Artificial Intelligence and Mapping a New Direction in Laboratory Medicine: A Review

2021 ◽  
Author(s):  
Daniel S Herman ◽  
Daniel D Rhoads ◽  
Wade L Schulz ◽  
Thomas J S Durant
Keyword(s):  
Artificial Intelligence ◽  
Best Practices ◽  
Clinical Laboratory ◽  
Laboratory Data ◽  
Laboratory Medicine ◽  
Clinical Diagnostics ◽  
In Vitro Diagnostics ◽  
Literature Reviews ◽  
Human Operators

Abstract Background Modern artificial intelligence (AI) and machine learning (ML) methods are now capable of completing tasks with performance characteristics that are comparable to those of expert human operators. As a result, many areas throughout healthcare are incorporating these technologies, including in vitro diagnostics and, more broadly, laboratory medicine. However, there are limited literature reviews of the landscape, likely future, and challenges of the application of AI/ML in laboratory medicine. Content In this review, we begin with a brief introduction to AI and its subfield of ML. The ensuing sections describe ML systems that are currently in clinical laboratory practice or are being proposed for such use in recent literature, ML systems that use laboratory data outside the clinical laboratory, challenges to the adoption of ML, and future opportunities for ML in laboratory medicine. Summary AI and ML have and will continue to influence the practice and scope of laboratory medicine dramatically. This has been made possible by advancements in modern computing and the widespread digitization of health information. These technologies are being rapidly developed and described, but in comparison, their implementation thus far has been modest. To spur the implementation of reliable and sophisticated ML-based technologies, we need to establish best practices further and improve our information system and communication infrastructure. The participation of the clinical laboratory community is essential to ensure that laboratory data are sufficiently available and incorporated conscientiously into robust, safe, and clinically effective ML-supported clinical diagnostics.

Regulation of in vitro diagnostics (IVDs) for use in clinical diagnostic laboratories: towards the light or dark in clinical laboratory testing?

2011 ◽  
Vol 49 (12) ◽  
Author(s):  
Emmanuel J. Favaloro ◽  
Mario Plebani ◽  
Giuseppe Lippi
Keyword(s):  
Clinical Laboratory ◽  
Regulatory Process ◽  
Adverse Outcomes ◽  
Personal Health ◽  
In Vitro Diagnostics ◽  
Clinical Diagnostic ◽  
In Vitro Diagnostic ◽  
The Usa ◽  
Clinical Laboratory Testing

AbstractA revised framework for the regulation of in vitro diagnostic devices (IVDs) came into force in Australia on July 1, 2010 that aims to ‘ensure that public and personal health are adequately protected’, but which instead may lead to adverse outcomes in clinical diagnosis and management. The regulatory process aims to regulate all IVDs, including those used by clinical diagnostic laboratories, which are already subject to scrutiny as part of the current laboratory accreditation process. The IVD regulatory process initiated in Australia is similar to that used in Canada, but different to that currently operating in the USA and Europe. However, it is feasible that other countries will in time adopt a similar regulatory framework, given that many countries are involved in the development process. In this opinion paper, the regulatory process for IVDs across several geographies are outlined, as are some benefits and weaknesses of the new regulatory process now applied to Australia, as potentially planned for other regions of the world.

Laboratory Medicine and Diagnostic Testing

2004 ◽  
Vol 94 (2) ◽  
pp. 194-197
Author(s):  
Noubar Kessimian
Keyword(s):  
Medical Practice ◽  
Clinical Laboratory ◽  
Diagnostic Testing ◽  
Laboratory Data ◽  
Laboratory Medicine ◽  
Test Results ◽  
Vital Component ◽  
Sensitivity Specificity

The clinical laboratory is a vital component of modern podiatric medical practice. In order to interpret laboratory data correctly, the practitioner must understand the essentials of diagnostic testing. These essentials include precision, accuracy, sensitivity, specificity, and prevalence-based values of a given test. In addition, the podiatric physician should be aware of the limitations, variations, and interferences that can spuriously alter test results. (J Am Podiatr Med Assoc 94(2): 194-197, 2004)

scholarly journals Laboratory-Developed Tests: A Legislative and Regulatory Review

