12:00 AM
Jul 23, 2015
 |  BC Innovations  |  Tools & Techniques

The price of a gold standard

Why getting to validated antibodies will be challenging

While a new protocol for validating antibodies from the Structural Genomics Consortium goes part way toward addressing one of the biggest sources of irreproducibility in academic research, stakeholders agree a widespread solution will likely require a matrix of methods rather than a single technique. But what they don't agree on is who should foot the bill.

The debate involves antibodies used as research reagents, and extends to four principal issues: Who should set the standards? Who should enforce them? Who should do the work of validating antibodies? And who should pay for it?

NIH's James Anderson told BioCentury there is no doubt that poor methods and reagents are one of the major causes of the low success rates in reproducing results from published papers - a growing concern in translational science.

"About half of the reagents researchers buy to track proteins don't recognize what's written on the label," or are not specific for the target protein, he told BioCentury.

Anderson is director of the Division of Program Coordination, Planning and Strategic Initiatives at NIH.

Stakeholders who spoke with BioCentury outlined several factors that are involved in ensuring antibody quality.

First, validation needs to address different technologies including polyclonal, monoclonal and recombinant antibodies, which have varying degrees of batch-to-batch variability.

Second, the requirements for validating an antibody vary by its use. For example, conditions used for antibodies in western blots differ from those used in immunohistochemistry or immunoprecipitation. That means that standards and techniques need to be developed for each use.

Third, the techniques used for validating antibodies might require expensive instrumentation and dedicated expertise, such as the new method developed by the SGC, which involves mass spectrometry. Those capabilities are often beyond the resources of many life science labs.

But who should do this work and who should pay for it is an open question.

Anderson suggested that because end users have a direct stake they should shoulder some of the responsibility.

"If investigators don't acknowledge this issue and validate reagents before they do an experiment, then their interpretation of their work can be false," he told BioCentury.

But other stakeholders believe the list of requirements suggests the problem won't be solved organically by individual researchers taking it upon themselves.

Instead, they propose that organizations such as NIH, the Global Biological Standards Institute (GBSI), the SGC or a for-profit company should drive the change.

Whose job?

According to Anderson, while NIH has a role to play in ensuring antibody quality, which it can manage through requirements for grant applications, it has no "regulatory authority" and can't set or...

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