Validation of a Reusable, Thermally Protective Specimen Shipper for Decentralized Sample Collections.

Background: The proliferation of decentralized sample collection models improves patient access and experience with laboratory medicine. However, many analytes have limited stability in liquid whole blood, serum, or plasma such that prompt transport under controlled temperature protection is crucial to analytical accuracy. Here we validate the Labcorp TrueTherm™ reusable shipper intended to thermally protect small volume specimens.

Methods: Various TrueTherm shipper models were configured using stainless steel vacuum bottles, rigid phase change material (PCM) packs, and foam stoppers. A series of bench and real-world trans-US shipping studies were performed to evaluate thermal endurance against frozen, refrigerated, room temperature, and incubated temperature allowance criteria under summer and winter exposure conditions. Analytical utility was assessed by measuring 25 serum-based clinical chemistry markers using Roche cobas® 8000 analyzers following shipment in microvolume containers centrifuged or uncentrifuged and using various shipping methods. Additional studies evaluated the effect of centrifugation and thermal exposures on specimens exposed to ISTA-7D summer and winter shipping profiles.

Results: The TrueTherm shipper exceeded 72-hour thermal endurance for most targeted applications when subjected to standard shipping validation thermal profiles. In real-world shipping studies, TrueTherm shippers paired with sample centrifugation prior to transport enabled most chemistry analytes to be measured with pair-wise comparisons within 2024 CLIA acceptance limits. Microsample hemolysis measurements showed that without centrifugation and thermal protection, average hemolysis levels fell well above maximum-allowable thresholds for laboratory analyzers.

Conclusion: The TrueTherm shipper provides a simple, effective, and reusable method for ensuring thermally protected shipment of small volume samples into centralized laboratories.