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Article ; Online: Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status.

Peaper, David R / Rhoads, Daniel D / Sullivan, Kaede V / Couturier, Marc R / Humphries, Romney M / Martin, Isabella W / Nolte, Frederick S / Rowlinson, Marie-Claire / She, Rosemary C / Simner, Patricia J / Theel, Elitza S / Wojewoda, Christina M

Journal of clinical microbiology

2021 Volume 59, Issue 10, Page(s) e0116721

Abstract: The U.S. Food & Drug Administration (FDA) regulates the marketing of manufacturers' ...

Abstract	The U.S. Food & Drug Administration (FDA) regulates the marketing of manufacturers'
MeSH term(s)	COVID-19 ; COVID-19 Testing ; Humans ; Pathologists ; SARS-CoV-2 ; United States ; United States Food and Drug Administration
Language	English
Publishing date	2021-07-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.01167-21
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Article ; Online: Fatal Zika Virus Infection with Secondary Nonsexual Transmission.

Swaminathan, Sankar / Schlaberg, Robert / Lewis, Julia / Hanson, Kimberly E / Couturier, Marc R

The New England journal of medicine

2016 Volume 375, Issue 19, Page(s) 1907–1909

MeSH term(s)	Adult ; Aged ; Fatal Outcome ; Humans ; Male ; RNA, Viral/analysis ; Sequence Analysis, RNA ; Zika Virus/genetics ; Zika Virus/isolation & purification ; Zika Virus Infection/transmission
Chemical Substances	RNA, Viral
Language	English
Publishing date	2016--10
Publishing country	United States
Document type	Case Reports ; Letter
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc1610613
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Ua VI Zs.34: Show issues

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Article ; Online: Epithelial Inclusions in Gallbladder Specimens Mimic Parasite Infection: Histologic and Molecular Examination of Reported Cystoisospora belli Infection in Gallbladders of Immunocompetent Patients.

Swanson, Eric A / March, Jordon K / Clayton, Frederic / Couturier, Marc R / Arcega, Ramir / Smith, Richard / Evason, Kimberley J

The American journal of surgical pathology

2018 Volume 42, Issue 10, Page(s) 1346–1352

Abstract: Recent publications have described epithelial cytoplasmic vacuoles and inclusions incidentally noted within gallbladder epithelium and concluded that they represent coccidian parasite infection, in particular, Cystoisospora belli. We identified 8 ... ...

Abstract	Recent publications have described epithelial cytoplasmic vacuoles and inclusions incidentally noted within gallbladder epithelium and concluded that they represent coccidian parasite infection, in particular, Cystoisospora belli. We identified 8 gallbladder specimens from our institution in the past 3 years in which this diagnosis was suggested or in which similar epithelial alterations were prominent. Molecular analysis was performed on the 8 gallbladder specimens and on 3 positive control specimens: small bowel biopsies from acquired immunodeficiency syndrome patients with diarrhea. Polymerase chain reaction using primers designed to amplify an internal transcribed spacer (ITS2) in the C. belli ribosomal gene cluster was performed on the DNA samples. All 8 gallbladder specimens were negative for amplification, while a product consistent with C. belli was amplified from all 3 positive controls. Histologically, the gallbladder cytoplasmic inclusions stained diffusely positive for Grocott-Gomori's methenamine silver and Periodic acid-Schiff with diastase. In contrast, sections from a positive control small bowel biopsy demonstrated organisms that were negative for Grocott-Gomori's methenamine silver and showed a distinct capsular and punctate internal staining on Periodic acid-Schiff with diastase in various parasite forms. Together, the lack of molecular evidence of C. belli and the distinct morphologic and special staining patterns in these gallbladders compared with positive control small bowel suggest that these epithelial changes do not represent true C. belli infection. Our results suggest that gallbladders of immunocompetent patients may occasionally show epithelial changes that can morphologically mimic C. belli infection. Pathologists should be aware of this histologic variant to minimize unnecessary treatment, testing, and patient anxiety.
MeSH term(s)	Adult ; Aged ; DNA, Protozoan/genetics ; Databases, Factual ; Diagnosis, Differential ; Epithelial Cells/immunology ; Epithelial Cells/parasitology ; Epithelial Cells/pathology ; Female ; Gallbladder/immunology ; Gallbladder/parasitology ; Gallbladder/pathology ; Gallbladder Diseases/immunology ; Gallbladder Diseases/parasitology ; Gallbladder Diseases/pathology ; Host-Pathogen Interactions ; Humans ; Immunocompetence ; Inclusion Bodies/immunology ; Inclusion Bodies/parasitology ; Inclusion Bodies/pathology ; Isospora/genetics ; Isospora/immunology ; Isospora/isolation & purification ; Isosporiasis/immunology ; Isosporiasis/parasitology ; Isosporiasis/pathology ; Male ; Middle Aged ; Polymerase Chain Reaction ; Predictive Value of Tests ; Retrospective Studies ; Staining and Labeling/methods
Chemical Substances	DNA, Protozoan
Language	English
Publishing date	2018-07-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	752964-8
ISSN	1532-0979 ; 0147-5185
ISSN (online)	1532-0979
ISSN	0147-5185
DOI	10.1097/PAS.0000000000001094
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Zs.A 1356: Show issues

