Evaluation of Cepheid Xpert Xpress CoV-2/Flu/RSV plus for nasal and nasopharyngeal specimens tested in CLIA-accredited and CLIA-waived settings.

Background: Respiratory viruses are responsible for millions of healthcare visits annually. The unpredictable periodicity of Coronavirus disease 2019 and seasonal patterns of influenza and respiratory syncytial virus result in concurrent circulation of these viruses with non-specific and overlapping clinical symptoms.

Study Design: This study evaluated the Cepheid Xpert Xpress CoV-2/Flu/RSV plus test using 3011 nasopharyngeal swab (NPS) and 2943 anterior nasal (NS) specimens.

Prospective, multi-site evaluation of the Cepheid Xpert Xpress CoV-2 test on nasal and nasopharyngeal swabs.

Unlabelled: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues its largely aseasonal spread with millions of cases per year. Highly sensitive, point-of-care testing is critical for rapid detection of coronavirus disease 2019 (COVID-19) cases and initiation of antiviral therapy to avert adverse health outcomes and reduce onward transmission of the virus. While hundreds of COVID-19 diagnostics received emergency use authorization from the FDA during the pandemic, significantly fewer have navigated the course to FDA clearance or approval.

Evaluation of a BioFire multiplex PCR panel for detection of joint infections using retrospective and prospectively collected specimens.

The BioFire Joint Infection Panel (JI panel) is a newly FDA-approved multiplex PCR assay for detection of common bone and joint pathogens with 39 targets which include select Gram-positive and Gram-negative bacteria, yeast, and antimicrobial resistance genes. We evaluated the performance of the JI panel in detecting joint infections in our patient population. Sixty-three frozen, residual joint fluid specimens were retrospectively tested using the JI panel.

Automated detection of methicillin-resistant with the MRSA CHROM imaging application on BD Kiestra Total Lab Automation System.

The virulence of methicillin-resistant (MRSA) and its potentially fatal outcome necessitate rapid and accurate detection of patients colonized with MRSA in healthcare settings. Using the BD Kiestra Total Lab Automation (TLA) System in conjunction with the MRSA Application (MRSA App), an imaging application that uses artificial intelligence to interpret colorimetric information (mauve-colored colonies) indicative of MRSA pathogen presence on CHROMagar chromogenic media, anterior nares specimens from three sites were evaluated for the presence of mauve-colored colonies. Results obtained with the MRSA App were compared to manual reading of agar plate images by proficient laboratory technologists.

Uncharacterized and lineage-specific accessory genes within the pan-genome landscape.

is a Gram-negative bacterium recognized for its unique swarming motility and urease activity. A previous proteomic report on four strains hypothesized that, unlike other Gram-negative bacteria, may not exhibit significant intraspecies variation in gene content. However, there has not been a comprehensive analysis of large numbers of genomes from various sources to support or refute this hypothesis.

Proceedings of the Clinical Microbiology Open 2018 and 2019 - a Discussion about Emerging Trends, Challenges, and the Future of Clinical Microbiology.

Clinical Microbiology Open (CMO), a meeting supported by the American Society for Microbiology's Clinical and Public Health Microbiology Committee (CPHMC) and Corporate Council, provides a unique interactive platform for leaders from diagnostic microbiology laboratories, industry, and federal agencies to discuss the current and future state of the clinical microbiology laboratory. The purpose is to leverage the group's diverse views and expertise to address critical challenges, and discuss potential collaborative opportunities for diagnostic microbiology, through the utilization of varied resources. The first and second CMO meetings were held in 2018 and 2019, respectively.

Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System.

Nucleic acid amplification testing (NAAT) for SARS-CoV-2 is the standard approach for confirming COVID-19 cases. This study compared results between two emergency use authorization (EUA) NAATs, with two additional EUA NAATs utilized for discrepant testing. The limits of detection (LOD) for the BD SARS-CoV-2 reagents for the BD MAX system (MAX SARS-CoV-2 assay), the bioMérieux BioFire respiratory panel 2.

Transfusion-Transmitted Malaria: Two Pediatric Cases From the United States and Their Relevance in an Increasingly Globalized World.

In non-endemic settings, transfusion-transmitted malaria (TTM) is rare but potentially fatal and becoming more common with globalization. We present two pediatric cases that demonstrate donor screening using questionnaires is subject to error and that TTM should be considered with fever following numerous transfusions in children, particularly sickle cell patients.

The Value and Institutional Impact of an In-System Laboratory Testing During the COVID-19 Pandemic.

