Multicenter Clinical Validation of the Molecular BD Max Enteric Viral Panel for Detection of Enteric Pathogens

ABSTRACT The conventional methodology for gastrointestinal pathogen detection remains time-consuming, expensive, and of limited sensitivity. The objective of this study was to evaluate the performance of the BD Max enteric viral panel (Max EVP) assay for identification of viral pathogens in stool specimens from individuals with symptoms of acute gastroenteritis, enteritis, or colitis. Prospective and archival stool specimens from adult and pediatric patients with diarrhea were collected in Cary-Blair medium or unpreserved containers. The results for specimens tested by the Max EVP (on the BD Max platform) were compared to those obtained by the reference method (alternate PCR assays, followed by bidirectional sequencing). Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated. A total of 2,239 specimens were collected, with 2,148 being included for analysis. In this population, 39.6% of specimens were from outpatients, 42.1% were from patients <21 years old, and 49.7% were from females. Prevalence rates for prospective specimens were 7.3%, 4.5%, 3.5%, 2.4%, and 1.2% for norovirus, sapovirus, astrovirus, rotavirus, and adenovirus, respectively. PPA was 92.8%, 84.9%, 93.0%, 100%, and 95.6%, for norovirus, sapovirus, astrovirus, rotavirus, and adenovirus, respectively. NPA was ≥99.4% for all targets. In conjunction with the clinical presentation, laboratory findings, and epidemiological information, the Max EVP assay is effective for the differential diagnosis of enteric disease caused by norovirus, sapovirus, astrovirus, rotavirus, and adenovirus. This assay can be used individually for patients at high risk for a viral enteropathogen (e.g., in outbreak settings) or as an adjunct to other enteric bacterial panels.

Download Full-text

Multisite Evaluation of the BD Max Extended Enteric Bacterial Panel for Detection of Yersinia enterocolitica, Enterotoxigenic Escherichia coli, Vibrio, and Plesiomonas shigelloides from Stool Specimens

Journal of Clinical Microbiology ◽

10.1128/jcm.00911-17 ◽

2017 ◽

Vol 55 (11) ◽

pp. 3258-3266 ◽

Cited By ~ 9

Author(s):

Patricia J. Simner ◽

Margret Oethinger ◽

Kathleen A. Stellrecht ◽

Dylan R. Pillai ◽

Ram Yogev ◽

...

Keyword(s):

Escherichia Coli ◽

Yersinia Enterocolitica ◽

Reference Method ◽

Enterotoxigenic Escherichia Coli ◽

Plesiomonas Shigelloides ◽

Content Type ◽

Culture Techniques ◽

Discrepant Result ◽

Percent Agreement ◽

Stool Specimens

ABSTRACTThe purpose of this study was to perform a multisite evaluation to establish the performance characteristics of the BD Max extended enteric bacterial panel (xEBP) assay directly from unpreserved or Cary-Blair-preserved stool specimens for the detection ofYersinia enterocolitica, enterotoxigenicEscherichia coli(ETEC),Vibrio, andPlesiomonas shigelloides. The study included prospective, retrospective, and prepared contrived specimens from 6 clinical sites. BD Max xEBP results were compared to the reference method, which included standard culture techniques coupled with alternate PCR and sequencing, except for ETEC, for which the reference method was two alternate PCRs and sequencing. Alternate PCR was also used to confirm the historical results for the retrospective specimens and for discrepant result analysis. A total of 2,410 unformed, deidentified stool specimens were collected. The prevalence in the prospective samples as defined by the reference method was 1.2% ETEC, 0.1%Vibrio, 0%Y. enterocolitica, and 0%P. shigelloides. Compared to the reference method, the positive percent agreement (PPA) (95% confidence interval [CI]), negative percent agreement (NPA) (95% CI), and kappa coefficient (95% CI) for the BD Max xEBP assay for all specimens combined were as follows: ETEC, 97.6% (87.4 to 99.6), 99.8% (99.5 to 99.9), and 0.93 (0.87 to 0.99);Vibrio, 100% (96.4 to 100), 99.7% (99.4 to 99.8), and 0.96 (0.93 to 0.99);Y. enterocolitica, 99.0% (94.8 to 99.8), 99.9% (99.8 to 99.9), and 0.99 (0.98 to 1);P. shigelloides, 100% (96.4 to 100), 99.8% (99.5 to 99.9), and 0.98 (0.95 to 1), respectively. In this multicenter study, the BD Max xEBP showed a high correlation (kappa, 0.97; 95% CI, 0.95 to 0.98) with the conventional methods for the detection of ETEC,Vibrio,Y. enterocolitica, andP. shigelloidesin stool specimens from patients suspected of acute gastroenteritis, enteritis, or colitis.

