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In the US, we are struggling with the pandemic and often overwhelmed by the news of its continued toll on the populace. But the pandemic is global. How are other countries grappling with the virus? Here's the story of a private laboratory in Russia rising to the challenge.

Helix Laboratories faces the challenge of SARS-COV-2 in Russia

January 2021

Irina Skibo, Director of Technology and Projects, Helix Laboratory Services. Clinical Pathologist.Assistant (lecturing in Molecular Medicine), Department of Laboratory Diagnostics, Pavlov First Saint Petersburg State Medical University

On 26 March, Helix Laboratory Services was the first private lab testing provider to receive state accreditation for COVID-19 testing. We started testing at our core labs in Moscow and in St. Petersburg with 2,500 tests a day. In the beginning, we used test systems produced by Rospotrebnadzor’s Vector Virology and Biotechnology Research Institute.

All positive samples had to be sent to public reference laboratories for confirmation. This regulation made the times between test ordering and result reporting rather long (up to 7-10 days).

A month later, Helix’s Laboratory Facilities were certified as reference laboratories for COVID-19 and now we could do confirmatory testing of positive screening samples ourselves. It was high rates of confirmation (over 95% of all COVID-19 samples) and absolute compliance with all biosafety regulations during handling and transporting COVID-19 samples why Helix was chosen as one of the Reference Centers for COVID-19 testing.

See even more stories about COVID-19 Laboratory Challenges...

In late March, we initiated testing for walk-in patients at Helix Patient Service Centers (PSCs) and for B2B clients: healthcare providers and non-health organizations. On 14 April, Helix started the Сдайнакоронавирус.рф (sdaynacoronavirus.rf) project, which was the first private lab testing service in Russia to provide contactless sample collection at home without clinical staff. As soon as you order and pay for the test online, a courier arrives at your door at the date and time of your choice to deliver a self-collection kit, waits while you take the sample (nose and throat swab), and takes it back to the lab for testing. The project started in Spring in St. Petersburg, Moscow, and Yekaterinburg. As of early 2021, it’s available in over 20 regions of Russia.

Сдайнакоронавирус.рф is a unique project, which helped organize mass volunteer contactless testing in large cities during lockdown and clinical personnel shortage

We didn’t want Helix to be dependent on one reagent vendor and wanted to be ready for ongoing growth of testing volumes, so we have diversified our suppliers of COVID-19 test systems. At this moment, Helix uses test systems by DNA Technology, Syntol, and Alkor Bio. The Alkor Bio test system allows sampling control. This test system is used for self-collected samples (Сдайнакоронавирус.рф)

Helix employs a well-developed IT architecture, very flexible in terms of technology – with high automation and proprietary IT solutions. We are capable of using different test systems and swiftly switching from one to another.

By September, Helix’s PCR testing capacity had grown 10-fold due to investments into equipment and due to business flow optimization – today, Helix Labs can do as many as 25,000 tests a day.

Helix was the first Russian private lab testing provider that brought on antibody testing, on 16 May 2020. The initial antibody test menu included qualitative IgM and IgG tests using ELISA systems by a Russian vendor Vector Best. Later, Helix started doing total IgM and IgG antibody testing using Roche Diagnostics (Switzerland) test systems and added the IgM and IgG CLIA testing by Abbott Diagnostics (USA) to the menu. We brought on quantitative testing for IgG in August 2020 – the DiaSorin test system (Italy) was tested by Helix to be approved for use in Russia. At the same time as we started quantitative antibody testing, Helix partnered with the Military Medical Academy (St. Petersburg, Russia) in a research project on the timing of IgG antibody development and measuring their concentrations in at different times after the infection has resolved.

PCR testing volumes

The PCR testing peaks shouldn’t be evaluated in terms of demand for tests, but rather in terms of capacities of our laboratories. In April, when we did about 200,000 tests, our labs were overwhelmed; in May, the volume rose by another 100,000 tests, as we increased capacity. There was some decline in the summer, the labs only did 250,000 tests a month, but starting from September, the volume rose to 300,000 peaking in October and November with 500,000 tests a month.

The statistics for antibody testing are a little different. We saw the first peaks – over 80,000 tests a month – in June and July, while the volumes dropped down to 60,000 tests a month in August and September. In the fall, the volume skyrocketed reaching 120,000 tests in October and 170,000 in November. Quantitative IgG testing accounts for 45% of total SARS-CoV-2 antibody testing.

