SeptiFast for diagnosis of sepsis in severely ill patients from a Brazilian hospital

Sitnik, Roberta; Marra, Alexandre R.; Petroni, Roberta Cardoso; Ramos, Ozires; Martino, Marinês Dalla Valle; Pasternak, Jacyr; Santos, Oscar Fernando Pavão dos; Mangueira, Cristóvão Luis Pitangueira; Pinho, João Renato Rebello

doi:10.1590/s1679-45082014ao2932

Cited by 13 publications

(12 citation statements)

References 29 publications

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“…45,69,[71][72][73][74][75][76][77][78][80][81][82][83][85][86][87][90][91][92][93][94][96][97][98][99][101][102][103]107,[109][110][111][112]114 Of these, nine studies reported blood volumes that did not comply with CE approval: Lehmann et al, 76 Lodes et al 92 and von Lilienfeld-Toal et al 71 all reported using 1 ml in adults; Bloos et al, 74 Lamoth et al, 75 Paolucci et al 99 and Sitnik et al 107 all reported using 3 ml in adults; Berger et al…”

Section: Details Of Index and Reference Tests Blood Sampling Methodsmentioning

confidence: 99%

“…Twenty-one SeptiFast studies reported data on the time to availability of results/pathogen identification. [44][45][46]59,60,64,68,69,77,80,81,85,88,93,96,97,101,106,107,110,112 However, for the majority of these studies, it was unclear if the value was the mean or median, and variance estimates or ranges were not reported. Across these studies, the reported time to pathogen identification with SeptiFast ranged from 4 hours 68 to a median of 26.25 hours [range 6.75-79 hours (for samples collected at beginning of a weekend)].…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…Across the remaining SeptiFast studies, 19 reported using the BACTEC system. 60,64,70,71,75,76,79,83,[85][86][87][92][93][94][95][96]107,110,112 Of these, one used the BACTEC system with MALDI-TOF MS. 112 Seventeen studies reported using the BacT/ALERT system. 45 70,75,83,99,109 For the remainder of the studies evaluating SeptiFast against blood culture (with or without MALDI-TOF MS) the unit of analysis was samples.…”

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Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi – a systematic review and economic evaluation

Stevenson

Pandor

James

et al. 2016

Health Technol Assess

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BackgroundSepsis can lead to multiple organ failure and death. Timely and appropriate treatment can reduce in-hospital mortality and morbidity.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of three tests [LightCycler SeptiFast Test MGRADE®(Roche Diagnostics, Risch-Rotkreuz, Switzerland); SepsiTestTM(Molzym Molecular Diagnostics, Bremen, Germany); and the IRIDICA BAC BSI assay (Abbott Diagnostics, Lake Forest, IL, USA)] for the rapid identification of bloodstream bacteria and fungi in patients with suspected sepsis compared with standard practice (blood culture with or without matrix-absorbed laser desorption/ionisation time-of-flight mass spectrometry).Data sourcesThirteen electronic databases (including MEDLINE, EMBASE and The Cochrane Library) were searched from January 2006 to May 2015 and supplemented by hand-searching relevant articles.Review methodsA systematic review and meta-analysis of effectiveness studies were conducted. A review of published economic analyses was undertaken and a de novo health economic model was constructed. A decision tree was used to estimate the costs and quality-adjusted life-years (QALYs) associated with each test; all other parameters were estimated from published sources. The model was populated with evidence from the systematic review or individual studies, if this was considered more appropriate (base case 1). In a secondary analysis, estimates (based on experience and opinion) from seven clinicians regarding the benefits of earlier test results were sought (base case 2). A NHS and Personal Social Services perspective was taken, and costs and benefits were discounted at 3.5% per annum. Scenario analyses were used to assess uncertainty.ResultsFor the review of diagnostic test accuracy, 62 studies of varying methodological quality were included. A meta-analysis of 54 studies comparing SeptiFast with blood culture found that SeptiFast had an estimated summary specificity of 0.86 [95% credible interval (CrI) 0.84 to 0.89] and sensitivity of 0.65 (95% CrI 0.60 to 0.71). Four studies comparing SepsiTest with blood culture found that SepsiTest had an estimated summary specificity of 0.86 (95% CrI 0.78 to 0.92) and sensitivity of 0.48 (95% CrI 0.21 to 0.74), and four studies comparing IRIDICA with blood culture found that IRIDICA had an estimated summary specificity of 0.84 (95% CrI 0.71 to 0.92) and sensitivity of 0.81 (95% CrI 0.69 to 0.90). Owing to the deficiencies in study quality for all interventions, diagnostic accuracy data should be treated with caution. No randomised clinical trial evidence was identified that indicated that any of the tests significantly improved key patient outcomes, such as mortality or duration in an intensive care unit or hospital. Base case 1 estimated that none of the three tests provided a benefit to patients compared with standard practice and thus all tests were dominated. In contrast, in base case 2 it was estimated that all cost per QALY-gained values were below £20,000; the IRIDICA BAC BSI assay had the highest estimated incremental net benefit, but results from base case 2 should be treated with caution as these are not evidence based.LimitationsRobust data to accurately assess the clinical effectiveness and cost-effectiveness of the interventions are currently unavailable.ConclusionsThe clinical effectiveness and cost-effectiveness of the interventions cannot be reliably determined with the current evidence base. Appropriate studies, which allow information from the tests to be implemented in clinical practice, are required.Study registrationThis study is registered as PROSPERO CRD42015016724.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Details Of Index and Reference Tests Blood Sampling Methodsmentioning

