Point-of-care testing


Book Description

The underlying technology and the range of test parameters available are evolving rapidly. The primary advantage of POCT is the convenience of performing the test close to the patient and the speed at which test results can be obtained, compared to sending a sample to a laboratory and waiting for results to be returned. Thus, a series of clinical applications are possible that can shorten the time for clinical decision-making about additional testing or therapy, as delays are no longer caused by preparation of clinical samples, transport, and central laboratory analysis. Tests in a POC format can now be found for many medical disciplines including endocrinology/diabetes, cardiology, nephrology, critical care, fertility, hematology/coagulation, infectious disease and microbiology, and general health screening. Point-of-care testing (POCT) enables health care personnel to perform clinical laboratory testing near the patient. The idea of conventional and POCT laboratory services presiding within a hospital seems contradictory; yet, they are, in fact, complementary: together POCT and central laboratory are important for the optimal functioning of diagnostic processes. They complement each other, provided that a dedicated POCT coordination integrates the quality assurance of POCT into the overall quality management system of the central laboratory. The motivation of the third edition of the POCT book from Luppa/Junker, which is now also available in English, is to explore and describe clinically relevant analytical techniques, organizational concepts for application and future perspectives of POCT. From descriptions of the opportunities that POCT can provide to the limitations that clinician’s must be cautioned about, this book provides an overview of the many aspects that challenge those who choose to implement POCT. Technologies, clinical applications, networking issues and quality regulations are described as well as a survey of future technologies that are on the future horizon. The editors have spent considerable efforts to update the book in general and to highlight the latest developments, e.g., novel POCT applications of nucleic acid testing for the rapid identification of infectious agents. Of particular note is also that a cross-country comparison of POCT quality rules is being described by a team of international experts in this field.




Medical Devices


Book Description

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9




Glucose Sensing


Book Description

An essential reference for any laboratory working in the analytical fluorescence glucose sensing field. The increasing importance of these techniques is typified in one emerging area by developing non-invasive and continuous approaches for physiological glucose monitoring. This volume incorporates analytical fluorescence-based glucose sensing reviews, specialized enough to be attractive to professional researchers, yet appealing to a wider audience of scientists in related disciplines of fluorescence.




WHO Guidelines on Drawing Blood


Book Description

Phlebotomy uses large, hollow needles to remove blood specimens for lab testing or blood donation. Each step in the process carries risks - both for patients and health workers. Patients may be bruised. Health workers may receive needle-stick injuries. Both can become infected with bloodborne organisms such as hepatitis B, HIV, syphilis or malaria. Moreover, each step affects the quality of the specimen and the diagnosis. A contaminated specimen will produce a misdiagnosis. Clerical errors can prove fatal. The new WHO guidelines provide recommended steps for safe phlebotomy and reiterate accepted principles for drawing, collecting blood and transporting blood to laboratories/blood banks.




The selection and use of essential in vitro diagnostics


Book Description

Technical report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro diagnostics (EDL 4)). This report also includes the applications received for the EDL 4 and a summary of the deliberations and recommendations by the SAGE IVD members and the methodologist that assessed the supportive evidence for the EDL 4 applications.




Medical Instruments and Devices


Book Description

Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. I




Quality Control and Regulatory Aspects for Biologicals


Book Description

This book serves as a comprehensive guide on quality control and regulatory aspects for biological products. It covers a wide range of topics, including regulatory requirements, quality control strategies, analytical methods, and risk management. It delves into the advantages and limitations of in vivo tests and discusses alternative methods that can be employed. The book explores the use of animal-based testing methods in quality control and examines viable alternatives. Key Features: Reviews various scientific and regulatory aspects involved in the quality control of biologicals Provides an overview of the roles of various national and international regulatory bodies and accreditation agencies Presents advanced analytical methods, innovative technologies, and the integration of molecular diagnostics in quality control processes Explores the use of animal-based testing methods in quality control, as well as their alternatives Discusses guidelines and methodologies involved in the development of biological products Overall, this book is an important reference source for various professionals in the pharmaceutical industry, including researchers, scientists, quality control personnel, and regulatory affairs professionals.




Real-World Evidence Generation and Evaluation of Therapeutics


Book Description

The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.