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Related Concept Videos

Sample Handling01:02

Sample Handling

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Transportation of samples from the collection point to the laboratory, as well as storage and preservation techniques, are crucial for maintaining sample integrity and ensuring accurate and reliable test results.
Samples should be transported carefully from collection points to the laboratory. They should be properly sealed and clearly labeled to prevent cross-contamination. To preserve the sample integrity, optimal temperature conditions during transport are essential. This could involve using...
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Validation of a Reusable, Thermally Protective Specimen Shipper for Decentralized Sample Collections.

Ulrich Y Schaff1, Bradley B Collier2, Gabriella Iacovetti1

  • 1Diagnostic Devices Research and Development, Labcorp, Pleasanton, CA, United States.

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The reusable TrueTherm shipper effectively maintains sample temperature for over 72 hours, ensuring accurate clinical chemistry marker analysis. This reusable shipping solution is vital for decentralized laboratory medicine, protecting small volume specimens during transit.

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Area of Science:

  • Laboratory medicine
  • Analytical chemistry
  • Specimen transport logistics

Background:

  • Decentralized sample collection enhances patient access but poses challenges for analyte stability.
  • Many analytes require controlled temperature during transport to maintain accuracy.
  • Small volume specimens are particularly vulnerable to temperature fluctuations.

Purpose of the Study:

  • To validate the Labcorp TrueTherm™ reusable shipper for thermally protecting small volume specimens.
  • To assess the shipper's thermal endurance under various environmental conditions.
  • To evaluate the analytical utility of specimens transported using the TrueTherm shipper.

Main Methods:

  • Configured various TrueTherm shipper models with vacuum bottles, phase change material (PCM) packs, and foam stoppers.
  • Conducted bench and real-world shipping studies evaluating thermal endurance against frozen, refrigerated, room temperature, and incubated criteria.
  • Assessed analytical utility by measuring 25 serum clinical chemistry markers and evaluating hemolysis in microvolume containers.

Main Results:

  • TrueTherm shippers demonstrated over 72-hour thermal endurance under standard validation profiles.
  • Specimens shipped with TrueTherm and prior centrifugation allowed most analytes to meet 2024 CLIA acceptance limits.
  • Uncentrifuged specimens without thermal protection showed excessive hemolysis, impacting laboratory analyzer thresholds.

Conclusions:

  • The TrueTherm shipper offers a reusable and effective solution for thermally protected shipment of small volume samples.
  • This system supports the integrity of laboratory testing in decentralized collection models.
  • Proper sample handling, including centrifugation, is critical for maintaining specimen quality during transport.