Rapid Detection of Gram-Positive Organisms by Use of the Verigene Gram-Positive Blood Culture Nucleic Acid Test and the BacT/Alert Pediatric FAN System in a Multicenter Pediatric Evaluation

Sullivan, Kaede V.; Turner, N. N.; Roundtree, Sylvester S.; Young, Stephen; Brock-Haag, C. A.; Lacey, Damon; Abuzaid, S.; Blecker-Shelly, Deborah; Doern, Christopher D.

doi:10.1128/jcm.01224-13

Cited by 62 publications

(44 citation statements)

References 20 publications

(24 reference statements)

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“…Four recent studies have evaluated the performance of the BC-GP assay on different bottle types (12)(13)(14)(15). Specifically, Sullivan et al reported high sensitivity and specificity in pediatric patients using BacT/Alert pediatric FAN (PF) blood cultures (14).…”

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confidence: 99%

Performance of the Verigene Gram-Positive Blood Culture Assay for Direct Detection of Gram-Positive Organisms and Resistance Markers in a Pediatric Hospital

et al. 2014

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The performance characteristics of the Verigene Gram-positive blood culture (BC-GP) assay were evaluated in pediatric patients. Concordance of the BC-GP assay was 95.8%, with significant decreases in turnaround time for identification and resistance detection. BC-GP is highly accurate and can be integrated into the routine workflow of the microbiology laboratory. Bloodstream infections are one of the leading causes of death in the United States, and prompt initiation of appropriate antimicrobial therapy is essential to significantly improve patient management and reduce the rate of mortality of bacteremic patients (1). Gram-positive pathogens are implicated in Ͼ50% of all bacterial bloodstream infections, with coagulase-negative staphylococci (CoNS) being the most common Gram-positive bacteria isolated from blood culture, followed by Staphylococcus aureus and Enterococcus spp. (2-4). Similar findings have been demonstrated in our institution where approximately 64% of all positive blood cultures consist of Gram-positive organisms. The workup of pathogens in the clinical microbiology laboratory is a key contributing factor in overall mortality rate, as delays in identification and susceptibility testing have been demonstrated to directly impact patient survival (5). Previous studies have been fundamental in directly correlating rapid identification of Gram-positive pathogens with improved patient outcome, decreased hospital length of stay, and decreased hospital costs (6-9). Moreover, direct detection of the mecA gene in methicillin-resistant S. aureus (MRSA) has been demonstrated to be an effective tool for managing vancomycin usage as well as reducing both hospital length of stay and costs (10, 11).The Verigene Gram-positive blood culture (BC-GP) assay (Nanosphere Inc., Northbrook, IL) is a microarray-based, multiplexed, molecular assay approved by the Food and Drug Administration (FDA) for rapid detection and identification of 12 Gram-positive targets (S. aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Staphylococcus spp., Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Listeria monocytogenes) and 3 resistance markers (mecA, vanA, vanB). Four recent studies have evaluated the performance of the BC-GP assay on different bottle types (12-15). Specifically, Sullivan et al. reported high sensitivity and specificity in pediatric patients using BacT/Alert pediatric FAN (PF) blood cultures (14). This study evaluated the performance characteristics of the BacT/Alert standard aerobic (SA) noncharcoal and PF charcoal blood culture bottles collected from pediatric patients admitted to Children's Hospital Los Angeles (CHLA), a freestanding pediatric tertiary care center. The implementation process and comparison of workflow and turnaround time (TAT) were also assessed. A total of 203 positive blood cultures (104 SA, 99 PF) from 203 pediatric patients submitted for routine workup to th...

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Performance of the Verigene Gram-Positive Blood Culture Assay for Direct Detection of Gram-Positive Organisms and Resistance Markers in a Pediatric Hospital

et al. 2014

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“…Several papers have already evaluated the Verigene panel dedicated to Gram-positive bacteria (8)(9)(10)(11)(12), but this is the first one on the BC-GN test. To investigate its potential clinical usefulness, we evaluated the following parameters: (i) the concordance of identification and of antibiotic susceptibility data with those obtained with the traditional blood culture flowchart, (ii) the time to definitive results, and (iii) the impact of the BC-GN test results on ongoing empirical therapy, evidencing the rate of potential BC-GN-induced antibiotic changes.…”

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Potential Impact of a Microarray-Based Nucleic Acid Assay for Rapid Detection of Gram-Negative Bacteria and Resistance Markers in Positive Blood Cultures

