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1.
J Clin Microbiol ; : e0070324, 2024 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-38953652

RESUMO

The clinical microbiology laboratory is capable of identifying microorganisms in clinical specimens faster and more accurately than ever before. At face value, this should enable patient care providers to make better-informed decisions and target antimicrobial therapies to deliver individualized care. Ironically, more complete and specific reporting of microorganisms isolated from specimens may result in overtreatment based on the presence of a pathogen, even in the absence of clear signs of clinical infection. This conundrum calls into question the role of the laboratory in contributing to care through selective or "exception" reporting whereby some results are selectively withheld when there is a low probability that laboratory findings correlate with the clinical infection. In a recent article published in the Journal of Clinical Microbiology, Bloomfield et al. (J Clin Microbiol 62:e00342-24, 2024, https://doi.org/10.1128/jcm.00342-24) examine the impact and safety of an exception reporting strategy applied to wound swab specimens. Canonical pathogens associated with skin and soft tissue infections including S. aureus and beta-hemolytic streptococci are withheld from the laboratory report if certain patient criteria are met that would put them at low risk of adverse outcomes if untreated, or if treated with guideline-recommended empiric therapy. Their central finding was an approximately 50% reduction in post-laboratory report antibiotic initiation without adverse events or increased 30-day admission rate (indicative of infection-related complications, e.g., disseminated disease). While effectively achieving their goal, the premise of exception reporting and other modified reporting strategies raises questions about the potential risk of underreporting and how to ensure that the message is being interpreted, and acted upon, by care providers as was intended by the laboratory.

2.
Microbiol Spectr ; 12(4): e0416423, 2024 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-38441465

RESUMO

We conducted a comparative evaluation of the FDA-cleared Simplexa GBS Direct and ARIES GBS molecular assays for the detection of Streptococcus agalactiae (Group B Streptococcus, GBS) in 386 prospectively collected, broth-enriched vaginal/rectal swab specimens. The sensitivity of each test was 96.2% and specificity was ≥98.7% when compared to a combined direct and enriched culture method using chromogenic culture medium. A total of four specimens were called positive by both molecular assays but negative by culture, likely representing specimens with a low burden of GBS in these specimens. Two specimens were reported positive by culture but negative by both molecular assays. One of these specimens demonstrated atypically colored colonies on chromogenic agar; the other yielded typically colored colonies only observed after broth enrichment. Our data demonstrate equivalent performance of Simplexa and ARIES molecular assays for the detection of GBS in clinical specimens.IMPORTANCEClinical laboratories often face decisions regarding which of the multiple available molecular platforms would best fit their needs based on cost, workflow, menu, and diagnostic performance. Therefore, objective clinical comparisons of similar molecular tests are valuable resources to aid these decisions. We provide a clinical comparison of two FDA-cleared tests to routine culture and to each other that can be used by clinical laboratories when determining which of the available molecular platforms would best fit their laboratory in terms of workflow, cost, and performance.


Assuntos
Complicações Infecciosas na Gravidez , Infecções Estreptocócicas , Gravidez , Feminino , Humanos , Complicações Infecciosas na Gravidez/diagnóstico , Vagina , Sensibilidade e Especificidade , Infecções Estreptocócicas/diagnóstico , Reto , Streptococcus agalactiae/genética
3.
Open Forum Infect Dis ; 10(4): ofad121, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37089773

RESUMO

Background: Ixodes scapularis ticks can carry Borrelia species as well as other pathogens that cause human disease. The frequency of tick-borne infections and coinfections in children with suspected Lyme disease is unknown, creating clinical uncertainty about the optimal approach to diagnosis. Methods: We enrolled children aged 1-21 years presenting to 1 of 8 Pedi Lyme Net emergency departments for evaluation of Lyme disease. We selected cases with serologically or clinically diagnosed Lyme disease (erythema migrans or early neurologic disease) matched by symptoms, age, gender, and center to control subjects without Lyme disease. We tested whole blood samples collected at the time of diagnosis using a multiplex high-definition polymerase chain reaction (HDPCR) panel to identify 9 bacterial or protozoan pathogens associated with human disease. We compared the frequency of tick-borne coinfections in children with Lyme disease to matched controls. Results: Of the 612 selected samples, 594 (97.1%) had an interpretable multiplex HDPCR result. We identified the following non-Borrelia tick-borne infections: Anaplasma phagocytophilum (2), Ehrlichia chaffeensis (1), and Babesia microti (12). Children with Lyme disease were more likely to have another tick-borne pathogen identified than matched controls (15/297 [5.1%] Lyme cases vs 0/297 [0%]; difference, 5.1% [95% confidence interval, 2.7%-8.2%]). Conclusions: Although a substantial minority of children with Lyme disease had another tick-borne pathogen identified, either first-line Lyme disease antibiotics provided adequate treatment or the coinfection was subclinical and did not require specific treatment. Further studies are needed to establish the optimal approach to testing for tick-borne coinfections in children.

