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[PMID]:28885416
[Au] Autor:McCash SI; Goldfrank DJ; Pessin MS; Ramanathan LV
[Ad] Endereço:Departments of Laboratory Medicine and Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
[Ti] Título:Reducing False-Positive Pregnancy Test Results in Patients With Cancer.
[So] Source:Obstet Gynecol;130(4):825-829, 2017 Oct.
[Is] ISSN:1873-233X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To assess whether the use of a laboratory test specific for intact human chorionic gonadotropin (hCG) would reduce the number of false-positive pregnancy test results. METHODS: From October 21, 2014, to January 20, 2015, and April 1, 2015, to June 2, 2015, all serum samples sent for pregnancy screening at a large cancer center with a value of 5 milli-international units/mL or greater total ß-hCG were frozen and stored and then retested using intact hCG reagent. We compared the accuracy of total ß-hCG and intact hCG results for the diagnosis of clinically confirmed pregnancy. A negative test was defined as 14 milli-international units/mL or less, our current institutional cutoff. We also assessed a cutoff of less than 5 milli-international units/mL, a historical cutoff to rule out pregnancy. RESULTS: We performed intact hCG testing on 64 patient samples, of which 34 had originally resulted positive when tested for total ß-hCG. These included 21 cases of clinically confirmed pregnancy and 13 false-positive cases. No women were pregnant when their intact hCG concentration was 14 milli-international units/mL or less, and all pregnancies were detected at and above this concentration. Intact hCG reduced the number of false-positive pregnancy test results from 13 to 1, a 92% reduction (95% CI 64-99%), corresponding to a reduction in the false-positive rate from 38% (95% CI 22-56%) to 3% (95% CI 1-15%). CONCLUSION: The use of intact hCG reagent in patients with cancer reduces the rate of false-positive pregnancy test results without increasing the rate of false-negative test results.
[Mh] Termos MeSH primário: Biomarcadores Tumorais/sangue
Gonadotropina Coriônica Humana Subunidade beta/sangue
Neoplasias
Testes Imunológicos de Gravidez
[Mh] Termos MeSH secundário: Adolescente
Adulto
Reações Falso-Positivas
Feminino
Seres Humanos
Meia-Idade
Valor Preditivo dos Testes
Gravidez
Adulto Jovem
[Pt] Tipo de publicação:EVALUATION STUDIES; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biomarkers, Tumor); 0 (Chorionic Gonadotropin, beta Subunit, Human)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171002
[Lr] Data última revisão:
171002
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170909
[St] Status:MEDLINE
[do] DOI:10.1097/AOG.0000000000002244


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[PMID]:27454808
[Au] Autor:Kricka LJ
[Ad] Endereço:a Department of Pathology and Laboratory Medicine , University of Pennsylvania Medical Center , Philadelphia , PA , USA.
[Ti] Título:Quality assurance for multiplexed assays - how can it be achieved?
[So] Source:Scand J Clin Lab Invest Suppl;245:S100-3, 2016.
[Is] ISSN:2166-1030
[Cp] País de publicação:Norway
[La] Idioma:eng
[Ab] Resumo:Multiplexed assays are now a common form of analysis in routine clinical and research laboratories. Assuring the quality of this type of complex, massively-parallel testing poses challenges not encountered in the traditional single-plex assay. A range of quality assurance measures is implemented at different stages in a multiplex assay, beginning in the manufacturing process, and the ensuing analytical and data interpretation stages. This article explores quality issues and the quality assurance measures that have been devised for multiplex assays ranging from simple two-plex assays to the types of assays that involve simultaneous testing on millions of test sites on a single analytical device.
[Mh] Termos MeSH primário: Testes Genéticos/normas
Sequenciamento de Nucleotídeos em Larga Escala/normas
Ensaios de Triagem em Larga Escala/normas
Ensaio de Proficiência Laboratorial/normas
Controle de Qualidade
[Mh] Termos MeSH secundário: Algoritmos
Feminino
Testes Genéticos/instrumentação
Testes Genéticos/métodos
Seres Humanos
Hipersensibilidade/sangue
Hipersensibilidade/diagnóstico
Masculino
Gravidez
Testes Imunológicos de Gravidez/normas
Reprodutibilidade dos Testes
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170322
[Lr] Data última revisão:
170322
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160726
[St] Status:MEDLINE
[do] DOI:10.1080/00365513.2016.1210335


