Error-free samples: a home DNA analyzer will detect infections with high accuracy

Russia has created the first nucleic acid analyzer to detect infections at home. The results become known in half an hour and allow you to diagnose the disease with an accuracy that was previously available only in the laboratory. Experts' opinions on the development are divided. Some believe that it will successfully replace the popular test strips for COVID-19 and flu. Others are sure that there will be no special benefit for an ordinary person in the invention, since he will still have to consult a doctor to confirm the result and prescribe treatment. For more information, see the Izvestia article.

The first home DNA analyzer

Pirogov University specialists have created the first Russian portable nucleic acid analyzer for home use. The device is specially designed for non-specialists in order to quickly diagnose any infections. Unlike existing systems for self-detection of pathogens, it has much greater sensitivity and accuracy, which were previously available only in the laboratory.

— To date, this is the first and so far the only solution in Russia for home diagnosis of infections by the method of nucleic acid testing — NAT (nucleic acid test). Mobile diagnostic systems have been on the market for a long time, but they cost hundreds of thousands of rubles and are used by rescue or military specialists. Our goal was to create a technology for the rapid detection of infectious agents at home," Alina Gamisonia, director of the Center for Coordination of Personnel Training for Genetic Technologies, told Izvestia.

Photo: Pirogov University

The small reusable device consists of an amplifier (increases the number of DNA copies for more accurate analysis) and a detector. Special disposable reagent cartridges are attached to it. The system allows you to quickly and accurately find out the cause of the malaise. Unlike test strips that are already familiar for home conditions (for example, for COVID-19), it does not use enzyme immunoassay, but isothermal amplification (a method of repeatedly copying sections of DNA or RNA), which is ten times more sensitive.

The diagnostic procedure — from taking a smear to starting the analysis — takes two to three minutes. And the measurement results are ready in 20-40 minutes. Up to six specific pathogens can be investigated in one study. Cartridges (for the diagnosis of viral, urogenital, hospital and dental infections) allow detecting almost any microbes at home. The technology helps to find both DNA and RNA viruses. The device has a monitoring system: if the biomaterial was assembled incorrectly, the device will report an error.

Photo: Pirogov University

The accuracy of home testing is slightly lower than laboratory testing, which is also due to possible errors by the patient during self-collection of biomaterial and examination, therefore it is recommended to confirm a positive result in the clinic.

— Our strategy is to make the technology mass-produced. It is logical to offer the detector and cartridges to the buyer through pharmacy chains. In conditions of periodic epidemics, it seems advisable that such a device be in every home medicine cabinet along with a blood pressure monitor and thermometer. Now the ambulance service is interested in the technology to equip the teams," said Alina Gamisonia.

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Will the device become popular with users

According to immunologist Mikhail Bolkov, in conditions of a constant increase in the number of new pathogens, including those transmitted to humans from animals, as well as new variants of influenza, the developed device will help to recognize the disease faster.

— Of course, overdiagnosis and improper use of the device are possible among users of the device. But for everyone who is currently buying diagnostic rapid tests, for example for COVID-19 or flu, such a device will definitely be more interesting. If the cartridges are available in pharmacies or with delivery, it will be very convenient. Today, a person was tested for chlamydia, tomorrow for HIV, and the day after tomorrow for coronavirus infection. Although you still need to see a doctor for symptoms, the patient will already have a preliminary diagnosis. After all, now in polyclinics, infections are not detected using molecular methods, but with the new device, every rural outpatient clinic can do this," he believes.

Photo: Pirogov University

According to Andrey Martyushev-Poklad, an expert at the National Technology Initiative "Helsnet" and the Union "Health of the Healthy", the device can serve as a decision-making support tool, especially in the context of epidemics. However, its use is associated with a number of problems. For example, the wide variety and high variability of pathogens of mass infections create a high risk of false results, both positive and negative.

— According to statistics, viral infections occur in most people once or twice a year, and most often they are mild. In this case, the severity does not depend on the pathogen, but on the state of the immune system. Therefore, it is logical to expect low demand for the device from individual consumers. It is definitely not suitable for a home medicine cabinet. It is more reasonable to use it in a team and by ambulance crews," said Andrey Martyushev-Poklad.

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According to Stanislav Strastanov, head of the laboratory for the analysis of public health indicators and digitalization of healthcare at MIPT, the benefits of the new device are possible when monitoring infections among participants in mass events, but this is usually handled by Rospotrebnadzor, which has its own developers of test systems.

— It is not entirely clear what to do if the device showed you the presence of some kind of infection at home, because it cannot prescribe treatment or issue a sick leave, - said the expert.

Photo: Pirogov University

Valery Polunovsky, market expert at Healthnet NTI and head of the development Department at National Center for Genetic Research LLC, agrees that the device is unlikely to be popular with end users. It would make more sense if the device would be purchased by private medical centers, primary care clinics, corporate medical services and, possibly, ambulance services — they have the qualifications to select the material, interpret the result and follow-up actions.