COVID-19 Diagnostic Testing: Lessons Learned for Innovative Product Development During A Public Health Emergency

2020 ◽  
Vol 25 (3) ◽  
Author(s):  
Christopher Lamb
Keyword(s):  
Public Health ◽  
Diagnostic Tests ◽  
Financial Incentives ◽  
Diagnostic Testing ◽  
Adaptive Immune Response ◽  
Lessons Learned ◽  
In Vitro Assays ◽  
Health Crisis ◽  
In Vitro Diagnostic

In response to the Coronavirus Disease-2019 (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) used its emergency authority through Emergency Use Authorizations (EUAs) to make COVID-19 in vitro diagnostic tests widely available to both diagnose active infection and help identify individuals with an adaptive immune response indicating recent or prior infection. Hundreds of innovative tests were quickly developed under Section IV.D. of FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. National reimbursement guidance through Centers for Medicare & Medicaid Services (CMS) provided significant financial incentives to track the endemic and enable healthcare workers and others get back to work more quickly. The US market for tests grew rapidly and the now exceeds $15 billion. However, many issues regarding product quality and availability have plagued the industry and called into question FDA’s policy and regulatory framework for allowing these tests to be commercially available. This paper analyzes the development of COVID-19 in vitro assays and the lessons learned for innovation during a public health crisis.

Japanese healthcare system: in vitro diagnostic tests and reimbursements

1994 ◽  
Vol 40 (8) ◽  
pp. 1663-1667 ◽  
Author(s):  
A Shimauchi
Keyword(s):  
Healthcare System ◽  
Prescription Drugs ◽  
Diagnostic Tests ◽  
Diagnostic Testing ◽  
Universal Coverage ◽  
Medical Expenditures ◽  
National Medical ◽  
Dental Procedures ◽  
In Vitro Diagnostic

Abstract In 1961, a new and mandatory National Health Insurance plan was enacted in Japan. This healthcare system has succeeded in providing universal coverage while also containing the growth of national medical expenditures (NME) to the rate of growth of the gross national product (GNP), namely, approximately 4-5% annually, for several decades. All Japanese medical procedures, including dental procedures, prescription drugs, and diagnostic tests, are reimbursed by a fee schedule set by the Ministry of Health and Welfare. The combination of strict fee control and low administration costs has kept the Japanese NME growth below that of the GNP. In 1990, NME was 20.6 trillion yen ($187 billion), total diagnostic testing expenditures (DTE) were 2.3 trillion yen, representing 11.2% of national medical expenditures (NME). Of this amount, in vitro diagnostic testing accounted for 1.4 trillion yen, representing 61% of DTE and 6.8% of NME. Annually, 1.8 billion in vitro diagnostic tests are performed.

Reflections on the next generation of hemostasis instrumentation. A glimpse into the future?

2015 ◽  
Vol 0 (0) ◽  
Author(s):  
Giuseppe Lippi ◽  
Chiara Bovo ◽  
Emmanuel J. Favaloro
Keyword(s):  
Diagnostic Tests ◽  
Diagnostic Testing ◽  
Therapeutic Management ◽  
Next Generation ◽  
Coagulation Tests ◽  
The Future ◽  
In Vitro Diagnostic ◽  
High Degree

AbstractHemostasis testing is conventionally referred to as performance of in vitro diagnostic tests for screening, diagnosis and therapeutic management of patients with either bleeding or thrombotic disorders. The ongoing revolution of diagnostic testing, squeezed between reduced funding and increasing volumes, carries notable implications in the way laboratory resources are organized and coagulation tests delivered. It is therefore predictable that the newer generation of hemostasis analyzers may be designed to face these emerging needs whilst maintaining a high degree in the quality of testing. In this opinion paper, we aim to discuss some concepts of redesigning coagulation analyzers in consideration of the most important aspects of the preanalytical, analytical and postanalytical phases in hemostasis testing.

scholarly journals The influence of sugar–protein complexes on the thermostability of C-reactive protein (CRP)

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Andreea Lorena Mateescu ◽  
Nicolae-Bogdan Mincu ◽  
Silvana Vasilca ◽  
Roxana Apetrei ◽  
Diana Stan ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Protein Complexes ◽  
C Reactive Protein ◽  
Time Resolved Fluorescence ◽  
Time Resolved ◽  
Reactive Protein ◽  
In Vitro Diagnostic ◽  
The Stability ◽  
Positive Controls

AbstractThe purpose of the present study was to evaluate de influence of protein–sugar complexation on the stability and functionality of C-reactive protein, after exposure to constant high temperatures, in order to develop highly stable positive controls for in-vitro diagnostic tests. C-reactive protein is a plasmatic protein used as a biomarker for the diagnosis of a series of health problems such as ulcerative colitis, cardiovascular diseases, metabolic syndrome, due to its essential role in the evolution of chronic inflammation. The sugar–protein interaction was investigated using steady state and time resolved fluorescence. The results revealed that there are more than two classes of tryptophan, with different degree of accessibility for the quencher molecule. Our study also revealed that sugar–protein complexes have superior thermostability, especially after gamma irradiation at 2 kGy, the protein being stable and functional even after 22 days exposure to 40 °C.

