Chemiluminescent techology underpins global adoption of tests for infectious diseases
Research has led to the development of blood screening and clinical tests that have been adopted worldwide for the detection of viruses and bacteria.
Nucleic acid amplification test (NAAT) technologies have allowed the development of highly sensitive tests that are capable of detecting small quantities of nucleic acids in infectious agents.
The superior analytical sensitivity can potentially produce a positive signal from as little as a single copy of the target DNA or RNA. However NAATs are prone to interference, potentially yielding incorrect results, particularly when conducted in automated, high-throughput systems.
Developing second-generation technology
Researchers in the School of Medicine led by Professor Ian Weeks and Professor Stuart Woodhead, investigated the light-emitting (chemiluminescent) properties of a family of chemical dyes and their use in biochemical analysis. By using two types of light-emitting dyes, one that flashes and one that glows, they were able to to sensitively detect and quantify multiple biochemical targets simultaneously.
Early research showing that the modified dyes could be used to develop clinical diagnostic tests formed the basis of patented inventions.
The research was transformative in providing a solution to the need for the internal control of nucleic acid amplification in high-sensitivity chemiluminescent in vitro screening and diagnostic assays.
The technology is used globally in more than 60 million in vitro diagnostic tests annually. Sales of the tests approach $500 million per year and the sub-licensee was subsequently sold for $3.8 billion.
Benefits for clinical practice and commerce
The research has led to the development of in-vitro blood screening and clinical diagnostic nucleic-acid amplification assays that have been adopted worldwide for the detection of infectious agents. Benefits include earlier disease detection and a reduced incidence of incorrect results.
The technology is used in a range of tests for infectious agents, for example HIV, HCV and HBV, the detection of which is vital in maximising the safety of blood transfusions and blood products.
Globally, the technology is used in more than 60 million in vitro diagnostic tests every year. Sales of the tests approach $500 million per year and the company that adopted the technology was sold for $3.8 billion.