4.
J Clin Microbiol ; 60(4): e0019222, 2022 04 20.
Artigo em Inglês | MEDLINE | ID: mdl-35369711

RESUMO

Automated continuous monitoring blood culture (CMBC) systems are a cornerstone of the clinical microbiology laboratory. Despite the critical role of these systems in diagnosing life-threatening bloodstream infections, their core technologies and performance characteristics have remained largely unchanged since their introduction in the 1990s. This stability and uniformity have enabled the development of quality benchmarks, such as percent positivity and contamination rate; downstream diagnostics, such as direct identification and susceptibility testing of microorganisms in positive cultures; and clinical guidelines based on time to positivity or duration of bacteriemia. In this issue of the Journal of Clinical Microbiology, Chavez et al. (J Clin Microbiol 60:e02261-21. 2021, https://doi.org/10.1128/JCM.02261-21) built on a prior study to examine clinical impacts following the introduction of a new blood culture system which boasts enhanced organism recovery and more rapid time to detection of positive blood cultures. While one might assume that these "improvements" would result in clinical benefits, the authors uncovered some unexpected consequences associated with altering long-accepted performance characteristics. Their central finding was that implementation of the new CMBC system did result in alterations to the management of patients with S. aureus bacteremia; however, this did not have any overall consequences for patient outcomes.


Assuntos
Bacteriemia , Sepse , Bacteriemia/diagnóstico , Bacteriemia/microbiologia , Hemocultura , Humanos , Laboratórios , Sepse/diagnóstico , Staphylococcus aureus
5.
Infect Control Hosp Epidemiol ; 43(4): 454-460, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-33985611

RESUMO

OBJECTIVES: The primary aim of this study was to assess the epidemiology of carbapenem-resistant Acinetobacter baumannii (CRAB) for 9 months following a regional outbreak with this organism. We also aimed to determine the differential positivity rate from different body sites and characterize the longitudinal changes of surveillance test results among CRAB patients. DESIGN: Observational study. SETTING: A 607-bed tertiary-care teaching hospital in Milwaukee, Wisconsin. PATIENTS: Any patient admitted from postacute care facilities and any patient housed in the same inpatient unit as a positive CRAB patient. METHODS: Participants underwent CRAB surveillance cultures from tracheostomy secretions, skin, and stool from December 5, 2018, to September 6, 2019. Cultures were performed using a validated, qualitative culture method, and final bacterial identification was performed using mass spectrometry. RESULTS: In total, 682 patients were tested for CRAB, of whom 16 (2.3%) were positive. Of the 16 CRAB-positive patients, 14 (87.5%) were residents from postacute care facilities and 11 (68.8%) were African American. Among positive patients, the positivity rates by body site were 38% (6 of 16) for tracheal aspirations, 56% (9 of 16) for skin, and 82% (13 of 16) for stool. CONCLUSIONS: Residents from postacute care facilities were more frequently colonized by CRAB than patients admitted from home. Stool had the highest yield for identification of CRAB.