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[PMID]:27429695
[Au] Autor:Gottlieb M; Wnek K; Moskoff J; Christian E; Bailitz J
[Ad] Endereço:John H. Stroger Hospital of Cook County, Department of Emergency Medicine, Chicago, Illinois.
[Ti] Título:Comparison of Result Times Between Urine and Whole Blood Point-of-care Pregnancy Testing.
[So] Source:West J Emerg Med;17(4):449-53, 2016 Jul.
[Is] ISSN:1936-9018
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Point-of-care (POC) pregnancy testing is commonly performed in the emergency department (ED). One prior study demonstrated equivalent accuracy between urine and whole blood for one common brand of POC pregnancy testing. Our study sought to determine the difference in result times when comparing whole blood versus urine for the same brand of POC pregnancy testing. METHODS: We conducted a prospective, observational study at an urban, academic, tertiary care hospital comparing the turnaround time between order and result for urine and whole blood pregnancy tests collected according to standard protocol without intervention from the investigators. After the blood was collected, the nurse would place three drops onto a Beckman Coulter ICON 25 Rapid HCG bedside pregnancy test and set a timer for 10 minutes. At the end of the 10 minutes, the result and time were recorded on an encoded data sheet and not used clinically. The same make and model analyzer was also used for urine tests in the lab located within the ED. The primary outcome was the difference in mean turnaround time between whole blood in the ED and urine testing in the adjacent lab results. Concordance between samples was assessed as a secondary outcome. RESULTS: 265 total patients were included in the study. The use of whole blood resulted in a mean time savings of 21 minutes (95% CI 16-25 minutes) when compared with urine (p<0.001). There was 99.6% concordance between results, with one false negative urine specimen with a quantitative HCG level of 81 mIU/L. CONCLUSION: Our results suggest that the use of whole blood in place of urine for bedside pregnancy testing may reduce the total result turnaround time without significant changes in accuracy in this single-center study.
[Mh] Termos MeSH primário: Gonadotropina Coriônica/sangue
Gonadotropina Coriônica/urina
Serviço Hospitalar de Emergência
Testes Imediatos
Testes Imunológicos de Gravidez/métodos
[Mh] Termos MeSH secundário: Adolescente
Adulto
Feminino
Seres Humanos
Laboratórios Hospitalares
Meia-Idade
Testes Imediatos/normas
Testes Imediatos/tendências
Valor Preditivo dos Testes
Gravidez
Estudos Prospectivos
Kit de Reagentes para Diagnóstico
Sensibilidade e Especificidade
Fatores de Tempo
Estados Unidos
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Chorionic Gonadotropin); 0 (Reagent Kits, Diagnostic)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170807
[Lr] Data última revisão:
170807
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160719
[St] Status:MEDLINE
[do] DOI:10.5811/westjem.2016.5.29989


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[PMID]:27388394
[Au] Autor:Shah K; Maghsoudlou P
[Ad] Endereço:Academic Foundation Doctor in the Department of Orthopaedics, Oxford University Clinical Academic Graduate School and Oxford University Hospitals, Oxford.
[Ti] Título:Enzyme-linked immunosorbent assay (ELISA): the basics.
[So] Source:Br J Hosp Med (Lond);77(7):C98-101, 2016 Jul.
[Is] ISSN:1750-8460
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Ensaio de Imunoadsorção Enzimática
[Mh] Termos MeSH secundário: Reações Cruzadas
Infecções por HIV/diagnóstico
Hepatite B/diagnóstico
Seres Humanos
Malária/diagnóstico
Testes Imediatos
Testes Imunológicos de Gravidez
Sensibilidade e Especificidade
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1609
[Cu] Atualização por classe:160708
[Lr] Data última revisão:
160708
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160709
[St] Status:MEDLINE
[do] DOI:10.12968/hmed.2016.77.7.C98