confidence: 99%

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

mentioning

confidence: 99%

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Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi – a systematic review and economic evaluation

Stevenson

Pandor

James

et al. 2016

Health Technol Assess

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“…Como a doença é uma das maiores causas de mortalidade no mundo, com incidência estimada de até 19 milhões de pessoas por ano (GUIDO et al, 2016), consequentemente, é um dos principais problemas de saúde pública (TORIO; ANDREWS, 2013). De modo geral, possui alta mortalidade no Brasil, alcançando quase 60% dos casos, enquanto a média mundial está em torno de 30% (SITNIK et al, 2014;SIQUEIRA-BATISTA et al, 2011).…”

Section: Introductionunclassified

Sepse Em Unidade De Terapia Intensiva Em Um Hospital Público: Estudo Da Prevalência, Critérios Diagnósticos, Fatores De Risco E Mortalidade

Ribeiro¹,

Pires²

2018

PIC

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A sepse é uma condição clínica resultante de uma desregulada resposta inflamatória a uma infecção, sendo a principal causa de morte em UTIs, com mortalidade alcançando 67,4% no Brasil. Os patógenos mais envolvidos são: bacilos gram-negativos (Klebsiella spp. e Pseudomonas aeruginosa) e cocos gram-positivos (principalmente Staphylococci), sendo que, a depender da bactéria, o prognóstico dos pacientes é alterado. Os principais fatores de risco para a doença são a presença de comorbidades, como diabetes mellitus, população idosa e o longo tempo de internação. Em relação aos critérios e definições para sepse, estes sofreram consideráveis revisões, sendo que a última foi em 2016 com a publicação do “Sepsis 3”. Segundo o Instituto Latino Americano da Sepse (ILAS), os novos conceitos não se aplicam à realidade brasileira, que possui baixa sensibilidade diagnóstica. A partir disso, o trabalho teve como objetivo investigar as características clínicas e diagnósticas, microbiológicas e epidemiológicas de pacientes com o diagnóstico de sepse internados na UTI do Hospital Regional da Asa Norte (HRAN). Os critérios de inclusão foram: pacientes admitidos na UTI do HRAN, internados por 24 horas ou mais com diagnóstico de sepse em 2017. Foram excluídos: pacientes sem diagnóstico de sepse. Os dados foram tabulados no programa Excel e analisados no Statistical Package of Social Science (SPSS) versão 20.0. Os resultados foram apresentados de forma descritiva adotando-se números absolutos e porcentagens. No estudo, 81 pacientes preencheram os critérios de inclusão. Na amostra, 49 pacientes eram do sexo masculino (60,49%) e 32 do sexo feminino (39,50%). A média de idade foi de 56 anos. A mortalidade foi de 58,02% (47 óbitos), sendo que, dentre os óbitos, 65,95% eram do sexo masculino e 34,04% do sexo feminino. Em relação ao foco infeccioso, os 3 sítios mais incidentes foram: respiratório (45,67%), abdominal (24,69%) e urinário (8,64%). Em relação à identificação do patógeno, 75,30% tiveram diagnóstico etiológico indeterminado, e, dentre as bactérias identificadas, Pseudomonas spp. (6,17%), Klebsiella spp. (3,70%) e Staphylococcus aureus (2,47%) foram as mais incidentes. Em relação a comorbidades, as mais prevalentes foram a Hipertensão Arterial Sistêmica (43,20%), Diabetes Mellitus (33,33%) e Doença Renal Crônica (6,172%). Em relação à análise estatística do impacto da idade na mortalidade, foi evidenciado