Assuntos
Infecções por Acinetobacter , Acinetobacter baumannii , Infecção Hospitalar , Infecções por Acinetobacter/tratamento farmacológico , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Carbapenêmicos/farmacologia , Infecção Hospitalar/microbiologia , Humanos , Testes de Sensibilidade Microbiana
6.
Am J Clin Pathol ; 157(5): 781-788, 2022 05 04.
Artigo em Inglês | MEDLINE | ID: mdl-34893797

RESUMO

OBJECTIVES: Aerococcus spp are Gram-positive cocci increasingly recognized as uropathogens. The Clinical and Laboratory Standards Institute recently published specific breakpoints for Aerococcus spp (M45, third edition); however, the standardized method used for antimicrobial susceptibility testing (AST) requires media not often maintained in clinical laboratories. The purpose of this study was to evaluate and compare alternative methods of AST for Aerococcus isolates. METHODS: AST was performed on 134 clinical isolates using the Etest on three different types of agar, Vitek 2, and BD Phoenix. These results were compared with broth microdilution using the Sensititre STP6F. RESULTS: Aerococcus exhibited low minimum inhibitory concentrations to benzylpenicillin, meropenem, linezolid, and vancomycin. Variable resistance was seen to levofloxacin, ceftriaxone, and tetracycline. Meropenem and vancomycin met all acceptance criteria with every alternative method tested. Benzylpenicillin and linezolid did not meet essential agreement on any AST method. Tetracycline met the majority of acceptance criteria with the exception of more than 3% very major error when using the Etest on chocolate agar, the Vitek 2, and BD Phoenix. CONCLUSIONS: Overall, the alternate AST method with the highest agreement with broth microdilution was the Etest on Mueller-Hinton agar with 5% sheep blood and may be an optimal alternative to broth microdilution.


Assuntos
Aerococcus , Ágar , Animais , Antibacterianos/farmacologia , Humanos , Linezolida/farmacologia , Meropeném , Testes de Sensibilidade Microbiana , Ovinos , Tetraciclinas , Vancomicina
7.
Clin Chem ; 68(1): 59-68, 2021 12 30.
Artigo em Inglês | MEDLINE | ID: mdl-34969110

RESUMO

BACKGROUND: Pneumonia is a common illness, accounting for a staggering amount of worldwide morbidity and mortality. The diagnosis of pneumonia is challenging given the variety of responsible pathogens. Diagnostic testing for bacterial pneumonia has traditionally relied on time-consuming culture-based methods, though recently multiplexed molecular approaches have been described. Multiplexed molecular assays for pneumonia have the potential to provide broad diagnostic information in a rapid timeframe. Much has yet to be learned about these assays regarding analytical performance, potential impact, and optimal implementation strategy. CONTENT: Herein we provide a summary of what is known and what has yet to be learned about multiplexed molecular pneumonia assays. We provide a comparison of the different commercially available assays and summarize the most current performance data for each. We further describe outcome data and lessons learned from those who have implemented these assays worldwide. Finally, based on the current state of performance and outcome data, we provide informed strategies and considerations for laboratories contemplating implementation. SUMMARY: Multiplexed molecular assays for the diagnosis of pneumonia boast high accuracy though the diagnostic information gained from these assays is inherently different from culture and must be interpreted in cultural context. Despite this, these assays can be powerful and effective diagnostic tools with a potential to positively impact patient care. The extent to which this is realized varies from setting to setting, though is dependent on thoughtful implementation and a focus on delivering clear, rapid, and actionable results that can be interpreted in the appropriate context.


Assuntos
Pneumonia , Humanos , Técnicas de Diagnóstico Molecular/métodos , Pneumonia/diagnóstico
8.
J Clin Microbiol ; 59(9): e0248420, 2021 08 18.
Artigo em Inglês | MEDLINE | ID: mdl-34232066

RESUMO

Bacteremia can progress to septic shock and death without appropriate medical intervention. Increasing evidence supports the role of molecular diagnostic panels in reducing the clinical impact of these infections through rapid identification of the infecting organism and associated antimicrobial resistance genes. We report the results of a multicenter clinical study assessing the performance of the GenMark Dx ePlex investigational-use-only blood culture identification Gram-negative panel (BCID-GN), a rapid diagnostic assay for detection of bloodstream pathogens in positive blood culture (PBC) bottles. Prospective, retrospective, and contrived samples were tested. Results from the BCID-GN were compared to standard-of-care bacterial identification methods. Antimicrobial resistance genes (ARGs) were identified using PCR and sequence analysis. The final BCID-GN analysis included 2,444 PBC samples, of which 926 were clinical samples with negative Gram stain results. Of these, 109 samples had false-negative and/or -positive results, resulting in an overall sample accuracy of 88.2% (817/926). After discordant resolution, overall sample accuracy increased to 92.9% (860/926). Pre- and postdiscordant resolution sample accuracy excludes 37 Gram-negative organisms representing 20 uncommon genera, 10 Gram-positive organisms, and 1 Candida species present in 5% of samples that are not targeted by the BCID-GN. The overall weighted positive percent agreement (PPA), which averages the individual PPAs from the 27 targets (Gram-negative and ARG), was 94.9%. The limit of detection ranged from 104 to 107 CFU/ml, except for one strain of Fusobacterium necrophorum at 108 CFU/ml.


