scholarly journals 651. Multi-Center Evaluation of the BioFire® FilmArray® Blood Culture Identification 2 Panel for the Detection of Microorganisms and Resistance Markers in Positive Blood Cultures

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S299-S300
Author(s):  
Yang Lu ◽  
Joseph Hatch ◽  
Kristen Holmberg ◽  
Anna Hurlock ◽  
Daria Drobysheva ◽  
...  
Keyword(s):  
Blood Culture ◽  
Fungal Pathogens ◽  
Clinical Performance ◽  
Carbapenem Resistance ◽  
Blood Cultures ◽  
Microbial Culture ◽  
Candida Auris ◽  
Comprehensive Test ◽  
Resistance Markers ◽  
Culture Identification

Abstract Background The BioFire® FilmArray® Blood Culture Identification 2 (BCID2) Panel is a diagnostic test that provides results for 26 bacterial, 7 fungal pathogens and 10 antimicrobial resistance (AMR) genes from positive blood culture (PBC) specimens in about an hour. The BCID2 Panel builds upon the existing BCID Panel with several additional assays that include Candida auris and an expanded AMR gene menu that provides methicillin-resistant Staphylococcus aureus (MRSA) results plus detection for mcr-1, carbapenem resistance, and ESBL. Here, we summarize studies conducted to establish clinical performance using an Investigational Use Only version of the BCID2 Panel. Methods Three studies were performed. The first involves prospective collection and testing of an expected ~1,000 residual PBCs at 7 US and 2 EU sites, which began in October 2018 and will conclude in June 2019. BCID2 Panel performance is compared with reference methods of microbial culture as well as PCR/sequencing for AMR genes. In addition, BCID2 Panel MRSA results are compared with the FDA-cleared Xpert MRSA/SA BC system (Cepheid, Inc). Relevant bacterial isolates recovered from PBCs are also evaluated by various phenotypic antimicrobial susceptibility testing (AST) methods. The prospective evaluation is supplemented with a second study that involves testing of ~300 pre-selected, archived PBCs containing rare organisms. The third study includes over 500 seeded blood cultures containing very rare organisms with an evaluation of co-spiked samples. Results With over 1,200 samples tested to date (out of an anticipated 1,800 total), the BCID2 Panel has demonstrated an overall sensitivity of >98% and specificity of >99% for identification of microorganisms compared with culture. Concordance between the BCID2 Panel and the Xpert MRSA/SA BC test is >99% for identification of MRSA. Evaluation of BCID2 Panel AMR gene detection relative to AST and PCR is ongoing. Conclusion The FilmArray® BCID2 Panel appears to be a sensitive, specific, and robust test for rapid detection of microorganisms and MRSA in PBCs. With the use of this comprehensive test, improved antimicrobial stewardship is anticipated. Disclosures All authors: No reported disclosures

scholarly journals Rapid molecular detection of pathogenic microorganisms and antimicrobial resistance markers in blood cultures: evaluation and utility of the next-generation FilmArray Blood Culture Identification 2 panel

2021 ◽  
Author(s):  
Tanja Holma ◽  
Jukka Torvikoski ◽  
Nathalie Friberg ◽  
Annika Nevalainen ◽  
Eveliina Tarkka ◽  
...  
Keyword(s):  
Antimicrobial Resistance ◽  
Blood Culture ◽  
Sensitivity And Specificity ◽  
Blood Cultures ◽  
Next Generation ◽  
Gene Markers ◽  
Rdna Sequencing ◽  
Antimicrobial Resistance Genes ◽  
Resistance Markers ◽  
Culture Identification

AbstractRapid detection of pathogens causing bloodstream infections (BSI) directly from positive blood cultures is of highest importance in order to enable an adequate and timely antimicrobial therapy. In this study, the utility and performance of a recently launched next-generation fully automated test system, the Biofire FilmArray® Blood Culture Identification 2 (BCID2) panel, was evaluated using a set of 103 well-characterized microbial isolates including 29 antimicrobial resistance genes and 80 signal-positive and 23 signal-negative clinical blood culture samples. The results were compared to culture-based reference methods, MALDI-TOF, and/or 16S rDNA sequencing. Of the clinical blood culture samples, 68 were monomicrobial (85.0%) and 12 polymicrobial (15.0%). Six samples contained ESBL (blaCTX-M), two MRSA (mecA), and three MRSE (mecA) isolates. In overall, the FilmArray BCID2 panel detected well on-panel targets and resistance markers from mono- and polymicrobial samples. However, one Klebsiella aerogenes and one Bacteroides ovatus were undetected, and the assay falsely reported one Shigella flexneri as Escherichia coli. Hence, the sensitivity and specificity for detecting microbial species were 98.8% (95%CI, 95.8–99.9%) and 99.9% (95%CI, 99.8–99.9%), respectively. The sensitivity and specificity for detecting of resistance gene markers were 100%. The results were available within 70 min from signal-positive blood cultures with minimal hands-on time. In conclusion, the BCID2 test allows reliable and simplified detection of a vast variety of clinically relevant microbes causing BSI and the most common antimicrobial resistance markers present among these isolates.

