“Good samples make good assays”: How to Source High Quality Biosamples
In vitro diagnostics is only as good as the quality of the biosamples used in the study. For an assay to truly meet the expected threshold for quality and reliability it must begin with biosamples that have an excellent preanalytical status. It’s equally as important to have the biosamples annotated with accurate metadata including biometrics of the sample donor, the diagnosis, imaging, and any treatment offered. In this article, we highlight a study that demonstrates the importance of good samples for good assays as well as offer tips on sourcing for high quality biosamples.
“Good Samples Make Good Assays” Belgian Article
This article was authored by Belgian researchers Sofie K. Van Houcke und Linda M. Thienpont and was published in Clinical Chemistry and Laboratory Medicine in 2012. [1]. In the article, the authors describe the experience of the IFCC Working Group for Standardization of Thyroid Function tests (WG-STFT) which the authors describe as “torturous.”
The WG-STFT Group conducted a 3-phase trial; we have only discussed challenegs enocutered in the phase III.
The WG-STFT had planned to collect two different sets of samples; the first with 90 samples for FT4 analysis and the second with 100 samples for TSH analysis. From each sample, they needed metadata from each donor such as biometrics, co-morbidities, as well as medications being used. They also required at least 15 mL of serum aliquoted in portions of 0.5 mL and stored at a temperature of –70°C.
Sample Collection Challenges
The WG first reached out to clinicians who treat thyroid disease from across the world for biosamples. While majority of the clinicians were interested in supplying the samples, the regulatory and ethical hurdles (ethical Committees and institutional review boards) became insurmountable.
The WG approached a commercial biospecimens supplier next. The supplier claimed to have the collection capacity and compliance required to provide the biospamples. While the price quoted was high, the WG was too eager to get the phase III study going and hence agreed to it. However, the sample procurement process was difficult and prolonged causing the deadline to be missed severally. This is in spite of efforts by the commercial vendor to contract new clinicians, hospitals and collection centers.
Finally, the chairholder of the WG made new contacts (endocrinologists) at the Belgian Thyroid Club where she had been invited as a guest speaker who were finally able to come through with the required samples. Unfortunately, the acquired samples did not meet the 15 mL volume requirement. The delays mentioned above stalled the phase III study for over one year.
The article quoted above showcases the difficulties that clinical researchers often go through when sourcing for biosamples that they need. The authors thus recommend “collaborative effort towards establishing a sample procurement infrastructure, based on a solid relationship not only with commercial suppliers, but also with a significant number of committed clinicians in hospitals” to prevent such costly delays.
How To Source High Quality Biospecimens
“High quality biospecimen” is not a universal term as this may vary depending on the nature of the study and the type of biospecimen in question. For example, in whole genome amplification studies it is crucial to maintain DNA integrity. Failure to do this may result in significant alterations in the clinical outcome. Quality issues in biospecimen may also result during the collection, processing, or storage.
Here are a few pointers to have in mind when sourcing for high quality biosamples.
If youre a researcher in the private sector, you can either access biosamples directly from biobanks or you can use a commercial intermediary. [2] Both routes have pros and cons that we have discussed below:
The Direct Route
As a private researcher you can approach a public sector biobank to supply you with biospecimen that you need for your research. This entails searching through biospecimen directories such as the UKCRC Tissue Directory and the BBMRI-ERIC Directory. Such directories are usually helpful when you are searching for biospecimens for common diseases with simple clinical information. However, should you be searching for biospecimen for rare diseases this might be a hard find. A prospective and bespoke biospecimen collection works best for this kind of research. Another shortcoming of public sector biobanks is an overly stringent access policy and administrative processes. On the flip side, direct access makes itr easy to trace the origin of the biospecimens.
The Indirect Route
Private researchers may be able to access biosamples through commercial intermediaries such as commercial biobanks, virtual biobanks or specimen brokers, and CROs. This route usually has less stringent access policies, administrative processes, and hence provides faster access. On the flip side, traceability of biosamples may be an issue.
Its an assumption that since commercial intermediaries must “make their cut,” the indirect route should be more expensive. However, this is not always the case. When biosamples are sourced from overseas cpountriewss such as India where costs of living are lower, the overall cost of biosamples may be cheaper.
Partner With the Best Biospecimen Provider
The ideal biospecimen provider should not only offer high quality biosamples but they also need to offer expertise on extracting the most value from the biosamples. This means going the extra mile to ensure that the biosamples are deeply-phenotyped and well annotated with metadata regarding disease type and severity, co-morbidities, past treatment offered and the response and such kind on information. In other words, the “full story” of the biosamples.
At Garner Biosolutions, we begin by understanding the research questions and use this information to provide biospecimens that will be relevant both for current and downstream research. We leverage our extensive network of hospitals in India to provide ethically sourced samples that meet USA compliance standards and protocols including 45 CFR part 46, HIPAA, 21CFR Part 50/56, and the Uniform Anatomical Gift Act. Our process is swift since all paperwork and protocols have been pre-established. Contact us today to learn how we can help you access high quality and racially diverse biosamples that meet your research needs in an efficient manner.
References
Van Houcke, S. K., & Thienpont, L. M. (2013). "Good samples make good assays" – the problem of sourcing clinical samples for a standardization project. Clinical chemistry and laboratory medicine, 51(5), 967–972. Retrieved from https://pubmed.ncbi.nlm.nih.gov/23045383/
Catapult Medicines Discovery: A guide to sourcing biosamples;The advantages and disadvantages of direct or indirect access. Retrieved from a Biobanking Specialist, Robert Hewitt. Retrieved from https://md.catapult.org.uk/a-guide-to-sourcing-biosamples/