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Editorial
The Brief Case
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Minireview
MinireviewBringing HIV Self-Testing to Scale in the United States: a Review of Challenges, Potential Solutions, and Future OpportunitiesHIV self-testing (HIVST) provides an at-home option to counter the barriers that patients face with testing performed in health care settings. HIVST has gradually increased in popularity in a time when social media and technology-based solutions are preferred. In this paper, we consider the aspects of self-testing that merit its integration into HIV testing and prevention systems in the United States.
Bacteriology
BacteriologyEvaluation of a Novel Multiplex High-Definition PCR Assay for Detection of Tick-Borne Pathogens in Whole-Blood SpecimensThe prevalence of tick-borne infections has been steadily increasing in both number and geographic distribution in the United States and abroad. This increase, in conjunction with the continued recognition of novel pathogens transmitted by ticks, has made accurate diagnosis of these infections challenging. Mainstay serologic tests are insensitive during the acute phase of infection and are often cross-reactive with similar pathogenic...
BacteriologySystematic Comparison of Four Methods for Detection of Carbapenemase-Producing Enterobacterales Directly from Blood CulturesEarly identification of infections caused by carbapenemase-producing Enterobacterales (CPE) can help to optimize patient treatment and improve outcome. In this study, protocols for rapid detection of carbapenemase production directly from positive blood cultures were developed applying a concentration and hemolysis step before a test for carbapenemase production was performed.
BacteriologyUltrasensitive Detection of Clostridioides difficile Toxins in Stool by Use of Single-Molecule Counting Technology: Comparison with Detection of Free Toxin by Cell Culture Cytotoxicity Neutralization AssayLaboratory tests for Clostridioides difficile infection (CDI) rely on the detection of free toxin or molecular detection of toxin genes. The Singulex Clarity C. diff toxins A/B assay is a rapid, automated, and ultrasensitive assay that detects C. difficile toxins A and B in stool. We compared CDI...
BacteriologyPerformance of Five Commercial Identification Platforms for Identification of Staphylococcus delphiniThe Staphylococcus intermedius group (SIG) is a collection of coagulase-positive staphylococci consisting of four distinct species, namely, Staphylococcus cornubiensis, Staphylococcus delphini,...
BacteriologyInvestigation of Preanalytical Variables Impacting Pathogen Cell-Free DNA in Blood and UrinePathogen cell-free DNA (pcfDNA) in blood and urine is an attractive biomarker; however, the impact of preanalytical factors is not well understood. Blood and urine samples from healthy donors spiked with cfDNA from Mycobacterium tuberculosis, Salmonella enterica,...
BacteriologyAutomated Detection of Streptococcus pyogenes Pharyngitis by Use of Colorex Strep A CHROMagar and WASPLab Artificial Intelligence Chromogenic Detection Module SoftwareColorex Strep A agar (CHROMagar, Paris, France) was evaluated with PhenoMATRIX chromogenic detection module (CDM) software (Copan Diagnostics Inc., Murrieta, CA) to detect group A Streptococcus (GAS) from throat specimens. The software results were compared to those of manual plate image reading. In addition, GAS PCR testing was performed on all specimens.
BacteriologyPilot Evaluation of a Fully Automated Bioinformatics System for Analysis of Methicillin-Resistant Staphylococcus aureus Genomes and Detection of OutbreaksGenomic surveillance that combines bacterial sequencing and epidemiological information will become the gold standard for outbreak detection, but its clinical translation is hampered by the lack of automated interpretation tools. We performed a prospective pilot study to evaluate the analysis of methicillin-resistant Staphylococcus aureus (MRSA) genomes using the Next...
BacteriologyMulticenter Clinical Evaluation of a Novel Multiplex Real-Time PCR (qPCR) Assay for Detection of Fluoroquinolone Resistance in Mycoplasma genitaliumMycoplasma genitalium causes a common sexually transmitted infection with a marked propensity to develop antimicrobial resistance. As few treatment options exist, this poses significant challenges to clinicians. Recent diagnostic advances have resulted in tests that report the simultaneous detection of M....
BacteriologyIncreased Clinical Specificity with Ultrasensitive Detection of Clostridioides difficile Toxins: Reduction of Overdiagnosis Compared to Nucleic Acid Amplification TestsClostridioides difficile infection (CDI) is one of the most common health care-associated infections, resulting in significant morbidity, mortality, and economic burden. Diagnosis of CDI relies on the assessment of clinical presentation and laboratory tests. We evaluated the clinical performance of ultrasensitive single-molecule counting technology for detection of...
