Fueled in part by the recent pandemic, telehealth and other remote patient/doctor interactions are gaining popularity as practical and viable healthcare alternatives. This momentum is carrying over to specimen testing as convenient diagnostic test kits are making significant strides in terms of effectiveness.
Each day tens of thousands of these kits are delivered to the world’s medical laboratories where blood, urine, stool, saliva, and other biological specimens are processed and sent on for testing. Lab results hinge on the uncompromised value of these specimens to ensure the quality of kits contents, and all shipments must adhere to strict Transportation of Dangerous Goods (TDG) regulations. This is where temperature control plays a critical role in maintaining specimen integrity every step of the way.
For companies that develop and manufacture these kits the logistics of safely transporting them across the supply chain in a safe and timely manner is challenging. Maintaining temperature from storage and outbound shipment to point of care then with the specimen to the laboratory accessioning process creates a challenge to maintain temperature for days.
Form and Function
Like all manufacturers serving the medical industry, today’s diagnostic kit providers must balance form with function to satisfy requirements from a range of customers and stakeholders. From in-home users, FDA and laboratory to internal R&D, manufacturing, marketing, and sales departments, these test kits must meet a wide variety of demands and expectations.
Diagnostic Test Kits must:
- Maintain a specified temperature range for a minimum of 48 hours
- Be convenient and easy to use
- Be cost-effective to produce utilizing components that are reusable and recyclable
- Allow for possible branding, configuration, and design requirements
As a long-time supply chain professional serving the healthcare community, Chris Ritter understands the challenges and limitations faced by the industry. “Temperature control is paramount throughout transportation,” said Ritter. “Even a slight variance for a short period of time can spoil, and otherwise compromise the integrity of a specimen. Traditionally icepacks or ice bricks have provided some protection, but their longevity, effectiveness, and overall reliability are limited. Consequently, any delay or disruption in the supply chain could easily render a specimen sample useless.”
According to Ritter, EPS compartments are often incorporated into the design process of kits to separate icepacks and similar cooling alternatives from specimen containers. This not only adds weight and cost to each kit but also limits options for branding or other unique identifiers for reuse.
In addition, because of non-flexible purchasing options, icepacks must often be purchased in bulk. This creates an unnecessary cost and burden associated with storing and managing excessive inventory levels.
Fortunately, a relatively new thermal control technology has emerged that not only extends the duration of cooling, but also checks the boxes on the growing list of requirements for both the test kit manufacturer and kit user alike.
Phase Change Material
In search of a more robust and reliable temperature control solution, Ritter reached out to industry colleagues for advice. It was here that he was first introduced to phase change material (PCM) and CAVU Group’s Microtek division. As a leading global thermal solutions provider, CAVU Group develops and leverages PCM technology to provide its clients with practical and reliable solutions to today’s increasingly complex temperature control and monitoring challenges.
Standard ice packs are often too cold at the outset and not capable of maintaining constant temperatures from storage to outbound shipping and finally through accessioning. Conversely, Microtek adaptek product lines include PCM-based pouches that provide consistent and long-lasting cooling. As the material in the pouch transforms between liquid and solid state the process releases constant cooling that protects the package content. The pouches recharge themselves when temperatures stabilize and reactivate to maintain a safe delivery. In the case of diagnostic test kits, this cycle provides continuous cooling that safeguards specimens allowing for a longer delivery window.
“I had no idea the phase change material technology existed,” Ritter confessed. “It sounded so futuristic.” To overcome his skepticism, Ritter subjected the PCM to a series of tests. And while the adaptek pouches performed as advertised in the incubator, it was a spontaneous field test that sealed the deal.
Subjecting PCM to the ultimate test, Ritter solicited some outside help for a field experiment. “I wanted to push the material’s cooling capacity by shipping it to an extremely warm climate. I assembled a specimen kit, inserted an adaptek pouch with a USB temperature data logger, and sent it to a colleague in Texas. I asked him to leave the package exposed outside in the heat and send it back to me the next day so that I could measure its temperature.”
Ritter explained that the experiment hit an unexpected snag when he learned that the parcel’s return would be delayed by 24 hours. “I received the specimen kit more than a day later than expected. Opening the packaging, I was shocked to discover that the content maintained a temperature under the acceptable 25° Celsius through transit.” Ritter also explained that with the tracking of the USB temperature data logger, he was able to confirm and verify that the temperature stayed within range throughout transportation.
Available in a variety of sizes and temperature ranges, reusable adaptek pouches allow even the most temperature-sensitive contents to be shipped with complete confidence. For medical kit manufacturers and users this means that specimen integrity will be maintained throughout the supply chain.
Because they are robust and long-lasting, fewer pouches are required to maintain safe temperatures. In most cases, the need for EPS compartmentalization is often eliminated too.
All of this saves space while reducing manufacturing and shipping weight costs. From a marketing perspective adaptek PCM pouches can be customized to incorporate company logos, branding, and other unique identifiers.
Medical diagnostic kits cooled with adaptek pouches:
- Are easy to use and effective
- Maintain safe temperatures of less than 25°C for more than 48 hours
- Work in all climate zones
- Eliminate the cost and need of multiple icepacks
- Are easily customized
- Require minimal sales staff training
- Developed for durability and repeat usage
Point of care kits arriving at the laboratory are managed through a process known as LaboratoryAccessioning. During this process approved specimens are catalogued, labeled, and prepped for testing. This may include mixing or spinning the sample to ensure that all the components are evenly distributed or in some bloodwork cases separated before being forwarded to pathology or laboratory medicine divisions.
Because improper collection or transportation may produce invalid test results, specimens which do not meet acceptable criteria are rejected by the laboratory. While samples may be refused for a variety of reasons, many are rejected due to temperature violations resulting from excessive delay in transport.
Other acceptance criteria include:
- Improperly labeled or unlabeled as to the patient identity
- The use of an improper collection container, improper preservative, or improper anticoagulant Specimen Receiving, Processing and Accessioning
- A lack of required accompanying information
- An inadequate volume specimen needed for analysis
- Specimen contaminated with biological hazardous material
It is during this accessioning stage that physical components of the kit are examined and reclaimed for reuse. This is an important step as recycling kit components reduce manufacturing costs and contribute toward corporate sustainability initiatives.
Thermal Management Solutions
Quality and reliability are important to all industries; but within the medical community they are simply non-negotiable. Temperature control is vital to the transport and storage of pharmaceuticals, vaccines, medicines, and specimens traveling through the medical supply chain at any given moment.
As point of care alternatives become more popular and accessible, it is important that technologies in this growing industry are also available. CAVU Group continues to respond with innovative thermal management technologies to meet the logistical challenges of this progressive industry.