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Blood, Tissue, & Bodily Fluid Diagnostics

Many blood diagnostic tests require strict temperature management to ensure the integrity and accuracy of the test results. The necessity for temperature control depends on the nature of the test, the stability of the analytes of interest, and the time expected between sample collection and analysis. The Illuminate Team provides expert guidance for manufacturers of “at-home” blood diagnostics tests as well as clinical applications currently using courier services. We specialize in shipper optimization for thermal performance, payload, size, cost, and ease of use. We will work with you to develop a new packaging design or use your current components more efficiently to provide overall costs savings while maintaining the proper temperature.

For At-Home Testing Kit Developers

Cold Chain Packaging Design and Temperature Guidance
The trend toward at-home diagnostic tests, including those requiring blood samples, has been growing, fueled by advances in technology and an increased desire for convenience and rapid results. These tests cover a range of conditions, from chronic disease management to wellness monitoring. The following at-home blood diagnostic tests typically require careful temperature management, either during storage before use or after sample collection and during transport to a laboratory for analysis.

At-Home Blood Glucose Testing Kits: These kits, widely used by individuals with diabetes, often need to be stored at room temperature and kept away from extreme heat or cold to ensure the accuracy of readings.

Cholesterol Testing Kits: Some at-home cholesterol testing kits may require the test strips to be stored within certain temperature ranges to maintain their integrity until use.

Hormone Testing Kits: Kits designed for testing various hormone levels, such as thyroid hormones, testosterone, or fertility-related hormones, may require the samples to be mailed back to a lab. The samples sometimes need to be kept at specific temperatures during transport to preserve the sample quality.

Nutritional Deficiency Tests: Tests for detecting deficiencies in vitamins and minerals might require temperature control for the blood samples collected at home before they are sent to a lab for analysis.

Genetic Testing and Ancestry Kits: While not typically affected by moderate temperature variations, some kits recommend storing the sample in a stable, cool environment away from direct sunlight before mailing.

Infectious Disease Tests: At-home tests for certain infectious diseases, including COVID-19 antibody tests that require blood samples, might have specific storage and transport temperature requirements to ensure the viability of the antibodies being detected.

While not all tests require stringent temperature control, handling all blood samples with care and according to best practices is essential to ensure diagnostic accuracy. Mismanagement of sample temperature can lead to the need for re-sampling, which delays diagnosis and treatment, and increases costs. In some cases, deviations from ideal temperature conditions might not invalidate a test, but they can introduce variability in results, making diagnosis more challenging. Understanding and adhering to the specific temperature requirements for each type of test is essential for accurate diagnosis and effective patient care.

Courier Services

Safe Transport of Temperature Sensitive Samples

Thoughtful cold chain packaging and design is essential for courier services transporting blood and tissue diagnostic tests to ensure sample integrity and viability. We engineer solutions using insulated containers such as our Ecochill or foam coolers to create a stable temperature environment, with ice packs or gel packs for refrigerated samples (2-8°C) and dry ice for frozen samples (-78.5°C). At Illuminate we design optimized solutions to easily carry the required thermal load while minimizing size and cost of the packaging material. 

For blood and tissue diagnostic tests, samples are placed in leak-proof primary containers, then in a durable, leak-proof secondary container with absorbent material, and finally in an insulated container with coolants. Temperature monitors, such as data loggers and time-temperature indicators, can be included to track and ensure the samples remain within the required temperature range throughout transit. The package is securely sealed and clearly labeled with instructions like “Refrigerate on Arrival” and “Biological Substance.” 

Regulatory Compliance

  • IATA Regulations: For air transport, comply with International Air Transport Association (IATA) regulations for shipping dangerous goods, which includes specific packaging and documentation requirements for biological substances.
  • Local Regulations: Follow any additional local or national regulations for the transport of medical specimens and biological substances
  • Contact our team of experts today to learn more about current regulations