A prospective multicenter evaluation of direct molecular detection of blood stream infection from a clinical perspective

Nieman, An-Emmie; Savelkoul, Paul H. M.; Beishuizen, A.; Henrich, Birgit; Lamik, Birgit; MacKenzie, Colin R.; Kindgen‐Milles, Detlef; Helmers, Andrew; Díaz, Carlos Augusto Rincón; Sakka, Samir G.; Schade, Rogier P.

doi:10.1186/s12879-016-1646-4

Cited by 34 publications

(24 citation statements)

References 38 publications

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“…In addition, fastidious or noncultivable organisms (such as Coxiella burnetii, Tropheryma whipplei, and Rickettsia species) do not grow in routine blood cultures, often evading detection. Also, there are inherent delays in the time to identification of pathogens related to the time to growth in currently used systems (31). There is therefore an unmet need for the rapid identification of pathogens directly from blood without incurring the time loss associated with culture-based methods.…”

Section: Detection Of Pathogens Directly From Bloodmentioning

confidence: 99%

“…The negative predictive value of this assay was 99.4% in a population with a 6% prevalence of Candida infection (33). In addition to panel-based diagnostics, other methods, such as 16S and 18S rRNA gene PCR/ sequencing and metagenomic shotgun sequencing, are being developed and evaluated for the detection of pathogens in blood (31).…”

Section: Detection Of Pathogens Directly From Bloodmentioning

confidence: 99%

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Syndromic Panel-Based Testing in Clinical Microbiology

et al. 2018

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The recent development of commercial panel-based molecular diagnostics for the rapid detection of pathogens in positive blood culture bottles, respiratory specimens, stool, and cerebrospinal fluid has resulted in a paradigm shift in clinical microbiology and clinical practice. This review focuses on U.S. Food and Drug Administration (FDA)-approved/cleared multiplex molecular panels with more than five targets designed to assist in the diagnosis of bloodstream, respiratory tract, gastrointestinal, or central nervous system infections. While these panel-based assays have the clear advantages of a rapid turnaround time and the detection of a large number of microorganisms and promise to improve health care, they present certain challenges, including cost and the definition of ideal test utilization strategies (i.e., optimal ordering) and test interpretation.

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Section: Detection Of Pathogens Directly From Bloodmentioning

confidence: 99%

Section: Detection Of Pathogens Directly From Bloodmentioning

confidence: 99%

Syndromic Panel-Based Testing in Clinical Microbiology

et al. 2018

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“…Pooled effects for sensitivity and specificity across four studies 48,113,118,119 (comprising 460 patients) comparing SepsiTest with blood culture suggest that SepsiTest has a higher specificity (0.86, 95% CrI 0.78 to 0.92) than sensitivity (0.48, 95% CrI 0.21 to 0.74). Although the pooled estimate indicates low sensitivity, the associated CrI is large.…”

Section: Assessment Of Cost-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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“…Several molecular assays have been recently tested for the direct molecular identification of pathogens in blood samples (8)(9)(10)(11)(12)(13). However, few studies have focused on commercially available PCR-based tests other than the SeptiFast test for the detection of BSI (14,15).…”

Section: Discussionmentioning

confidence: 99%

Magicplex^TM Sepsis real-time test for the rapid diagnosis of bloodstream infections in adults

Zboromyrska

Cillóniz

Cobos-Trigueros

et al. 2018

Preprint

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Sepsis is a serious health condition worldwide, affecting more than 30 million people globally each year. In 2017, the World Health Organization (WHO) adopted a resolution on sepsis: "improving the prevention, diagnosis and clinical management of sepsis", with the aim of improving early diagnosis, management and prevention to save lives. Blood culture (BC) is generally used to diagnose sepsis because of the low quantity of microbes occurring in the blood during such infections. However, approximately 50% of bloodstream infections (BSI) give negative BC, this figure being higher for sepsis, which delays the start of appropriate antimicrobial therapy. This prospective study evaluated a multiplex real-time polymerase chain reaction, the Magicplex TM Sepsis test (MP), for the detection of pathogens from whole blood, comparing it to routine BC. We analysed 809 blood samples from 636 adult patients, with 132/809 (16.3%) of the samples positive for one or more relevant microorganism according to BC and/or MP. The sensitivity and specificity of MP were 29% and 95%, respectively, while the level of agreement between BC and MP was 87%. The rate of contaminated samples was higher for BC (10%) than MP (4.8%) (P < 0.001). Patients with only MP-positive samples were more likely to be on antimicrobial treatment (47%) than those with only BC-positive samples (18%) (P = 0.002). In summary, the MP test reduces the time taken to identify the microbial pathogen, improving the diagnosis of BSI in patients on antibiotic treatment.

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A prospective multicenter evaluation of direct molecular detection of blood stream infection from a clinical perspective

Cited by 34 publications

References 38 publications

Syndromic Panel-Based Testing in Clinical Microbiology

Syndromic Panel-Based Testing in Clinical Microbiology

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

Magicplex^TM Sepsis real-time test for the rapid diagnosis of bloodstream infections in adults

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A prospective multicenter evaluation of direct molecular detection of blood stream infection from a clinical perspective

Cited by 34 publications

References 38 publications

Syndromic Panel-Based Testing in Clinical Microbiology

Syndromic Panel-Based Testing in Clinical Microbiology

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

MagicplexTM Sepsis real-time test for the rapid diagnosis of bloodstream infections in adults

Contact Info

Product

Resources

About

Magicplex^TM Sepsis real-time test for the rapid diagnosis of bloodstream infections in adults