scholarly journals The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech

2021 ◽  
Vol 2 ◽  
pp. 138-141
Author(s):  
Matthew Robinson ◽  
Charlotte Gaydos ◽  
Barbara Van Der Pol ◽  
Sally McFall ◽  
Yu-Hsiang Hsieh ◽  
...  
Keyword(s):  
Clinical Review ◽  
Diagnostic Tests ◽  
Review Committee ◽  
In Vitro Diagnostic

scholarly journals Four pandemics: lessons learned, lessons lost

2020 ◽  
Keyword(s):  
Public Health ◽  
Lessons Learned ◽  
World Health ◽  
Swine Flu ◽  
Global Public Health ◽  
Health Crisis ◽  
The World ◽  
Spanish Flu ◽  
Future Events ◽  
Health Organization

In the past 100 years, the world has faced four distinctly different pandemics: the Spanish flu of 1918-1919, the SARS pandemic of 2003, the H1N1 or “swine flu” pandemic of 2012, and the ongoing COVID-19 pandemic. Each public health crisis exposed specific systemic shortfalls and provided public health lessons for future events. The Spanish flu revealed a nursing shortage and led to a great appreciation of nursing as a profession. SARS showed the importance of having frontline clinicians be able to work with regulators and those producing guidelines. H1N1 raised questions about the nature of a global organization such as the World Health Organization in terms of the benefits and potential disadvantages of leading the fight against a long-term global public health threat. In the era of COVID-19, it seems apparent that we are learning about both the blessing and curse of social media.

Current nursing practice of point-of-care laboratory diagnostic testing in critical care units

1995 ◽  
Vol 4 (6) ◽  
pp. 429-434 ◽  
Author(s):  
Lamb LSJr ◽  
RS Parrish ◽  
SF Goran ◽  
MH Biel
Keyword(s):  
Critical Care ◽  
Patient Care ◽  
Laboratory Testing ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Critical Care Nurses ◽  
Point Of Care Testing ◽  
Critical Care Units ◽  
In Vitro Diagnostic

BACKGROUND: The development of user-friendly laboratory analyzers, combined with the need for rapid assessment of critically ill patients, has led to the performance of in vitro diagnostic testing at the point of care by personnel without formal laboratory training. OBJECTIVES: To determine the range of laboratory testing performed by critical care nurses and their attitudes toward this role. METHODS: A survey of critical care nursing consultants was conducted, using a modified Likert scale, to assess objective measures of point-of-care testing practice in critical care units and to determine nurses' attitudes toward the practice of point-of-care testing. Statistical analysis was performed to determine significant trends in responses. RESULTS: Of the units responding to the survey, 35% used critical care nurses exclusively to perform point-of-care testing, 32.5% used laboratory technicians and critical care nurses, and 25% used other personnel. Of critical care nurses performing laboratory testing, 95.5% performed blood glucose analysis; 18.7%, arterial blood gas analysis; 4.5%, electrolyte analysis; 4.5%, hematology profiles; and 22.7%, other testing. Most agreed that stat tests were not reported promptly, thereby necessitating bedside testing. Respondents indicated that they would prefer that laboratory personnel operate in vitro diagnostic equipment and that requirements for critical care nurses to perform laboratory testing detracted from other patient care duties. CONCLUSIONS: Most nurses who perform point-of-care testing responded that it was necessary and helpful in patient management. However, they would prefer, because of their other patient care responsibilities, that laboratory personnel take this responsibility.

scholarly journals Lessons earned and lessons learned: What should be done next to counter the COVID-19 infodemic?

European View ◽  
2020 ◽  
Vol 19 (2) ◽  
pp. 154-163
Author(s):  
Nad’a Kovalčíková ◽  
Ariane Tabatabai
Keyword(s):  
Public Health ◽  
Lessons Learned ◽  
The Novel ◽  
Health Crisis ◽  
The Public ◽  
Public Health Crisis ◽  
Societal Challenges ◽  
The World ◽  
Information Manipulation ◽  
Novel Coronavirus

As governments and citizens around the world have struggled with the novel coronavirus, the information space has turned into a battleground. Authoritarian countries, including Russia, China and Iran, have spread disinformation on the causes of and responses to the pandemic. The over-abundance of information, also referred to as an ‘infodemic’, including manipulated information, has been both a cause and a result of the exacerbation of the public health crisis. It is further undermining trust in democratic institutions, the independent press, and facts and data, and exacerbating the rising tensions driven by economic, political and societal challenges. This article discusses the challenges democracies have faced and the measures they have adopted to counter information manipulation that impedes public health efforts. It draws seven lessons learned from the information war and offers a set of recommendations on tackling future infodemics related to public health.

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