Nothing Basic About It: Guiding the Judicious Use of Diagnostic Tests
A lot has been written about the advent of molecular diagnostics and their impact on clinical care.1,2 Without a doubt, since their introduction in clinical laboratories, molecular microbiology tests have resulted in better diagnostics and better patient care in a significantly shorter time to results. Innovation in enzyme chemistry and engineering has allowed for increased democratization of molecular testing to the point where testing is no longer limited to testing in high-complexity CLIA laboratories by highly trained medical laboratory scientists but available for use directly to the patient in the comfort of their ho...
Source: Clinics in Laboratory Medicine - December 20, 2023 Category: Laboratory Medicine Authors: N. Esther Babady, Jennifer Dien Bard Tags: Preface Source Type: research

Diagnostic Stewardship for Next-Generation Sequencing Assays in Clinical Microbiology
This article provides an overview of diagnostic stewardship approaches as applied to these assays, focusing on principles of collaboration, differential diagnosis formation, and seeking the best patient, syndrome, sample, timing, and test for improved patient care. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - December 6, 2023 Category: Laboratory Medicine Authors: David C. Gaston, Augusto Dulanto Chiang, Kevin Dee, Daniel Dulek, Ritu Banerjee, Romney M. Humphries Source Type: research

Working with the Electronic Health Record and Laboratory Information System to Maximize Ordering and Reporting of Molecular Microbiology Results
Molecular microbiology assays have a higher cost of testing compared to traditional methods and need to be utilized appropriately. Results from these assays may also require interpretation and appropriate follow-up. Electronic tools available in the electronic health record and laboratory information system can be deployed both preanalytically and postanalytically to influence ordering behaviors and positively impact diagnostic stewardship. Next generation technologies, such as machine learning and artificial intelligence, have the potential to expand upon the capabilities currently available and warrant additional study a...
Source: Clinics in Laboratory Medicine - December 6, 2023 Category: Laboratory Medicine Authors: Meghan W. Starolis, Mark A. Zaydman, Rachael M. Liesman Source Type: research

Home and Clinical Laboratory Improvement Amendments –Waived Testing for Infectious Diseases—How Do These Fit in the Testing Landscape?
Though testing for infectious diseases has long been performed in traditional clincial laboratory settings, more widespread availability of waived testing is expanding accessibility of patients to rapid test results. This is being further expanded to home testing. Nevertheless, with this greater democratization and availability of clinical testing there are important limitations that need to be balanced. In this article, we review the current test landscape for infectious diseases waived testing and opportunities for assuring optimal quality testing. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - November 29, 2023 Category: Laboratory Medicine Authors: Jacky Lu, Susan M. Butler-Wu Source Type: research

Point of Care Molecular Testing
Inappropriate ordering practices, either under or over ordering of diagnostic tests, are recognized problems with possible negative downstream consequences. As the menu of clinical tests, especially molecular tests grows, it is becoming increasingly important to provide guidance to providers on the appropriate utilization. Diagnostic stewardship programs have been established at many institutions to help direct the appropriate utilization of laboratory testing to ultimately guide patient management and treatment decisions. Many molecular tests have now received Clinical Laboratory Improvement Amendments (CLIA)-waived statu...
Source: Clinics in Laboratory Medicine - November 15, 2023 Category: Laboratory Medicine Authors: Caitlin Otto, Dan Chen Source Type: research

The Report Says What?
The applications of next-generation sequencing (NGS) in the clinical microbiology laboratory are expanding at a rapid pace. The medical microbiologist thus plays a key role in translating the results of these emerging technologies to the practicing clinician. Here we discuss the factors to consider to successfully develop standardized reporting for microbial targeted or metagenomic NGS testing in the clinical laboratory. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - November 14, 2023 Category: Laboratory Medicine Authors: Cristina Costales, Jennifer Dien Bard Source Type: research

Preanalytical Challenges of Molecular Microbiology Tests
As infectious disease diagnostics increasingly incorporates molecular techniques, there are unique preanalytical concerns that must be considered. First, noninvasive specimen types that may be inadequate for culture-based diagnostics may be acceptable when using molecular tests. Second, specimen containers must be evaluated for the presence of substances that may interfere with amplification or sequencing reactions. Finally, the capacity of transport, storage, and processing conditions to maintain nucleic acid integrity and avoid contamination must be assessed. This review explores these issues and the effects they may hav...
Source: Clinics in Laboratory Medicine - November 13, 2023 Category: Laboratory Medicine Authors: Anisha Misra, Eleanor A. Powell Source Type: research

Is It Possible to Test for Viral Infectiousness?
Identifying and managing individuals with active or chronic disease, implementing appropriate infection control measures, and mitigating the spread of the COVID-19 pandemic highlighted the need for tests of infectiousness. The gold standard for assessing infectiousness has been the recovery of infectious virus in cell culture. Using cycle threshold values, antigen testing, and SARS-CoV-2, replication intermediate strands were used to assess infectiousness, with many limitations. Infectiousness can be influenced by host factors (eg, preexisting immune responses) and virus factors (eg, evolution). (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - November 13, 2023 Category: Laboratory Medicine Authors: Heba H. Mostafa Source Type: research

Present and Future Non-Culture-Based Diagnostics: Stewardship Potentials and Considerations
The medical microbiologist plays a key role in the transition from culture-based to molecular test methods for diagnosis of infectious diseases. They must understand the scientific and technical bases underlying these tests along with their associated benefits and limitations and be able to educate administrators and patient providers on their proper use. Coordination of testing practices between clinical departments and the spectrum of public health and research laboratories is essential to optimize health care delivery. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - November 11, 2023 Category: Laboratory Medicine Authors: Arryn Craney, Steve Miller Source Type: research

Diagnostic Stewardship for Multiplex Respiratory Testing
Syndromic respiratory panels are now widely available in clinical microbiology laboratories and health care institutions. These panels can rapidly diagnose infections and detect antimicrobial resistance genes allowing for more rapid therapeutic optimization compared to standard microbiology approaches. However, given reimbursement concerns and limitations of multiplex molecular testing and results interpretation, maximum clinical utility and positive clinical outcomes depend on active diagnostic stewardship. Here, the authors review clinical outcomes of both upper and lower respiratory panels and present diagnostic steward...
Source: Clinics in Laboratory Medicine - November 8, 2023 Category: Laboratory Medicine Authors: Jose Lucar, Rebecca Yee Source Type: research

Taking Center Stage
This article will discuss diagnostic stewardship from the perspective of those who are just starting, or have recently started, a diagnostic stewardship effort. This document will provide guidance on how to identify opportunities for intervention and tools that can be used to affect change. Specifically, we will discuss key components of a diagnostic stewardship committee, referral laboratory testing, prior authorization, miscellaneous test orders, establishing a laboratory test formulary, and conclude with some specific examples of interventions that can be considered. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - November 8, 2023 Category: Laboratory Medicine Authors: Christopher D. Doern, Chelsea Kidd Source Type: research

Myelodysplastic Syndromes
CLINICS IN LABORATORY MEDICINE (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - October 20, 2023 Category: Laboratory Medicine Authors: Alexa J. Siddon Source Type: research

Copyright
Elsevier (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - October 20, 2023 Category: Laboratory Medicine Source Type: research

Contributors
MILENKO JOVAN TANASIJEVIC, MD, MBA (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - October 20, 2023 Category: Laboratory Medicine Source Type: research

Contents
Alexa J. Siddon (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - October 20, 2023 Category: Laboratory Medicine Source Type: research