Statistical applications for in vitro diagnostic tests and other medical device clinical trials

1997 ◽  
Vol 7 (4) ◽  
pp. 579-591
Author(s):  
Chang S. Lao
Keyword(s):  
Clinical Trials ◽  
Medical Device ◽  
Diagnostic Tests ◽  
In Vitro Diagnostic

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

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.

scholarly journals Regulatory hurdles in bringing an in vitro diagnostic device to market

1996 ◽  
Vol 42 (9) ◽  
pp. 1556-1557 ◽  
Author(s):  
K M Smith ◽  
J A Kates
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
New Products ◽  
New Product ◽  
Diagnostic Device ◽  
Regulatory Strategy ◽  
The Us ◽  
In Vitro Diagnostic ◽  
Medical Device Regulation

Abstract We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.

scholarly journals US Food and Drug Administration Perspectives on Clinical Mass Spectrometry

2016 ◽  
Vol 62 (1) ◽  
pp. 41-47 ◽  
Author(s):  
Julia Tait Lathrop ◽  
Douglas A Jeffery ◽  
Yvonne R Shea ◽  
Peter F Scholl ◽  
Maria M Chan
Keyword(s):  
Mass Spectrometry ◽  
Clinical Trials ◽  
Drug Administration ◽  
Review Process ◽  
Food And Drug Administration ◽  
Regulatory Review ◽  
In Vitro Diagnostic ◽  
Guidance Documents ◽  
Proteins And Peptides

Abstract Mass spectrometry–based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry–based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry–based devices and enhance their entry into the clinic.

scholarly journals New medical device regulations: the regulator’s view

2019 ◽  
Vol 4 (6) ◽  
pp. 351-356 ◽  
Author(s):  
Tom Melvin ◽  
Marina Torre
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Clinical Investigation ◽  
Pool Data ◽  
Critical Function ◽  
Core Dataset ◽  
Medical Device Manufacturers ◽  
In Vitro Diagnostic ◽  
And Performance

Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). These regulations will replace the current directives over the coming years. These regulations, for the first time introduce requirements relating to registries. Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording and analysing data on safety and performance. Registries can assist public health protection in very practical ways, for example, to help urgently identify patients or devices. Registries can also be powerful tools for collecting and appraising real-world clinical evidence concerning medical devices. Clinical investigations are limited in terms of the sample size and the duration of follow-up which can reasonably be expected. Registries may also be the only available tool to examine rare adverse effects, sub-populations or for time durations which it is not possible or feasible to study in a clinical investigation. By ensuring that a core dataset is collected which can be compared to other registries or trial data, it is possible to pool data to better examine outcomes. There are a range of excellent initiatives which have aimed at ensuring the appropriate regulatory application of registry data. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180061

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.

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