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[PMID]:26122608
[Au] Autor:Wong JX; Li X; Liu FS; Yu HZ
[Ad] Endereço:Department of Chemistry, Simon Fraser University, 8888 University Drive, Burnaby, British Columbia V5A 1S6, Canada.
[Ti] Título:Direct Reading of Bona Fide Barcode Assays for Diagnostics with Smartphone Apps.
[So] Source:Sci Rep;5:11727, 2015 Jun 30.
[Is] ISSN:2045-2322
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:The desire to develop new point-of-care (POC) diagnostic tools has led to the adaptation of smartphones to tackle limitations in state-of-the-art instrumentation and centralized laboratory facilities. Today's smartphones possess the computer-like ability to image and process data using mobile apps; barcode scanners are one such type of apps. We demonstrate herein that a diagnostic assay can be performed by patterning immunoassay strips in a bona fide barcode format such that after target binding and signal enhancement, the linear barcode can be read directly with a standard smartphone app. Quantitative analysis can then be performed based on the grayscale intensities with a customized mobile app. This novel diagnostic concept has been validated for a real-world application, i.e., the detection of human chorionic gonadotropin, a pregnancy hormone. With the possibility of multiplex detection, the barcode assay protocol promises to boost POC diagnosis research by the direct adaptation of mobile devices and apps.
[Mh] Termos MeSH primário: Aplicativos Móveis
Sistemas Automatizados de Assistência Junto ao Leito
Smartphone
[Mh] Termos MeSH secundário: Processamento Automatizado de Dados
Gonadotropina Coriônica/urina
Computadores de Mão
Feminino
Seres Humanos
Gravidez
Testes Imunológicos de Gravidez
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Chorionic Gonadotropin)
[Em] Mês de entrada:1607
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150701
[St] Status:MEDLINE
[do] DOI:10.1038/srep11727


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[PMID]:25848265
[Au] Autor:Chen CY; Hwu YM; Chen CP; Chang CC
[Ad] Endereço:Department of Medicine, Mackay Medical College, New Taipei City, Taiwan ; Department of Obstetrics and Gynecology, Mackay Memorial Hospital, Taipei, Taiwan ; Mackay Junior College of Medicine, Nursing, and Management, Taipei, Taiwan.
[Ti] Título:Quantitative analysis of total ß-subunit of human chorionic gonadotropin concentration in urine by immunomagnetic reduction to assist in the diagnosis of ectopic pregnancy.
[So] Source:Int J Nanomedicine;10:2475-83, 2015.
[Is] ISSN:1178-2013
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The initial diagnosis of ectopic pregnancy depends on physical examination, ultrasound, and serial measurements of total ß-subunit of human chorionic gonadotropin (hCGß) concentrations in serum. The aim of this study was to explore the possibility of using quantitative analysis of total hCGß in urine rather than in serum by immunomagnetic reduction (IMR) assay as an alternative method to diagnose an ectopic pregnancy. METHODS: We established a standard calibration curve of IMR intensity against total hCGß concentration based on standard hCGß samples, and used an IMR assay to detect total hCGß concentrations in the urine of pregnant women with lower abdominal pain and/or vaginal bleeding. The final diagnosis of ectopic pregnancy was based on ultrasound scans, operative findings, and pathology reports. In this prospective study, ten clinical samples were used to analyze the relationship of total hCGß IMR signals between urine and serum. Furthermore, 20 clinical samples were used to analyze the relationship between urine IMR signals and serum levels of total hCGß. RESULTS: The calibration curve extended from 0.01 ng/mL to 10,000 ng/mL with an excellent correlation (R(2)=0.999). In addition, an excellent correlation of total hCGß IMR signals between urine and serum was noted (R(2)=0.994). Furthermore, a high correlation between urine IMR signals and serum levels of total hCGß was noted (R(2)=0.862). CONCLUSION: An IMR assay can quantitatively analyze total hCGß concentrations in urine, and is a potential candidate for point-of-care testing to assist in the diagnosis of ectopic pregnancy.
[Mh] Termos MeSH primário: Gonadotropina Coriônica Humana Subunidade beta/urina
Separação Imunomagnética/métodos
Testes Imunológicos de Gravidez/métodos
Gravidez Ectópica/diagnóstico
[Mh] Termos MeSH secundário: Calibragem
Feminino
Seres Humanos
Gravidez
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Chorionic Gonadotropin, beta Subunit, Human)
[Em] Mês de entrada:1605
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150408
[St] Status:MEDLINE
[do] DOI:10.2147/IJN.S81201


