Sep 29, 2021
Jim Edwards is the executive vice president of product management at Indigo BioAutomation, Inc.
Q: What factors created a need for automation in qPCR and rtPCR analysis?
A: The rapid, somewhat unprecedented demand for qPCR and rtPCR analysis due to the SARS-CoV-2 pandemic led to many challenges for the molecular diagnostics/infectious disease laboratory. Simply procuring the necessary instrumentation, consumables, and reagents was an enormous undertaking. In parallel with the selection and availability of the required hardware and chemistry, equally important for the total workflow was the personnel—the linchpin of any laboratory’s ability to provide high quality, highly reliable results. Finding and training staff was daunting and determining the best ways to deploy the scientists was its own challenge. Tying all this together were software systems—both at the instrument level and the business level. Any of this could be done manually, but all of it can be supported and enhanced by a variety of automation approaches. And that has proved critical in providing health care in these challenging times.
Q: How is ARQ software being implemented to improve productivity in molecular laboratories?
A: Given the challenges described above, providing laboratories the most flexibility and support in how they arrange and carry out their work is crucial. The ARQ system provides a mechanism by which a foundational level of computing power and automation is made instantly available to the lab, upon which they can continue to build. Each lab is different, and each has unique needs and requirements. The ARQ system is built from the ground up to be optimized in specific ways for each and every lab, providing automation support in the exact location and manner that they require it. Coupling ARQ with the sophisticated chemistries and performant hardware that is available, as either IVDs or LDTs, means that the entire workflow levels up together, improving productivity and quality in tandem.
Q: How can automation improve the accuracy and accessibility of qPCR and rtPCR data?
A: Result and release automation systems, such as ARQ, help operationalize all the valuable and unique experiences of the experts in the lab. In essence, these systems allow data to be processed as if the entire staff was in the same room, all reviewing every sample together and all bringing their expertise to the table. ARQ provides a level of collaboration, consistency, and accuracy enhancement that would otherwise be cost and time-prohibitive.
Another key factor is the way that work can then be done. At various times, scientists may be unable to be physically present in the lab. This may be because they are tending to a family member who is ill, or they may be under quarantine due to close contact with an infected person. A hosted system, such as ARQ, means that people can work from home or another location and be productive team members while having the flexibility that their specific life situations require.
Q: How does an automated system affect quality assurance and quality control?
A: Just as the system provides support for an individual patient sample, it can also apply a holistic quality architecture to an entire set of samples, and in fact, multiple batches over time. This can be as straightforward as the periodic generation of Levey-Jennings control charts or as sophisticated as the lab expert can discover. A system such as ARQ provides a way to look “beyond the batch,” monitoring instrument performance, sample trends, logistical and operational details, and overall quality in as automated a manner as the review and release of individual patient results.
Q: Beyond COVID-19, how can molecular laboratories continue to benefit from automation software for qPCR and rtPCR analysis?
A: This type of testing could be required in one form or another for some time. And along with this demand, there still exists all the other types of testing that were being done before using qPCR and rtPCR. As well, there may be needs for various types of multiplexed testing, such as RSV, influenza, and SARS-CoV-2 in a single test. Software automation systems provide opportunities for quality and operational enhancement on an ongoing basis, allowing routine testing to be performed with less manual effort. This means that the lab staff can focus on new assay development, process improvement, client consultation, and other activities where personal communication and human creativity are invaluable.