Regulatory Compliance for Point-of-Care Testing: A Perspective from the United States (Circa 2000)

2001 ◽  
Vol 21 (2) ◽  
pp. 241-254 ◽  
Author(s):  
Elizabeth Lee-Lewandrowski ◽  
Kent Lewandrowski
Keyword(s):  
United States ◽  
Point Of Care ◽  
The United States ◽  
Regulatory Compliance ◽  
Point Of Care Testing

scholarly journals Economic Evaluation of FebriDx®: A Novel Rapid, Point-of-Care Test for Differentiation of Viral versus Bacterial Acute Respiratory Infection in the United States

2021 ◽  
Vol 8 (2) ◽  
pp. 56-62
Author(s):  
Katherine Dick ◽  
John Schneider
Keyword(s):  
United States ◽  
Economic Evaluation ◽  
Antibiotic Treatment ◽  
Bacterial Infections ◽  
Point Of Care ◽  
The United States ◽  
Antibiotic Prescribing ◽  
Point Of Care Testing ◽  
Antibiotic Resistant ◽  
Point Of Care Test

Background: Acute respiratory infections (ARIs) are commonly treated with antibiotics in outpatient settings, but many infections are caused by viruses and antibiotic treatment is therefore inappropriate. FebriDx®, a rapid point-of-care test that can differentiate viral from bacterial infections, can inform antibiotic treatment decisions. Objectives: The primary aim of this study is to conduct a literature-based US economic evaluation of a novel rapid point-of-care test, FebriDx®, that simultaneously measures two key infection biomarkers, C-reactive protein (CRP) and\ Myxovirus resistance protein A (MxA), to accurately differentiate viral from bacterial infection. Methods: A budget impact model was developed based on a review of published literature on antibiotic prescribing for ARIs in the United States. The model considers the cost of antibiotic treatment, antibiotic resistant infections, antibiotic-related adverse events, and point-of-care testing. These costs were extrapolated to estimate savings on a national level. Results: The expected national cost to treat ARIs under standard of care was US $8.25 billion, whereas the expected national cost of FebriDx point-of-care-guided ARI treatment was US $5.74 billion. Therefore, the expected national savings associated with FebriDx® rapid point-of-care testing was US $2.51 billion annually. Conclusions: FebriDx, a point of care test that can reliably aid in the differentiation of viral and bacterial infections, can reduce antibiotic misuse and, therefore, antibiotic resistant infections. This results in significant cost savings, driven primarily by the reduction in antibiotic resistant infections.

scholarly journals 2158. Cost-Effectiveness and Budget Impact of a Point-of-Care Nucleic Acid Amplification Test for Diagnosis of Group A Streptococcal Pharyngitis in the United States

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S732-S732
Author(s):  
James Karichu ◽  
Mindy Cheng ◽  
Joanna Sickler ◽  
Julie Munakata ◽  
S Pinar Bilir ◽  
...  
Keyword(s):  
United States ◽  
Cost Effectiveness ◽  
Nucleic Acid ◽  
Budget Impact ◽  
Point Of Care ◽  
Cost Savings ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Sensitivity Analyses ◽  
Group A

Abstract Background Group A streptococcal (GAS) pharyngitis is common in the United States (US). Each year, approximately 12 million people seek medical care for pharyngitis, accounting for ~2% of ambulatory care visits. The gold standard method for diagnosing GAS is culture. However, because culture is time intensive, rapid antigen detection tests (RADTs), with or without culture confirmation, are commonly used. Although RADTs provide results quickly, test sensitivity has been shown to be sub-optimal, which can lead to inappropriate treatment decisions. Recently, highly sensitive point-of-care nucleic acid amplification tests (POC NAAT), such as the cobas® Liat® System, have emerged. The objective of this study was to evaluate the cost-effectiveness (CE) and budget impact (BI) of adopting POC NAAT compared with RADT+culture confirmation to diagnose GAS pharyngitis from the US third-party payer perspective. Methods A decision-tree economic model was developed in Microsoft Excel to quantify costs and clinical outcomes associated with POC NAAT and RADT+culture over a one-year period. All model inputs were derived from published literature and public databases. Model outputs included costs and clinical effects measured as quality-adjusted life days (QALDs) lost. One-way and probabilistic sensitivity analyses were performed to assess the impact of uncertainty on results. Results CE analysis showed that POC NAAT would cost $44 per patient compared with $78 with RADT+ culture. POC NAAT was associated with fewer QALDs lost relative to RADT+ culture. Therefore, POC NAAT may be considered the “dominant” strategy (i.e., lower costs and higher effectiveness). Findings were robust in sensitivity analyses. BI analysis showed that adopting POC NAAT for diagnosis of GAS could yield cost-savings of 0.3% vs. current budget over 3 years. This is due to savings associated with testing, GAS-related complications, antibiotic treatment and treatment-associated complication costs. Conclusion Results suggest that adopting POC NAAT to diagnose GAS would be considered cost-effective and yield cost-savings for US payers relative to RADT+culture. Access to POC NAAT would be important to optimize appropriate GAS diagnosis and treatment decisions. Disclosures All authors: No reported disclosures.

Digital Instrumentation and Control Systems Upgrades in Current Generation Nuclear Power Plants

2010 ◽  
Author(s):  
Steven A. Arndt
Keyword(s):  
United States ◽  
Cyber Security ◽  
Nuclear Power ◽  
Power Plants ◽  
Nuclear Power Plants ◽  
Plant Protection ◽  
The United States ◽  
Regulatory Compliance ◽  
Digital Systems

Over the past 20 years, the nuclear power industry in the United States (U.S.) has been slowly replacing old, obsolete, and difficult-to-maintain analog technology for its nuclear power plant protection, control, and instrumentation systems with digital systems. The advantages of digital technology, including more accurate and stable measurements and the ability to improve diagnostics capability and system reliability, have led to an ever increasing move to complete these upgrades. Because of the difficulties with establishing digital systems safety based on analysis or tests, the safety demonstration for these systems relies heavily on establishing the quality of the design and development of the hardware and software. In the United States, the U.S. Nuclear Regulatory Commission (NRC) has established detailed guidelines for establishing and documenting an appropriate safety demonstration for digital systems in NUREG-0800, “Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,” Chapter 7, “Instrumentation and Controls,” Revision 5, issued March 2007 [1], and in a number of regulatory guides and interim staff guidance documents. However, despite the fact that the United States has a well-defined review process, a number of significant challenges associated with the design, licensing, and implementation of upgrades to digital systems for U.S. plants have emerged. Among these challenges have been problems with the quality of the systems and the supporting software verification and validation (V&V) processes, challenges with determining the optimum balance between the enhanced capabilities for the new systems and the desire to maintain system simplicity, challenges with cyber security, and challenges with developing the information needed to support the review of new systems for regulatory compliance.

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