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Article ; Online: Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests.

Caliendo, Angela M / Couturier, Marc R / Ginocchio, Christine C / Hanson, Kimberly E / Miller, Melissa B / Walker, Kimberly E / Frank, Gregory M

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2016 Volume 63, Issue 2, Page(s) 151–154

Abstract: In 2014, the US Food and Drug Administration (FDA) proposed to regulate laboratory-developed tests (LDTs)-diagnostics designed, manufactured, and used within a single laboratory. The Infectious Diseases Society of America, the American Society for ... ...

Abstract	In 2014, the US Food and Drug Administration (FDA) proposed to regulate laboratory-developed tests (LDTs)-diagnostics designed, manufactured, and used within a single laboratory. The Infectious Diseases Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology recognize that the FDA is committed to protecting patients. However, our societies are concerned that the proposed regulations will limit access to testing and negatively impact infectious diseases (ID) LDTs. In this joint commentary, our societies discuss why LDTs are critical for ID patient care, hospital infection control, and public health responses. We also highlight how the FDA's proposed regulation of LDTs could impair patient access to life-saving tests and stifle innovation in ID diagnostics. Finally, our societies make specific recommendations for the FDA's consideration to reduce the burden of the proposed new rules on clinical laboratories and protect patients' access to state-of-the art, quality LDTs.
MeSH term(s)	Communicable Diseases/diagnosis ; Diagnostic Tests, Routine ; Health Planning Guidelines ; Health Services Accessibility ; Humans ; Laboratories/legislation & jurisprudence ; Policy Making ; Societies, Medical ; United States ; United States Food and Drug Administration
Language	English
Publishing date	2016--15
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciw260
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Zs.A 1505: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Evaluation of Modified Two-Tiered Testing Algorithms for Lyme Disease Laboratory Diagnosis Using Well-Characterized Serum Samples.

Pegalajar-Jurado, Adoracion / Schriefer, Martin E / Welch, Ryan J / Couturier, Marc R / MacKenzie, Tiffany / Clark, Rebecca J / Ashton, Laura V / Delorey, Mark J / Molins, Claudia R

Journal of clinical microbiology

2018 Volume 56, Issue 8

Abstract: Standard two-tiered testing (STTT) is the recommended algorithm for laboratory diagnosis of Lyme disease (LD). Several limitations are associated with STTT that include low sensitivity in the early stages of disease, as well as technical complexity and ... ...