BacteriologyImproved Species-Level Clinical Identification of Enterobacteriaceae through Broad-Range dnaJ PCR and SequencingEnterobacteriaceae represent a diverse and medically important family of bacteria that are difficult to identify to the species level using the standard molecular method of 16S rRNA gene sequencing. Prior work has demonstrated the value of dnaJ gene sequence analysis in resolving different members of the family. However, existing protocols are not optimized...
BacteriologyComparison of the Panther Fusion and BD MAX Group B Streptococcus (GBS) Assays for Detection of GBS in Prenatal Screening SpecimensStreptococcus agalactiae or group B Streptococcus (GBS) is the cause of early- and late-onset GBS disease in neonates and can present as septicemia, meningitis, and pneumonia. Our objective was to compare the performance of two FDA-approved nucleic acid amplification tests (NAATs), the Panther Fusion and BD MAX systems, for detection of GBS in vaginal-rectal...
BacteriologyPerformance Evaluation of the Luminex Aries C. difficile Assay in Comparison to Two Other Molecular Assays within a Multihospital Health Care CenterClostridioides difficile infection (CDI) remain a serious issue in the United States. Fast and accurate diagnosis of CDI is paramount to achieve immediate infection control initiation, triaging, and isolation, as well as appropriate antibiotic treatment. However, both, over- and underdiagnosis can lead to adverse patient outcomes, such as unnecessary administration of...
BacteriologyMolecular Testing for Mycoplasma genitalium in the United States: Results from the AMES Prospective Multicenter Clinical StudyA prospective multicenter clinical study involving subjects from 21 sites across the United States was conducted to validate the performance of a new in vitro diagnostic nucleic acid amplification test (NAAT) for the detection of Mycoplasma genitalium.
BacteriologyUpdating Molecular Diagnostics for Detecting Methicillin-Susceptible and Methicillin-Resistant Staphylococcus aureus Isolates in Blood Culture BottlesMolecular diagnostic tests can be used to provide rapid identification of staphylococcal species in blood culture bottles to help improve antimicrobial stewardship. However, alterations in the target nucleic acid sequences of the microorganisms or their antimicrobial resistance genes can lead to false-negative results.
BacteriologyClinical and Molecular Characteristics of Klebsiella pneumoniae Isolates Causing Bloodstream Infections in Japan: Occurrence of Hypervirulent Infections in Health CareAlthough hypervirulent Klebsiella pneumoniae (hvKp) has been associated with severe community-acquired infections that occur among relatively healthy individuals, information about hvKp infections in health care settings remains limited. Here, we systematically analyzed the clinical and molecular characteristics of...
BacteriologyMulticenter Evaluation of Colistin Broth Disk Elution and Colistin Agar Test: a Report from the Clinical and Laboratory Standards InstituteSusceptibility testing of the polymyxins (colistin and polymyxin B) is challenging for clinical laboratories. The Clinical and Laboratory Standards Institute (CLSI) Antimicrobial Susceptibility Testing Subcommittee evaluated two methods to enable accurate testing of these agents. These methods were a colistin broth disk elution (CBDE) and a colistin agar test (CAT), the latter of which was evaluated using two inoculum volumes, 1 μl (CAT...
BacteriologyA Cost-Effective Method for Identifying Enterobacterales with OXA-181OXA-181 is the second most common global OXA-48-like carbapenemase and is endemic in the Indian subcontinent. Molecular studies have shown that Enterobacterales with OXA-181 are often introduced into regions of nonendemicity. Distinguishing OXA-181 from other OXA-48-like enzymes often requires sequencing, which is rather expensive and time-consuming.
BacteriologyDual Reporting of Clostridioides difficile PCR and Predicted Toxin Result Based on PCR Cycle Threshold Reduces Treatment of Toxin-Negative Patients without Increases in Adverse OutcomesNucleic acid amplification tests are commonly used to diagnose Clostridioides difficile infection (CDI). Two-step testing with a toxin enzyme immunoassay is recommended to discriminate between infection and colonization but requires additional resources. Prior studies showed that PCR cycle threshold (CT) can predict toxin positivity with high...
Mycobacteriology and Aerobic Actinomycetes
Mycobacteriology and Aerobic ActinomycetesHow Well Do Routine Molecular Diagnostics Detect Rifampin Heteroresistance in Mycobacterium tuberculosis?Rifampin heteroresistance—where rifampin-resistant and -susceptible tuberculosis (TB) bacilli coexist—may result in failed standard TB treatment and potential spread of rifampin-resistant strains. The detection of rifampin heteroresistance in routine rapid diagnostic tests (RDTs) allows for patients to receive prompt and effective multidrug-resistant-TB treatment and may improve rifampin-resistant TB control.
