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European Biopharmaceutical Review

The Quest for a Cure

In 2003, the outbreak of severe acute respiratory syndrome (SARS) became the first pandemic of the 21st century and exemplified the rapid rate at which a virus can spread internationally. Originating in China, SARS quickly spread to other Asian countries, in addition to confirmed cases outside of the continent, there were four cases in the UK, and a significant outbreak in Toronto, Canada (1-2). Since then, several viral outbreaks have occurred globally, including the Zika epidemic, occurring in South and North America between 2015-2016, and the COVID-19 (SARS-CoV-2) pandemic 2019-2020. In comparison to SARS (over 8,000 cases), and Zika (approximately 1.5 million cases), the current COVID-19 outbreak has over 4.9 million cases, with 248,297 total laboratory-confirmed cases in the UK alone at the time of writing (2-4). The rapid growth at which this virus has spread internationally exemplifies the urgent and increasing need for rapid development of readily available, high-performing diagnostic tools, to support global efforts in controlling pandemics.

As stated by WHO, diagnostic testing for COVID-19 is critical to track the virus, understand epidemiology, inform case management, and suppress transmission (5). With COVID-19 symptoms not easily distinguishable from the common cold or flu, rapid population screening paired with lab diagnostic testing is one of the most effective methods to control the spread of infection, enabling earlier quarantine and treatment. However, for this to be effective, diagnostic developers must evaluate and manufacture tests as quickly as possible while we are still learning about the emerging virus, and be able to quickly adapt to changes in the outbreak, to best prepare for reoccurrences.

Traditional Lab Testing

Diagnostic testing methods for an infectious disease harness a variety of technologies, including molecular and immunoassay platforms. Once an infectious disease outbreak is known, polymerase chain reaction (PCR) molecular testing is the frontline response as the required primers can quickly be developed and implemented once the viral sequence is known (6). PCR enables the amplification of a small sample of DNA to accurately detect the presence of viral RNA or the viral genome early on in infection, rather than detecting antibodies, the body’s immune response, which take longer to present. An additional step is required when using PCR to test for RNA viruses, such as SARS-CoV-2, to enable the conversion of viral RNA to a complementary DNA template via reverse transcription-PCR (7).

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David Wilson is Commercial Director of Avacta’s Reagents & Diagnostics programme. He has over 25 years’ international experience in business development, marketing, and sales management in the in vitro diagnostic medical devices industry. David is a board member for two early-stage diagnostic businesses developing novel point-ofcare diagnostic testing platforms, and has served on the executive committee of the British In Vitro Diagnostics Association.
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