scholarly journals Evaluation of the BioFire® FilmArray® Blood Culture Identification Panel on positive blood cultures in a regional hospital laboratory in KwaZulu-Natal

2016 ◽  
Vol 5 (1) ◽  
Author(s):  
Mokshanand Fhooblall ◽  
Fikile Nkwanyana ◽  
Koleka P. Mlisana
Keyword(s):  
Blood Culture ◽  
Antimicrobial Susceptibility ◽  
Reference Method ◽  
Blood Cultures ◽  
Combination Methods ◽  
Single Organism ◽  
Hospitalised Patients ◽  
Short Run ◽  
Culture Identification ◽  
Study Laboratory

Background: There are presently many non-culture-based methods commercially available to identify organisms and antimicrobial susceptibility from blood culture bottles. Each platform has its benefits and limitations. However, there is a need for an improved system with minimal hands-on requirements and short run times.Objectives: In this study, the performance characteristics of the FilmArray® BCID Panel kit were evaluated to assess the efficiency of the kit against an existing system used for identification and antimicrobial susceptibility of organisms from blood cultures.Methods: Positive blood cultures that had initially been received from hospitalised patients of a large quaternary referral hospital in Durban, South Africa were processed as per routine protocol at its Medical Microbiology Laboratory. Positive blood cultures were processed on the FilmArray BCID Panel kit in parallel with the routine sample processing. Inferences were then drawn from results obtained.Results: Organism detection by the FilmArray BCID panel was accurate at 92.6% when organisms that were on the repertoire of the kit were considered, compared to the combination methods (reference method used in the study laboratory). Detection of the antimicrobial resistance markers provided by the panel and reference method demonstrated 100% consistency. Blood cultures with a single organism were accurately identified at 93.8% by FilmArray, while blood cultures with more than one organism were identified at 85.7%.Conclusion: The FilmArray BCID Panel kit is valuable for detection of organisms and markers of antibiotic resistance for an extensive range of organisms.

scholarly journals Clinical Evaluation of the iCubate iC-GPC Assay for Detection of Gram-Positive Bacteria and Resistance Markers from Positive Blood Cultures

2018 ◽  
Vol 56 (9) ◽  
Author(s):  
Paul A. Granato ◽  
Melissa M. Unz ◽  
Raymond H. Widen ◽  
Suzane Silbert ◽  
Stephen Young ◽  
...  
Keyword(s):  
Blood Culture ◽  
Staphylococcus Epidermidis ◽  
Bloodstream Infections ◽  
Blood Cultures ◽  
Gram Positive ◽  
Content Type ◽  
Gram Positive Bacteria ◽  
Sequencing Method ◽  
Resistance Markers ◽  
Gram Positive Cocci

ABSTRACT The iC-GPC Assay (iCubate, Huntsville, AL) is a qualitative multiplex test for the detection of five of the most common Gram-positive bacteria (Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Enterococcus faecalis, and Enterococcus faecium) responsible for bacterial bloodstream infections, performed directly from positive blood cultures. The assay also detects the presence of the mecA, vanA, and vanB resistance determinants. This study comparatively evaluated the performance of the iC-GPC Assay against the Verigene Gram-positive blood culture (BC-GP) assay (Luminex Corp., Austin, TX) for 1,134 patient blood culture specimens positive for Gram-positive cocci. The iC-GPC Assay had an overall percent agreement with the BC-GP assay of 95.5%. Discordant specimens were further analyzed by PCR and a bidirectional sequencing method. The results indicate that the iC-GPC Assay together with the iCubate system is an accurate and reliable tool for the detection of the five most common Gram-positive bacteria and their resistance markers responsible for bloodstream infections.

scholarly journals Detection of Neisseria meningitidis from Negative Blood Cultures and Cerebrospinal Fluid with the FilmArray Blood Culture Identification Panel

2014 ◽  
Vol 52 (6) ◽  
pp. 2262-2264 ◽  
Author(s):  
J. Pardo ◽  
K. P. Klinker ◽  
S. J. Borgert ◽  
B. M. Butler ◽  
K. H. Rand ◽  
...  
Keyword(s):  
Cerebrospinal Fluid ◽  
Blood Culture ◽  
Neisseria Meningitidis ◽  
Blood Cultures ◽  
Culture Identification

scholarly journals Antimicrobial Stewardship Opportunities in Patients with Bacteremia Not Identified by BioFire FilmArray

2019 ◽  
Vol 57 (5) ◽  
Author(s):  
P. Ny ◽  
A. Ozaki ◽  
J. Pallares ◽  
P. Nieberg ◽  
A. Wong-Beringer
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Blood Culture ◽  
Intensive Care Unit Admission ◽  
Clinical Characteristics ◽  
Length Of Hospital Stay ◽  
Blood Cultures ◽  
Rapid Diagnostics ◽  
Admission Data ◽  
Culture Identification