Assuntos
Bacteriemia , Hemocultura , Bacteriemia/diagnóstico , Bactérias Gram-Negativas/genética , Humanos , Reação em Cadeia da Polimerase , Estudos Prospectivos , Estudos Retrospectivos
9.
Clin Microbiol Newsl ; 43(11): 89-96, 2021 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-34035555

RESUMO

Monitoring the spread of emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants relies on rapid genetic testing of the viral genome. The sequencing method commonly called next-generation sequencing can identify virus variants. At times, for target-specific mutation detection, reverse transcriptase polymerase chain reaction is used to identify specific variants. The Centers for Disease Control and Prevention's national SARS-CoV-2 Strain Surveillance Program is a comprehensive, population-based U.S. surveillance system to monitor SARS-CoV-2 genes, identifying emerging SARS-CoV-2 variants to determine implications for coronavirus disease 2019 (COVID-19) diagnostics, therapy, and vaccines. This review describes the main viral variants of concern and their potential impacts and briefly describes testing strategies.

10.
Am J Clin Pathol ; 156(1): 24-33, 2021 06 17.
Artigo em Inglês | MEDLINE | ID: mdl-33940605

RESUMO

OBJECTIVES: We conducted an analytic and clinical comparison of a novel high-definition polymerase chain reaction PCR (HDPCR) assay to traditional real-time PCR (RT-PCR) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in upper respiratory specimens. METHODS: Analytic performance of RT-PCR, HDPCR, and extraction-free HDPCR was established through replicate testing of a serially diluted clinical specimen containing SARS-CoV-2. A clinical comparison of all 3 assays was conducted using 351 prospectively collected upper respiratory swab specimens obtained from symptomatic and asymptomatic individuals collected in various transport media. RESULTS: RT-PCR and HDPCR assays using extracted nucleic acid demonstrated similar analytic limits of detection (LoD) and clinical performance, with 100% positive and negative agreement. Extraction-free HDPCR demonstrated a 1.5 to 2.0 log10 increase in LoD based on cycle threshold values. However, clinical performance of extraction-free HDPCR remained high, demonstrating 97.8% positive and 99.6% negative agreement with RT-PCR. An overall increase in "invalid" and "presumptive" results was observed when using the extraction-free method, but this was highly variable based on transport medium used. CONCLUSIONS: HDPCR performs similar to RT-PCR for the detection of SARS-CoV-2. The use of an extraction-free HDPCR protocol maintained high clinical performance despite reduced analytic LoD, with the benefit of reduced hands-on time and cost of reagents associated with nucleic acid extraction.


Assuntos
COVID-19/genética , RNA Viral/análise , Reação em Cadeia da Polimerase em Tempo Real , SARS-CoV-2/genética , COVID-19/diagnóstico , Teste para COVID-19/métodos , Humanos , Limite de Detecção , Reação em Cadeia da Polimerase em Tempo Real/métodos , SARS-CoV-2/patogenicidade , Sensibilidade e Especificidade , Manejo de Espécimes/métodos
11.
Infect Control Hosp Epidemiol ; 42(3): 287-291, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32933595