Download Full-text

Molecular and epidemiologyical analysis of a Campylobacter jejuni outbreak in China, 2018

The Journal of Infection in Developing Countries ◽

10.3855/jidc.11408 ◽

2019 ◽

Vol 13 (12) ◽

pp. 1086-1094 ◽

Cited By ~ 5

Author(s):

Mei Qu ◽

Maojun Zhang ◽

Xin Zhang ◽

Lei Jia ◽

Jun Xu ◽

...

Keyword(s):

Campylobacter Jejuni ◽

Southern China ◽

Resistance Pattern ◽

Common Source ◽

Viral Pathogens ◽

Gastrointestinal Pathogen ◽

Stool Specimens ◽

Sequence Types ◽

Campylobacter Spp ◽

Close Contacts

Introduction: Campylobacter spp. is the most common gastrointestinal pathogen worldwide with a very low reported incidence in China. In April 2018, one 36 cases of diarrhea outbreak occurred in a high school in Beijing after a trip to another province in Southern China. The investigation for the enteric pathogen infection was conducted to identify the cause. Methodology: Eighteen stool specimens from 11 diarrheal patients and 3 close contacts were collected and tested for 16 enteric bacterial and viral pathogens using real-time PCR methods. Multilocus Sequence Typing (MLST), pulsed-field gel electrophoresis (PFGE) and antimicrobial susceptibility testing were applied to C. jejuni isolates in this outbreak in order to characterize the incident. Results: Ten (90.9%) of 11 stool specimens from diarrheal patients were positive for Campylobacter jejuni, confirmed as the cause of outbreak. Eight C. jejuni strains were obtained and produced 2 sequence types (STs) and 3 PFGE patterns. Six of them had the same ST (ST2274) and PFGE pattern (SMA001). The dominant outbreak strain with an identical subtyping profile was clustered with most chicken isolates from national MLST and PulseNet Campylobacter database. The entire 8 isolates were multi-drug resistant, with the dominant resistance pattern of nalidixic acid, tetracycline and ciprofloxacin combined, except for 2 isolates resistant to florfenicol. Conclusion: Molecular typing confirmed that most of the cases belonged to a clonal cluster supporting the hypothesis of a common source; however, the source was not identified. This was the first recognized Campylobacteriosis outbreak in China among 20 years.

Download Full-text

Von-Willebrand-Syndrom Typ 1 und Schwangerschaft

Hämostaseologie ◽

10.1055/s-0037-1619742 ◽

2011 ◽

Vol 31 (S 01) ◽

pp. S11-S13 ◽

Cited By ~ 1

Author(s):

J. Oppermann ◽

A. Siegemund ◽

R. Schobess ◽

U. Scholz

Keyword(s):

Clinical Presentation ◽

Bleeding Disorder ◽

Bleeding Tendency ◽

Laboratory Findings ◽

Mucous Membranes ◽

Von Willebrand

SummaryThe von Willebrand-Jürgens syndrome (VWJS) type 1 is a common hereditary bleeding disorder with a bleeding tendency located especially in the mucous membranes. Women suffering from VWJS type 1 show menorrhagia and prolonged postoperative bleedings. During pregnancy the clinical presentation varies by the increase of the von Willebrand factors.In this article the laboratory findings and the clinical presentation of patients with VWJS during pregnancy was examined. The necessity of interventions during pregnancy and at the time of delivery was under consideration.

