Clinics in Laboratory Medicine Current Issue

Immunology Laboratory Testing

James E. Kirby

MILENKO JOVAN TANASIJEVIC, MD, MBA

Elsevier

CLINICS IN LABORATORY MEDICINE

In 1 or 2 generations, we have gone from a world in which there were no cures for most infections to a declaration that the war against infectious disease was won. That period of ephemeral confidence was followed by the inexorable march toward increasingly resistant pathogens that quickly learned to evade each new advance and our own race, sometimes successful, sometimes faltering, to produce new antimicrobials and vaccines.

Sepsis and pneumonia cause significant morbidity and mortality worldwide. Despite improvements in diagnostic methodologies for organism identification, the early recognition and further risk stratification of these infections can be challenging. Although traditional clinical scoring systems are beneficial for the management of sepsis and pneumonia, biomarkers supporting the diagnosis and management of these infectious diseases are needed. Many biomarkers have been identified and there is no lack of studies and meta-analyses assessing the utility of biomarkers. Focusing primarily on sepsis and pneumonia, this article discusses the most commonly used biomarkers for which clinical laboratory testing methods are available.

This article describes the current state of the art with regards to commercially available syndromic panels for blood stream infections, gastrointestinal pathogen detection, respiratory tract infections, and central nervous system infections, while providing a provocative and speculative look into the future of syndromic panel testing for infectious diseases.

We discuss the current practice of point-of-care diagnostics in infectious diseases as methods transition from antigen-based to molecular, and beyond simple molecular to the next generations of point-of-care testing methods. We evaluate the role of point-of-care at different sites of care and describe and evaluate trends likely to be driven by advances in molecular methodology, emerging biomarkers, and informatics. We describe strengths, weaknesses, opportunities, and threats to the development of point-of-care diagnostics in the near (1–10 years) and more distant (10–20 years) future.

Next-generation sequencing (NGS) applications have been transitioning from research tools to diagnostic methods and are becoming more commonplace in clinical microbiology laboratories. These applications include (1) whole-genome sequencing, (2) targeted next-generation sequencing methods, and (3) metagenomic next-generation sequencing. The introduction of these methods into the clinical microbiology laboratory has led to the theoretic question of “Will NGS-based methods supplant traditional methods for strain typing, identification, and antimicrobial susceptibility prediction?” The authors address this question and discuss where we are at now with clinical NGS applications for infectious diseases, what does the future hold, and at what cost?

The first clinical microbiology laboratory in the United States adopted total automation for bacteriology processing in 2014. Since then, others have followed with installation of either the BD Kiestra TLA or the Copan WASPLab. This article discusses commercially available automated systems in the United States; why automation is needed; and quality improvements, efficiency, and cost savings associated with automation. After learning how these systems are used, gains and losses experienced, and how one can afford the most expensive equipment ever purchased for clinical microbiology laboratories, the question is, how can one afford not to purchase one of these microbiology automation systems?