Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance Proceedings of a Workshop (2023) / Chapter Skim
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3 Lessons Learned from the COVID-19 Pandemic
3 Lessons Learned from the COVID-19 Pandemic
Pages 23-40
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From page 23... ...
(Rodriguez) • There are resources and support available through the National Institute of Allergy and Infectious Diseases (NIAID)
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From page 24... ...
In this session of the workshop, speakers and participants considered the unique challenges for the development of rapid point-of-care diagnostics to address antibiotic resistance. Speakers shared lessons learned from other disease areas, including COVID-19, discussed the development and use of rapid diagnostics to address drug-resistant bacterial infections, and considered generalizable applications and practical approaches to overcome barriers to innovation.
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From page 25... ...
As of October 2022, the FDA had issued EUAs for a variety of SARS-CoV-2 tests, including almost 300 molecular tests, 51 antigen tests, and 85 serology tests (FDA, 2022)
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From page 26... ...
Lutgring cautioned that there can be unintended consequences of using multiple diagnostics, particularly if clinicians do not understand what a positive or negative result means. For example, a patient with a positive nucleic acid amplification test and a negative toxin enzyme immunoassay test might be treated with antibiotics even if they do not have an active infection.
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From page 27... ...
True point-of-care tests are delivered in a primary care facility and do not require lab equipment or reliable power to be stored and administered. Near-patient point-of-care tests are conducted in district hospitals and may FIGURE 3-1 Fit-for-purpose testing NOTE: BSL = biological safety level; POC = point-of-care SOURCE: Presented by William Rodriguez, October 13, 2022; Image courtesy of FIND (www.finddx.org)
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From page 28... ...
He noted that more complex tests, such as multiplex molecular tests, will likely have an even greater challenge getting through regulatory hurdles. In addition to advancing the development and deployment of molecular and rapid tests, Rodriguez noted that the ACT Accelerator also dramatically improved the global capacity to perform genomic sequencing tests.
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From page 29... ...
Rodriguez laid out a few challenges during the COVID-19 pandemic that may be relevant for AMR, including • complexity of the global problem requiring collaboration among clinicians, epidemiologists, and politicians; • limited evidence to inform policy; FIGURE 3-2 COVID-19 tests conducted per 1000 individuals per day SOURCE: Presented by William Rodriguez, October 13, 2022; Image courtesy of FIND (www.finddx.org) , based on data from the FIND COVID-19 test tracker, 2023.
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From page 30... ...
began by describing what he means by "AMR" and "AST," noting that these terms are used in different ways by different people. For the purposes of his talk, AMR means antimicrobial resistance prediction based on genotypic data, while AST refers to antibacterial susceptibility characterization through empirical data.
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From page 31... ...
The areas of focus for 2023 include • Faster bacterial identification direct from whole blood in under 4 hours; • AST from positive blood culture or bacterial isolate in less than 2 hours; • Improved performance in nucleic acid sequencing, mass spec sensi tivity, protein sequencing, antigen or toxin capture and detection. The awards for BAA are based on milestones and successful deliverables, based on a negotiated statement of work.
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From page 32... ...
There have been significant advances in rapid diagnostics in the healthcare space in recent years. Multiplex testing platforms, such as the BioFire FilmArray Pneumonia plus Panel, have demonstrated rapid automated testing of more than 30 targets with turnaround time of about an hour and hands-on time expected to be about a minute (Buchan et al., 2020)
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From page 33... ...
Fourth, it is a challenge to get specimens for validation of new markers. As there are greater numbers of esoteric antimicrobial resistance markers, labs need to be able to order bacterial panels to validate targets.
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From page 34... ...
. There is growing complexity of resistance mechanisms for each antimicrobial class; complex issues including the numbers of sample types, different transport media, and CLIA waivers; and accessing the required specimens for clinical trials is difficult given the decreasing number of labs willing to participate.
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From page 35... ...
Government support was criti cal in validating the assays, said Persing. For example, the Antimicrobial Resistance Isolate Bank has bacterial isolates with emerging AMR genes that have been confirmed by DNA sequence analysis.7 Persing said that this continually updated resource is very valuable due to its comprehensiveness.
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From page 36... ...
Carroll said that an important consideration is where the infection is located and what this means for interpretation of a test for resistance markers. For example, if a patient has signs and symptoms of a UTI and there are resistance markers in the otherwise sterile urine sample, Carroll would feel comfortable using this information to direct treatment without information about the specific pathogen.
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From page 37... ...
For example, emergency department physicians are accustomed to making decisions with minimal data to triage patients, while an infectious disease specialist may want a more comprehensive dataset. Ultimately, it may come down to regulators and payers and how they view the utility of these tests.
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From page 38... ...
However, he emphasized that the ability to access a test usually "dramatically outweighs the small drop-off in performance from self-testing." Leveraging pandemic collaborations for AMR Eder shared a list of resources that NIAID offers to developers and stated that public-private partnerships bring together the resources of the government with the ingenuity of the private sector. Roth shared a project in which NIH collaborated with the University of Massachusetts to collect data on COVID-19 testing; these data were collected during an emergency situation and are now being used to make regulatory decisions.
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From page 39... ...
A workshop participant observed that due to COVID-19, there has never been a more acute awareness of infectious disease. "Amidst chaos lies opportunity," he said, and this is the time to get out the message that antimicrobial resistance is a major threat to health.
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