Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance Proceedings of a Workshop (2023) / Chapter Skim
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2 Exploring the Need for Rapid Diagnostics
2 Exploring the Need for Rapid Diagnostics
Pages 5-22
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From page 5... ...
Carroll (Director, Division Medical Microbiology and P rofessor of Pathology, Johns Hopkins University School of Medicine) provided an overview of the current state of rapid diagnostic development and gaps that rapid diagnostics might be best suited to address (e.g., to support targeted treatment decisions or to enable real-time surveillance)
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is ranked by the WHO as one of the top ten global public health threats facing humanity (WHO, 2021)
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In contrast, antibiotics do not benefit from federal incentives such as EUA, expedited review, transferable exclusivity vouchers, orphan drug designations, tax incentives, and reimbursement subsidies. Bioethics Perspective Treatment decisions involving antibiotics -- including whether to prescribe an antibiotic, which antibiotic to use, and the appropriate duration of use -- are incorrect in 30 to 50 percent of cases, said Tracey L
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In summary, said Cohen, rapid diagnostics will help healthcare p roviders mitigate improper treatment decisions which harm patients in violation of the bioethical principles. Stakeholders -- including pharmaceutical and bio technology companies, government entities, healthcare providers, and thirdparty payers -- have corresponding bioethical imperatives to create, distribute, utilize, and subsidize reliable, rapid point-of-care diagnostics.
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Clinical Microbiology Laboratory Perspective Clinical microbiology laboratories largely depend on traditional c ulture-based techniques (e.g., inoculation of specimens to plated media)
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Over the last several decades, disruptive technologies have advanced diagnostics in clinical labs and made transformative changes. Some culture-based methods have been replaced by multiplexed molecular syn dromic panel tests, and organisms can be identified faster using Matrix Assisted Laser Desorption Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)
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Issues including workforce shortages, lack of institutional investment in clinical laboratories, and regulatory impediments are hindering the development and implementation of new tools that could transform testing and the care of patients. Further, she noted a need for diagnostic stewardship and the implementation of guidelines to help ensure appropriate test utilization and optimize patient care.
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Emerging POC testing technologies include microfluidics, biosensors, digital droplet polymerase chain reaction (PCR) , and paper-based devices.
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There are several current and future POC tests for STIs; most provide results within 30 minutes and are comparable to the high-throughput instruments currently in clinical labs. Carroll emphasized that the short timeframe is critical because studies show that patients presenting to STI clinics or the emergency department (ED)
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valves com/ Abbott ID Now Isothermal Nasal/NP/ throat Manual/Manual Fluorescence Portable instrument https://www.abbott.com/ with LED screen NOTE: LCD = liquid-crystal display; LFA = lateral flow assay; NP = nasopharyngeal; POC = point-of-care; RT-PCR = reverse transcription-polymerase chain reaction SOURCE: Presented by Karen Carroll, October 13, 2022.
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In the case of AMR, he said, the need is for rapid antimicrobial testing for susceptibility or resistance, and design requirements include • time to results; • target (e.g., bacteria) ; • specimen (e.g., whole blood, respiratory specimen)
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per milliliter of specimen, it can be difficult to ensure that the CFUs are detected by the test. Reimbursement Perspective Susan Van Meter (President, American Clinical Laboratory Association)
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✓ ✓ Limited Limited ✓ Limited Limited Clinical Workflow ✓ ✓ Adjunct SA Adjunct SA SA IVDD/IVDR Gold Std ✓ ✓ AI ✓ AI Cost $ $ $$ $$$ $$ $$$ $$$ Comprehensive Limited / Potential X / $$$ ✓ Available * Baseline SA = Stand Alone NOTE: AI = artificial intelligence; AMR = antimicrobial resistance; AST = antimicrobial susceptibility testing; Iso = isothermal; IVDD = In Vitro Diagnostic Medical Devices Directive; IVDR = In Vitro Diagnostic Medical Devices Regulation; PCR = polymerase chain reaction; Std = standard; Trad = traditional SOURCE: Presented by Craig Whitford, October 13, 2022.
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Van Meter added that oversight of the development to tests can cause uncertainty for developers, explaining that there is a lack of an overarching regulatory apparatus for diagnostic tests and technologies. Some tests are developed in laboratories; these laboratory developed tests (LDTs)
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Van Meter emphasized that laboratory substructure -- whether commercial labs, hospital labs, or point-of-care testing used in physician office labs -- is part of the nation's critical infrastructure. The recent reductions in Medicare reimbursement threaten the stability of this groundwork, and it is essential that the nation makes the necessary investments in building infrastructure to serve patients and communities, noted Van Meter.
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Bioethical considerations for clinical laboratories Robin Patel (ID Physician, Clinical Microbiology Laboratory Director, Mayo Clinic) asked Cohen to comment on the bioethical considerations for clinical microbiology laboratory directors in the AMR space.
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Carroll emphasized a need to simultaneously push point-of-care testing to inform treatment decisions and diagnostic tests that enable the collection of public health data for surveillance purposes. Van Meter took a broader view of prioritization and said that efforts could be focused based on a variety of criteria: the type of bug, the areas where there is the most inappropriate prescribing, or care settings for which tools are available but are not being used.
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