Toward Higher Standards in Viral Diagnostics
From pig pancreases to precision medicine, we rely on quality assurance and validation to keep tests accurate and reliable – but standardization also plays a crucial role
Neil Almond |
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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