TestGene, LLC From Ulyanovsk Nanocenter Launches Mass Production of the Developed Genetic Test to Detect Coronavirus COVID-19 Infection

18 May 2020

The novel test system “CoV-2-Test” was developed by TestGene scientists in about a month. On May 15, the test system received a registration certificate from Roszdravnadzor (Federal Service for Surveillance in Healthcare). Now first batches of the tests are already being prepared for shipment to the regions of Russia. The test systems enable the real-time testing of 1 samples per 2 minutes. If the testing is carried out correctly at all stages the test system enables the detection SARS-CoV-2 RNA with maximum accuracy (at least 96%).

The development of the CoV-2 Test is based on a reverse transcription polymerase chain reaction, which detects the presence of genetic material from a virus. A test sample is biomaterial collected from a person’s nasal or oropharyngeal mucosa or sputum. Testing takes about 2 hours.

According to the guidelines of the World Health Organization, tests for COVID-19 coronavirus should be performed using reverse transcription polymerase chain reaction (RT-PCR). As stated in the recommendations, today this is the most accurate and reliable method for detecting a viral infection. It detects even a very small amount of virus RNA in human biological material. This helps to detect the disease during incubation period or at early stages. When developing the test system, the recommendations of the US Food and Drug Administration (FDA) were also taken into account.

According to Denis Viktorov, Ph.D. in Biology, Head of Laboratory for Scientific and Technical Development of TestGene, real-time RT-PCR method is the best laboratory method for detecting SARS-CoV-2 coronavirus, since it is highly sensitive and allows detecting even single copies of the virus RNA in a biological sample. It is also highly specific as the flexibility at the development stage allows selecting unique nucleotide sequences found only in this virus.

The new test system has successfully passed clinical trials in Federal State Budgetary Healthcare Institution “Head Center of Hygiene and Epidemiology of FMBA of Russia” (Moscow) and showed 96-100% accuracy when carried out correctly at all stages, the sensitivity is 500 copies/ml for the virus.

Andrey Toropovsky, Ph.D. in Medicine, CEO of TestGene, LLC: “The company’s production capacity and GOST ISO 13485 certification allow us to produce up to 50,000 tests per day at the initial stage, and in the future to upscale production to 2 million per month. TestGene will provide any assistance in the delivery of test systems to the regions of Russia. All PCR laboratories are equipped with devices for performing such tests and consequently, testing can be carried out not only in specialized centers, but also in any laboratory. To enter the foreign market, we are preparing to receive the European CE certificate for the test system (French: Conformité Européenne — ‘European compliance’).”

According to Mr. Toropovsky, one of the bottlenecks in diagnostics for now is the throughput capability of laboratories, the so-called “human factor” — during one shift, one laboratory assistant can qualitatively isolate RNA from about 100 samples, but the demand for tests is much higher. Therefore, the need to automate routine procedures becomes obvious.

“When developing the test system, we initially considered the possibility of automating the process with the use of robotic stations which would increase the productivity of laboratories by 8 times. For instance, one such laboratory can perform up to 800 tests per day, i.e. 1 tests per 2 minutes, which means that diagnostics will become more accessible, reliable and fast,” said Andrey Toropovsky.

Key parameters of the CoV-2-Test test system:

  • The test meets requirements of the WHO and Ministry of Health of the Russian Federation for the diagnosis of COVID-19, has Roszdravnadzor registration certificate (RU No. RZN 2020/10364 of 15.05.2020).

  • RT-PCR method can be used in any PCR laboratory.

  • Testing sample — biomaterial from nasal or oropharyngeal mucosa, sputum from lungs.

  • Test accuracy — 96-100%, provided that it is carried out correctly at all stages.

  • Test sensitivity — from 500 copies/ml.

  • Delivers results in 2 hours.

  • Disease is diagnosed in the incubation period and at the earliest stages.

  • Initial production capacity — 50,000 tests per day, planned — 2 million tests per month.

  • It is IMPORTANT to perform properly all pre-testing stages, which begin even beyond the lab. The test system is intended to detect the virus in a specific sample delivered to a laboratory. Incorrect collection of biomaterial, errors during transportation can lead to the absence of the virus in the sample.

TestGene, LLC (Ulyanovsk, Russia) is a developer and manufacturer of genetic test systems for molecular diagnostics in the following areas: non-invasive prenatal diagnostics, diagnostics in oncology, identification of the mutations associated with targeted therapy response or resistance, diagnostics of infectious diseases. TestGene has been a resident of ULNANOTECH since 2013.

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