Abstract	Standard two-tiered testing (STTT) is the recommended algorithm for laboratory diagnosis of Lyme disease (LD). Several limitations are associated with STTT that include low sensitivity in the early stages of disease, as well as technical complexity and subjectivity associated with second-tier immunoblotting; therefore, modified two-tiered testing (MTTT) algorithms that utilize two sequential first-tier tests and eliminate immunoblotting have been evaluated. Recently, a novel MTTT that uses a VlsE chemiluminescence immunoassay followed by a C6 enzyme immunoassay has been proposed. The purpose of this study was to evaluate the performance of the VlsE/C6 MTTT using well-characterized serum samples. Serum samples from the CDC Lyme Serum Repository were tested using three MTTTs, VlsE/C6, whole-cell sonicate (WCS)/C6, and WCS/VlsE, and three STTTs (immunoblotting preceded by three different first-tier assays: VlsE, C6, and WCS). Significant differences were not observed between the results of the MTTTs assessed; however, the VlsE/C6 MTTT resulted in the highest specificity (100%) when other diseases were tested and the lowest sensitivity (75%) for LD samples. Significant differences were present between the results for various MTTTs and STTTs evaluated. Specifically, all MTTTs resulted in higher sensitivities than the STTTs for all LD groups combined and were significantly more accurate (i.e., higher proportion of correct classifications) for this group, with the exception of the WCS/ViraStripe STTT. Additionally, when other diseases were tested, only the results of the VlsE/C6 MTTT differed significantly from those of the WCS/ViraStripe STTT, with the VlsE/C6 MTTT resulting in a 6.2% higher accuracy. Overall, the VlsE/C6 MTTT offers an additional laboratory testing algorithm for LD with equivalent or enhanced performance compared to that of the other MTTTs and STTTs evaluated in this study.
MeSH term(s)	Algorithms ; Antibodies, Bacterial/blood ; Antigens, Bacterial/immunology ; Bacterial Proteins/immunology ; Borrelia burgdorferi/immunology ; Borrelia burgdorferi/isolation & purification ; Humans ; Immunoassay/standards ; Lipoproteins/immunology ; Lyme Disease/blood ; Lyme Disease/diagnosis ; Sensitivity and Specificity ; Serologic Tests/standards
Chemical Substances	Antibodies, Bacterial ; Antigens, Bacterial ; Bacterial Proteins ; Lipoproteins ; VlsE protein, Borrelia burgdorferi
Language	English
Publishing date	2018-07-26
Publishing country	United States
Document type	Comparative Study ; Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.01943-17
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Article ; Online: Optimization of matrix-assisted laser desorption ionization-time of flight mass spectrometry analysis for bacterial identification.

Khot, Prasanna D / Couturier, Marc R / Wilson, Andrew / Croft, Ann / Fisher, Mark A

Journal of clinical microbiology

2012 Volume 50, Issue 12, Page(s) 3845–3852

Abstract: Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is a relatively new addition to the clinical microbiology laboratory. The performance of the MALDI Biotyper system (Bruker Daltonics) was compared to those of ... ...

Abstract	Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is a relatively new addition to the clinical microbiology laboratory. The performance of the MALDI Biotyper system (Bruker Daltonics) was compared to those of phenotypic and genotypic identification methods for 690 routine and referred clinical isolates representing 102 genera and 225 unique species. We systematically compared direct-smear and extraction methods on a taxonomically diverse collection of isolates. The optimal score thresholds for bacterial identification were determined, and an approach to address multiple divergent results above these thresholds was evaluated. Analysis of identification scores revealed optimal species- and genus-level identification thresholds of 1.9 and 1.7, with 91.9% and 97.0% of isolates correctly identified to species and genus levels, respectively. Not surprisingly, routinely encountered isolates showed higher concordance than did uncommon isolates. The extraction method yielded higher scores than the direct-smear method for 78.3% of isolates. Incorrect species were reported in the top 10 results for 19.4% of isolates, and although there was no obvious cutoff to eliminate all of these ambiguities, a 10% score differential between the top match and additional species may be useful to limit the need for additional testing to reach single-species-level identifications.
MeSH term(s)	Bacteria/chemistry ; Bacteria/classification ; Bacteria/isolation & purification ; Bacterial Infections/diagnosis ; Bacterial Infections/microbiology ; Bacterial Typing Techniques ; Bacteriological Techniques/methods ; Humans ; Molecular Typing ; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization/methods
Language	English
Publishing date	2012-09-19
Publishing country	United States
Document type	Comparative Study ; Evaluation Study ; Journal Article
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.00626-12
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Article ; Online: First case reports of Ignatzschineria (Schineria) indica associated with myiasis.