Experience with different testing platforms and instruments

For serology tests, we used a validation protocol involving at least 20 positive and 20 negative samples. Positive results for IgG tests done on two main tests systems – Abbott Architect и DiaSorin Liaison – were separately evaluated. The results were comparable.

In April 2020, Helix carried out a comparative study of self-collected samples vs samples collected by clinical staff. The subjects, who volunteered to participate, self-collected samples, after that clinical staff did the swabbing. The objective evaluation of sample quality was based on the epithelial cell counts and total amount of genetic material in each paired sample. The results showed no significant disagreement of self-collected samples and samples collected by clinical staff. The results of this study were published in a peer-reviewed journal. This helped us make a decision about starting at-home sample collection for COVID-19 testing.

Testing protocols

We’ve been through three stages involving different architectures of testing:

1. March to April – confirmation of positive COVID-19 screening tests was done at public reference labs;
2. May to October – confirmatory testing of positive samples was done by Helix. (Helix Laboratory Facilities were certified as reference centers for COVID-19.);
3. From November 2020 – PCR testing without follow-up confirmatory testing (under the decision of the National Sanitary and Epidemiological Service). However, Helix still does confirmatory testing of ambiguous results.

Serology testing does not require confirmation.

In compliance with the requirements of the authorities, it’s mandatory that Helix performs testing of the clinical personnel once a week, and except the individuals who have IgG antibodies.

QC for COVID19 methods

We mostly use QC materials provided by the manufacturer of the test system. Third-party QC materials have not yet been approved in Russia.

External quality control programs are being used at Helix: Federal Service of External Evaluation for Quality of Laboratory Tests and CAP (College of American Pathologists)

Supply challenges with swabs, reagents, and other supplies.

In the beginning, we faced challenges with consumables for automated PCR testing. Standard materials (tubes, Eppendorf tubes, etc.) have always been available. In the first months, we had some shortages of specific consumables that we use (because all stages of PCR testing are highly automated). However, thanks to long-term commitment of our suppliers and largely exclusive partnership terms, we receive our orders full and complete. In the beginning, it was obvious that the volumes would be rising, so we increased our stockpiles of some materials from a two-week volume to a two-month volume. In addition, we increased and diversified our pool of vendors to minimize the risk of supply disruptions.

One of the challenges was that starting from September the sample had to be collected from two sites: nose and throat – before that only throat swabs were required. The demand in swabs increased two-fold, but our suppliers have managed to help us with this.

In spring, the situation with individual protection equipment was extremely troubling, vendors almost ran out of them. Later, many clothing manufacturers converted to producing PPE, and now masks, one-piece protective suits, etc. are available.

Plans for 2021

Helix Laboratory Services is planning to increase the capacity of PCR labs to up to 60,000 tests a day by February 2021. First of all, thanks to starting PCR labs in regional Laboratory Facilities in Krasnodar and Yekaterinburg. In Spring, a fifth laboratory facility is scheduled to be opened in the city of Novosibirsk – this will make result reporting faster and help increase the number of B2C and B2B customers in the Siberian Federal District.

Helix will continue with developing mobile services for customers: lab diagnostics at home, self-collection, and remote consulting.

The public health situation in Russia

In the beginning of the pandemic, when all efforts were focused on providing enough COVID-19 tests, private labs got actively engaged in the testing. Those who wanted to get a work permit needed to undergo checks for compliance with regulations on proper sample transport and disposal, infection safety for personnel, and testing quality. Helix was the first lab to get the accreditation by the National Sanitary and Epidemiological Service and to start testing for COVID-19. We partnered with federal and regional offices of Rospotrebnadzor and within the first month we fine-tuned the process so that it was in compliance with all requirements. The requirements were mostly about accountability – Helix managed to rapidly set up automatic notifications of the relevant agencies about positive results and provision of statistics in different perspectives. Besides that, we delivered several governmental contracts from Moscow Department of Health and from regional Health Ministries. To do so we connected to regional HISs – this helps include the samples in the workflow and thus report the results faster. Moreover, this minimizes the risk of human error, since the whole information exchange is done electronically.

We thank Helix for sharing their story with us.