For clinical lab test developers, the quest to identify a reference interval or normal range for their test is as important as defining zero in mathematics. At every stage of test development, especially late-stage and post-market production, having a good normal control is crucial. In most cases, having access to carefully characterized samples from healthy individuals is the key to success in the validation process.
This is also true for labs working on developing standards for tests or comparing two tests, where having a large number of normal control human samples to run side by side sets a solid baseline and assists in quantitative comparison between the tests.
However, finding a large set of serum and plasma samples from healthy donors for research at an affordable price can be challenging. Biobanks that distribute human blood samples typically have smaller sample sets comprising samples collected at different times and with poor ethnic, geographic, and age diversity. They also may not include laboratory characterization of the samples. These sample conditions are often a roadblock for researchers who want to develop test standards.
In 2015, leaders of the AACC Biomarkers of Acute Cardiovascular Diseases (BACD) Division focused on the need to compare values from different cardiac troponin (cTn) I assay platforms, as new high-sensitivity cTn assays are not widely available in the market.
As Paul O. Collinson, MD, explained in his editorial in the May 2017 Issue of the Journal of Applied Laboratory Medicine, “The knowledge of the comparability of values will prove to be invaluable in assessing and refining the findings from clinical studies where different methods have been issued.”
For such a comparison researchers needed large sets of human blood samples from healthy individuals. In response to this need, the BACD Division urged AACC to establish a human blood sample bank. Not only would the sample bank enable the BACD Division scientists to directly compare the analytical sensitivity and imprecision between high sensitive cTn assays, other researchers and clinical assay developers would have access to this valuable resource for many types of clinical research.
AACC approved the Universal Sample Bank project in 2015, and at the 2015 AACC Annual Meeting in Atlanta, Georgia, more than 700 meeting attendees committed to help fill the scientific gap and volunteered to donate blood for the sample bank. Now their de-identified samples are available and can be used in a variety of clinical studies, including assay development, standardization, and reference range studies.
A number of AACC industry and academic partners have taken advantage of this resource and obtained sample sets.
“Normally, the expense for performing a well-characterized normal range study greatly exceeds that of AACC’s asking price for a set,” said Alan Wu, PhD, professor of laboratory medicine at the University of California, San Francisco and lead principal investigator of the AACC Universal Sample Bank project. “This sample bank will help both the in vitro diagnostics industry and researchers conducting studies on novel biomarkers.”
Today, AACC’s goal is to ensure the samples and our service to industry and academic partners meet the needs of the community and support laboratory medicine research and development.
• Ethnically and geographically diverse adult population (18+)
• IRB-approved collection protocol
• Comprehensive donor data with health screening information
• Results of HbA1c, Creatinine, and NT-proBNP screens
• Available in serum, EDTA plasma, or lithium heparin plasma
To learn more, visit www.myadlm.org/samplebank