Barker, Heather S / Snyder, James W / Hicks, Adam B / Yanoviak, Stephen P / Southern, Paul / Dhakal, Bijaya K / Ghimire, Giri R / Couturier, Marc R

Journal of clinical microbiology

2014 Volume 52, Issue 12, Page(s) 4432–4434

Abstract: We report three cases of infection due to the Gram-negative rod Ignatzschineria (Schineria) indica involving bacteremia and the urinary tract. Two cases were clearly associated with maggot infestation, and the third could conceivably have had ... ...

Abstract	We report three cases of infection due to the Gram-negative rod Ignatzschineria (Schineria) indica involving bacteremia and the urinary tract. Two cases were clearly associated with maggot infestation, and the third could conceivably have had unrecognized maggot infestation of the urinary tract. We believe these cases to be the first I. indica infections reported in association with maggot infestation and myiasis.
MeSH term(s)	Adult ; Aged ; Bacteremia/diagnosis ; Bacteremia/microbiology ; DNA, Bacterial/chemistry ; DNA, Bacterial/genetics ; DNA, Ribosomal/chemistry ; DNA, Ribosomal/genetics ; Gram-Negative Bacterial Infections/diagnosis ; Gram-Negative Bacterial Infections/microbiology ; Humans ; Male ; Middle Aged ; Myiasis/complications ; RNA, Ribosomal, 16S/genetics ; Sequence Analysis, DNA ; Urinary Tract Infections/diagnosis ; Urinary Tract Infections/microbiology ; Xanthomonadaceae/classification ; Xanthomonadaceae/genetics ; Xanthomonadaceae/isolation & purification
Chemical Substances	DNA, Bacterial ; DNA, Ribosomal ; RNA, Ribosomal, 16S
Language	English
Publishing date	2014-10-08
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.02183-14
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Article ; Online: Helicobacter pylori lipopolysaccharide is synthesized via a novel pathway with an evolutionary connection to protein N-glycosylation.

Hug, Isabelle / Couturier, Marc R / Rooker, Michelle M / Taylor, Diane E / Stein, Markus / Feldman, Mario F

PLoS pathogens

2010 Volume 6, Issue 3, Page(s) e1000819

Abstract: Lipopolysaccharide (LPS) is a major component on the surface of Gram negative bacteria and is composed of lipid A-core and the O antigen polysaccharide. O polysaccharides of the gastric pathogen Helicobacter pylori contain Lewis antigens, mimicking ... ...