Download Full-text

A Pain in the Butt: A Case Series of Gluteal Compartment Syndrome

Clinical Practice and Cases in Emergency Medicine ◽

10.5811/cpcem.2021.3.51801 ◽

2021 ◽

Vol 2 (5) ◽

pp. 144-147

Author(s):

Jessica Jackson ◽

Kraftin Schreyer

Keyword(s):

Compartment Syndrome ◽

Clinical Presentation ◽

Case Series ◽

Morbidity And Mortality ◽

Emergency Physicians ◽

Laboratory Findings ◽

Diagnosis And Management ◽

Gluteal Compartment Syndrome

Introduction: Gluteal compartment syndrome is a rare and difficult-to-diagnose form of compartment syndrome. Case Series: We present three patients with gluteal compartment syndrome and review the clinical presentation, imaging, and laboratory findings that assist in diagnosis. Suggestions for more readily diagnosing gluteal compartment syndrome are provided. Conclusion: Emergency physicians must be familiar with the diagnosis and management of gluteal compartment syndrome to prevent the significant associated morbidity and mortality.

Download Full-text

Gender-related differences in clinical presentation, electrocardiography signs, laboratory markers and outcome in patients with acute pulmonary embolism

Vojnosanitetski pregled ◽

10.2298/vsp150716093o ◽

2016 ◽

Vol 73 (9) ◽

pp. 844-849 ◽

Cited By ~ 1

Author(s):

Slobodan Obradovic ◽

Boris Dzudovic ◽

Sinisa Rusovic ◽

Vesna Subota ◽

Dragana Obradovic

Keyword(s):

Pulmonary Embolism ◽

Acute Pulmonary Embolism ◽

Clinical Presentation ◽

Univariate Analysis ◽

Pulmonary Angiography ◽

Laboratory Findings ◽

Laboratory Markers ◽

Significant Difference ◽

Echocardiographic Examination ◽

Gender Specific Differences

Background/Aim. Acute pulmonary embolism (PE) is a potentially life threating event, but there are scarce data about genderrelated differences in this condition. The aim of this study was to identify gender-specific differences in clinical presentation, the diagnosis and outcome between male and female patients with PE. Methods. We analysed the data of 144 consecutive patients with PE (50% women) and compared female and male patients regarding clinical presentation, electrocardiography (ECG) signs, basic laboratory markers and six-month outcome. All the patients confirmed PE by visualized thrombus on the multidetector computed tomography with pulmonary angiography (MDCTPA), ECG and echocardiographic examination at admission. Results. Compared to the men, the women were older and a larger proportion of them was in the third tertile of age (66.0% vs 34.0%, p = 0.008). In univariate analysis the men more often had hemoptysis [OR (95% CI) 3.75 (1.16-12.11)], chest pain [OR (95% CI) 3.31 (1.57-7.00)] febrile state [OR (95% CI) 2.41 (1.12-5.22)] and pneumonia at PE presentation [OR (95% CI) 3.40 (1.25-9.22)] and less likely had heart decompensation early in the course of the disease [OR (95%CI) 0.48 (0.24-0.97)]. In the multivariate analysis a significant difference in the rate of pneumonia and acute heart failure between genders disappeared due to strong influence of age. There was no significant difference in the occurrence of typical ECG signs for PE between the genders. Women had higher level of admission glycaemia [7.7 mmol/L (5.5-8.2 mmol/L) vs 6.9 mmol/L (6.3-9.6 mmol/L), p = 0.006] and total number of leukocytes [10.5 x 109/L (8.8-12.7 x 109/L vs 8.7 x 109/L (7.0-11.6 x 109/L)), p = 0.007]. There was a trend toward higher plasma level of brain natriuretic peptide in women compared to men 127.1 pg/mL (55.0-484.0 pg/mL), p = 0.092] vs [90.3 pg/mL (39.2-308.5 pg/mL). The main 6-month outcomes, death and major bleeding, had similar frequencies in both sexes. Conclusion. There are several important differences between men and women in the clinical presentation of PE and basic laboratory findings which can influence the diagnosis and treatment of PE.

