LightCycler SeptiFast assay as a tool for the rapid diagnosis of sepsis in patients during antimicrobial therapy

Vince, Adriana; Lepej, Snježana Židovec; Baršić, Bruno; Dušek, Davorka; Mitrović, Zdravko; Serventi‐Seiwerth, Ranka; Labar, Boris

doi:10.1099/jmm.0.47797-0

Cited by 53 publications

(35 citation statements)

References 5 publications

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“…However, it is acknowledged that culture remains of importance to isolate other species, such as anaerobic bacteria, HACEK group bacteria and other rarely isolated organisms. Of course, culture is also required to test the isolates for antimicrobial susceptibility, as SF can only detect meticillin resistance in the case of specimens positive for S. aureus or CoNS (Vince et al, 2008).…”

Section: Discussionmentioning

confidence: 99%

“…The targets for amplification are the internal transcribed sequences between the bacterial 16S and 23S genes, and the fungal 18S and 5.6S rRNA genes (Lehmann et al, 2008). In several studies it has been demonstrated that this test can be more sensitive than blood culture for the diagnosis of sepsis in different settings (Mancini et al, 2008;Yanagihara et al, 2010), especially in patients already receiving antibiotics (Vince et al, 2008). Moreover, in nonsepsis infections, such as bacterial endocarditis, joint or other deep infections, it is often difficult to isolate bacterial agents from clinical specimens, especially if patients undergo antibiotic treatment.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of conventional culture with SeptiFast real-time PCR for microbial pathogen detection in clinical specimens other than blood

Mencacci

Leli

Cardaccia

et al. 2011

Journal of Medical Microbiology

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Early detection of aetiological agents is pivotal for adequate therapy for bacterial infections. Although culture is still considered the mainstay for laboratory diagnosis, it often lacks sensitivity, especially in patients already treated with antibiotics. The present study investigated the potential clinical utility of the commercial real-time-PCR-based system SeptiFast (SF), originally intended for diagnosis of sepsis from blood specimens, in the aetiological diagnosis of other bacterial infections, in patients undergoing antibiotic therapy. A total of 53 non-blood specimens were analysed for microbial pathogen detection by conventional culture and with SF real-time PCR: 19 (35.8 %) synovial fluids, 9 (17.0 %) cardiac valve tissues and 25 (47.2 %) purulent exudates from various body sites. Overall, the number of specimens positive for a pathogen by SF (26/53; 49.1 %) was significantly greater (P50.001) than that of specimens positive by culture (10/53; 18.9 %). In particular, SF was superior to culture for pathogen detection in cardiac valve tissues and synovial fluids. The analysis of concordance showed a fair agreement between the two methods (kappa value50.314; 95 % confidence interval50.531-0.097). Even with the limitation of the low number of specimens, this study confirmed the great potential of diagnosing bacterial infections by a molecular approach, and indicates that the real-time PCR SF system can be used for specimens other than blood, from patients undergoing antibiotic treatment.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of conventional culture with SeptiFast real-time PCR for microbial pathogen detection in clinical specimens other than blood

Mencacci

Leli

Cardaccia

et al. 2011

Journal of Medical Microbiology

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“…Based on comparison of models with and without covariates for an age category, there was no evidence that sensitivity and specificity was affected by the age of the subjects (see Appendix 5). l People exposed to antibiotics prior to blood sample collection The proportion of patients receiving antibiotics prior to blood draw was recorded in 24 studies 24,62,64,65,68,70,71,74,77,80,83,[90][91][92][93][94][97][98][99]104,106,110,111,119 and ranged from 0% to 100% with a median of 72%. The remaining studies either did not report prior exposure to antibiotics or provided only limited information and were, therefore, excluded from the analysis.…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

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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“…The SF system has been shown to be superior to BC in antimicrobial pre-treated patients with sepsis (Vince et al, 2008). In IE patients, Casalta et al (2009) found that the SF system detected an aetiological agent in three out of 20 patients with negative BC due to antibiotic pretreatment.…”

mentioning

confidence: 99%

Diagnosis of infective endocarditis: comparison of the LightCycler SeptiFast real-time PCR with blood culture

Mencacci

Leli

Montagna

et al. 2012

Journal of Medical Microbiology

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LightCycler SeptiFast assay as a tool for the rapid diagnosis of sepsis in patients during antimicrobial therapy

Cited by 53 publications

References 5 publications

Comparison of conventional culture with SeptiFast real-time PCR for microbial pathogen detection in clinical specimens other than blood

Comparison of conventional culture with SeptiFast real-time PCR for microbial pathogen detection in clinical specimens other than blood

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

Diagnosis of infective endocarditis: comparison of the LightCycler SeptiFast real-time PCR with blood culture

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