In Vitro Diagnostic Tests Come Out of the Lab and Into the Home

Over the past 50 years, a number of key in vitro diagnostic (IVD) technologies previously used only in clinical laboratories have trickled into hospital rooms, doctors’ offices, and homes. Advances in technology, patients’ desire for empowerment, and the need for…

Over the past 50 years, a number of key in vitro diagnostic (IVD) technologies previously used only in clinical laboratories have trickled into hospital rooms, doctors’ offices, and homes. Advances in technology, patients’ desire for empowerment, and the need for improved healthcare efficiency and outcomes are driving this trend.

But as IVD devices move outside of the lab, manufacturers must better understand these new environments and users in order to develop products and services for this new context.

A History of At-Home Tests

The first pregnancy test was undertaken in a laboratory, where the urine of the suspected pregnant woman was injected into an immature female rabbit, mouse, or rat. In the case of pregnancy, the ovaries of the rodent would enlarge, showing follicular maturation caused by the presence of the hormone human chorionic gonadotropin (hCG). While crude, this technique, developed in 1927, was accurate, with an error rate of less than 2%. That early hCG-based test drove the development of the IVD hCG test in the 1960s. By the early 1970s, women could collect urine samples at home to be sent into the clinical laboratory for diagnosis. These tests were complicated and performed by trained medical professionals. The first home pregnancy tests did not hit the market until the late 1970s. This test kit took two hours to give a result and by today’s standards was about as user friendly as a child’s home chemistry set, with solutions, test tubes, and other components.
Despite its complexity, the home test was advantageous because it protected the privacy of women who might not want others to know they were sexually active and empowered them to take an active role in their own healthcare. Additional advances in technology led to the one-step lateral flow test chemistry used today.
Similarly, as our understanding of diabetes increased, testing of blood glucose levels has also moved from the clinical laboratory to the doctor’s office and into the home. Early blood glucose measurement, dating back to the 1950s, was a cumbersome technique performed by skilled healthcare professionals in the clinical laboratory setting. As technology advanced, a test strip method was developed in the 1960s, which allowed doctors to take a drop of blood onto a strip and then compare the color of the strip with a calibration chart of glucose levels. While this test offered the advantage of a more immediate response because it was performed in the doctor’s office, it still required patients to visit their doctors regularly to monitor their glucose levels. Home blood glucose testing began in the mid 1970s, with a benchtop system designed to read the color changes on a test strip and output a glucose level response to the user. While still a far cry from the small, fast, and exceedingly accurate systems used today, this device empowered patients to manage their diabetes by giving them the tools to self-monitor and self-adjust their diet and insulin doses.
The transition of IVD devices into the home continues today, as shown by the recent FDA approval of OraSure’s OraQuick HIV test for use in the home. HIV was identified in 1984, and the first test for it was developed in 1985. Rapid testing followed in 1992, but it wasn’t until 2003 when these methods were granted a Clinical Laboratory Improvement Amendments (CLIA) waiver, that they could be used outside of a clinical laboratory setting. Prior to its approval for home use in the summer of 2012, OraSure’s technology was CLIA-waived and had been used in doctors’ offices since 2004. The home test uses a mouth swab that is placed into the device, and provides a result in 20–40 minutes. Previously, the only approved home-use device required the user to collect a few blood drops from a finger prick and send the sample to a laboratory for processing.
There was much controversy associated with the approval of OraSure’s technology for the home market. There was concern that home testers would interpret positive test results as death sentences and take extreme, possibly harmful action as a result. However, thanks to current treatment options, people with HIV can live longer than ever before. An at-home test should therefore empower more users to test themselves and, if necessary, begin considering treatment options earlier without facing the potential stigma associated with a more public HIV diagnosis.
The Usability Imperative
Within the controlled environment of the clinical laboratory, mandated processes and user training streamline human behavior to yield acceptable levels of IVD accuracy and repeatability while ensuring user safety. However, when some or all of these controls are absent in the point-of-care setting or at home, it becomes imperative to consider the usability of the instrument in compliance with regulatory standards such as IEC 62366.
Beyond ensuring regulatory compliance, IVD device manufacturers will see additional benefits, such as the following, when integrating usability into their medical product development:
Reduced product risk due to a decreasing likelihood of medical incidents associated with use error and subsequent recalls and preventative actions.
Reduced product development risk and fewer delays associated with last-minute product iterations because the user was not considered up front.
Increased commercial and competitive advantage from product differentiation based on improved user experience.
Tools and Techniques