RESUMO

BACKGROUND: The association between Clostridioides difficile colonization and C. difficile infection (CDI) is unknown in solid-organ transplant (SOT) patients. We examined C. difficile colonization and healthcare-associated exposures as risk factors for development of CDI in SOT patients. METHODS: The retrospective study cohort included all consecutive SOT patients with at least 1 screening test between May 2017 and April 2018. CDI was defined as the presence of diarrhea (without laxatives), a positive C. difficile clinical test, and the use of C. difficile-directed antimicrobial therapy as ordered by managing clinicians. In addition to demographic variables, exposures to antimicrobials, immunosuppressants, and gastric acid suppressants were evaluated from the time of first screening test to the time of CDI, death, or final discharge. RESULTS: Of the 348 SOT patients included in our study, 33 (9.5%) were colonized with toxigenic C. difficile. In total, 11 patients (3.2%) developed CDI. Only C. difficile colonization (odds ratio [OR], 13.52; 95% CI, 3.46-52.83; P = .0002), age (OR, 1.09; CI, 1.02-1.17; P = .0135), and hospital days (OR, 1.05; 95% CI, 1.02-1.08; P = .0017) were independently associated with CDI. CONCLUSIONS: Although CDI was more frequent in C. difficile colonized SOT patients, the overall incidence of CDI was low in this cohort.


Assuntos
Clostridioides difficile , Infecções por Clostridium , Transplante de Órgãos , Clostridioides , Infecções por Clostridium/epidemiologia , Humanos , Transplante de Órgãos/efeitos adversos , Estudos Retrospectivos , Fatores de Risco
12.
Am J Clin Pathol ; 155(3): 455-460, 2021 02 11.
Artigo em Inglês | MEDLINE | ID: mdl-32949141

RESUMO

OBJECTIVES: The purpose of this study is to describe and evaluate the impact of the participation of an antimicrobial stewardship program (ASP) pharmacist in microbiology rounds at our institution. METHODS: This single-center retrospective descriptive study included inpatient and ambulatory adults (≥18 years) with a susceptibility request reviewed during microbiology rounds between October 2018 and March 2019. In October 2018, multidisciplinary telephone microbiology rounds were initiated with the medical directors of the clinical microbiology laboratory and ASP pharmacist to review susceptibility requests. Numbers and types of interventions made by an ASP pharmacist and potential benefits were recorded and analyzed. RESULTS: Sixty-seven susceptibility requests were reviewed by an ASP pharmacist, of which 83.6% were inpatient. An ASP pharmacist completed chart reviews for 92.5% of requests and contacted the requester or primary team 74.6% of the time. About half (47.8%) of susceptibility requests were approved, and only 65.2% of requests from an infectious diseases provider were approved (P = .039). The most frequent potential benefits of the intervention included preventing unnecessary susceptibility testing (47.8%), improving clinician understanding (40.3%), and preventing treatment of a culture result deemed as a contaminant (19.4%). CONCLUSIONS: ASP pharmacists are uniquely accessible and able to assist with preventing unnecessary susceptibility testing, optimizing antimicrobial therapy, and providing education to other health care professionals.


Assuntos
Gestão de Antimicrobianos , Farmacêuticos , Avaliação de Programas e Projetos de Saúde , Humanos , Estudos Retrospectivos
13.
WMJ ; 120(4): 301-304, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35025178

RESUMO

BACKGROUND: Poverty and high viral load are associated with worse outcomes among COVID-19 patients. METHODS: We included patients admitted to Froedtert Health between March 16 and June 1, 2020. SARS-CoV-2 viral load was proxied by cycle-threshold values. To measure poverty, we used Medicaid or uninsured status and residence in socially disadvantaged areas. We assessed the association between viral load and length of stay and discharge disposition, while controlling for demographics and confounders. RESULTS: Higher viral load was associated with longer length of stay (coefficient -0.02; 95% CI, -0.04 to 0.01; P = 0.006) and higher likelihood of death (coefficient -0.11; 95% CI, -0.17 to -0.06; P < 0.001). Poverty, residence in disadvantaged areas, and race were not. DISCUSSION: This study confirms a relationship of viral load with in-hospital death, even after controlling for race and poverty.


