FilmArray Blood Culture Identification Panel Research Articles

Clinical Impact of the FilmArray Blood Culture Identification Panel Performed on Positive Blood Cultures From Intensive Care Patients With Septicemia

Clinical Impact of the FilmArray Blood Culture Identification Panel Performed on Positive Blood Cultures From Intensive Care Patients With Septicemia

Rapid identification of nonblood sterile site broth cultures using the FilmArray blood culture identification panel

The FilmArray Blood Culture Identification Panel was validated for nonblood sterile site specimens with clinical impact of rapid identification compared to conventional diagnostics. The panel accurately identified target organisms from 98% of positive broth cultures a median 1.1 day faster than conventional techniques (P < 0.0001) with potential clinical impact in 22% of cases.

Application of BioFire FilmArray Blood Culture Identification panel for rapid identification of the causative agents of ventilator-associated pneumonia

ObjectiveTo evaluate the ability of the BioFire FilmArray Blood Culture Identification (BCID) panel to rapidly detect pathogens producing late-onset ventilator-associated pneumonia (VAP), a severe infection often produced by Gram-negative bacteria. These microorganisms are frequently multidrug resistant and typically require broad-spectrum empiric treatment. MethodsIn the context of an international multicentre clinical trial (MagicBullet), respiratory samples were collected at the time of suspicion of VAP from 165 patients in 32 participating hospitals in Spain, Greece and Italy. Microorganisms were identified using the BCID panel and compared with results obtained by conventional microbiologic techniques. ResultsPseudomonas aeruginosa, Acinetobacter baumannii and Klebsiella pneumoniae were the most commonly identified species, representing 54.7% (70/128) of microorganisms. The BCID panel showed high global specificity (98.1%; 95% confidence interval, 96–100) and negative predictive values (96.6%) and a global sensitivity and positive predictive value of 78.6% (95% confidence interval, 70–88) and 87.3%, respectively, for these microorganisms. Importantly, the BCID panel provided results in only 1 hour directly from respiratory samples with minimal sample processing times. ConclusionsThe BCID panel may have clinical utility in rapidly ruling out microorganisms causing VAP, specifically multidrug-resistant Gram-negative species. This could facilitate the optimization of empiric treatment.

BioFire Film Array Blood Culture Identification Panel for Rapid Detection of Pathogens from Sterile Sites - A Diagnostic Accuracy Study

Background: Rapid diagnosis of the causative organism of invasive infections is critical to the improved care of patients. A new platform, FilmArray (BioFire Diagnostics, LLC, Salt Lake City, UT) allows for rapid PCR to be performed in less than two hours on positive blood cultures Objective: The aim was to perform a retrospective diagnostic accuracy study in a paediatric tertiary referral hospital comparing results from culture, our gold standard, against those obtained when the samples were tested directly using the FilmArray Blood Culture Identification (BCID) Panel (BioFire Diagnostics, LLC, Salt Lake City, UT). Method: Samples from sterile site infections were tested using traditional culture based methods as well as PCR testing, and these results were then compared to testing which was done directly on the FilmArray BC-ID panel. Results: Ninety-four samples were tested in total and concordant results were observed in 71 samples (76%). Correlation between detection of pathogens such as Staphylococcus aureus and Streptococcus pyogenes by PCR and culture result was high (94% and 88% respectively). Discordant results could be explained by the cultured organism not having a target on the panel (n=8) or PCR detection of potentially non-viable bacteria in the sample (n=8); the remaining samples (n=9) were negative by PCR despite culturing an organism with a target present on the panel for that organism. We have demonstrated an overall correlation of 76% and that in some instances the PCR detected non-viable yet clinically significant bacteria. Conclusion: Use of the FilmArray BCID panel directly for samples from sterile sites should be considered when there is a high index of suspicion of a single-organism infection at that site prior to sampling.

Evaluation of the biofire filmarray blood culture identification panel on positive blood cultures in a regional hospital laboratory

Evaluation of the biofire filmarray blood culture identification panel on positive blood cultures in a regional hospital laboratory

Evaluation of the FilmArray Blood Culture Identification Panel on Detection of Pathogenic Microorganisms in Positive Blood Cultures: the First Clinical Report in Japan.