A variety of tools and techniques can be integrated into a medical product development process to ensure usability is considered throughout. These tools allow medical device manufacturers to gain an understanding of the context of use of their future devices and ensure this understanding is taken forward into the development of the devices—from requirement specification to risk mitigation activities, culminating in verification and validation.
Contextual Inquiry. There are many contextual factors that influence product interaction, including the target user, environment of use, and usage scenarios. These aspects must be understood to ensure the development of optimal product embodiment.
Contextual inquiry combines observations and in situ interviews to understand the context of device use and unmet user needs. Observing and interviewing users in the context of their actual use environment provides access to insights that traditional qualitative market research might miss.
Depending on the application, this research may need to be augmented with user diaries, which enable the continued collection of qualitative data over a period of days or weeks, or provide a way of collecting data when an observer cannot be present for safety, privacy, or ethics reasons. The resulting diaries provide insights into users’ habits, feelings, and frustrations that might remain undiscovered during a contextual inquiry session. The use of multimedia devices during research as part of user diaries ensures key moments of discovery can be shared with the development teams. Raw video data can spark innovation and promote the importance of the project and specific user needs with the broader project team.
These studies provide information about the context of use, which must then be fed into requirement specification documents, risk management activities, and usability testing. These findings also deliver an understanding of current market needs, such as issues with current products or processes that, if corrected, may result in an opportunity for competitive differentiation of the new product.
Requirement Specification. Findings from the contextual inquiry must be translated into a clear set of customer requirements. Customer requirements include high-level performance requirements and usability requirements to ensure key stakeholders are able to safely and comfortably interact with the device.
The customer requirement specification document is then used to define product requirements, ensuring product specifications are decided based on a common understanding of user goals.
Use Error Risk Assessment. A series of risk management activities should also be performed to identify and mitigate known and foreseeable hazards and safety concerns. These consist of the following:
Task analysis. Using the contextual inquiry as a basis, user tasks are outlined throughout the lifetime of the system. These tasks are then assessed to identify frequently used functions that involve constant or repeated interaction with the device as well as tasks that may implicate user safety, potential hazards, or environmental harm. These primary operating functions are noted and assessed in more detail via a user failure mode effects analysis (FMEA).
User FMEA. Leveraging an understanding of the user (including training level; cognitive, sensory, and motor capabilities; ergonomic considerations), the environment, and scenario of usage, known and foreseeable risks associated with key usage steps of the device are examined. Much like a traditional FMEA, each failure mode is assessed in terms of severity, frequency of occurrence, and probability of detection.
Risk mitigation. Risks are then mitigated through changes to the design of the instrument, ensuring both the breadth and limits of human capacities is understood and applied.
Usability Testing. Usability testing is the process of testing prototypes and devices with representative users in their use environments and in different usage scenarios. The resulting outputs help guide design decisions at different stages of development, both by optimizing the user experience and eliminating the potential for safety-critical user errors that may occur during device use.
Testing designs early with end users or a panel of experts will help to explore trade-offs and validate concepts. Even using simple 2-D and 3-D models can help provide valuable feedback on early ideas, while looks-like, acts-like prototypes, which maximize realism, will eliminate risks from a design direction prior to detailed design.
Each detailed design loop generates looks-like, works-like prototypes that can then be used for formative usability testing. Following each loop of testing, designs are refined to improve user interaction and reduce user-related risks.
For medical devices, summative usability testing is used to validate the resulting device and can be undertaken as part of or separate from clinical trials.
Usability Integration
Usability cannot be performed in a vacuum. To realize the benefits of a user-centered approach, these tools must be integrated into the product development process to ensure key design decisions are made with an understanding of user needs, capabilities, and expectations.
Recent examples of user-centered designs include the OraQuick in-home HIV test and iBG Star blood glucose meter.
OraSure OraQuick In-Home HIV Test. OraSure implemented these usability tools and techniques to redesign its point-of-care diagnostic device for the over-the-counter market. The initial device was approved for various medical settings, including public health settings, physician offices, community health clinics, laboratories, and emergency rooms. OraSure conducted risk assessments to identify the new risks that came with implementation in the home market for use by nonmedical professionals. The company used this risk assessment to determine what mitigations were needed to reduce the risks identified before the initiation of clinical trials.
OraSure’s OraQuick product was the first FDA-approved oral swab in-home test for HIV.