Assuntos
COVID-19 , SARS-CoV-2 , Mortalidade Hospitalar , Humanos , Pobreza , Estudos Retrospectivos
14.
JAMA Netw Open ; 3(9): e2021892, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32975575

RESUMO

Importance: Initial public health data show that Black race may be a risk factor for worse outcomes of coronavirus disease 2019 (COVID-19). Objective: To characterize the association of race with incidence and outcomes of COVID-19, while controlling for age, sex, socioeconomic status, and comorbidities. Design, Setting, and Participants: This cross-sectional study included 2595 consecutive adults tested for COVID-19 from March 12 to March 31, 2020, at Froedtert Health and Medical College of Wisconsin (Milwaukee), the largest academic system in Wisconsin, with 879 inpatient beds (of which 128 are intensive care unit beds). Exposures: Race (Black vs White, Native Hawaiian or Pacific Islander, Native American or Alaska Native, Asian, or unknown). Main Outcomes and Measures: Main outcomes included COVID-19 positivity, hospitalization, intensive care unit admission, mechanical ventilation, and death. Additional independent variables measured and tested included socioeconomic status, sex, and comorbidities. Reverse transcription polymerase chain reaction assay was used to test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Results: A total of 2595 patients were included. The mean (SD) age was 53.8 (17.5) years, 978 (37.7%) were men, and 785 (30.2%) were African American patients. Of the 369 patients (14.2%) who tested positive for COVID-19, 170 (46.1%) were men, 148 (40.1%) were aged 60 years or older, and 218 (59.1%) were African American individuals. Positive tests were associated with Black race (odds ratio [OR], 5.37; 95% CI, 3.94-7.29; P = .001), male sex (OR, 1.55; 95% CI, 1.21-2.00; P = .001), and age 60 years or older (OR, 2.04; 95% CI, 1.53-2.73; P = .001). Zip code of residence explained 79% of the overall variance in COVID-19 positivity in the cohort (ρ = 0.79; 95% CI, 0.58-0.91). Adjusting for zip code of residence, Black race (OR, 1.85; 95% CI, 1.00-3.65; P = .04) and poverty (OR, 3.84; 95% CI, 1.20-12.30; P = .02) were associated with hospitalization. Poverty (OR, 3.58; 95% CI, 1.08-11.80; P = .04) but not Black race (OR, 1.52; 95% CI, 0.75-3.07; P = .24) was associated with intensive care unit admission. Overall, 20 (17.2%) deaths associated with COVID-19 were reported. Shortness of breath at presentation (OR, 10.67; 95% CI, 1.52-25.54; P = .02), higher body mass index (OR per unit of body mass index, 1.19; 95% CI, 1.05-1.35; P = .006), and age 60 years or older (OR, 22.79; 95% CI, 3.38-53.81; P = .001) were associated with an increased likelihood of death. Conclusions and Relevance: In this cross-sectional study of adults tested for COVID-19 in a large midwestern academic health system, COVID-19 positivity was associated with Black race. Among patients with COVID-19, both race and poverty were associated with higher risk of hospitalization, but only poverty was associated with higher risk of intensive care unit admission. These findings can be helpful in targeting mitigation strategies for racial disparities in the incidence and outcomes of COVID-19.


Assuntos
Negro ou Afro-Americano , Infecções por Coronavirus/etnologia , Disparidades nos Níveis de Saúde , Hospitalização , Unidades de Terapia Intensiva , Pneumonia Viral/etnologia , Adulto , Idoso , Betacoronavirus , Índice de Massa Corporal , COVID-19 , Estudos de Coortes , Comorbidade , Infecções por Coronavirus/complicações , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/virologia , Estudos Transversais , Dispneia/epidemiologia , Dispneia/etiologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Grupos Minoritários , Razão de Chances , Pandemias , Pneumonia Viral/complicações , Pneumonia Viral/mortalidade , Pneumonia Viral/virologia , Pobreza , Respiração Artificial , SARS-CoV-2 , Wisconsin/epidemiologia
15.
Am J Clin Pathol ; 154(4): 479-485, 2020 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-32687186

RESUMO

OBJECTIVES: We examined the distribution of reverse transcription polymerase chain reaction (RT-PCR) cycle threshold (CT) values obtained from symptomatic patients being evaluated for coronavirus disease 2019 (COVID-19) to determine the proportion of specimens containing a viral load near the assay limit of detection (LoD) to gain practical insight to the risk of false-negative results. We also examined the relationship between CT value and patient age to determine any age-dependent difference in viral load or test sensitivity. METHODS: We collected CT values obtained from the cobas severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) assay corresponding to 1,213 combined nasopharyngeal-oropharyngeal specimens obtained from symptomatic individuals that were reported as positive or presumptive positive for SARS-CoV-2. CT values were stratified by SARS-CoV target and patient age group. RESULTS: In total, 93.3% to 98.4% of specimens demonstrated CT values greater than 3× the assay LoD, at which point false-negative results would not be expected. The mean of CT values between age groups was statistically equivalent with the exception of patients in age group 80 to 89 years, which demonstrated slightly lower CTs. CONCLUSIONS: Based on the distribution of observed CT values, including the small proportion of specimens with values near the assay LoD, there is a low risk of false-negative RT-PCR results in combined nasopharyngeal-oropharyngeal specimens obtained from symptomatic individuals.


