Molecular Detection of Late-Onset Neonatal Sepsis in Premature Infants Using Small Blood Volumes: Proof-of-Concept

Kasper, David C.; Altiok, Ipek; Mechtler, Thomas P.; Böhm, Judith; Straub, Julia; Langgartner, Michaela; Pollak, Arnold; Herkner, Kurt; Berger, Angelika

doi:10.1159/000346365

Cited by 42 publications

(38 citation statements)

References 25 publications

(33 reference statements)

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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%

“…community, emergency department, hospital, intensive/critical care, general/ specialist) was not reported for nine SeptiFast studies, 44,65,69,72,88,98,100,105,110 or for one multitest SeptiFast and SepsiTest study 118 (confidential information has been removed). The setting across the remaining studies varied (see Table 4).…”

Section: Study Design Characteristicsmentioning

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. 48 (Confidential information has been removed.)…”

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

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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: Study Design Characteristicsmentioning

confidence: 99%

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

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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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“…In a small study on 34 infants with suspected cases of LOS [61], 7/7 etiologic agents of definitive neonatal sepsis were identified by the multiplex PCR, whereas only 3/7 were detected by culture. In a collective of 46 preterm infants with suspected neonatal sepsis [62], SeptiFast (Roche Diagnostics GmbH, Basel, Switzerland) multiplex real-time PCR was more sensitive than culture (90 % vs. 71 %), but less specific (80 % vs. 100 %) because of 5/21 non-infected patients with positive PCR for coagulase-negative staphylococci.…”

Section: Pcr On Whole Blood and Other Sterile Fluids Of Septic Neonatesmentioning

confidence: 99%

Molecular-based Screening for Perinatal Group B Streptococcal Infection: Implications for Prevention and Therapy

2013

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Group B streptococci (GBS) are a leading cause of infectious neonatal morbidity and mortality. Timely and accurate identification of colonized pregnant women is imperative to implement intrapartum antibioprophylaxis (IAP) to reduce the risk of early neonatal sepsis. Current guidelines recommend screening for GBS carriage with vaginal-rectal cultures. However, cultures require 24-72 h, thus precluding their use for intrapartum screening and these are only performed at 35-37 weeks gestation. New rapid molecular-based tests can detect GBS within hours. They have the potential to be used intrapartum and to allow for selective IAP in women carrying GBS. An advantage is that they can sometimes be performed by non-laboratory staff in the labor suite, thus avoiding delays in sample transfers to the microbiology laboratory. Another possible use of molecular-based assays is for the diagnosis of neonatal sepsis, where tests with a short turnaround time and high sensitivity and specificity are crucial. In this situation, the detection of microorganisms once antibiotic therapy has already been started is important, as treatment is started immediately once sepsis is suspected without waiting for microbiological confirmation. In this article, we discuss the state-of-the-art molecular-based tests available for GBS screening during pregnancy, as well as their implications for IAP for the diagnosis and prevention of neonatal sepsis.

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Molecular assays for the diagnosis of sepsis in neonates

Pammi

Flores²,

Versalovic

et al. 2017

Cochrane Database of Systematic Reviews

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Molecular Detection of Late-Onset Neonatal Sepsis in Premature Infants Using Small Blood Volumes: Proof-of-Concept

Cited by 42 publications

References 25 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

Molecular-based Screening for Perinatal Group B Streptococcal Infection: Implications for Prevention and Therapy

Molecular assays for the diagnosis of sepsis in neonates

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