Download Full-text

Frequency of Rotavirus, Adenovirus and Astrovirus among Patients with Acute Diarrhea by Chromatographic Immunoassay and Enzyme

Journal of Biotechnology Research Center ◽

10.24126/jobrc.2016.10.2.485 ◽

2016 ◽

Vol 10 (2) ◽

pp. 58-64

Author(s):

Arwa Mujahid Abdullah Al-Shuwaikh

Keyword(s):

Clinical Settings ◽

City Hospital ◽

Viral Pathogens ◽

Inappropriate Use ◽

Medical City ◽

Elisa Technique ◽

Stool Samples ◽

Infant And Young Children ◽

Stool Specimens ◽

Age Range

Diarrhea is a major cause of illness and death in children worldwide; however, little information exists about the origin of childhood diarrhea in Iraq. Rotavirus, Adenovirus and Astrovirus are the major causes of sever gastroenteritis in infant and young children, pattern also observed in adult. Confirmation of viral infection by laboratory testing is necessary for reliable surveillance and can be useful in clinical settings to avoid inappropriate use of antimicrobial therapy. Methods: A total of 188 patients their age range from 1-19 (Mean=5.57 ± S.D. = 4.81) years old suffering from diarrhea were included in this study. Stool samples were collected and tested for Rotavirus, Adenovirus and Astrovirus antigens by using the rapid chromatographic test and for Rotavirus and Adenovirus Antigens, ELISA also was done. Rotavirus, Adenovirus and Astrovirus antigens were determined by rapid chromatographic immunoassay in 27 specimens (14.36%), 0 (0%) and 0 (0%) of 188 frozen stool specimens, respectively. Moreover, of these 188 specimens, Rotavirus was found in 35 specimens (18.62%) and Adenovirus in 6 specimens (3.19 %) by using ELISA technique. The present results revealed that Rotaviruses and Adenoviruses have an important role in diarrhea among children especially those less than 5 year’s old and viral pathogens should be investigated routinely in diarrhea stool specimens. This study was aimed to determine the frequency of Rotavirus, Adenovirus and Astrovirus in patients with acute gastroenteritis admitted to Al-Emamain Al-Kadhemain Medical City Hospital in Baghdad-Iraq.

Download Full-text

398. Description of a Large Pediatric Lyme Arthritis Cohort in an Endemic Region

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.471 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S203-S204

Author(s):

Ancil J Abney ◽

Megan Reinhard ◽

Bazak Sharon

Keyword(s):

