Comparative epidemiology of diarrhoeal organisms in high-risk adults using multiplex PCR gastrointestinal panel testing: a multicentre observational study.

Objectives: Infectious diarrhoea remains a significant cause of morbidity and mortality in immunocompromised and high-risk populations. However, pathogen-specific epidemiology and diagnostic utility of molecular gastrointestinal panels (GIPs) in these groups remain poorly defined. Our objective was to describe diarrhoeal pathogen distribution across ten high-risk conditions and evaluate the diagnostic yield of GIPs in these populations to inform the development of improved diagnostic algorithms.

First description of the performance of the VITEK MITUBE device used with MALDI-TOF mass spectrometry to achieve identification of gram-negative bacteria directly from positive blood culture broth.

Improving the rapidity of identification of bacteria causing bacteremia continues to be a focus for quality improvement within the discipline of clinical microbiology. This multicenter study was used to obtain In Vitro Diagnostic Regulation Conformite Europeenne (CE) mark in Europe and describes the performance of the VITEK MITUBE to matrix-assisted laser desorption/ionization (MALDI) workflow for identification of 10 species of gram-negative bacteria directly from positive blood culture broth without subculture. One hundred twenty-five (125) prospective clinical samples, including (69), (4), (3), (29), (9), (10), and (1), were included; and 123 (98.

Multicenter evaluation of the QIAstat-Dx Gastrointestinal Panel 2, a multiplex PCR platform for the diagnosis of acute gastroenteritis.

The QIAstat-Dx Gastrointestinal Panel 2 (GI2 Panel) is a sample-to-answer multiplex PCR instrument that can detect 17 targets in a run time of about 80 minutes. The performance of the QIAstat-Dx GI2 Panel was evaluated by testing 1,939 prospective, 119 prospectively collected and then archived positive clinical samples and 750 retrospective clinical specimens across 13 sites in Europe and the United States. Specimens tested included bulk stool samples preserved in modified Cary-Blair transport medium.

Proceedings of the Clinical Microbiology Open 2024: artificial intelligence applications in clinical microbiology.

The Clinical Microbiology Open (CMO) is a meeting sponsored by the American Society for Microbiology (ASM) in collaboration with its Corporate Council and Clinical and Public Health Microbiology representatives, which is held to discuss topics that are relevant to both industry and practicing clinical microbiologists. The 2024 CMO was held in Oceanside, California on February 1 and 2. Participants included clinical and public health laboratory directors, representatives from government agencies, and biotechnology industry partners.

Another way? An investigation into an institution's use of the Wayson stain in re-evaluating "no organisms seen" on Gram stain smears from positive blood cultures.

Automated continuous monitoring blood culture instruments identify metabolism byproducts and flag blood culture bottles as "positive." A Gram stain is used to visualize and characterize the microbial growth in the broth and initiate additional testing. When no organisms are seen (NOS) on Gram stain, in our laboratory, bottles are reevaluated with a Wayson stain, a rapid one-step stain that provides contrast between organisms and the background, especially in Gram-negative organisms.

External validation of predictive models for antibiotic susceptibility of urine culture.

Objective: To develop, externally validate, and test a series of computer algorithms to accurately predict antibiotic susceptibility test (AST) results at the time of clinical diagnosis, up to 3 days before standard urine culture results become available, with the goal of improving antibiotic stewardship and patient outcomes.

Patients And Methods: Machine learning algorithms were developed and trained to predict susceptibility or resistance using over 4.7 million discrete AST classifications from urine cultures in a cohort of adult patients from outpatient and inpatient settings from 2012 to 2022.

ARGONAUT-IV: susceptibility of carbapenemase-producing to the oral bicyclic boronate β-lactamase inhibitor ledaborbactam combined with ceftibuten.

Ledaborbactam (formerly VNRX-5236), a bicyclic boronate β-lactamase inhibitor with activity against class A, C, and D β-lactamases, is under development as an orally bioavailable etzadroxil prodrug (VNRX-7145) in combination with ceftibuten for the treatment of urinary tract infections. At ceftibuten breakpoints of ≤1 mg/L (EUCAST) and ≤8 mg/L (CLSI), 92.5% and 99.

A molecular analysis of meropenem-vaborbactam non-susceptible KPC-producing .

We characterized the molecular determinants of meropenem-vaborbactam (MV) non-susceptibility among non-metallo-β-lactamase-producing KPC- (KPC-). Whole-genome sequencing was performed to identify mutations associated with MV non-susceptibility. Isolates with elevated MV MICs were found to have mutations encoding truncated or altered OmpK36 porins and increased copy numbers.

ARGONAUT-III and -V: susceptibility of carbapenem-resistant and multidrug-resistant to the bicyclic boronate β-lactamase inhibitor taniborbactam combined with cefepime.

