Evidence-based point-of-care tests and device designs for disaster preparedness

Brock, T. Keith; Mecozzi, Daniel M.; Sumner, Stephanie L.; Kost, Gerald J.

doi:10.5055/ajdm.2010.0034

Cited by 22 publications

(22 citation statements)

References 20 publications

(8 reference statements)

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“…17,18 Data analysis and study design go hand in hand, and both should be considered before a CNA is undertaken. Regardless of the model one chooses, it is important to write a clear analysis plan at the beginning of the study to ensure that the interview guide or survey tool being developed will generate the kind of data consistent with planned downstream analysis methods.…”

Section: Discussionmentioning

confidence: 99%

The Value of Clinical Needs Assessments for Point-of-Care Diagnostics

Weigl¹,

Gaydos²,

Kost³

et al. 2012

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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Most entrepreneurial ventures fail long before the core technology can be brought to the marketplace because of disconnects in performance and usability measures such as accuracy, cost, complexity, assay stability, and time requirements between technology developers’ specifications and needs of the end-users. By going through a clinical needs assessment (CNA) process, developers will gain vital information and a clear focus that will help minimize the risks associated with the development of new technologies available for use within the health care system. This article summarizes best practices of the principal investigators of the National Institute of Biomedical Imaging and Bioengineering point-of-care (POC) centers within the National Institute of Biomedical Imaging and Bioengineering POC Technologies Research Network. Clinical needs assessments are particularly important for product development areas that do not sufficiently benefit from traditional market research, such as grant-funded research and development, new product lines using cutting-edge technologies developed in start-up companies, and products developed through product development partnerships for low-resource settings. The objectives of this article were to (1) highlight the importance of CNAs for development of POC devices, (2) discuss methods applied by POC Technologies Research Network for assessing clinical needs, and (3) provide a road map for future CNAs.

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Section: Discussionmentioning

confidence: 99%

The Value of Clinical Needs Assessments for Point-of-Care Diagnostics

Weigl¹,

Gaydos²,

Kost³

et al. 2012

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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show abstract

“…Kost, et al 21-23 used surveys targeting disaster medicine experts to determine future point-of-care designs, instrument characteristics, and test clusters for POC tests use in emergency and disaster care with a focus on infectious disease testing. Future surveys need to be extended to point-of-service hematology and coagulation tests.…”

Section: Challenges Of Clia-waivermentioning

confidence: 99%

Point-of-Care Hematology and Coagulation Testing in Primary, Rural Emergency, and Disaster Care Scenarios

Curtis¹,

Kost²,

Louie³

et al. 2012

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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The purpose of this article is to review current principles and criteria for obtaining Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) waiver, identify existing point-of-care (POC) coagulation and hematology technologies, and analyze regulatory challenges regarding CLIA-waiver for those and future devices. CLIA ’88 documentation requires tests performed by laboratories with a Certificate of Waiver to be so simple that the likelihood of erroneous results by the user is negligible, or poses no unreasonable risk of harm to the patient if performed incorrectly as determined by the Secretary of Health and Human Services. “Simple” means that the test uses unprocessed samples, has a direct read-out of test results, does not have specifications for user training, and includes instructions for confirmatory testing when advisable. Currently the CLIA-waived hematology and coagulation POC devices only test for hemoglobin (Hb), hematocrit (Hct), and prothrombin time/international normalized ratio (PT/INR). The problem with these devices is the lack of multiplexing. POC coagulation and hematology devices face challenges for obtaining a waiver. These challenges include the lack of clinical needs assessment, miniturized assays that correct for interfering substances, and assays simple enough to be combined in a multiplex platform. Several scenarios demonstrate how POC coagulation or hematology devices can improve crisis care. Industry should perform needs assessment on clinicians and emergency responders to determine which analytes to incorporate on multiplex POC coagulation and hematology devices, and produce devices that address confounding factors.

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“…13–15 Clinical needs assessment surveys conducted by the University of California, Davis POC Technologies Center revealed the need for bloodstream and respiratory infection detection in disaster settings—emphasizing the critical need for rapid pathogen detection during crises. 16,17 …”

Section: Establishing a Disaster-emergency-critical Care Continuummentioning

confidence: 99%

“…Escherichia coli , Pseudomonas aeruginosa , and Staphylococcus aureus infections are common following disasters. 16,17 Every hour delay in initiating appropriate antimicrobial therapy in severe sepsis is associated with a 12.7% decrease in survival. 38 Existing hospital pathogen detection technologies such as culture are not suitable for disasters.…”

Section: Value Propositionsmentioning

confidence: 99%

Point-of-Care Testing at the Disaster–Emergency–Critical Care Interface

Tran

Godwin

Bockhold

2012

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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Point-of-care (POC) testing allows for medical testing to be performed across the disaster-emergency-critical care continuum. The disaster-emergency-critical care continuum begins with the identification of at-risk patients, followed by patient stabilization, and ultimately transfer to an alternate care facility or mobile hospital for comprehensive critical care. Gaps at the interfaces for each of these settings leads to excess mortality and morbidity. Disaster victims are at risk for acute myocardial infarctions, acute kidney injury (AKI), and sepsis. However cardiac biomarker testing, renal function testing, and multiplex rapid pathogen detection are often unavailable or inadequate during disasters. Cardiac biomarker reagents require refrigeration; traditional renal function tests (i.e., serum creatinine) exhibit poor sensitivity for predicting AKI in critically ill patients, and culture-based pathogen detection is too slow to help initiate early-directed antimicrobial therapy. We propose three value propositions detailing how rapid, POC, and environmentally hardened cardiac biomarker, AKI and multiplex pathogen testing harmonizes the interface between disaster, emergency, and critical care.

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Evidence-based point-of-care tests and device designs for disaster preparedness

Cited by 22 publications

References 20 publications

The Value of Clinical Needs Assessments for Point-of-Care Diagnostics

The Value of Clinical Needs Assessments for Point-of-Care Diagnostics

Point-of-Care Hematology and Coagulation Testing in Primary, Rural Emergency, and Disaster Care Scenarios

Point-of-Care Testing at the Disaster–Emergency–Critical Care Interface

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