As each at-home medical device gradually becomes more complex and intuitive than its predecessor, home diagnostic kits and testing have become a ground-breaking advancement in technology. The question that the home diagnostic kit raises, however, is the strain and risk management concerns put on the diagnostic laboratory.
Primarily concerned with the reception, testing and management of diagnostic kits, the diagnostic laboratory’s challenges and pressures will continue to rise as the number of at-home tests, sample collection devices and diagnostic kits are manufactured.
Joined by a shared goal to expedite patient diagnoses, diagnostic labs persist in broadening their capabilities and incorporating new, innovative, and technologically advanced methods for specimen testing and ongoing management.
With each challenge comes a new, cutting-edge solution. At RDi, we are proud to be one such provider that leverages technology to transform the way diagnostic labs deliver their services. Our expert life science professionals have detailed the common challenges faced by diagnostic laboratories in recent years, all of which have moulded the development of our state-of-the-art resources.
The history and evolution of home diagnostic kits
In today’s healthcare market, we can see a variety of laboratories adapting their testing workflows and services to the growing devices and technology available for the identification, prevention and treatment of disease.
The diagnostic laboratory is no exception, with the COVID-19 pandemic proving a pivotal moment in history for the collection of samples and the testing for the coronavirus respiratory disease.
Although home diagnostic kits had not been derived specifically from the pandemic, their uptake has increased dramatically since March 2020, with the global at-home testing market sitting at a value of $7.1 Billion in 2022. These at-home testing kits can take the form of many different devices, with the primary focus being to provide an immediate positive or negative result to a patient from the comfort of their own home.
Whether it is the 1970’s originated at home pregnancy test, or the 2023 order-to-home hepatitis C tests, each year comes with a new medical testing kit which can help eliminate deadly diseases and encourage patients to gain diagnosis.
What we don’t realise, however, is that the at-home testing market has also driven the remote sample collection and home diagnostic kitting products and service industry as well. The key differentiator of these types of testing is that one is an immediate ‘good enough’ indicator of disease, while the other is a safer alternative which sees a biological sample transported safely and compliantly to a diagnostic lab for testing.
Home diagnostic kits are as in demand as at-home testing kits, as patients become more accustomed to healthcare at home. With the rising demand for home sample collection, however, comes the demand faced by diagnostic laboratories to meet turnaround times, regulatory compliance, patient safety and effective data and results management.
At RDi, we’re passionate about helping the healthcare market to deliver diagnoses to patients sooner, to safeguard and improve overall public health. By this very mission, we are also dedicated to helping diagnostic labs to overcome some of the challenges that supply and demand has had on their operations, fulfilment, transportation, and compliance.
Challenges faced by diagnostics labs
Problem: Data management, losses, and errors
As the complexity of the home diagnostic kitting network continues to expand, diagnostic laboratories can struggle to maintain quality data and provide patients with timely results. With a lack of control over the quantity of home diagnostic kits being delivered to patients, the diagnostic lab must comply with the influx and reception of countless biological samples.
Healthcare data security is stringent regulatory compliance which can result in financial losses should breaches occur. From legal fees to potential lawsuits and regulation penalties, the incident in 2017 involving the NHS’s potential data loss shows the crucial sensitivity of medical correspondence, particularly surround test results and diagnoses.
Solution: Traceable home diagnostic kits
At RDi, data is at the heart of what we do. It is not only what laid the foundations of our business, but it continues to be an arm of our healthcare services which transforms the data management approach of many medical businesses, including the diagnostic lab.
Through our full track and trace technology, we can capture every element at every stage of the diagnostic journey. Our post-issuance insight tracks each home diagnostic kit through the supply chain and onto the return journey. Diagnostic labs can now estimate the quantity of kits coming to their facility and also streamline the patient data that accompanies them.
Problem: Integrating data
As well as patient data, diagnostic laboratories also handle an abundance of other types of data including sample management data, testing data, workflows and instrumentation data, LIMS, administrative data, and regulatory QA/QC data.
It often becomes the case that laboratories attempt to integrate various systems, software, and platforms to manage and maintain everyday performance. In many instances, however, the integration isn’t seamless and can actually result in stand-alone tools that can’t correspond with one another.
Solution: Sophisticated, automated software
After spending over a decade streamlining our automation and data solutions, RDi have developed a sophisticated software which monitors all product, action, output, post market activity and more.
For diagnostic laboratories, this will enable them to access online portals which provide operational insights, allowing them to understand, evaluate and predict the streams of home diagnostic kits heading to their facility.
This provides them with the unique opportunity to plan ahead of their next delivery and communicate clearly through an automated system which ties the distributor of the kits with the labs that will receive them.
Problem: Regulatory oversight and compliance
Reporting to the UKHSA, the ISO standards and the MHRA, a UK-based diagnostic laboratory is governed by a number of internal auditing, QA/QC and documentation requirements in order to meet ongoing regulations. The complexity of data history can often mean that diagnostic laboratories become limited as they begin to scale.
Solution: Uniquely coded home diagnostic kits
At RDi, automation drives our capabilities, and we can share this with the diagnostic sector. A laboratories scalability should not be hindered by their data management. We understand high-volume, high-speed workflows which is why our pharma services can be employed to meet medical device regulations, ensure compliance and embed easily audited quality management systems.
By distributing uniquely coded testing kits, we can drive an automation-based transportation trail which can be audited at any point to ensure compliance.
Partner with innovation at RDi
Although the diagnostic laboratory will face several challenges as the healthcare sector continues to transform and evolve toward more patient centric methods of diagnosis, data management, error-free early results and regulatory compliance are some of the many hurdles which partnering with RDi can solve.
If you’re a diagnostic laboratory looking to ensure that your kit delivery and diagnostic services don’t hinder at the hands of at-home diagnostic kits, then get in touch with our team of life science and pharmaceutical experts.