Clinical Setting ◽

Clinical Presentation ◽

Laboratory Data ◽

Chronic Arthritis ◽

Lyme Arthritis ◽

Steady Increase ◽

Medical Organization ◽

Endemic Region ◽

Laboratory Findings ◽

High Index Of Suspicion

Abstract Background In endemic areas, Lyme arthritis (LA) is a leading cause of joint swelling. Due to the shared inflammatory nature and common clinical features, acute LA is often misdiagnosed as septic arthritis (SA) while recurrent disease is at times difficult to differentiate from other causes of chronic arthritis. In Minnesota, there has been a steady increase in cases of Lyme disease. This has not been met by a clear guideline and there is no consensus for the management of pediatric arthritis. In this context, we sought to characterize the epidemiology and clinical presentation of a large local cohort. Methods This is a retrospective review of medical charts from children with confirmed LA, presented at a large academic medical organization in the Upper Midwest between January 2011 to December 2017. Demographic, clinical, and laboratory data were collected and analyzed. Results Lyme arthritis was confirmed in 109 children. Acute presentation was more common (67) while the rest (42) had either persistence or reoccurrence of symptoms [Figure 1]. Elevated inflammatory markers and synovial pleocytosis were common, unlike fever and refusal to bear weight which were seen occasionally [Figure 2]. Seasonal distribution and the clinical setting for initial presentation as well as admissions are summarized in Figure 3. The knee was involved in all but 2 patients, both had acute monoarthritis (elbow and hip) [Figure 4]. Conclusion LA causes a spectrum of disease, is seen year round, and across the clinical setting continuum. Acute knee monoarthritis is the most common presentation (54% in our cohort) and is often misdiagnosed as SA leading to unnecessary hospitalizations and aggressive interventions. This occurs more frequently at the ED setting and for children with significant synovial pleocytosis. When evaluating a child with arthritis, laboratory findings are none specific and should be used in caution. Pediatric providers in endemic regions, especially those in primary, hospital, or emergency care must be familiar with the clinical presentation and have a high index of suspicion for LA in order to prevent mismanagement. Disclosures All authors: No reported disclosures.

Download Full-text

Clinical Presentation of COVID-19: A Systematic Review Focusing on Upper Airway Symptoms

Ear Nose & Throat Journal ◽

10.1177/0145561320920762 ◽

2020 ◽

Vol 99 (9) ◽

pp. 569-576 ◽

Cited By ~ 69

Author(s):

Andrea Lovato ◽

Cosimo de Filippis

Keyword(s):

Systematic Review ◽

Clinical Presentation ◽

Nasal Congestion ◽

Upper Airway ◽

Ground Glass Opacity ◽

Common Finding ◽

Laboratory Findings ◽

Pooled Data ◽

Presenting Symptoms ◽

Airway Symptoms

Aim: Pharyngodynia, nasal congestion, rhinorrhea, smell, and taste dysfunctions could be the presenting symptoms of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2. The aim was to perform a systematic review of current evidences on clinical presentation of COVID-19, focusing on upper airway symptoms in order to help otolaryngologists identifying suspected cases. Methods: We searched PubMed and Web of Science electronic databases. Results: We included 5 retrospective clinical studies for a total of 1556 hospitalized patients with COVID-19, 57.5% were male and mean age was 49.1 years. Pooled data revealed that pharyngodynia was present in 12.4% of patients, nasal congestion in 3.7%, and rhinorrhea was rare. No reports on COVID-19 and olfactory/gustative disorders matched inclusion criteria but preliminary evidences suggested they could be present. Common symptoms were fever (85.6%), cough (68.7%), and fatigue (39.4%). Frequent comorbidities were hypertension (17.4%), diabetes (3.8%), and coronary heart disease (3.8%); 83% of patients had alterations on chest computed tomography that were bilateral in 89.5% of cases. Ground-glass opacity was the most common finding (50%). Lymphopenia (77.2%) and leucopenia (30.1%) were common. Critical cases with complications were 9%, intensive care unit admission was required in 7.3%, invasive ventilation in 3.4%, and mortality was 2.4%. Conclusion: Otolaryngologists should know that pharyngodynia, nasal congestion, olfactory, and gustative disorders could be the presenting symptoms of COVID-19. Clinical presentation together with radiological and laboratory findings could help to identify suspected cases.

Download Full-text

665. Key Clinical and Laboratory Features in Early Diagnosis of Ehrlichiosis in an Endemic Area of Long Island, New York

Open Forum Infectious Diseases ◽

10.1093/ofid/ofy210.672 ◽

2018 ◽

Vol 5 (suppl_1) ◽

pp. S240-S241

Author(s):

Olga Kaplun ◽

Kalie Smith ◽

Teresa Khoo ◽

Eric Spitzer ◽

Fredric Weinbaum ◽

...

