Introduction
What is required of a molecular diagnostic device that can rapidly detect pathogens at the point of need? What do users need to bring highly sensitive testing out of the lab into farms, fields, food processing plants, and veterinary and clinical settings?
Alveo Technologies is working to expand access to real-time molecular diagnostics across industry sectors and pathogen types. We believe that a platform that anybody can use, for a wide variety of needs, will help solve some of the greatest diagnostic challenges facing our planet today. To achieve this, Alveo has developed a testing platform that is rapid, accurate, multiplex capable, and notably rugged.
Ruggedness (adj)
presenting a severe test of ability, stamina, or resolution
WHY RUGGED IS REQUIRED
Traditional molecular diagnostic devices (both PCR and LAMP) are often developed with a central lab in mind, and involve complex and finely tuned technologies that must remain on a level surface to complete a test. To provide end users across industries access to highly accurate, actionable data, Alveo believes in bringing the molecular diagnostic test to the point of need, and producing results within minutes, not days. This means the device needs to provide reliable results between rows of crops, within the unique environmental setting of a poultry farm, or on the floor of a food processing plant. It should escape the idyllic environment of the lab and must be able to withstand movement, temperature variations, accidental droppage, and multiple runs on a single charge.
ANALYZER DETAILS
The Alveo platform is a rapid, portable, reusable, and rugged multiplexed molecular diagnostic platform. It pairs advanced molecular assays with cloud-enabled data analytics to provide highly accurate and sensitive real-time detection, analysis, and diagnosis of diseases, pathogens, and contaminants. The analyzer employs Alveo’s globally patented direct-electrical sensing approach to pathogen identification, leveraging loop-mediated isothermal amplification (LAMP), meaning that it avoids complex optical sensing technologies and the need for a lab environment. Furthermore it is solid state, with no moving parts, and is built for durability within a unitary aluminum shell smaller than most cell phones. This portable molecular lab can deliver rapid test results at the point-of-need or in the field.
RUGGEDNESS TESTING METHODOLOGY
To evaluate the device’s ruggedness, testing was conducted within our internal research & development lab and at a third-party testing facility across three primary parameters: environmental resilience, resistance to movement/vibration, and the impact of dropping the analyzer mid-test. Additionally, the device was subjected to repeated cleaning with common disinfecting agents and tested consecutive runs on one battery charge. Testing protocols were meticulously designed to simulate real-world field conditions, ensuring the reliability and relevance of the results obtained.
Research + Findings
Environmental Resilience
Initial testing focused on assessing the device’s performance under extreme temperature and humidity conditions. The study evaluated the system’s ability to operate safely across the intended use range of from 5°C to 40°C at a relative humidity of 80% per IEC-61010. An additional environmental condition beyond the IEC standard (40°C at 95% relative humidity) was tested to align with COVID-19 FDA Emergency Use Authorization (EUA) recommendations.
STUDY DETAILS
Monitored Incubation chambers were used to establish controlled climatic conditions at the following ranges:
5°C ±2°C, uncontrolled humidity
40°C ±2°C @ 80 % ±5% RH
40°C ±2°C @ 95 % ±5% RH
RESULTS
After 24 hours of equilibration to the designated condition, analyzer performance was verified at the indicated test conditions to confirm safe and effective operation.
KEY TAKEAWAY
The analyzer can effectively operate from 5°C to 40°C and up to 95% relative humidity.
Resistance to Movement/Vibration
The device was evaluated for durability against movement and vibration, common challenges encountered in field settings. Testing was performed at a third-party facility1 and used standard industry test protocols to simulate the vibrations and movements that occur in the back of a moving delivery truck2.
STUDY DETAILS
44 Cartridges Tested - 20 Negative, 24 Positive
2 Positions - LED Up and LED down
RESULTS
100% accuracy when tested face up (LED up).
94% accuracy when tested face down (LED down).
KEY TAKEAWAY
The device exhibited stability and reliability, even when subjected to significant levels of movement and vibration. Data demonstrates minimal deviation in results, underscoring the device’s robust design and engineering.
We recommend running the analyzer LED up on a flat surface.
Drop Testing
The device underwent drop testing to verify the ability of the analyzer to maintain performance functionality when dropped while in-use at three heights (10 cm, 50 cm and 1 meter) onto a 50 mm thick hardwood board having a density of more than 700 kg/m3 lying flat on a rigid concrete base. The equipment was dropped so that it landed in the position expected to present the most severe condition.
STUDY DETAILS
6 Cartridges Tested
3 Heights - 10 cm, 50 cm, 1 m
RESULTS
100% of tests ran to completion and produced accurate results.
KEY TAKEAWAY
The testing demonstrated the analyzer’s robustness and ability to withstand up to a 1-meter drop and successfully complete a test.
Cleaning
Testing was conducted to verify that the analyzer is unaffected by cleaning with common disinfectants. Five analyzers were used for this study, with one analyzer corresponding to each disinfectant. Analyzers were wiped down 200 times with a single disinfectant. The analyzer was then visually assessed for damage, LEDs and charging were assessed, and a test was run on the analyzer to assess full functionality.
RESULTS
Commercial bleach (10%) — ✓ Pass
Hand sanitizer (>60% ethanol) — ✓ Pass
Isopropyl alcohol (70%) — ✓ Pass
Hydrogen peroxide (3%) — ✓ Pass
QAC (Quaternary ammonium compounds) — ✓ Pass
KEY TAKEAWAY
The analyzer withstands 200 wipe-downs without damage, and may be disinfected by a range of common household cleaners.
Other Findings
ANALYZER BATTERY LIFE
The ability to test in atypical locations requires a device that can run multiple tests on one charge. Competitors in the field either require the device to be continually plugged in, are single use battery-powered or have the ability to run unplugged but are finicky and sensitive to disturbances.
The Alveo analyzer has sufficient battery capacity to operate for a minimum of 120 minutes of active use at ambient temperature when fully charged. A backup USB power supply can be used to extend the test range per wall charge.
CARTRIDGE STABILITY
Reagents for each assay are dried down and packaged with a desiccant to promote extended stability and shelf life.
Competitive Comparison
In our evaluation, we assessed similar portable solutions available on the market for their resilience to impacts and their response to motion and vibration during testing. Supplementary data was gathered from Instructions for Use manuals and content available on competitor websites.
Implications for Field Applications
The outcomes of ruggedness testing have far-reaching implications for various field applications. The device’s resilience supports the mission of providing consistent performance at the point of need – be it remote locations, disaster zones, fields, farms and beyond. Its ability to deliver relatively reliable results under adverse conditions can empower users with actionable data for timely interventions.
As we continue to test the limits of our product, we are committed to ongoing innovation to further enhance the performance of the device. We are actively investing in research and development efforts aimed at optimizing the device’s capabilities to operate effectively in any orientation.
From healthcare diagnostics to environmental monitoring, the device’s rugged design unlocks new possibilities for on-site analysis and decision-making. As industries increasingly rely on rapid and accurate diagnostic solutions, the Alveo analyzer should emerge as a game-changer, poised to revolutionize field operations, and enhance outcomes across diverse sectors.
DISCLAIMER
For best results, the analyzer should be run on a clean, flat surface.