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Published: 16 Sep 2011

Immunoassays for Human Diagnostic Testing

With the focus and excitement within the Diagnostic sector for Molecular Diagnostics (MDx) and Point-of-Care Testing (POCT) the major contribution that has been made by Immunoassays in the past and that continues today might be overlooked. Such a situation is not unexpected in this modern world with the need to have new things all the time. It is also true that on a broad front Immunoassays are in a maturing stage of market development whilst these new areas for Diagnostics of MDx and POCT are in the early growth phase. This might be clearer in the diagram below where the various technologies used within the in vitro diagnostic (IVD) sector are shown. In this diagram the level and cost of technology development is related to the level of product performance achieved and in the context of the customer's expectation or needs.

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Life being what it is the user needs move ahead very quickly once the basic technology problems have been solved. It is now forgotten how the various problems with Immunoassays were overcome and the impact that occurred once the use of radioactive labels was replaced by non-radioisotope labels. This development allowed the very rapid growth of such tests through the 1990s to the present day. A key driver of this growth was the capability of automating the non-radioactive Immunoassays in a way that with the small volumes of sample and reagent there was limited waste of key reagents through priming and dead volumes.

The position in 2011 for the various technologies used in IVD tests is shown in the pie chart below where the importance of Immunoassays can be clearly seen.

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The global spread of the Immunoassay IVD technology is seen in the following chart that shows the global spread of the technology as of 2011.

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Immunoassays have had a major impact on diagnostic testing and scientific research and for many years they were unsurpassed in specificity and sensitivity for diagnosis and patient monitoring. Developments to enhance the core technology with non-radioactive labels and particularly automation widened the use of the technology. At the two extremes these tests are now run on high throughput automated analysers in a wide range of laboratories and are readily available from pharmacies for self-testing in the form of pregnancy tests.

From the first commercial Immunoassay for Insulin in the late 1960s, the technology has followed a typical technology development path and is now a maturing market. There are limited technology developments as the core technology is established with addition of a few new analytes coming to market and different ways of carrying out the tests. It is for this reason that there is a shift of customer base to different segments, the POCT products, and the focus on MDx assays that allow new information to be obtained.

More information can be found here