FilmArray (FA) is a multiplex PCR-based desktop microbial detection system. The blood culture identification (BCID) panel is an adaptable panel for FA, which diagnoses sepsis and/or systemic infections by detecting 14 bacterial species, 4 bacterial genera, 1 bacterial family, 5 yeast species, and 3 antimicrobial resistance genes (mecA, Klebsiella pneumoniae carbapenemase [KPC], and vanA/B) in positive blood cultures within 1 h. We retrospectively evaluated the FA-BCID panel using 54 positive blood cultures, in which 57 bacterial and 3 yeast strains were identified by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). The FA-BCID panel revealed 59 microorganisms in 53 samples; this performance was similar to that of MALDI-TOF MS analysis; however, 1 bacterium in 1 sample was not detected. In addition, mecA genes were detected in 12 Staphylococcus species, which all manifested methicillin resistance in susceptibility testing, whereas genes KPC and vanA/B were not detected, in agreement with the results of antimicrobial susceptibility testing. Although more information on antimicrobial resistance, including activity of IMP-metallo-β-lactamases, is required in Japan, the FA-BCID panel can detect pathogenic microorganisms in positive blood cultures rapidly, and this method could be beneficial for proper treatment of sepsis and/or systemic infections, especially in small hospitals.

Cumulative Effect of an Antimicrobial Stewardship and Rapid Diagnostic Testing Bundle on Early Streamlining of Antimicrobial Therapy in Gram-Negative Bloodstream Infections.

The use of rapid diagnostic tests (RDTs) enhances antimicrobial stewardship program (ASP) interventions in optimization of antimicrobial therapy. This quasi-experimental cohort study evaluated the combined impact of an ASP/RDT bundle on the appropriateness of empirical antimicrobial therapy (EAT) and time to de-escalation of broad-spectrum antimicrobial agents (BSAA) in Gram-negative bloodstream infections (GNBSI). The ASP/RDT bundle consisted of system-wide GNBSI treatment guidelines, prospective stewardship monitoring, and sequential introduction of two RDTs, matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) and the FilmArray blood culture identification (BCID) panel. The preintervention period was January 2010 through December 2013, and the postintervention period followed from January 2014 through June 2015. The postintervention period was conducted in two phases; phase 1 followed the introduction of MALDI-TOF MS, and phase 2 followed the introduction of the FilmArray BCID panel. The interventions resulted in significantly improved appropriateness of EAT (95% versus 91%; P = 0.02). Significant reductions in median time to de-escalation from combination antimicrobial therapy (2.8 versus 1.5 days), antipseudomonal beta-lactams (4.0 versus 2.5 days), and carbapenems (4.0 versus 2.5 days) were observed in the postintervention compared to the preintervention period (P < 0.001 for all). The reduction in median time to de-escalation from combination therapy (1.0 versus 2.0 days; P = 0.03) and antipseudomonal beta-lactams (2.2 versus 2.7 days; P = 0.04) was further augmented during phase 2 compared to phase 1 of the postintervention period. Implementation of an antimicrobial stewardship program and RDT intervention bundle in a multihospital health care system is associated with improved appropriateness of EAT for GNBSI and decreased utilization of BSAA through early de-escalation.

Assessment of Rapid-Blood-Culture-Identification Result Interpretation and Antibiotic Prescribing Practices.

Rapid pathogen identification can alter antibiotic prescribing practices if interpreted correctly. Microbiology reporting can be difficult to understand, and new technology has made it more challenging. Nebraska Medicine recently implemented the BioFire FilmArray blood culture identification panel (BCID) coupled with stewardship-based education on interpretation. Physician BCID result interpretation and prescribing were assessed via an electronic survey, with a response rate of 40.8% (156/382 surveys). Seven questions required respondents to interpret BCID results, identify the most likely pathogen, and then choose therapy based on the results. The tallied correct responses resulted in a knowledge score. General linear models evaluated the effect of role, specialty, and utilization of the BCID interpretation guide on the mean knowledge score. The specialties of the respondents included 55.7% internal medicine, 19.7% family medicine, and 24.6% other. Roles included 41.1% residents, 5.0% fellows, and 53.9% faculty. Most reported that they reviewed antimicrobial susceptibility results (89.4%) and adjusted therapy accordingly (81.6%), while only 60% stated that they adjusted therapy based on BCID results. The correct response rates ranged from 52 to 86% for the interpretation questions. The most common errors included misinterpretation of Enterobacteriaceae and Staphylococcus genus results. Neither role nor specialty was associated with total knowledge score in multivariate analysis (P = 0.13 and 0.47, respectively). In conclusion, physician interpretation of BCID results is suboptimal and can result in ineffective treatment or missed opportunity to narrow therapy. With the implementation of new technology, improved reporting practices of BCID results with clinical decision support tools providing interpretation guidance available at the point of care is recommended.

Performance of the FilmArray Blood culture identification panel in positive blood culture bottles and cerebrospinal fluid for the diagnosis of sepsis and meningitis.

