BACKGROUND: New DNA-based microarray platforms enable rapid detection and species identification of many pathogens, including bacteria. We assessed the sensitivity, specificity, and turnaround time of a new molecular sepsis assay. METHODS: 2107 positive blood-culture samples of 3318 blood samples from patients with clinically suspected sepsis were investigated for bacterial species by both conventional culture and Prove-it sepsis assay (Mobidiag, Helsinki, Finland) in two centres (UK and Finland). The assay is a novel PCR and microarray method that is based on amplification and detection of gyrB, parE, and mecA genes of 50 bacterial species. Operators of the test assay were not aware of culture results. We calculated sensitivity, specificity, and turnaround time according to Clinical and Laboratory Standards Institute recommendations. FINDINGS: 1807 of 2107 (86%) positive blood-culture samples included a pathogen covered by the assay. The assay had a clinical sensitivity of 94.7% (95% CI 93.6-95.7) and a specificity of 98.8% (98.1-99.2), and 100% for both measures for meticillin-resistant Staphylococcus aureus bacteraemia. The assay was a mean 18 h faster than was the conventional culture-based method, which takes an additional 1-2 working days. 34 of 3284 (1.0%) samples were excluded because of technical and operator errors. INTERPRETATION: Definitive identification of bacterial species with this microarray platform was highly sensitive, specific, and faster than was the gold-standard culture-based method. This assay could enable fast and earlier evidence-based management for clinical sepsis. Copyright 2010 Elsevier Ltd. All rights reserved.
BACKGROUND: New DNA-based microarray platforms enable rapid detection and species identification of many pathogens, including bacteria. We assessed the sensitivity, specificity, and turnaround time of a new molecular sepsis assay. METHODS: 2107 positive blood-culture samples of 3318 blood samples from patients with clinically suspected sepsis were investigated for bacterial species by both conventional culture and Prove-it sepsis assay (Mobidiag, Helsinki, Finland) in two centres (UK and Finland). The assay is a novel PCR and microarray method that is based on amplification and detection of gyrB, parE, and mecA genes of 50 bacterial species. Operators of the test assay were not aware of culture results. We calculated sensitivity, specificity, and turnaround time according to Clinical and Laboratory Standards Institute recommendations. FINDINGS: 1807 of 2107 (86%) positive blood-culture samples included a pathogen covered by the assay. The assay had a clinical sensitivity of 94.7% (95% CI 93.6-95.7) and a specificity of 98.8% (98.1-99.2), and 100% for both measures for meticillin-resistant Staphylococcus aureus bacteraemia. The assay was a mean 18 h faster than was the conventional culture-based method, which takes an additional 1-2 working days. 34 of 3284 (1.0%) samples were excluded because of technical and operator errors. INTERPRETATION: Definitive identification of bacterial species with this microarray platform was highly sensitive, specific, and faster than was the gold-standard culture-based method. This assay could enable fast and earlier evidence-based management for clinical sepsis. Copyright 2010 Elsevier Ltd. All rights reserved.
Authors: Helen Won; Richard Rothman; Padmini Ramachandran; Yu-Hsiang Hsieh; Aleksandar Kecojevic; Karen C Carroll; Deborah Aird; Charlotte Gaydos; Samuel Yang Journal: J Clin Microbiol Date: 2010-07-14 Impact factor: 5.948
Authors: M Bernhard; G Marx; K Weismüller; C Lichtenstern; K Mayer; F M Brunkhorst; M A Weigand Journal: Anaesthesist Date: 2010-05 Impact factor: 1.041
Authors: Russell R Miller; Bert K Lopansri; John P Burke; Mitchell Levy; Steven Opal; Richard E Rothman; Franco R D'Alessio; Venkataramana K Sidhaye; Neil R Aggarwal; Robert Balk; Jared A Greenberg; Mark Yoder; Gourang Patel; Emily Gilbert; Majid Afshar; Jorge P Parada; Greg S Martin; Annette M Esper; Jordan A Kempker; Mangala Narasimhan; Adey Tsegaye; Stella Hahn; Paul Mayo; Tom van der Poll; Marcus J Schultz; Brendon P Scicluna; Peter Klein Klouwenberg; Antony Rapisarda; Therese A Seldon; Leo C McHugh; Thomas D Yager; Silvia Cermelli; Dayle Sampson; Victoria Rothwell; Richard Newman; Shruti Bhide; Brian A Fox; James T Kirk; Krupa Navalkar; Roy F Davis; Roslyn A Brandon; Richard B Brandon Journal: Am J Respir Crit Care Med Date: 2018-10-01 Impact factor: 21.405