Couturier, Marc Roger

Advances in laboratory techniques have revolutionized parasitology diagnostics over the past several decades. Widespread implementation of rapid antigen detection tests has greatly expanded access to tests for global parasitic threats such as malaria, while next-generation amplification and sequencing methods allow for sensitive and specific detection of human and animal parasites in complex specimen matrices.

Routine antimicrobial susceptibility testing (AST) of Helicobacter pylori by agar dilution is difficult to perform and not practical in most clinical microbiology laboratories. The Etest gradient diffusion method can be a reliable alternative for H. pylori AST with the advantage of being a less laborious quantitative method. This work reveals that an optimized Etest method can provide acceptable performance for H. pylori AST and describes the challenges associated with this methodology.

The U.S. Food & Drug Administration (FDA) regulates the marketing of manufacturers’ in vitro diagnostic tests (IVDs), including assays for the detection of SARS-CoV-2.

Interest continues to grow regarding the role of serologic assays for the detection of prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) status to many SARS-CoV-2 serologic assays. In this document, expert recommendations from clinical microbiologist members of the American Society for Microbiology (ASM) concerning detailed verification strategies for SARS-CoV-2 serologic assays with FDA EUA are provided, as are insights into assay limitations and reporting considerations for laboratories.

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) brought with it rapid development of both molecular and serologic assays for identification of COVID-19 infections. While Food and Drug Administration (FDA) emergency use authorization (EUA) is required for clinical application of SARS-CoV-2 molecular tests, submission for EUA is currently a voluntary process for manufacturers of serologic assays. The absence of FDA oversight of serologic tests is concerning given that the commercially available serologic assays are highly variable, differing in their format, the antibody class detected, the targeted antigen, and the acceptable specimen types.

The morphologic similarities of the microfilariae and their infrequency in clinical specimens in settings of endemicity present challenges to clinical laboratories in maintaining competence for accurate identification and differentiation.

Abstract Background Current American College of Gastroenterology (ACG) guidelines suggest that Helicobacter pylori serologic testing may be helpful to rule out H. pylori in areas with low disease prevalence. However, even in low prevalence regions, the positive predictive value of a positive serologic result remains low. Additionally, both the ACG and the American Gastroenterological Association recommend that this noninvasive testing be avoided entirely for patients 55 years and older. Methods The objective of this multicenter retrospective study was to assess H. pylori seroprevalence rates among symptomatic patients and serologic test utilization at the local, state, and national level. Submitted specimens were presumed to be collected from patients with upper gastrointestinal symptoms suspicious for an H. pylori etiology. Results for H. pylori IgG serologic tests performed between 2005 and 2014 were collected from 5 medical centers. Data were evaluated in the context of professional practice guidelines, with a focus on patients ages 55 years and older. Results Nationwide seropositivity among symptomatic individuals is approximately 25%, and 4 of 5 centers reported decreasing seropositivity rates over this 10-year period. State-specific seropositivity among symptomatic patients ranged from 12.4% in the state of Washington to 33.9% in Mississippi. Conclusions We demonstrate that for 48 states >25% of all H. pylori serologic testing was performed in individuals ≥55 years. Despite recommendations to avoid serologic evaluation for H. pylori infection, this study indicates that serology continues to be used at high rates across age-groups.