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[PMID]:24788076
[Au] Autor:Cowsill BJ; Zhao X; Waigh TA; Eapen S; Davies R; Laux V; Haertlein M; Forsyth VT; Lu JR
[Ad] Endereço:Biological Physics Group, School of Physics and Astronomy, The University of Manchester , Schuster Building, Manchester M13 9PL, U.K.
[Ti] Título:Interfacial structure of immobilized antibodies and perdeuterated HSA in model pregnancy tests measured with neutron reflectivity.
[So] Source:Langmuir;30(20):5880-7, 2014 May 27.
[Is] ISSN:1520-5827
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Experimental studies of antibody adsorption and antigen binding that mimicked pregnancy test immunoassays have been performed using neutron reflectivity studies of a model antibody/antigen system immobilized on the silica/water interface. The study revealed the nature of the antibody/antigen interaction and also the importance of a blocking protein, in this case human serum albumin (HSA), that enhances the immunoassay's specificity and efficiency. Of central importance to this study has been the use of a perdeuterated human serum albumin (d-HSA), providing contrast that highlights the orientation and position of the blocking agent within the adsorbed layer. It was found that the adsorbed HSA filled the gaps between the preadsorbed antibodies on the substrate, with decreased adsorption occurring as a function of increased antibody surface coverage. In addition, the antigen binding capacity of the adsorbed antibodies was investigated as a function of antibody surface coverage. The amount of specifically bound antigen was found to saturate at approximately 0.17 mg/m(2) and became independent of the antibody surface coverage. The ratio of bound antigen to immobilized antibody decreased with increased antibody surface coverage. These results are of importance for a full understanding of immunoassay systems that are widely used in clinical tests and in the detection of environmental contaminants.
[Mh] Termos MeSH primário: Anticorpos/química
Modelos Químicos
Testes Imunológicos de Gravidez
Albumina Sérica/química
[Mh] Termos MeSH secundário: Feminino
Seres Humanos
Gravidez
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Antibodies); 0 (Serum Albumin)
[Em] Mês de entrada:1504
[Cu] Atualização por classe:140527
[Lr] Data última revisão:
140527
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:140503
[St] Status:MEDLINE
[do] DOI:10.1021/la4036166


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[PMID]:23778026
[Au] Autor:Terwijn M; van Schie A; Blankenstein MA; Heijboer AC
[Ad] Endereço:Department of Clinical Chemistry, VU University Medical Center, Amsterdam, The Netherlands.
[Ti] Título:Pregnancy detection by quantitative urine hCG analysis: the need for a lower cut-off.
[So] Source:Clin Chim Acta;424:174, 2013 Sep 23.
[Is] ISSN:1873-3492
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Mh] Termos MeSH primário: Gonadotropina Coriônica/urina
Testes Imunológicos de Gravidez/normas
[Mh] Termos MeSH secundário: Feminino
Seres Humanos
Limite de Detecção
Gravidez
Adulto Jovem
[Pt] Tipo de publicação:CASE REPORTS; LETTER
[Nm] Nome de substância:
0 (Chorionic Gonadotropin)
[Em] Mês de entrada:1404
[Cu] Atualização por classe:130909
[Lr] Data última revisão:
130909
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:130620
[St] Status:MEDLINE


