- Human Biospecimens
- For Researchers
- For Biospecimen Contributors
- For Patients
July 11, 2016
Every day millions of Americans go in for diagnostic testing to check the status of their health or the progression of disease. In vitro diagnostics (IVD), tests performed in a lab setting on biological samples that are taken from the body, are conducted billions of times per year in the United States and thousands of such tests exist. Of utmost importance to medical testing, as we discussed in a previous post, is clinical accuracy. That post covered the human component of making sure tests are performed correctly, but there is also a purely technical component – validating that the instruments themselves, such as machinery and testing kits, are functioning as they should. For the June Specimen Spotlight, we cover procuring fresh whole blood within hours of draw for an IVD company testing its equipment.
Instrument validation requires procuring biospecimens that adhere closely to real-life conditions under which the tools are used. In this case, the IVD company was testing hematology equipment and required a large volume of fresh blood from normal healthy donors. Over a three-month period, iSpecimen collected daily from consenting research donors, taking under four hours to get the samples to our customer, from blood draw to delivery. Fresh and fast, the samples were taken from participants twenty-five 2mL tubes at a time, from approximately 30 donors per week, resulting in a grand total of close to 10,000 tubes of fresh normal blood delivered for the project.
Rigorous collection, packing, and transport schedules were critical to the success of this endeavor. The comprehensive pre-planning gave way to a process that ran quite literally like clockwork, enabling our customer to assuredly validate its tools with a fresh and plentiful blood supply. The next time you go to a doctor’s visit and need to have diagnostic testing, remember that philanthropic patients and the donation of high-quality human biospecimens are essential to ensuring the accuracy of your results.