et al. 2014

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We evaluated the Verigene Gram-negative blood culture (BC-GN) test, a microarray that detects Gram-negative bacteria and several resistance genes. A total of 102 positive blood cultures were tested, and the BC-GN test correctly identified 97.9% of the isolates within its panel. In cases of sepsis, timely microbiological diagnosis, including data on antimicrobial susceptibility, is crucial for prompt initiation of targeted drug therapy (1). This is not possible with currently used methods, thus causing a significant delay in specific treatment and the empirical use of broad-spectrum antimicrobials (2-4). Nucleic acid-based assays are considered to be a potential adjuvant tool for improving the microbiological diagnosis of sepsis (5-7). These assays may be classified into one of two groups (5-7): (i) those using positive blood cultures, which are potentially useful but burdened by the usual culture-associated drawbacks (i.e., interfering effect of ongoing antibiotics, long time to positivity, and the presence of fastidious pathogens), and (ii) those using blood samples, which are promising but still not developed for the sensitive detection of resistance markers (5-7).In this pilot study, we evaluated the Verigene Gram-negative blood culture (BC-GN) test (Nanosphere, Northbrook, IL, USA), a microarray-based, almost fully automated, and random-access system allowing for bacterial identification (Table 1) and detection of several resistance genes (Table 2) from positive blood cultures. The turnaround time is 2 h, with a hands-on time of Ͻ10 min. The BC-GN test has been approved for clinical use in Europe and is currently under submission for use in the United States.Several papers have already evaluated the Verigene panel dedicated to Gram-positive bacteria (8-12), but this is the first one on the BC-GN test. To investigate its potential clinical usefulness, we evaluated the following parameters: (i) the concordance of identification and of antibiotic susceptibility data with those obtained with the traditional blood culture flowchart, (ii) the time to definitive results, and (iii) the impact of the BC-GN test results on ongoing empirical therapy, evidencing the rate of potential BC-GN-induced antibiotic changes. In this analysis, the following phases of the standard management of blood cultures were considered: time from blood sampling to the loading of bottles into the bioMérieux BacT/Alert system, time to positivity, and time from positivity to Gram stain and subculturing on solid medium (positive bottles are downloaded every 2 h, from 8:00 a.m. to 6:00 p.m. Monday to Friday, 8:00 a.m. to 2:00 p.m. on Saturday, and 9:00 a.m. to 1:00 p.m. on Sunday).Our study prospectively included all blood cultures positive for Gram-negative pathogens submitted to our center from June to September 2013, but only one positive bottle was considered per patient. Antibiotic susceptibility was phenotypically evaluated by disk diffusion from positive blood culture broth (preliminary antibiotic susceptibility testing [pAST]) and by au...

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“…There were no discordant results encountered between the BC-GP and MicroScan Walkaway systems. Although the overall number of SAG isolates included in previous evaluations of the Verigence BC-GP system was low, the majority of reports have also observed 100 % accuracy for this group (Beal et al, 2013; Sullivan et al, 2013). Species identification and characterization of haemolysis were able to be performed on 31 of the 34 SAG isolates.…”

Section: Microbiology and Antimicrobial Susceptibilitymentioning

confidence: 89%

Clinical and microbiological outcomes in patients with Streptococcus anginosus group bacteraemia identified through use of a rapid microarray assay

Wenzler

Chandrasekaran

Salvador

et al. 2015

Journal of Medical Microbiology

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Limited data exist evaluating outcomes in patients with serious Streptococcus anginosus group infections, particularly bacteraemia. A retrospective, single-centre cohort study was conducted to characterize potential risk factors along with clinical and microbiological outcomes in patients with S. anginosus group bacteraemia (SAGB). Adult inpatients with SAGB identified using the Verigene Gram-positive blood culture assay between March 2013 and April 2014 were included. Patients aged j18 or .89 years, those with SAGB identified at an outside facility and those who were incarcerated were excluded. Differences between groups were explored using a Wilcoxon rank-sum test, x 2 test, Student's t-test or Fisher's exact test as appropriate and a two-tailed P value of j0.05 was considered statistically significant. The 34 patients who met the inclusion criteria were 57¡14 (mean¡SD) years old and had a median Charlson co-morbidity index of 4 [interquartile range (IQR) 1-6] and 10 (29 %) were immunosuppressed at baseline. Almost half (47 %) had received antibiotics in the previous 90 days. Twelve (35 %) patients had gastrointestinal malignancies and the commonest source of bacteraemia was the gastrointestinal tract (53 %). The primary species responsible for SAGB was S. anginosus (68 %), and overall susceptibility to penicillin was 91 %. Patients were most often treated with a b-lactam/blactamase inhibitor combination (36 %) for a duration of 8 (IQR 4-13) days. Length of stay (LOS) and infection-related LOS were 10 (IQR 5-17) and 9 (IQR 4-12) days, respectively. Twenty [59 %] patients achieved a clinical cure, while 29 (85 %) achieved a microbiological cure. Four (12 %) patients died and one patient was readmitted within 30 days. In the largest cohort of patients with SAGB to date, gastrointestinal malignancies may have been an important risk factor for SAGB, while rapid identification via a microarray assay likely contributed to improved disease recognition and timely pharmacological and non-pharmacological therapy.

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Rapid Detection of Gram-Positive Organisms by Use of the Verigene Gram-Positive Blood Culture Nucleic Acid Test and the BacT/Alert Pediatric FAN System in a Multicenter Pediatric Evaluation

Cited by 62 publications

References 20 publications

Performance of the Verigene Gram-Positive Blood Culture Assay for Direct Detection of Gram-Positive Organisms and Resistance Markers in a Pediatric Hospital

Performance of the Verigene Gram-Positive Blood Culture Assay for Direct Detection of Gram-Positive Organisms and Resistance Markers in a Pediatric Hospital

Potential Impact of a Microarray-Based Nucleic Acid Assay for Rapid Detection of Gram-Negative Bacteria and Resistance Markers in Positive Blood Cultures

Clinical and microbiological outcomes in patients with Streptococcus anginosus group bacteraemia identified through use of a rapid microarray assay

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