Sepsis and meningitis are life threatening medical conditions. Culture-based methods are used for identification of the causative pathogens, but they can be improved by implementation of additional test systems. We evaluated the performance of the novel FilmArray blood culture identification (BCID; Biofire Diagnostics) panel for rapid and accurate identification of microorganisms in positive blood cultures and additionally, in this cerebrospinal fluid (CSF) pilot study for direct testing of CSF. A total of 107 positive blood cultures and 20 CSF samples (positive and negative) were investigated and compared to the routine procedures. Of the 107 positive blood cultures, 90.7% (97/107) showed monomicrobial growth and 9.3% (10/107) polymicrobial growth. The FilmArray BCID panel covered 89.3% (25/28) of the bacteria and 100% (2/2) of the yeasts found in this study and accurately identified all of them.From the 20 retrospective analyzed CSF, in 9 positive specimens 6 different bacterial species were identified. Discrepant identification results were found in 25% (5/20) and a low sensitivity of 50% (95% CI of 15.7% to 84.3%) was detected.Our study confirms the FilmArray BCID panel as a rapid, easy to handle PCR system with a good performance in positive blood cultures without Gram-staining result. However, our results additionally suggest that the system is not useful for direct CSF testing due to poor sensitivity.

Clinical Impact and Provider Acceptability of Real-Time Antimicrobial Stewardship Decision Support for Rapid Diagnostics in Children With Positive Blood Culture Results.

Rapid diagnostic technologies for infectious diseases have the potential to improve clinical outcomes, but guideline-recommended antimicrobial stewardship (AS) strategies are not currently optimized for rapid intervention. We evaluated the clinical impact and provider acceptability of implementing real-time AS decision support for children with positive blood culture results according to the FilmArray blood culture identification panel (BCID [BioFire Diagnostics]) at Children's Hospital Colorado. A pre-post quasi-experimental design was used to compare the outcomes of 100 postintervention children with positive blood culture results matched with 200 preintervention control children. Causative organisms in the preintervention group were identified using conventional microbiologic techniques and communicated to providers by a microbiology technologist. Postintervention organisms were identified by the BCID and communicated by an AS provider in real time with interpretation and antimicrobial recommendations. The primary outcome was time to optimal antimicrobial therapy (time from blood culture collection to start of predetermined pathogen-specific regimen or antimicrobial discontinuation for contaminants) compared by a log-rank test and Kaplan-Meier analysis. Provider acceptability of the intervention was assessed via E-mailed surveys. The median time to optimal therapy decreased from 60.2 hours before intervention to 26.7 hours after intervention (P = .001). Among children with blood cultures that contained true pathogens, the time to effective antimicrobial therapy decreased from 6.9 to 3.4 hours (P = .03). Unnecessary antibiotic initiation for children with a culture that contained organisms considered to be contaminants decreased from 76% to 26% (P < .001). Providers reported a change in management as a result of BCID results in 73% of the cases and a mean overall satisfaction rating of 4.8 on a 5-point Likert scale. Real-time AS decision support for rapid diagnostics is associated with improved antimicrobial use and high satisfaction ratings by providers.

Impact of a rapid multiplex polymerase chain reaction blood culture identification technology on outcomes in patients with vancomycin-resistant Enterococcal bacteremia

Background: Early appropriate antibiotic selection is associated with favorable clinical outcomes. We evaluated the clinical impact of rapid detection of vancomycin-resistant Enterococcal bacteremia (VREB) by the FilmArray blood culture identification (BCID) panel coupled with antimicrobial stewardship program (ASP) interventions.Methods: Hospitalized adult patients with VREB identified by conventional methods (CM) were compared to patients with VREB identified by BCID. Real time alerts of BCID results were provided to the ASP for intervention. Outcomes were compared between groups.Results: Sixty-eight patients with VREB were included (CM, n = 45; BCID, n = 23). No significant differences in demographics, pre-existing conditions, or clinical characteristics were observed. Significant reductions were demonstrated between CM and BCID groups in median hours to organism identification (47.7 versus 18.2, p < 0.001), to identification of vancomycin resistance from time of culture positivity (50.1 versus 1.2, p < 0.001), and time to effective therapy (50.3 versus 20.8, p < 0.001). Differences between CM and BCID did not reach statistical significance for mortality (35.6% versus 26.1%), 30-day readmission rate (31.0% versus 17.6%), intensive care length of stay [LOS] (8.0 versus 7.0 days), post-culture LOS (14.6 versus 14.1 days) or median hospital costs per patient ($95,826 versus $53,195).Conclusions: In patients with VREB, rapid organism and resistance detection by the BCID panel with ASP intervention significantly reduced time to initiation of effective therapy by over 24 hours. Non-significant improvements in clinical outcomes were observed. Additional studies are needed to determine the full implications of BCID technology on patient outcome.

