Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing
<bold>Background:</bold> Over-the-counter (OTC) diagnostic testing is on the rise with many in vitro diagnostic tests being lateral flow assays (LFAs). A growing number of these are adopting reader technologies, which provides an alternative to visual readouts for results interpretation,...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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IEEE
2024-01-01
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| Series: | IEEE Open Journal of Engineering in Medicine and Biology |
| Subjects: | |
| Online Access: | https://ieeexplore.ieee.org/document/10413534/ |
| _version_ | 1797243275486167040 |
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| author | Mia Cirrincione Maren Downing Kevin Leite Samuel Dolphin Adam Samuta Mack Schermer Kimberly Noble Brian Walsh |
| author_facet | Mia Cirrincione Maren Downing Kevin Leite Samuel Dolphin Adam Samuta Mack Schermer Kimberly Noble Brian Walsh |
| author_sort | Mia Cirrincione |
| collection | DOAJ |
| description | <bold>Background:</bold> Over-the-counter (OTC) diagnostic testing is on the rise with many in vitro diagnostic tests being lateral flow assays (LFAs). A growing number of these are adopting reader technologies, which provides an alternative to visual readouts for results interpretation, allowing for improved accessibility of OTC diagnostics. As the reader technology market develops, there are many technologies entering the market, but no clear, single solution has yet been identified. The purpose of this research is to identify and discuss important parameters for the assessment of LFA reader technologies for consideration by manufacturers or researchers. <bold>Methods:</bold> As part of The National Institute of Biomedical Imaging and Bioengineering's Rapid Acceleration of Diagnostics (RADx) Tech program, reader manufacturers were interviewed to investigate the current state of reader technology development through several parameters identified as important industry standards. Readers were categorized by technology type and parameters including cost, detection method, multiplex capabilities, assay type, maturity, and use case were all assessed. <bold>Results:</bold> Fifteen reader manufacturers were identified and interviewed, and information on a total of 19 technologies was assessed. Reader technology type was found to be predictive of other attributes, whether the reader is smart technology only, a standalone reader, a reader with smart technology required, or a reader with smart technology optional. <bold>Conclusions:</bold> Pairing reader technology with OTC diagnostic tests is important for improving existing COVID-19 tests and can be utilized in other diagnostics as the OTC use case grows in popularity. Reader technology type, which is predictive of core reader attributes, should be considered when selecting a reader technology for a specific LFA test within the context of regulatory guidance. As diagnostics increase in complexity, readers provide solutions to accessibility challenges, facilitate public health reporting, and ease the transition to multiplex testing, therefore increasing market availability. |
| first_indexed | 2024-04-24T18:52:32Z |
| format | Article |
| id | doaj.art-350de90f4cb04553b8dbd6135c38cc54 |
| institution | Directory Open Access Journal |
| issn | 2644-1276 |
| language | English |
| last_indexed | 2024-04-24T18:52:32Z |
| publishDate | 2024-01-01 |
| publisher | IEEE |
| record_format | Article |
| series | IEEE Open Journal of Engineering in Medicine and Biology |
| spelling | doaj.art-350de90f4cb04553b8dbd6135c38cc542024-03-26T17:49:20ZengIEEEIEEE Open Journal of Engineering in Medicine and Biology2644-12762024-01-01521021510.1109/OJEMB.2024.335570110413534Assessment of Reader Technologies for Over-the-Counter Diagnostic TestingMia Cirrincionehttps://orcid.org/0000-0001-6587-5674Maren Downinghttps://orcid.org/0000-0001-5121-4584Kevin Leitehttps://orcid.org/0009-0003-6492-6048Samuel Dolphinhttps://orcid.org/0000-0002-4257-6708Adam Samutahttps://orcid.org/0009-0006-4438-0414Mack Schermerhttps://orcid.org/0000-0003-2312-7074Kimberly Noblehttps://orcid.org/0009-0002-8752-1724Brian Walshhttps://orcid.org/0000-0001-5151-0674<bold>Background:</bold> Over-the-counter (OTC) diagnostic testing is on the rise with many in vitro diagnostic tests being lateral flow assays (LFAs). A growing number of these are adopting reader technologies, which provides an alternative to visual readouts for results interpretation, allowing for improved accessibility of OTC diagnostics. As the reader technology market develops, there are many technologies entering the market, but no clear, single solution has yet been identified. The purpose of this research is to identify and discuss important parameters for the assessment of LFA reader technologies for consideration by manufacturers or researchers. <bold>Methods:</bold> As part of The National Institute of Biomedical Imaging and Bioengineering's Rapid Acceleration of Diagnostics (RADx) Tech program, reader manufacturers were interviewed to investigate the current state of reader technology development through several parameters identified as important industry standards. Readers were categorized by technology type and parameters including cost, detection method, multiplex capabilities, assay type, maturity, and use case were all assessed. <bold>Results:</bold> Fifteen reader manufacturers were identified and interviewed, and information on a total of 19 technologies was assessed. Reader technology type was found to be predictive of other attributes, whether the reader is smart technology only, a standalone reader, a reader with smart technology required, or a reader with smart technology optional. <bold>Conclusions:</bold> Pairing reader technology with OTC diagnostic tests is important for improving existing COVID-19 tests and can be utilized in other diagnostics as the OTC use case grows in popularity. Reader technology type, which is predictive of core reader attributes, should be considered when selecting a reader technology for a specific LFA test within the context of regulatory guidance. As diagnostics increase in complexity, readers provide solutions to accessibility challenges, facilitate public health reporting, and ease the transition to multiplex testing, therefore increasing market availability.https://ieeexplore.ieee.org/document/10413534/Diagnosticshome testlateral flow assayOTCreaders |
| spellingShingle | Mia Cirrincione Maren Downing Kevin Leite Samuel Dolphin Adam Samuta Mack Schermer Kimberly Noble Brian Walsh Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing IEEE Open Journal of Engineering in Medicine and Biology Diagnostics home test lateral flow assay OTC readers |
| title | Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing |
| title_full | Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing |
| title_fullStr | Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing |
| title_full_unstemmed | Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing |
| title_short | Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing |
| title_sort | assessment of reader technologies for over the counter diagnostic testing |
| topic | Diagnostics home test lateral flow assay OTC readers |
| url | https://ieeexplore.ieee.org/document/10413534/ |
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