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Outside the Lab Quality assurance and quality control, Microbiology and immunology, Regulation and standards

Toward Higher Standards in Viral Diagnostics

At a Glance

  • When it comes to diagnostics and treatments, standardization is key – but often inadequate
  • Without the ability to compare between assays, it’s difficult to determine whether differences in the results of two samples are meaningful 
  • Adequate assay standardization requires reliable units and trustworthy reference materials
  • As technology – especially next generation sequencing – advances, we need to develop new reference materials to ensure we can keep evaluating test reliability

How much insulin is present in a preparation of pig pancreas for treating diabetes?

How much bacterial antitoxin is present in the serum of a horse immunized against infection?

These are just two of the questions that scientists were grappling with 100 years ago and ultimately gave rise to the National Institute for Biological Standards and Control (NIBSC) – an organization that has spent the last half-century tackling the challenge of measuring biological medicines. Although such medicines may seem crude to the modern practitioner (pig pancreas or horse serum, anyone?), the methodologies we developed then still have a lot to teach us, even in the age of synthetics and biosimilars.

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About the Author

Neil Almond

Neil Almond is Head of the Blood and Tissue Pathogens, Adventitious Agents and Diagnostics group in the Division of Virology at NIBSC.

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