Rapid Identification of Microorganisms by FilmArray Blood Culture Identification Panel Improves Clinical Management in Children.

Blood cultures are a common investigation for children admitted to hospital. In routine practice, it takes at least 24 hours to identify an organism as a contaminant or clinically significant. FilmArray Blood Culture Identification Panel (FA-BCIP) is a multiplex polymerase chain reaction that can detect 24 pathogens within 1 hour. We assessed whether results from FA-BCIP lead to changes in clinical management in a tertiary referral paediatric hospital. We prospectively studied children having blood cultures taken at our tertiary children's hospital. Blood cultures were monitored and organisms identified using standard methods. FA-BCIP was performed when growth was initially detected in first positive blood cultures per episode, between January 1 and June 30, 2014. Assessment of whether the FA-BCIP result altered clinical management was made, specifically focused on antimicrobial stewardship and length of stay. FA-BCIP was done on 117 positive blood cultures; 74 (63%) grew clinically significant organisms, 43 (37%) grew contaminants. FA-BCIP results were judged to alter clinical management in 63 of the 117 episodes (54%). Antimicrobials were started/altered in 23 (19%) episodes and de-escalated/withheld/stopped in 29 (25%) episodes. Ten children were discharged from hospital earlier, which saved a cumulative total of 14 bed days. Rapid identification of microorganisms in pediatric blood cultures by FA-BCIP, led to changes in clinical management for half of the episodes. This improved antimicrobial stewardship and allowed early discharge from hospital for 10% of children. Future studies should focus on how best to use this technology in a cost-effective manner.

Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial.

Sepsis is a major cause of morbidity, mortality, and increased medical expense. Rapid diagnosis improves outcomes and reduces costs. The FilmArray blood culture identification panel (BioFire Diagnostics LLC, Salt Lake City, UT), a highly multiplexed PCR assay, can identify 24 etiologic agents of sepsis (8 Gram-positive, 11 Gram-negative, and 5 yeast species) and three antimicrobial resistance genes (mecA, vanA/B, and blaKPC) from positive blood culture bottles. It provides results in about 1 h with 2 min for assay setup. We present the results of an eight-center trial comparing the sensitivity and specificity of the panel with those of the laboratories' standard phenotypic identification techniques, as well as with molecular methods used to distinguish Acinetobacter baumannii from other members of the A. calcoaceticus-A. baumannii complex and to detect antimicrobial resistance genes. Testing included 2,207 positive aerobic blood culture samples, 1,568 clinical and 639 seeded. Samples were tested fresh or were frozen for later testing within 8 h after the bottles were flagged as positive by an automated blood culture system. At least one organism was detected by the panel in 1,382 (88.1%) of the positive clinical specimens. The others contained primarily off-panel organisms. The panel reported multiple organisms in 81 (5.86%) positive clinical specimens. The unresolved blood culture identification sensitivity for all target detections exceeded 96%, except for Klebsiella oxytoca (92.2%), which achieved 98.3% sensitivity after resolution of an unavoidable phenotypic error. The sensitivity and specificity for vanA/B and blaKPC were 100%; those for mecA were 98.4 and 98.3%, respectively.

Clinical and economic impact of antimicrobial stewardship interventions with the FilmArray blood culture identification panel

The purpose of this study was to evaluate the impact of the FilmArray Blood Culture Identification (BCID) Panel on the management of patients with blood cultures growing gram positive cocci and Candida. We retrospectively compared clinical and economic outcomes between patients during the BCID testing period and a matched historical control group before BCID testing was introduced. A total of 84 BCID patients were matched to 252 historical controls. BCID identification of coagulase negative staphylococci contaminants resulted in shorter post-culture length of stay (P < 0.008) and saved roughly $30,000 per 100 patients tested. The BCID led to shorter duration of empirical vancomycin for patients with contaminated blood cultures (P = 0.005) and methicillin-susceptible Staphylococcus aureus bacteremia (P < 0.001). Patients with vancomycin-resistant enterococcal bacteremia received active therapy earlier than historical controls (P = 0.047). The BCID, coupled with antimicrobial stewardship intervention, was a cost effective tool to improve patient care.

Efficacy of the FilmArray blood culture identification panel for direct molecular diagnosis of infectious diseases from samples other than blood.

