
  
• Detection limit: 10 – 100 DNA copies in the starting material