Mycobacteriology and Aerobic ActinomycetesComparing QuantiFERON-TB Gold Plus with Other Tests To Diagnose Mycobacterium tuberculosis InfectionThe fourth-generation QuantiFERON test for tuberculosis infection, QuantiFERON-TB Gold Plus (QFT-Plus) has replaced the earlier version, QuantiFERON-TB Gold In-Tube (QFT-GIT). A clinical need exists for information about agreement between QFT-Plus and other tests. We conducted this study to assess agreement of test results for QFT-Plus with those of QuantiFERON-TB Gold In-Tube (QFT-GIT), T-SPOT.TB (T-SPOT), and the tuberculin skin test...
Mycology
MycologyIdentification of Candida auris by Use of the Updated Vitek 2 Yeast Identification System, Version 8.01: a Multilaboratory Evaluation StudyCandida auris is an emerging multidrug-resistant yeast that has been systematically incorrectly identified by phenotypic methods in clinical microbiology laboratories. The Vitek 2 automated identification system (bioMérieux) recently included C. auris in its database (version 8.01). We evaluated the...
Parasitology
ParasitologyRecombinant Cysteine Proteinase B from Leishmania braziliensis and Its Domains: Promising Antigens for Serodiagnosis of Cutaneous and Visceral Leishmaniasis in DogsLeishmaniasis represents a group of parasitic diseases caused by a protozoan of the genus Leishmania and is widely distributed in tropical and subtropical regions. Leishmaniasis is one of the major tropical neglected diseases, with 1.5 to 2 million new cases occurring annually. Diagnosis remains a challenge despite advances in parasitological, serological, and molecular methods. Dogs are an important host for the parasite and...
Virology
VirologyComparison of Three Adenovirus Quantitative PCR Assays with ATCC Reference Strains and Clinical SamplesAdenoviruses (AdV) have been associated with a variety of human diseases and are recognized as causing significant morbidity and mortality in immunocompromised or transplant patients. Quantification of AdV DNA in plasma is notoriously difficult due to the genetic diversity of the 71 different serotypes identified to date. There is no World Health Organization standard available to harmonize quantitative data, so results between labs...
VirologyMultilaboratory Assessment of Epstein-Barr Virus Serologic Assays: the Case for StandardizationIgA antibodies targeting Epstein-Barr virus (EBV) have been proposed for screening for nasopharyngeal carcinoma (NPC). However, methods differ, and the antigens used in these assays differ considerably between laboratories. To enable formal comparisons across a range of established EBV serology assays, we created a panel of 66 pooled serum samples and 66 pooled plasma samples generated from individuals with a broad range of IgA antibody...
Epidemiology
EpidemiologyFrequency and Characteristics of Biological False-Positive Test Results for Syphilis Reported in Florida and New York City, USA, 2013 to 2017Discordant syphilis test results, with a reactive nontreponemal test and nonreactive treponemal test are usually considered biological false-positive test results (BFPs), which can be attributed to other conditions. Syphilis surveillance laws mandate laboratory reporting of reactive syphilis tests, which include many BFPs. We describe the frequency of BFPs, titer distributions, and titer increases from reported test results in Florida...
EpidemiologyMacrolide-Resistant Mycoplasma pneumoniae in the United States as Determined from a National Surveillance ProgramThere are sparse data to indicate the extent that macrolide-resistant Mycoplasma pneumoniae (MRMp) occurs in the United States or its clinical significance. Between 2015 and 2018, hospitals in 8 states collected and stored respiratory specimens that tested positive for M. pneumoniae and sent them to...
Letters to the Editor
Letter to the EditorKinetics of Anti-Zika Virus Antibodies after Acute Infection in Pregnant Women
Letter to the EditorIdentification of an Unusual 16S rRNA Mutation in Neisseria gonorrhoeae
Letter to the EditorAdoption of the New CLSI Fluoroquinolone Breakpoints for Enterobacteriaceae
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Journal of Clinical Microbiology® (JCM) publishes the most current research related to the laboratory diagnosis of human and animal infections and the role of the laboratory in both the management of infectious diseases and the elucidation of the epidemiology of infections.
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Dr. Alexander J. McAdam, Editor in Chief