Abstract	Lipopolysaccharide (LPS) is a major component on the surface of Gram negative bacteria and is composed of lipid A-core and the O antigen polysaccharide. O polysaccharides of the gastric pathogen Helicobacter pylori contain Lewis antigens, mimicking glycan structures produced by human cells. The interaction of Lewis antigens with human dendritic cells induces a modulation of the immune response, contributing to the H. pylori virulence. The amount and position of Lewis antigens in the LPS varies among H. pylori isolates, indicating an adaptation to the host. In contrast to most bacteria, the genes for H. pylori O antigen biosynthesis are spread throughout the chromosome, which likely contributed to the fact that the LPS assembly pathway remained uncharacterized. In this study, two enzymes typically involved in LPS biosynthesis were found encoded in the H. pylori genome; the initiating glycosyltransferase WecA, and the O antigen ligase WaaL. Fluorescence microscopy and analysis of LPS from H. pylori mutants revealed that WecA and WaaL are involved in LPS production. Activity of WecA was additionally demonstrated with complementation experiments in Escherichia coli. WaaL ligase activity was shown in vitro. Analysis of the H. pylori genome failed to detect a flippase typically involved in O antigen synthesis. Instead, we identified a homolog of a flippase involved in protein N-glycosylation in other bacteria, although this pathway is not present in H. pylori. This flippase named Wzk was essential for O antigen display in H. pylori and was able to transport various glycans in E. coli. Whereas the O antigen mutants showed normal swimming motility and injection of the toxin CagA into host cells, the uptake of DNA seemed to be affected. We conclude that H. pylori uses a novel LPS biosynthetic pathway, evolutionarily connected to bacterial protein N-glycosylation.
MeSH term(s)	Cell Line ; Epithelial Cells/metabolism ; Epithelial Cells/microbiology ; Escherichia coli/enzymology ; Escherichia coli/genetics ; Escherichia coli Proteins/genetics ; Escherichia coli Proteins/metabolism ; Evolution, Molecular ; Gastric Mucosa/cytology ; Glycosylation ; Glycosyltransferases/genetics ; Glycosyltransferases/metabolism ; Helicobacter pylori/enzymology ; Helicobacter pylori/genetics ; Humans ; Lewis Blood Group Antigens/metabolism ; Ligases/genetics ; Ligases/metabolism ; Lipopolysaccharides/biosynthesis ; Mutation ; O Antigens/genetics ; O Antigens/metabolism ; Peptidyl Transferases/metabolism ; Phenotype ; Phosphotransferases (Alcohol Group Acceptor)/genetics ; Phosphotransferases (Alcohol Group Acceptor)/metabolism ; Transferases (Other Substituted Phosphate Groups)/genetics ; Transferases (Other Substituted Phosphate Groups)/metabolism
Chemical Substances	Escherichia coli Proteins ; Lewis Blood Group Antigens ; Lipopolysaccharides ; O Antigens ; Peptidyl Transferases (EC 2.3.2.12) ; Glycosyltransferases (EC 2.4.-) ; Phosphotransferases (Alcohol Group Acceptor) (EC 2.7.1.-) ; WaaP protein, E coli (EC 2.7.1.-) ; Transferases (Other Substituted Phosphate Groups) (EC 2.7.8.-) ; wecA protein, E coli (EC 2.7.8.-) ; Ligases (EC 6.-)
Language	English
Publishing date	2010-03-19
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2205412-1
ISSN	1553-7374 ; 1553-7366
ISSN (online)	1553-7374
ISSN	1553-7366
DOI	10.1371/journal.ppat.1000819
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Article ; Online: Economic analysis of rapid and sensitive polymerase chain reaction testing in the emergency department for influenza infections in children.

Nelson, Richard E / Stockmann, Chris / Hersh, Adam L / Pavia, Andrew T / Korgenksi, Kent / Daly, Judy A / Couturier, Marc R / Ampofo, Krow / Thorell, Emily A / Doby, Elizabeth H / Robison, Jeff A / Blaschke, Anne J

The Pediatric infectious disease journal

2015 Volume 34, Issue 6, Page(s) 577–582

Abstract: Background: Rapid multiplex polymerase chain reaction (PCR) assays simultaneously detect several respiratory viral pathogens with high sensitivity. Maximizing detection of influenza at the point of care has the potential to reduce unnecessary antibiotic ...