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[PMID]:23634647
[Au] Autor:Barbato O; Melo de Sousa N; Barile VL; Canali C; Beckers JF
[Ad] Endereço:Department of Biopathological Veterinary Science, Faculty of Veterinary Medicine, University of Perugia, Perugia, 06126, Italy. barbato@unipg.it
[Ti] Título:Purification of pregnancy-associated glycoproteins from late-pregnancy Bubalus bubalis placentas and development of a radioimmunoassay for pregnancy diagnosis in water buffalo females.
[So] Source:BMC Vet Res;9:89, 2013 May 01.
[Is] ISSN:1746-6148
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Pregnancy-associated glycoproteins (PAGs) were first described as placental antigens present in the blood serum of the mother soon after implantation. Here, we describe the purification of several pregnancy-associated glycoproteins from water buffalo placenta (wbPAGs). A specific radioimmunoassay (RIA) was developed for early pregnancy diagnosis in buffalo species. RESULTS: Amino-terminal microsequencing of immunoreactive placental proteins allowed the identification of eleven wbPAGs sequences [Swiss-Prot accession numbers: P86369 to P86379]. Three polyclonal antisera (AS#858, AS#859 and AS#860) were raised in rabbits against distinct wbPAG fractions. A new RIA (RIA-860) was developed and used to distinguish between pregnant (n=33) and non-pregnant (n=26) water buffalo females. CONCLUSIONS: Our results confirmed the multiplicity of PAG expression in buffalo placenta. In addition, the RIA-860 system was shown to be sensitive, linear, reproducible, accurate and specific in measuring PAG concentrations in buffalo plasma samples from Day 37 of gestation onwards.
[Mh] Termos MeSH primário: Búfalos/metabolismo
Glicoproteínas/isolamento & purificação
Placenta/química
Proteínas da Gravidez/isolamento & purificação
Testes Imunológicos de Gravidez/veterinária
Radioimunoensaio/veterinária
[Mh] Termos MeSH secundário: Sequência de Aminoácidos
Animais
Sequência de Bases
Feminino
Glicoproteínas/sangue
Glicoproteínas/imunologia
Soros Imunes/imunologia
Dados de Sequência Molecular
Gravidez
Proteínas da Gravidez/sangue
Proteínas da Gravidez/imunologia
Testes Imunológicos de Gravidez/métodos
Coelhos/imunologia
Radioimunoensaio/métodos
Reprodutibilidade dos Testes
Sensibilidade e Especificidade
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Glycoproteins); 0 (Immune Sera); 0 (Pregnancy Proteins)
[Em] Mês de entrada:1312
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:130503
[St] Status:MEDLINE
[do] DOI:10.1186/1746-6148-9-89


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[PMID]:21875776
[Au] Autor:Fromm C; Likourezos A; Haines L; Khan AN; Williams J; Berezow J
[Ad] Endereço:Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY 11209, USA.
[Ti] Título:Substituting whole blood for urine in a bedside pregnancy test.
[So] Source:J Emerg Med;43(3):478-82, 2012 Sep.
[Is] ISSN:0736-4679
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Point-of-care testing for rapid detection of pregnancy in women of reproductive age is common practice in the emergency department. Commercially available rapid human chorionic gonadotropin (hCG) immunoassays are validated for use with urine and serum, but not whole blood. STUDY OBJECTIVES: We assessed the validity of using whole blood to detect pregnancy using a point-of-care hCG assay by comparing it to a laboratory quantitative serum hCG assay as the criterion standard. METHODS: A convenience sample of female patients of reproductive age (18-51 years) submitted 5mL of whole blood, from which two drops were immediately applied to a point-of-care hCG kit, with results recorded at 10min. The remainder of each whole blood specimen was sent to the hospital laboratory for the criterion-standard quantitative serum hCG assay. The criterion standard for a positive pregnancy test was defined as quantitative serum hCG≥5 mIU/mL. Investigators performing the whole blood test and laboratory technicians performing the quantitative serum assay were blinded to one another's results. RESULTS: There were 633 patients enrolled, with a mean age of 30 years (± 7.7 years); 34% of the patients were pregnant. Overall, the whole blood pregnancy test was 95.8% sensitive (negative predictive value 97.9%), whereas the urine test was 95.3% sensitive (negative predictive value 97.6%); the specificity and positive predictive value of both tests was 100%. CONCLUSION: Using a standard point-of-care qualitative hCG immunoassay kit, whole blood may be used for rapid detection of pregnancy with similar, or greater, accuracy than urine.
[Mh] Termos MeSH primário: Gonadotropina Coriônica/sangue
Sistemas Automatizados de Assistência Junto ao Leito
Testes Imunológicos de Gravidez/métodos
Kit de Reagentes para Diagnóstico
[Mh] Termos MeSH secundário: Adolescente
Adulto
Serviço Hospitalar de Emergência
Feminino
Seres Humanos
Laboratórios Hospitalares
Meia-Idade
Valor Preditivo dos Testes
Gravidez
Estudos Prospectivos
Sensibilidade e Especificidade
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T; VALIDATION STUDIES
[Nm] Nome de substância:
0 (Chorionic Gonadotropin); 0 (Reagent Kits, Diagnostic)
[Em] Mês de entrada:1302
[Cu] Atualização por classe:120911
[Lr] Data última revisão:
120911
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:110831
[St] Status:MEDLINE
[do] DOI:10.1016/j.jemermed.2011.05.028



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