em nosso estudo que os idosos morrem significativamente mais por sepse que os não idosos. Quando se avalia a chance de sobreviver é 3,08 vezes maior nos mais jovens ou a razão de prevalência é de 0,63, ou seja, ser mais jovem atua como um fator de proteção, sendo o valor de p = 0,016. Com o estudo, pôde-se observar que a sepse ainda apresenta alta mortalidade em UTI, o que corrobora com outros estudos acerca do tema, além da identificação de fatores de risco (como idade e comorbidades), que estão associados a mau prognóstico. Os focos infecciosos mais incidente foram congruentes com a literatura: pulmonar, abdominal e urinário

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“…The detection of the pathogen by this molecular diagnostic tool permits the rapid diagnosis of bacteremia/ fungemia and an earlier administration of appropriate antibiotic therapy. 112,113 The detection limit is 100 CFU/mL for Candida glabrata, Streptococcus spp., and coagulase-negative Staphylococcus, and ranges from 3 to 30 for the others, depending on the infective agent. 114 Limitations include its high cost (150-200 € per test), trained personnel requirement, and lack of information on antibiotic sensitivity.…”

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confidence: 99%

In vitro diagnosis of sepsis: a review

Marcello

Tumolo²,

Donno³

et al. 2016

PLMI

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Sepsis, severe sepsis and septic shock, systemic inflammatory response, and other related manifestations represent a relevant medical problem with high morbidity and mortality, despite the improvements in diagnosis, treatment, and preventive measures over the last few decades. The limited knowledge of the pathophysiology in association with the lack of in vitro diagnostic methods for the certain and quick determination of the causative microbiological agents and their antibiotic resistance means the condition is still critical and of high impact in health care. The current gold standard method to detect the sepsis-causing pathogens, which is based on blood culture, is still insufficiently sensitive and slow. The new culture-independent molecular biology-based techniques can lead to the identification of a broad range of microorganisms and resistance markers within a few hours and with high sensitivity and specificity; nevertheless, limitations of, for example, the polymerase chain reaction-based methods still hamper their application in the clinical routine. This review summarizes the in vitro diagnostic methods and their approach in the clinical diagnosis of the bloodstream infections, and explores their advantages and disadvantages at the current state of the art. A quick analysis of the future prospective in multiplex technologies for microbiological diagnosis of sepsis is also provided.

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SeptiFast for diagnosis of sepsis in severely ill patients from a Brazilian hospital

Cited by 13 publications

References 29 publications

Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi – a systematic review and economic evaluation

Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi – a systematic review and economic evaluation

Sepse Em Unidade De Terapia Intensiva Em Um Hospital Público: Estudo Da Prevalência, Critérios Diagnósticos, Fatores De Risco E Mortalidade

In vitro diagnosis of sepsis: a review

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