Keyword(s):

New York ◽

Clinical Presentation ◽

Average Length ◽

Kidney Injury ◽

Length Of Hospital Stay ◽

Retrospective Chart Review ◽

Suffolk County ◽

University Hospital ◽

Laboratory Findings ◽

Significant Difference

Abstract Background Human monocytic ehrlichiosis (HME) is a tick-borne disease caused by Ehrlichia chafeensis in the northeast United States. Suffolk County, New York has the highest amount of HME cases in NY (176 from 2010 to 2014). Our aim is to identify risk factors for HME and compare clinical presentation and laboratory findings of young vs. older adults. Methods A retrospective chart review from January 1, 2014 to December 31, 2017 was performed on all patients ≥18 years who presented to the ER at Stony Brook University Hospital (SBUH) or Stony Brook Southampton Hospital (SBSH) with (i) ICD-9 code 082.4 or ICD-10 code A77.40 and (ii) a positive E. Chafeensis PCR. Data were collected on demographics, clinical presentation, and laboratory results. Results Twenty-seven cases of HME were found and separated into Group 1 (G1, n = 10) or Group 2 (G2, n = 17) based on age (Table 1). G1 had a significantly higher chance of being Hispanic than G2. Twenty-four of the 27 patients (89%) were hospitalized with an average length of stay of 3.4 days (range 1–14 days).The only significant difference in clinical presentation was that G1 was more likely to have myalgia (P = 0.02). 40% or more of patients in both groups presented with an acute kidney injury and the average length of hospital stay in days was 4.0 ± 2.9 and 3.2 ± 3.1 for G1 and G2, respectively. The number of cases overall have increased 6.0% per year between 2014 and 2017. Thrombocytopenia presented in all cases. Conclusion. HME is prevalent in Suffolk County. Clinical presentation and laboratory findings were largely similar between the two groups, except the younger population more often presented with myalgia. A risk factor in this study was to be young and Hispanic, likely due to occupational exposure. Disclosures All authors: No reported disclosures.

Download Full-text

The Validation of the Sample6 DETECTTM HT/L for AOAC Research Institute

Journal of AOAC International ◽

10.5740/jaoacint.17-0484 ◽

2018 ◽

Vol 101 (5) ◽

pp. 1584-1592

Author(s):

Kakolie Banerjee ◽

Brittney Pierson ◽

Chuxuan Hu ◽

Elijah Carrier ◽

Lauren Malsick ◽

...

Keyword(s):

Pathogen Detection ◽

Incubation Temperature ◽

Detection System ◽

Reference Method ◽

Culture Method ◽

The Elderly ◽

Sample Volume ◽

Test Portion ◽

Environmental Surfaces ◽

The Matrix

Abstract Background: Listeria spp. are an important foodborne human pathogen because of their ability to cause disease and high mortality in individuals, particularly pregnant women, neonates, the elderly, immunocompromised individuals, and children. The Sample6 DETECTTM HT/L Kit is a semi-automated qualitative pathogen detection system designed to detect Listeria spp. (L. monocytogenes, L. innocua, L. ivanovii, L. seeligeri, L. welshimeri, and L. marthii) in environmental samples using the Sample6 BioIlluminationTM technology. Objective: The study was done to evaluate the Sample6 DETECT HT/L Kit. The assay was evaluated for inclusivity, exclusivity, robustness, product consistency, and stability, and a matrix study of one environmental surface. Methods: The performance of the Sample6 DETECT HT/L was compared with U.S. Food and Drug Administration reference culture method for Listeria using an unpaired study design. Results: The Sample6 DETECT HT/L assay correctly identified all 50 inclusivity isolates and correctly excluded all 30 nontarget strains evaluated. The assay was not affected by minor variations in incubation temperature and time, or sample volume. Results across three production lots spanning the shelf life of the assay were consistent. In the matrix study, the Sample6 DETECT HT/L for Listeria correctly identified each test portion for the presence or absence of Listeria, and there were no statistically significant differences between candidate and reference method results. Conclusions: The data collected in this study demonstrate that the Sample6 DETECT HT/L assay is a reliable method for the detection of Listeria spp. on stainless-steel environmental surfaces after 22 h of enrichment.

Download Full-text