Abstract	Background: Rapid multiplex polymerase chain reaction (PCR) assays simultaneously detect several respiratory viral pathogens with high sensitivity. Maximizing detection of influenza at the point of care has the potential to reduce unnecessary antibiotic use, laboratory tests and hospitalizations. However, the cost-effectiveness of rapid multiplex PCR assays for influenza has not been compared with other diagnostic methods in children. Methods: For children presenting to the emergency department with influenza-like illness, we compared costs and outcomes using 4 different testing strategies for detection of influenza: (1) a rapid multiplex PCR platform (FilmArray); (2) traditional PCR; (3) direct-fluorescent antibody and (4) rapid antigen tests. Costs were assessed from the hospital perspective, and effectiveness was defined as quality-adjusted life years (QALYs). Input parameters were obtained from previous studies, and the model was run separately for children aged 3-36 months and 3-18 years. Results: Rapid multiplex PCR testing was the most effective testing strategy for children in both age groups. The incremental cost-effectiveness when compared with rapid antigen tests was $115,556 per QALY for children aged 3-36 months and from $228,000 per QALY for children aged 3-18 years. The cost-effectiveness of rapid multiplex PCR was sensitive to estimates for influenza prevalence, the proportion of patients treated with antivirals and the cost per test. Conclusions: Our model identifies scenarios in which identification of influenza in the emergency department using rapid multiplex PCR testing is a cost-effective strategy for infants and children 3 months through 18 years. Including detection of other respiratory viruses in the analysis would further improve cost-effectiveness.
MeSH term(s)	Adolescent ; Child ; Child, Preschool ; Cost-Benefit Analysis ; Emergency Medicine/economics ; Emergency Medicine/methods ; Emergency Service, Hospital ; Female ; Humans ; Immunoassay/economics ; Immunoassay/methods ; Infant ; Influenza, Human/diagnosis ; Male ; Molecular Diagnostic Techniques/economics ; Molecular Diagnostic Techniques/methods ; Multiplex Polymerase Chain Reaction/economics ; Multiplex Polymerase Chain Reaction/methods ; Time Factors
Language	English
Publishing date	2015-06
Publishing country	United States
Document type	Comparative Study ; Evaluation Studies ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	392481-6
ISSN	1532-0987 ; 0891-3668
ISSN (online)	1532-0987
ISSN	0891-3668
DOI	10.1097/INF.0000000000000703
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Zs.A 1852: Show issues

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Article ; Online: Comparison of Shiga toxin-producing Escherichia coli detection methods using clinical stool samples.

Chui, Linda / Couturier, Marc R / Chiu, Theodore / Wang, Gehua / Olson, Adam B / McDonald, Ryan R / Antonishyn, Nick A / Horsman, Greg / Gilmour, Matthew W

The Journal of molecular diagnostics : JMD

2010 Volume 12, Issue 4, Page(s) 469–475

Abstract: Molecular diagnostic tools capable of identifying Shiga toxin-specific genetic determinants in stool specimens permit an unbiased approach to detect Shiga toxin-producing Escherichia coli (STEC) in clinical samples and can indicate when culture-based ... ...

Abstract	Molecular diagnostic tools capable of identifying Shiga toxin-specific genetic determinants in stool specimens permit an unbiased approach to detect Shiga toxin-producing Escherichia coli (STEC) in clinical samples and can indicate when culture-based isolation methods are required. It is increasingly recognized that clinically relevant STEC are not limited to the singular O157 serotypes, and therefore diagnostic assays targeting toxin-encoding determinants must be able to account for any genetic variation that exists between serotypes. In this study conventional PCR and four real-time PCR assays (HybProbe, TaqMan, SYBR Green, and LUX) targeting the stx1 and stx2 Shiga toxin coding sequences were used to identify STEC in enriched stool samples (n = 36) and a panel of O157 and non-O157 strains (n = 64). PCR assays targeting stx1 and stx2 had variable specificity and sensitivity values with enriched stool samples. Molecular assays using DNA from pure cultures revealed that some primers were not sensitive to all stx2 variants. This evaluation concluded that the TaqMan-based probes were most appropriate in high throughput clinical diagnostic laboratories in consideration of cost, turn around time, and assay performance.
MeSH term(s)	Biological Assay ; Feces/microbiology ; Humans ; Polymerase Chain Reaction/economics ; Polymerase Chain Reaction/methods ; Sensitivity and Specificity ; Shiga Toxin 1/genetics ; Shiga Toxin 2/genetics ; Shiga-Toxigenic Escherichia coli/genetics ; Shiga-Toxigenic Escherichia coli/isolation & purification ; Time Factors
Chemical Substances	Shiga Toxin 1 ; Shiga Toxin 2
Language	English
Publishing date	2010-05-13
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	2000060-1
ISSN	1943-7811 ; 1525-1578
ISSN (online)	1943-7811
ISSN	1525-1578
DOI	10.2353/jmoldx.2010.090221
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