2017 ◽  
Vol 63 (10) ◽  
pp. 1575-1584 ◽  
Author(s):  
Jonathan R Genzen ◽  
Jeffrey S Mohlman ◽  
Jerry L Lynch ◽  
Michael W Squires ◽  
Ronald L Weiss
Keyword(s):  
Clinical Laboratory ◽  
Draft Guidance ◽  
In Vitro Diagnostics ◽  
Regulatory Oversight ◽  
Regulatory Review ◽  
Policy Documents ◽  
Congressional Hearings ◽  
Clinical Laboratory Improvement Amendments ◽  
Intense Debate

Abstract BACKGROUND Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that “home brew” tests—now commonly referred to as laboratory-developed tests (LDTs)—are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. CONTENT This review provides an overview of federal statutes and regulations related to IVDs and clinical laboratory operations, with a focus on those potentially applicable to LDTs and proposed regulatory efforts. Sources reviewed include the Code of Federal Regulations, the Federal Register, congressional hearings, guidance and policy documents, position statements, published literature, and websites. SUMMARY Federal statutes regarding IVDs were passed without substantive evidence of congressional consideration toward the concept of LDTs. The FDA has clear oversight authority over IVD reagents introduced into interstate commerce. A 16-year delay in publicly asserting FDA authority over LDTs, the pursuit of a draft guidance approach toward oversight, and establishment of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) applicable to LDTs contributed to community uncertainty toward LDT oversight. Future regulatory and/or legislative efforts may be required to resolve this uncertainty.

scholarly journals Challenges of Laboratory Medicine: European Answers

2011 ◽  
Vol 30 (4) ◽  
pp. 273-278 ◽  
Author(s):  
Irena Korita ◽  
Victor Blaton
Keyword(s):  
Strategic Alliances ◽  
Business Models ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biomedical Sciences ◽  
Clinical Laboratories ◽  
Laboratory Services ◽  
Enhance Efficiency

Challenges of Laboratory Medicine: European Answers Medical laboratories play a vital role in modern healthcare, and qualified specialists in Clinical Chemistry and Laboratory Medicine are essential for the provision of high-quality preanalytical, analytical and consultative services. Laboratory medicine has undergone major transformations during the last decade. Ongoing technological developments have considerably improved the productivity of clinical laboratories. Information on laboratory services is globally available, and clinical laboratories worldwide face international competition and there is a huge pressure to reduce costs. To be prepared for the future, clinical laboratories should enhance efficiency and reduce the cost increases by forming alliances and networks, consolidating, integrating or outsourcing, and more importantly create additional value by providing knowledge services related to in vitro diagnostics. Therefore, business models that increase efficiency such as horizontal and vertical integration are proposed, based on collaborative networks for the delivery of clinical laboratory services. Laboratories should cooperate, consolidate and form strategic alliances to enhance efficiency and reduce costs. There is a growing conflict between the science and the art of clinical practice and on the role of the biomedical sciences in medical practice. We have a dehumanizing effect on medical care. Disease is defined at the level of sick molecules and cells and curative medicine is being replaced by the preventive care of the disease. Undoubtedly all those questions will raise considerable problems and challenges for the medical educators.

Properties and Units in the Clinical Laboratory Sciences. Part XIX. Properties and Units for Transfusion Medicine and Immunohematology (IUPAC Technical Report)

2003 ◽  
Vol 75 (10) ◽  
pp. 1477-1600 ◽  
Author(s):  
K. Varming ◽  
U. Forsum ◽  
Ivan Bruunshuus ◽  
H. Olesen
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Laboratory Data ◽  
Working Party ◽  
Laboratory Medicine ◽  
General Introduction ◽  
International Union ◽  
Ongoing Effort ◽  
Technical Report ◽  
Clinical Laboratory Sciences

This document is part of an ongoing effort to standardize transmission of laboratory data across cultural and linguistic domains, without attempting to standardize the routine language used by clinicians and laboratory practitioners. It comprises a general introduction and an alphabetic list of properties. The list is based on the syntax for properties recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Union of Pure and Applied Chemistry (IUPAC). The nomenclature is primarily from the Working Party on Terminology of the International Society of Blood Transfusion (ISBT).

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