Automatic biopathogen analyzer "Detector-Bio"

2016−2020

Partners
Ministry of Health of the Russian Federation
The National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya of the Ministry of Health of the Russian Federation
JSC "Krasnogorsky Zavod" (KMZ "ZENIT") (Shvabe, Rostekh)

Automatic device for detection and identification of pathogenic biological agents based on two independent detection methods

Challenge

For security services to detect hazardous biological pathogens in the air at airports, train stations, stadiums and other public places, routine air sampling is needed. It requires a laboratory with 5−6 employees working 24/7. Such a laboratory cannot be organized everywhere.

The Russian Ministry of Health requested for developing a device for automatic screening of indoor air. We were faced with the task of automating the processes of sampling, sample processing, analyzing for various pathogens, and evaluating the results.

Solution

Together with our partners, we created the device "Detector-Bio", a bioanalytical laboratory assembled in a single case, with all the processes automated. The device analyzes air samples and sends the results to a specialized information network.

To meet the specifications — the device should fit through a standard room door — we had to solve the problem of how to fit the functionality of an entire laboratory into such a small space. Finally, we managed to put everything necessary for sample collection, analysis and storage, as well as the control and emergency power systems, inside the housing.

In the device, we implemented a process of efficiently collecting aerosol particles, concentrating them, and transferring the sample into the liquid phase. Our partners developed a special powerful impactor, which pumps 10,000 liters of air per minute. Microparticles and pathogenic biological agents are transferred from the pumped air into an aqueous solution further treated with ultrasound, which destroys the bacterial membranes. Next, sample preparation is performed for the two types of analysis.

We have implemented in the "Detector-Bio" the ability to work both by schedule and by trigger. For this purpose, an additional aerosol particle counter was installed to the main impactor, continuously screening and triggering the analysis process when the background rate is exceeded.

To detect as many pathogens as possible, the instrument uses two independent bioanalytical methods: multiplex immunoassay and real-time PCR. The immunoassay detects specific proteins of bacteria, viruses, and toxins. PCR analysis detects bacterial and viral nucleic acids.

PCR is performed inside the reaction chambers of a microfluidic cartridge specially designed for the instrument. Each of the six chambers is pre-filled with specific reagents: allowing the sample to be tested for sixty different pathogens at at the same time.

Given that reagents and samples need to be stored at +5˚C in a refrigerator, the device has been designed with zones that continuously maintain the required temperature regimes.

The most challenging and exciting part was to design the automation for each analysis step and create protocols with sequences of each node.

We managed to implement a smooth process of sampling, preparation, two analyses, results processing and sending, and sample archiving. We also provided the possibility of remote control through an intuitive interface.

To sum up, with all the processes performed by robots following one another without pauses, the complete analysis cycle in "Detector-Bio" takes only about 2 hours. To compare: if we had a stationary laboratory, this would take 5−6 hours (during working hours and without taking logistics into account).

Result

A pilot batch of devices has been released. The device has successfully passed state testing.

Team

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