Assuntos
Betacoronavirus/isolamento & purificação , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Limite de Detecção , Pneumonia Viral/diagnóstico , RNA Viral/isolamento & purificação , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus/genética , COVID-19 , Teste para COVID-19 , Criança , Pré-Escolar , Infecções por Coronavirus/virologia , Reações Falso-Negativas , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/virologia , RNA Viral/análise , SARS-CoV-2 , Sensibilidade e Especificidade , Carga Viral , Wisconsin , Adulto Jovem
16.
J Mol Diagn ; 22(8): 968-974, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32565306

RESUMO

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.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Pandemias , Patologia Molecular , Pneumonia Viral/epidemiologia , COVID-19 , Infecções por Coronavirus/diagnóstico , Humanos , Liderança , Técnicas de Diagnóstico Molecular , Patologia Molecular/organização & administração , Pneumonia Viral/diagnóstico , SARS-CoV-2 , Sociedades Médicas , Estados Unidos/epidemiologia
17.
J Clin Microbiol ; 58(7)2020 06 24.
Artigo em Inglês | MEDLINE | ID: mdl-32350045

RESUMO

Lower respiratory tract infections, including hospital-acquired and ventilator-associated pneumonia, are common in hospitalized patient populations. Standard methods frequently fail to identify the infectious etiology due to the polymicrobial nature of respiratory specimens and the necessity of ordering specific tests to identify viral agents. The potential severity of these infections combined with a failure to clearly identify the causative pathogen results in administration of empirical antibiotic agents based on clinical presentation and other risk factors. We examined the impact of the multiplexed, semiquantitative BioFire FilmArray Pneumonia panel (PN panel) test on laboratory reporting for 259 adult inpatients submitting bronchoalveolar lavage (BAL) specimens for laboratory analysis. The PN panel demonstrated a combined 96.2% positive percent agreement (PPA) and 98.1% negative percent agreement (NPA) for the qualitative identification of 15 bacterial targets compared to routine bacterial culture. Semiquantitative values reported by the PN panel were frequently higher than values reported by culture, resulting in semiquantitative agreement (within the same log10 value) of 43.6% between the PN panel and culture; however, all bacterial targets reported as >105 CFU/ml in culture were reported as ≥105 genomic copies/ml by the PN panel. Viral targets were identified by the PN panel in 17.7% of specimens tested, of which 39.1% were detected in conjunction with a bacterial target. A review of patient medical records, including clinically prescribed antibiotics, revealed the potential for antibiotic adjustment in 70.7% of patients based on the PN panel result, including discontinuation or de-escalation in 48.2% of patients, resulting in an average savings of 6.2 antibiotic days/patient.


Assuntos
Gestão de Antimicrobianos , Pneumonia , Infecções Respiratórias , Adulto , Humanos , Técnicas de Diagnóstico Molecular , Reação em Cadeia da Polimerase Multiplex , Infecções Respiratórias/diagnóstico , Infecções Respiratórias/tratamento farmacológico
18.
JAMA Netw Open ; 3(1): e1919132, 2020 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-31922563

