"Proof of concept" pilot study: bioprocess chain of custody and bioresource sample management temperature observations. Sample level temperature trends and stability data obtained via utilization of bluechiip(®) temperature tracking technology.

Background: Preservation and optimization of biosample integrity to foster relevant research results and outcomes is a guiding principle of sample management. Tracking pre-analytical biospecimen lifecycle variables and bioprocessing chain of custody data enables documentation of adherence to best, regulatory and quality biobanking practices. Knowledge of individual sample and sample set temperature variability is believed to enhance delineation of artifacts during downstream analysis. Analysis of temperature responses may elucidate understanding of temperature trends which can aid downstream interpretation and provide an empirical foundation for "fit for purpose" sample management protocols and evidence-based biobanking practices. Bluechiip and the American Type Culture Collection (ATCC) conducted a pilot to test the bluechiip technology(®) performance and validate key proofs of concept for tracking temperature of biological samples.

Methods: One hundred six (106) Corning(®) cryovials with bluechiip(®) buttons and one hundred six (106) standard Corning(®) cryovials labeled with 1-dimensional (1D) barcoded labels were evaluated. Identifiers were tracked and temperature data recorded in corresponding environments ranging from -192°C to +57°.

Results: Nine of ten proof of concepts, defined in collaboration with ATCC successfully demonstrated functional capabilities of the bluechiip(®) technology. Bar-code label read performance was compared, producing evidence demonstrating a high rate of failure on the bar-code arm.

Conclusion: Temperature data collected heightened observations of sample temperature variability. Prevalence of bar-code label read failure and issues affecting reliability of barcode performance may be under-reported and unrecognized in sample management practice, particularly when the temperatures are lower than -60°C. It appears the bluechiip(®) tracking technology may offer increased reliability over one-dimensional (1D) bar-coding technology; however while promising these findings require validation in future trials, including two-dimensional (2D) bar-coding technologies.