Results and Relevance of Molecular Detection of Pathogens by SeptiFast – A Retrospective Analysis in 75 Critically Ill Children

Tschiedel, Eva; Steinmann, Joerg; Buer, Jan; Jg, Onnebrink; Felderhoff-Müser, Ursula; Pm, Rath; Dohna-Schwake, Christian

doi:10.1055/s-0031-1285878

Cited by 24 publications

(25 citation statements)

References 7 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%

“…Six of the SeptiFast studies 70,85,93,96,99,111 included both adults and children, two included children and neonates 86,109 and one included children and infants. 105 Three SeptiFast studies 69,73,98 and one IRIDICA study 115 included neonates and infants, and one SepsiTest study included adults and children.…”

Section: Patient Characteristics Of Included Studiesmentioning

confidence: 99%

“…112 93 Pasqualini (2012) 94 Rath (2012) 95 Tschiedel (2012) 96 Herne (2013) 97 Kasper (2013) 98 Leitner ( …”

Section: Assessment Of Clinical Effectivenessunclassified

“…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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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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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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