Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing
IEEE Open Journal of Engineering in Medicine and Biology
|April 12, 2024
Summary
Reader technologies enhance over-the-counter (OTC) diagnostic tests, especially lateral flow assays (LFAs). Selecting the right reader technology type is crucial for optimizing OTC diagnostics and improving accessibility.
Area of Science:
- Biomedical Engineering
- Diagnostic Technology
- In Vitro Diagnostics
Background:
- Over-the-counter (OTC) diagnostic testing is rapidly expanding, with lateral flow assays (LFAs) being a common format.
- Reader technologies are increasingly integrated into LFAs to offer objective result interpretation, enhancing accessibility beyond visual readouts.
- The evolving market for LFA reader technologies lacks a standardized assessment framework, necessitating guidance for manufacturers and researchers.
Purpose of the Study:
- To identify and discuss key parameters for evaluating lateral flow assay (LFA) reader technologies.
- To provide a framework for manufacturers and researchers selecting LFA reader technologies for over-the-counter (OTC) diagnostic applications.
Main Methods:
- Interviews with reader manufacturers were conducted as part of the National Institute of Biomedical Imaging and Bioengineering's Rapid Acceleration of Diagnostics (RADx) Tech program.
- Reader technologies were assessed based on parameters including cost, detection method, multiplex capabilities, assay type, maturity, and use case.
- Readers were categorized by technology type: smart technology only, standalone, smart technology required, or smart technology optional.
Main Results:
- Information from 15 reader manufacturers on 19 distinct technologies was analyzed.
- Reader technology type was identified as a significant predictor of other reader attributes.
- The categorization of readers based on smart technology integration revealed distinct market segments.
Conclusions:
- Integrating reader technology with OTC diagnostic tests, including COVID-19 tests, is vital for improving performance and expanding diagnostic capabilities.
- The type of reader technology should be a primary consideration in selection, aligning with specific LFA test requirements and regulatory guidelines.
- LFA readers offer solutions for accessibility, public health reporting, and the shift towards multiplex testing, thereby broadening market availability of advanced diagnostics.
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