In-system clinical laboratories have proven themselves to be a fundamentally important resource to their institutions during the COVID-19 pandemic of the past year. The ability to provide SARS-CoV-2 molecular testing to our hospital system allowed us to offer the best possible care to our patients, and to support neighboring hospitals and nursing homes. In-house testing led to significant revenue enhancement to the laboratory and institution, and attracted new patients to the system.

From Testing to Decision-Making: A Data-Driven Analytics COVID-19 Response.

In March 2020, NorthShore University Health System laboratories mobilized to develop and validate polymerase chain reaction based testing for detection of SARS-CoV-2. Using laboratory data, NorthShore University Health System created the Data Coronavirus Analytics Research Team to track activities affected by SARS-CoV-2 across the organization. Operational leaders used data insights and predictions from Data Coronavirus Analytics Research Team to redeploy critical care resources across the hospital system, and real-time data were used daily to make adjustments to staffing and supply decisions.

Evaluating the Rapid Emergence of Daptomycin Resistance in : a Multicenter Study.

Members of the genus are increasingly recognized as pathobionts and can be very resistant to antimicrobial agents. Previous studies have demonstrated that can rapidly develop high-level daptomycin resistance (HLDR) (MIC, ≥256 μg/ml). Here, we conducted a multicenter study to assay for this phenotype in diverse species.

Panels and Syndromic Testing in Clinical Microbiology.

Syndromic panels have allowed clinical microbiology laboratories to rapidly identify bacteria, viruses, fungi, and parasites and are now fully integrated into the standard testing practices of many clinical laboratories. To maximize the benefit of syndromic testing, laboratories must implement strict measures to ensure that syndromic panels are being used responsibly. This article discusses commercially available syndromic panels, the benefits and limitations of testing, and how diagnostic and laboratory stewardship can be used to optimize testing and improve patient care while keeping costs at a minimum.

Responding to the Challenges of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): Perspectives from the Association for Molecular Pathology Infectious Disease Subdivision Leadership.

Clinical molecular laboratory professionals are at the frontline of the response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, providing accurate, high-quality laboratory results to aid in diagnosis, treatment, and epidemiology. In this role, we have encountered numerous regulatory, reimbursement, supply-chain, logistical, and systems challenges that we have struggled to overcome to fulfill our calling to provide patient care. In this Perspective from the Association for Molecular Pathology Infectious Disease Subdivision Leadership team, we review how our members have risen to these challenges, provide recommendations for managing the current pandemic, and outline the steps we can take as a community to better prepare for future pandemics.

Machine Learning Takes Laboratory Automation to the Next Level.

Clinical microbiology laboratories face challenges with workload and understaffing that other clinical laboratory sections have addressed with automation. In this issue of the , M. L.

Faropenem resistance causes in vitro cross-resistance to carbapenems in ESBL-producing Escherichia coli.

Objective: Faropenem is an oral penem drug with activity against Gram-positive and Gram-negative bacteria, including CTX-M-15-type extended spectrum beta-lactamase (ESBL)-producing Enterobacteriales and anaerobic bacteria. As there are structural similarities, there is concern for the development of carbapenem cross-resistance; however, there are no studies confirming this. This study examined whether in vitro development of faropenem resistance in Escherichia coli isolates would result in cross-resistance to carbapenems.

Diagnostic Challenges and Laboratory Considerations for Pediatric Sepsis.

Background: Sepsis is a leading cause of death for children in the US and worldwide. There is a lack of consensus how sepsis is clinically defined, and sepsis definitions and diagnostic guidelines for the pediatric population have remained unchanged for more than a decade now. Current pediatric definitions are largely based on adult guidelines and expert opinion rather than evidence based on outcomes in the pediatric populations.

Total Laboratory Automation: What Is Gained, What Is Lost, and Who Can Afford It?

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.

Clinical Impact of Rapid Point-of-Care PCR Influenza Testing in an Urgent Care Setting: a Single-Center Study.

Seasonal influenza virus causes significant morbidity and mortality each year. Point-of-care (POC) testing using rapid influenza diagnostic tests (RIDTs), immunoassays that detect viral antigens, are often used for diagnosis by physician offices and urgent care centers. These tests are rapid but lack sensitivity, which is estimated to be 50 to 70%.

Blood Culture Results Reporting: How Fast Is Your Laboratory and Is Faster Better?

Blood cultures are one of the most common and most important tests performed in clinical microbiology laboratories. Variables and technology that improve and speed the recovery of blood stream pathogens have been published in the Journal of Clinical Microbiology since its inception in 1975. Despite the importance of blood cultures, little research has focused on the turnaround time of blood culture reports.