RESUMO

Importance: Clostridioides difficile infection is the most frequent health care-associated infection in the United States. However, exposure to this organism might occur outside the health care setting. Objective: To examine whether exposure to environmental factors, such as livestock farms, is associated with a higher probability of being colonized with C difficile at hospital admission. Design, Setting, and Participants: This retrospective cohort study was conducted from May 1, 2017, to June 30, 2018, at a teaching-affiliated hospital in Milwaukee, Wisconsin. All consecutive patients underwent C difficile screening using a nucleic acid amplification test at hospital admission. Data analyses were performed from July 2018 to October 2019. Exposures: The distances from patient residence to the nearest livestock farms, meat processing plants, raw materials services, and sewage facilities were measured in addition to risk factors previously evaluated in other studies. Main Outcomes and Measures: The main outcome was a positive result on C difficile screening tests performed within 72 hours of hospital admission. Results: A total of 3043 patients admitted to the hospital were included in the final analysis. Of those, 1564 (51.4%) were women and 2074 (68.9%) were white, with a mean (SD) age of 62.0 (15.9) years; 978 patients (32.1%) were admitted to hematology-oncology units. At first admission, 318 patients (10.4%) were detected through testing as C difficile carriers. Multivariable logistic regression analyses were performed on a stratified sample of patients based on hematology-oncology admission status. These analyses indicated that although patients admitted to hematology-oncology units were 35% more likely to be colonized with C difficile, no significant association existed between their sociodemographic and economic characteristics or health care and environmental exposures and the likelihood of a positive C difficile test result. In contrast, among patients admitted to non-hematology-oncology units, comorbidities increased the likelihood for colonization by more than 4 times; women had 60% greater colonization than men, and a history of recent hospitalization (ie, within the preceding 6 months) increased the likelihood of colonization by 70%. Residential proximity to livestock farms were all significantly associated with a higher likelihood of a positive C difficile test result. Residential proximity to livestock farms more than doubled the probability of C difficile colonization in patients admitted to non-hematology-oncology units. Conclusions and Relevance: A shorter distance between residence and livestock farms was associated with C difficile colonization. Knowledge of the epidemiology of C difficile in the community surrounding the hospital is important, as it has potential implications for the incidence of hospital-onset C difficile infection.


Assuntos
Infecções por Clostridium/epidemiologia , Infecções Comunitárias Adquiridas/epidemiologia , Exposição Ambiental/efeitos adversos , Hospitalização/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Clostridioides difficile/isolamento & purificação , Infecções por Clostridium/microbiologia , Infecções Comunitárias Adquiridas/microbiologia , Fazendas , Fezes/microbiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
19.
J Clin Microbiol ; 58(4)2020 03 25.
Artigo em Inglês | MEDLINE | ID: mdl-31941690

RESUMO

Automation of the clinical microbiology laboratory has become more prominent as laboratories face higher specimen volumes and understaffing and are becoming more consolidated. One recent advancement is the use of digital image analysis to rapidly distinguish between chromogenic growth for screening bacterial cultures. In this study, colony segregation software developed by Copan (Brescia, Italy) was evaluated to distinguish between significant growth and no growth of urine cultures plated onto standard blood and MacConkey agars. Specimens from 3 sites were processed on a WASP instrument (Copan) and incubated on the WASPLab platform (Copan), and plates were imaged at 0 and 24 hours postinoculation. Images were read by technologists following validated laboratory protocols (VLPs), and results were recorded in the laboratory information systems (LIS). Image analysis performed colony counts on the 24-hour images, and results were compared with the VLP. A total of 12,931 urine cultures were tested and analyzed with an overall sensitivity and specificity of 99.8% and 72.0%, respectively. After secondary review, 91.1% of manual-positive/automation-negative specimens were due to expert rules that reported the plate as contaminated or growing only normal flora and not due to threshold counts. Nine specimens were found to be manual-positive/automation-negative; a secondary review demonstrated that the results of 8 of these specimens were due to growth of microcolonies that were programmed to be ignored by the software and 1 were due to a colony count near the limit of significance. Overall, the image analysis software proved to be highly sensitive and can be utilized by laboratories to batch-review negative cultures to improve laboratory workflow.


Assuntos
Automação Laboratorial , Técnicas Bacteriológicas , Meios de Cultura , Humanos , Itália , Software , Urina
20.
Infect Control Hosp Epidemiol ; 41(3): 358-360, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31918767

RESUMO

Previously, we showed that disinfection of sink drains is effective at decreasing bacterial loads. Here, we report our evaluation of the ideal frequency of sink-drain disinfection and our comparison of 2 different hydrogen peroxide disinfectants.


Assuntos
Desinfetantes/farmacologia , Desinfecção/métodos , Contaminação de Equipamentos/prevenção & controle , Infecção Hospitalar/prevenção & controle , Humanos , Microbiologia da Água , Wisconsin
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