The Role of Point-of-Care Testing in Specific Populations
Diagnostics for particular populations outside of traditional health care settings have driven development of point-of-care testing (POCT). POCT is particularly suitable for patients with infections conditions to mitigate infection spread via its provision in venues with less concern for stigma. Patients in rural or resource-limited settings can benefit from POCT through more timely diagnosis and linkage-to-care. However, gaps in POCT availability compared with better-resourced, urban counterparts persist. Leveraging communication technologies, using mobile clinics, changing national health care policy, and implementing no...
Source: Clinics in Laboratory Medicine - March 15, 2023 Category: Laboratory Medicine Authors: Nicholas Yared Source Type: research
Point-of-Care Testing for the Diagnosis of Fungal Infections
Invasive fungal infections are increasing worldwide due to factors such as climate change and immunomodulating therapies. Unfortunately, the detection of these infections is limited due to the low sensitivity and long periods required for laboratory testing. Point-of-care testing could lead to more rapid diagnosis of these often devasting infections. However, there are currently no true point-of-care tests on the market for the detection of fungi. In this article, the current state of fungal antigen and molecular testing is reviewed, with commentary on the potential for development and use in the point-of-care setting. (So...
Source: Clinics in Laboratory Medicine - March 15, 2023 Category: Laboratory Medicine Authors: Paul M. Luethy Source Type: research
Regulatory Approach to Point-of-Care/At-Home Testing in the United States
The Clinical Laboratory Improvement Amendments (CLIA) classifications were activated in the 1990s in partnership with the Centers for Medicare and Medicaid Services and Food and Drug Administration and included waived, moderate, and high complexity testing. The waived section of CLIA certificates allows laboratories to perform testing of analytes and methods of samples by the Food and Drug Administration. During the COVID-19 pandemic, many molecular or antigen laboratory testing methods for COVID-19 virus were quickly approved by emergency use authorization. Waived testing is now done in highly complex, moderately complex,...
Source: Clinics in Laboratory Medicine - February 27, 2023 Category: Laboratory Medicine Authors: Robert L. Sautter Source Type: research
Regulatory Approach to Point of Care/At Home Testing in the United States
The CLIA classifications (1988) were activated in the 1990s in partnership with CMS and FDA and included Waived, Moderate and High Complexity testing. The Waived section of CLIA certificates allow laboratories to perform testing of analytes and methods of samples by the FDA. After approval, some testing may also be performed at home although this is not regulated under CLIA. During the COVID 19 pandemic (2019), many molecular or antigen laboratory testing methods for the COVID 19 virus were quickly approved by EUA (Emergency Use Authorization). Now the waived testing can be done in Highly Complex, Moderately Complex and Wa...
Source: Clinics in Laboratory Medicine - February 27, 2023 Category: Laboratory Medicine Authors: Robert L. Sautter Source Type: research
Using Artificial Intelligence to Better Predict and Develop Biomarkers
Advancements in technology have improved biomarker discovery in the field of heart failure (HF). What was once a slow and laborious process has gained efficiency through use of high-throughput omics platforms to phenotype HF at the level of genes, transcripts, proteins, and metabolites. Furthermore, improvements in artificial intelligence (AI) have made the interpretation of large omics data sets easier and improved analysis. Use of omics and AI in biomarker discovery can aid clinicians by identifying markers of risk for developing HF, monitoring care, determining prognosis, and developing druggable targets. Combined, AI h...
Source: Clinics in Laboratory Medicine - February 9, 2023 Category: Laboratory Medicine Authors: Sam A. Michelhaugh, James L. Januzzi Source Type: research
Laboratory Aspects of Minimal / Measurable Residual Disease Testing in B-Lymphoblastic Leukemia
This article details the leukemia associated immunophenotype analysis approach for flow cytometry–based minimal residual disease detection used at St. Jude Children’s Research Hospital and importance of using guide gates and back-gating. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 9, 2023 Category: Laboratory Medicine Authors: John Kim Choi, Paul E. Mead Source Type: research
Artificial Intelligence in the Genetic Diagnosis of Rare Disease
More than 7000 rare diseases have been described, with prevalence ranging from fewer than 1 in a million (eg, metachromatic leukodystrophy) to greater than 1 in 10,000 (eg, sickle cell anemia), and of these, approximately 70% are largely genetic in origin1. In total, an estimated 263 to 446 million individuals are thought to be afflicted by rare diseases worldwide1. The identification of causal genetic variants in these individuals enables patient-specific clinical management, referred to as genomic or precision medicine, which has the potential to improve patient survival and quality of life, and reduce health care costs2...
Source: Clinics in Laboratory Medicine - February 9, 2023 Category: Laboratory Medicine Authors: Kiely N. James, Sujal Phadke, Terence C. Wong, Shimul Chowdhury Source Type: research
Artificial Intelligence in the Clinical Laboratory: Current Practice and Emerging Opportunities
CLINICS IN LABORATORY MEDICINE (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 9, 2023 Category: Laboratory Medicine Authors: Jason M. Baron Source Type: research
Copyright
Elsevier (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 9, 2023 Category: Laboratory Medicine Source Type: research
Contributors
MILENKO JOVAN TANASIJEVIC, MD, MBA (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 9, 2023 Category: Laboratory Medicine Source Type: research
Contents
Jason M. Baron (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 9, 2023 Category: Laboratory Medicine Source Type: research
Forthcoming Issues
Point of Care Testing (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 9, 2023 Category: Laboratory Medicine Source Type: research
Digital Health
Artificial intelligence (AI) is becoming an indispensable tool to augment decision making in different health care settings and by various members of the patient pathway, including the patient. AI provides the ability to optimize data to bring clinical decision support for clinicians and laboratorians and/or empower patients to actively participate in their own health care. Though there are many examples of AI in health care, the exact role of AI and digital health solutions is still taking shape. Although AI will not replace the clinician, those who do not adopt AI may in time, be left behind. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - January 9, 2023 Category: Laboratory Medicine Authors: Alison Hellmann, Ashley Emmons, Matthew Stewart Prime, Ketan Paranjape, Denise L. Heaney Source Type: research
Artificial Intelligence Applications in Clinical Chemistry
Artificial intelligence (AI) applications are an area of active investigation in clinical chemistry. Numerous publications have demonstrated the promise of AI across all phases of testing including preanalytic, analytic, and postanalytic phases; this includes novel methods for detecting common specimen collection errors, predicting laboratory results and diagnoses, and enhancing autoverification workflows. Although AI applications pose several ethical and operational challenges, these technologies are expected to transform the practice of the clinical chemistry laboratory in the near future. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - December 16, 2022 Category: Laboratory Medicine Authors: Dustin R. Bunch, Thomas JS. Durant, Joseph W. Rudolf Source Type: research
Artificial Intelligence in the Clinical Laboratory
Artificial intelligence (AI) has become ubiquitous in many areas outside of health care with application so wide-ranging to include agricultural decision making, smartphone navigation, e-mail spam detection, predictive text, targeted marketing, environmental protection, criminal sentencing, employee hiring, and robotics among thousands of others. Clinical practice lags behind many other areas in terms of AI adoption, still relying primarily on manual human decision making. Nonetheless, clinical AI development and adoption are progressing and are poised to play a central role in many aspects of clinical practice in future d...
Source: Clinics in Laboratory Medicine - December 13, 2022 Category: Laboratory Medicine Authors: Jason M. Baron Tags: Preface Source Type: research
