Another critical component the reagent in the sample collection device should have is pathogen inactivation. With the ability to render pathogens non-infectious, the receiving lab that processes the sample is only required to be a Bio Safety Level (BSL) 2, and not a BSL-3. BSL-2 labs are more widely available than BSL-3, and less costly, as they do not require enhanced safety measures designed to handle highly infectious samples.
While there are several sample collection devices on the marketing that offer pathogen inactivation, the design is often what sets them apart. With the intention of the collection device being at-home or unsupervised collection, this presents more opportunities for accidental ingestion and thus the need for safety precautions. Some collection devices are designed with the preservation solution in the cap or as part of the saliva funnel. While this is convenient for users it still poses the safety risk of exposure to the solution as the funnel needs to be taken off and replaced with the cap after the solution is added. Additionally, devices with preservation solution chambers outside of the tube can easily expose users if the film on the chamber is accidentally removed.
User safety is perhaps the most critical aspect of a sample collection device, as it limits liability while ensuring sample integrity for accurate results. Opt for a collection device designed around user safety and ease of use, that minimizes collection errors and prevents access to the preservation solution by containing it inside the tube with a safety seal. By sealing the solution inside the tube and only allowing the seal to be punctured after collection, the risk of accidental exposure can be mitigated.
As a direct-to-consumer business scales and acquires new customers, a larger volume of samples will need to be processed, requiring increased efficiency only made possible by automation. An important consideration when choosing a sample collection device is how easily it can be integrated into automated workflows such as de-capping, aliquoting, and recapping. Some automation suppliers offer stock automated platforms, such as the Sarstedt DC/RC 900 Flex system, specifically developed to perform some of the steps found in sample accessioning. To facilitate integration into some of the pre-existing accessioning systems there are certain dimension and shape constraints to consider for a collection device. For instance, the DC/RC 900 Flex system only de-caps tubes in the diameter range of 11-16mm, with additional limitations on dimensions for recapping. In blunter terms, a square device will be harder to work with in an industry adapted towards cylindrical tubes.
While custom automated solutions are always an option for unique device designs, it is an added complication and cost for companies seeking to rapidly expand their throughput without the hassle of having to develop new equipment from scratch. There can also be some overlooked characteristics that are problematic in automation; for example, brittle collection device materials will be more prone to cracking when exposed to grip or torque forces. Given these constraints, companies should only consider sample collection devices that can be reliably integrated into automated accessioning systems even if manual processing is relied upon early on so manual processing does not inhibit business growth.
It’s no secret that the global supply chain has become a concern for businesses in most industries. Considering the reliability of a sample collection device manufacturer should not be overlooked, as backordered components for sample collection devices can bring a company’s growth to a halt. A sample collection device manufacturer should control the entirety of their supply chain to ensure consistent production, so they are not inhibited by relying on components from other suppliers. Additionally, a sample collection device manufacturer should have the flexibility and production capacity to scale with the growth of the businesses they supply to.
With all of these considerations, finding a sample collection device may seem like a daunting task, but there are two options that meet all of the above criteria. Zymo Research’s SafeCollect Saliva Collection Kit and SafeCollect Swab Collection Kit were designed specifically for unsupervised sample collection and at-home testing applications.
SafeCollect devices come in two formats: one for swabs and one for saliva (Figure 2). Both formats feature DNA/RNA Shield in the sealed tube chamber, a solution that inactivates infectious agents, stabilizes DNA and RNA for up to 30 days at ambient temperature (or indefinitely when frozen), and an automation-compatible tube and cap. Spills are prevented by a safety seal that isolates the DNA/RNA Shield reagent from user contact.