Molecular-based techniques reduce the delay in diagnosing infectious diseases and therefore contribute to better patient outcomes. We assessed the FilmArray blood culture identification (BCID) panel (Biofire Diagnostics/bioMérieux) directly on clinical specimens other than blood: cerebrospinal, joint, pleural and ascitic fluids, bronchoscopy samples and abscesses. We compared the results from 88 samples obtained by culture-based techniques. The percentage of agreement between the two methods was 75 % with a Cohen κ value of 0.51. Global sensitivity and specificity using the FilmArray BCID panel were 71 and 97 %, respectively. Sensitivity was poorer in samples with a low bacterial load, such as ascitic and pleural fluids (25 %), whereas the sensitivity for abscess samples was high (89 %). These findings suggest that the FilmArray BCID panel could be useful to perform microbiological diagnosis directly from samples other than positive blood cultures, as it offers acceptable sensitivity and moderate agreement with conventional microbiological methods. Nevertheless, cost-benefit studies should be performed before introducing this method into algorithms for microbiological diagnostics.

Rapid Detection of Bloodstream Pathogens in Liver Transplantation Patients With FilmArray Multiplex Polymerase Chain Reaction Assays: Comparison With Conventional Methods

BackgroundBloodstream infection (BSI) is an important concern in transplant patients. Early intervention with appropriate antimicrobial therapy is critical to better clinical outcome; however, there is significant delay when conventional identification methods are used. MethodsWe aimed to determine the diagnostic performance of the FilmArray Blood Culture Identification Panel, a recently approved multiplex polymerase chain reaction assay detecting 24 BSI pathogens and 3 resistance genes, in comparison with the performances of conventional identification methods in liver transplant (LT) patients. A total of 52 defined sepsis episodes (signal-positive by blood culture systems) from 45 LT patients were prospectively studied. ResultsThe FilmArray successfully identified 37 of 39 (94.8%) bacterial and 3 of 3 (100%) yeast pathogens in a total of 42 samples with microbial growth, failing to detect only 2 of 39 (5.1%) bacterial pathogens that were not covered by the test panel. The FilmArray could also detect additional pathogens in 3 samples that had been reported as having monomicrobial growth, and it could detect Acinetobacter baumannii in 2 samples suspected of skin flora contamination. The remaining 8 blood cultures showing a positive signal but yielding no growth were also negative by this assay. Results of MecA, KPC, and VanA/B gene detection were in high accordance. The FilmArray produced results with significantly shorter turnaround times (1.33 versus 36.2, 23.6, and 19.5 h; P < .05) than standard identification methods, Vitek II, and Vitek MS, respectively. ConclusionsThis study showed that the FilmArray appeared as a reliable alternative diagnostic method with the potential to mitigate problems with protracted diagnosis of the BSI pathogens in LT patients.

Comparison between MALDI-TOF MS and FilmArray Blood Culture Identification panel for rapid identification of yeast from positive blood culture

In this study we evaluated MALDI-TOF MS and FilmArray methods for the rapid identification of yeast from positive blood cultures. FilmArray correctly identified 20/22 of yeast species, while MALDI-TOF MS identified 9/22. FilmArray is a reliable and rapid identification system for the direct identification of yeasts from positive blood cultures.

Clinical Evaluation of the FilmArray Blood Culture Identification Panel in Identification of Bacteria and Yeasts from Positive Blood Culture Bottles

The FilmArray platform (FA; BioFire, Salt Lake City, UT) is a closed diagnostic system allowing high-order multiplex PCR analysis with automated readout of results directly from positive blood cultures in 1 h. In the present study, we evaluated the clinical performance of the FilmArray blood culture identification (BCID) panel, which includes 19 bacteria, five yeasts, and three antibiotic resistance genes. In total, 206 blood culture bottles were included in the study. The FilmArray could identify microorganisms in 153/167 (91.6%) samples with monomicrobial growth. Thirteen of the 167 (7.8%) microorganisms were not covered by the FilmArray BCID panel. In 6/167 (3.6%) samples, the FilmArray detected an additional microorganism compared to blood culture. When polymicrobial growth was analyzed, the FilmArray could detect all target microorganisms in 17/24 (71%) samples. Twelve blood culture bottles that yielded a positive signal but showed no growth were also negative by FilmArray. In 3/206 (1.5%) bottles, the FilmArray results were invalid. The results of the FilmArray were reproducible, as demonstrated by the testing and retesting of five bottles in the same day and a longitudinal follow-up of five other blood cultures up to 4 weeks. The present study shows that the FilmArray is a rapid identification method with high performance in direct identification of bacteria and yeasts from positive blood culture bottles.