To ensure the device design met the requirements of the new user and environmental setting, OraSure hired a design firm to design and develop consumer friendly packaging and labeling. The firm performed usability testing on the designs. In all, more than 30 iterative versions of the product were tested by more than 800 users.
One specific change implemented as part of the home-use usability assessment was an alteration in device packaging. OraSure developed a flip-up laptop design for the product. By building the test stand into the box itself, the design allowed for a more robust testing platform and enabled users to flip through step-by-step instructions as they conducted the test.
Another change implemented was the modification of the developer vial cap. This was altered to add thumb indentations to the cap, making it easier for the consumer to open the vial without spilling the solution.
Beyond considering the new user and environment, OraSure considered the new usage scenario created by this device—one in which the healthcare professional would not be present when the user receives a diagnosis. To that end, OraSure decided that an around-the-clock call center was necessary to provide support for customers. This support includes general information on HIV and AIDS, assistance on how to conduct the test and referral to care. While creating this feature, OraSure ensured support would be provided while allowing the caller to remain anonymous, protecting their privacy.
Sanofi Diabetes’ iBGStar. Sanofi Diabetes’s iBGStar blood glucose meter extends the progression from clinical lab to home medical device and has moved further into a new realm of mobile health. This device, which received FDA approval in December 2011, is a compact blood glucose meter that plugs directly into the iPhone, offering accurate blood glucose measurements synced seamlessly into the lives of iPhone users with diabetes.
Sanofi’s iBGStar blood glucose monitor works with the iPhone and iPod touch.

Blood glucose meters have historically been under scrutiny and have been recalled in the past due to confusing display options. This confusion caused users to misinterpret test results, leading them to make hazardous diet alterations and administer improper insulin doses resulting in health issues such as hyperglycemia. With its iBGStar blood glucose meter, Sanofi took time to understand the device’s users—on-the-go men and women who are always connected and looking for an effective way to manage their diabetes.
By plugging into a familiar user interface, the iBGStar device gains the intuitiveness of Apple’s graphical user interface while offering diabetes patients additional functionality, including an app that allows users to analyze their glucose levels. The app provides statistics, graphs, and trends to help users make informed decisions about their healthcare and enables them to share information with healthcare professionals. These features help to improve users’ ability to manage their disease through a familiar platform that minimizes user error.
Conclusion
In today’s world of increased cost pressures and healthcare reform, we will continue to see diagnostic devices move away from the clinical laboratory into the point-of-care setting and, in some cases, the home. With this transformation of care comes increased regulation. Medical device manufacturers have an increasing responsibility to ensure their devices are compatible with the changing environment and lay user population. These considerations are imperative when entering the home diagnostics market, where the user is a consumer taking a test without any training, often for the first time. The device manufacturer must ensure the user is able to conduct the test and receive accurate results without harming themselves or the environment. Device manufacturers must consider the entire usage scenario of their devices. As in the case of OraSure, this means ensuring safe, convenient use during testing and extends as far as considering the home user after they receive their results.
One day, every diagnostic test may be as user friendly as the home pregnancy test. Technological advancements coupled with proper usability work could make this a reality.
Lucy Sheldon is an associate with Sagentia (Boston). As a human factors and user research practicioner, her focus is on needs-driven, design-led innovation that uses technology to improve the world around us.
Karen Unterman is a front-end innovation and usability expert. Her experience is in applying technical expertise to understand stakeholders’ needs, identify new business opportunities, and help develop safe and effective customer-focused solutions, predominantly in the healthcare and wellness sectors.
Mick Withers is managing director at Sagentia, where he is responsible for innovation, technology, and outsourced R&D activities across the medical, consumer, and industrial sectors. Withers can be reached at mick.withers@sagentia.com.
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