Taniborbactam, a bicyclic boronate β-lactamase inhibitor with activity against carbapenemase (KPC), Verona integron-encoded metallo-β-lactamase (VIM), New Delhi metallo-β-lactamase (NDM), extended-spectrum beta-lactamases (ESBLs), OXA-48, and AmpC β-lactamases, is under clinical development in combination with cefepime. Susceptibility of 200 previously characterized carbapenem-resistant and 197 multidrug-resistant (MDR) to cefepime-taniborbactam and comparators was determined by broth microdilution. For (192 KPC; 7 OXA-48-related), MIC values of β-lactam components for cefepime-taniborbactam, ceftazidime-avibactam, and meropenem-vaborbactam were 2, 2, and 1 mg/L, respectively.

High Prevalence of Multistep Algorithms in Diagnostic Clostridioides difficile Laboratory Testing.

Context.—: Laboratory testing practices for diagnosis of Clostridioides difficile infection (CDI) have evolved in response to published guidelines, availability of highly sensitive nucleic acid amplification tests (NAATs), perceived problems with the specificity of NAATs, and CDI reporting requirements.

Objective.

Urinalysis is predictive for absence of urinary tract infection in men with and without catheters.

Objectives: To determine accuracy of negative urinalysis (UA) for predicting negative urine culture and the absence of urinary tract infection (UTI), and optimal urine culture growth cutoff for UTI diagnosis in men with and without urinary catheters.

Subjects And Methods: UAs with urine cultures within 1 week from adult men were identified and evaluated. Predictive values for the absence of UTI (absence of ≥1 of the following criteria: documentation of UTI diagnosis, antibiotic prescription, uropathogen presence on culture) were calculated.

The Use of Machine Learning for Image Analysis Artificial Intelligence in Clinical Microbiology.

The growing transition to digital microbiology in clinical laboratories creates the opportunity to interpret images using software. Software analysis tools can be designed to use human-curated knowledge and expert rules, but more novel artificial intelligence (AI) approaches such as machine learning (ML) are being integrated into clinical microbiology practice. These image analysis AI (IAAI) tools are beginning to penetrate routine clinical microbiology practice, and their scope and impact on routine clinical microbiology practice will continue to grow.

False positive congenital cytomegalovirus saliva screening results with an FDA-approved assay at two institutions.

Background: Congenital cytomegalovirus (CMV) infection is a significant cause of childhood hearing loss and developmental delay. Congenital CMV screening was implemented at two large hospital-affiliated laboratories using the FDA-approved Alethia CMV Assay Test System. In July 2022, an increase in suspected false-positive results was noted, leading to implementation of prospective quality management strategies.

Multicenter Evaluation of the BIOFIRE Blood Culture Identification 2 Panel for Detection of Bacteria, Yeasts, and Antimicrobial Resistance Genes in Positive Blood Culture Samples.

Diagnostic tools that can rapidly identify and characterize microbes growing in blood cultures are important components of clinical microbiology practice because they help to provide timely information that can be used to optimize patient management. This publication describes the bioMérieux BIOFIRE Blood Culture Identification 2 (BCID2) Panel clinical study that was submitted to the U.S.

Urinalysis Exhibits Excellent Predictive Capacity for the Absence of Urinary Tract Infection.

Objective: To assess predictive value of urinalysis for negative urine culture and absence of urinary tract infection, re-evaluate the microbial growth threshold for positive urine culture result, and describe antimicrobial resistance features. Urine culture is associated with 27% of U.S.

Tailored Treatment Based on Helicobacter pylori Genetic Markers of Resistance Is Associated With Higher Eradication Success.

Introduction: Increasing antimicrobial resistance with Helicobacter pylori infection has focused efforts to tailor eradication therapy based on identifying genetic markers of resistance to predict antimicrobial susceptibility.

Methods: In this retrospective study, we report the effect of routine inclusion of antimicrobial susceptibility testing and recommendations for eradication therapy with gastric specimens with H. pylori .

Design and Implementation of Improved SARS-CoV-2 Diagnostic Assays To Mitigate the Impact of Genomic Mutations on Target Failure: the Xpert Xpress SARS-CoV-2 Experience.

In 2020, the U.S. Food and Drug Administration (FDA) enabled manufacturers to request emergency use authorization (EUA) to facilitate the rapid authorization of diagnostic (IVD) platforms for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Diagnostic stewardship for urinary tract infection: A snapshot of the expert guidance.

The urine culture, the cornerstone for laboratory diagnosis of urinary tract infection (UTI), is associated with a high frequency of false-positive and false-negative results, and its diagnostic threshold is debated. Urine culture takes days to result, and antibiotics are often initiated while awaiting final culture readings. Further, asymptomatic bacteriuria-the presence of bacteria in urine in the absence of UTI symptoms-generally does not warrant treatment.

Meningococcal Urethritis: Old and New.

Neisseria meningitidis is a common commensal bacterium found in the respiratory tract, but it can also cause severe, invasive disease. Vaccines have been employed which have been successful in helping to prevent invasive disease caused by encapsulated N. meningitidis from the A, C, W, Y, and B serogroups.