ABSTRACTA subset of bacteremia cases are caused by organisms not detected by a rapid-diagnostics platform, BioFire blood culture identification (BCID), with unknown clinical characteristics and outcomes. Patients with ≥1 positive blood culture over a 15-month period were grouped by negative (NB-PC) versus positive (PB-PC) BioFire BCID results and compared with respect to demographics, infection characteristics, antibiotic therapy, and outcomes (length of hospital stay [LOS] and in-hospital mortality). Six percent of 1,044 positive blood cultures were NB-PC. The overall mean age was 65 ± 22 years, 54% of the patients were male, and most were admitted from home; fewer NB-PC had diabetes (19% versus 31%,P= 0.0469), although the intensive care unit admission data were similar. Anaerobes were identified in 57% of the bacteremia cases from the NB-PC group by conventional methods:Bacteroidesspp. (30%),Clostridium(11%), andFusobacteriumspp. (8%). Final identification of the NB-PC pathogen was delayed by 2 days (P< 0.01) versus the PB-PC group. The sources of bacteremia were more frequently unknown for the NB-PC group (32% versus 11%,P< 0.01) and of pelvic origin (5% versus 0.1%,P< 0.01) compared to urine (31% versus 9%,P< 0.01) for the PB-PC patients. Fewer NB-PC patients received effective treatment before (68% versus 84%,P= 0.017) and after BCID results (82% versus 96%,P= 0.0048). The median LOS was similar (7 days), but more NB-PC patients died from infection (26% versus 8%,P< 0.01). Our findings affirm the need for the inclusion of anaerobes in BioFire BCID or other rapid diagnostic platforms to facilitate the prompt initiation of effective therapy for bacteremia.

scholarly journals Impact of Direct From Blood Culture Identification of Pathogens Paired With Antimicrobial Stewardship Interventions in a Pediatric Hospital

2021 ◽  
Vol 26 (8) ◽  
pp. 802-808
Author(s):  
Lauren M. Puckett ◽  
Poonam Rajkotia ◽  
Lisa Coppola ◽  
Lori Baumgartner ◽  
Amity L. Roberts ◽  
...  
Keyword(s):  
Blood Culture ◽  
Positive Blood Culture ◽  
Pediatric Patients ◽  
Clinical Decision Making ◽  
Blood Cultures ◽  
Improvement Project ◽  
Maldi Tof ◽  
Culture Identification ◽  
Contaminated Blood ◽  
Organism Identification

OBJECTIVE Identification of organisms directly from positive blood culture by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) has the potential for improved clinical outcomes through earlier organism identification and shorter time to appropriate clinical intervention. The uses of this technology in pediatric patients and its impact in this patient population have not been well described. METHODS Direct from positive blood culture organism identification via MALDI-TOF was implemented in September 2019. A quality improvement project was performed to assess its impact on admissions for contaminant blood cultures and time to effective and optimal antimicrobials and clinical decision-making. A pre- and post-implementation retrospective review for consecutive September through February time periods, was conducted on patients with positive monomicrobial blood cultures. Statistics were evaluated using Mann-Whitney U and χ2 tests. RESULTS One hundred nineteen patients with 131 unique blood cultures (65 in pre- and 66 in post-implementation) were identified. Time to identification was shorter, median 35.4 hours (IQR, 22.7–54.3) versus 42.3 hours (IQR, 36.5–49) in post- and pre-groups, respectively (p = 0.02). Patients were less likely to be admitted for a contaminated blood culture in the post-implementation, 26% versus 11% in the pre-implementation (p = 0.03) group. In patients treated for bacteremia, there was a shorter time to optimal therapy from Gram stain reporting in the post-implementation (median 42.7 hours [IQR, 27.2–72]) versus pre-implementation (median 60.8 hours [IQR, 42.9–80.6]) (p = 0.03). CONCLUSIONS Direct from positive blood culture identification by MALDI-TOF decreased time to effective and optimal antimicrobials and decreased unnecessary admission in pediatric patients for contaminated blood cultures.

scholarly journals 300. Pediatric Center Evaluation of the BioFire® Blood Culture Identification 2 Panel Versus the Original BioFire®FilmArray® Blood Culture Identification Panel for the Detection of Microorganisms and Resistance Markers in Positive Blood Cultures

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S148-S149
Author(s):  
Kristina B Pierce ◽  
Rebecca Barr ◽  
Aubrie Hopper ◽  
Charlotte Bowerbank ◽  
Anne Shaw ◽  
...  
Keyword(s):  
Blood Culture ◽  
False Negative ◽  
Bloodstream Infections ◽  
Turnaround Time ◽  
Rapid Identification ◽  
Blood Cultures ◽  
Species Level ◽  
Genus Level ◽  
Antimicrobial Resistance Genes ◽  
Culture Identification

Abstract Background Studies show a rising annual incidence of severe sepsis, with bloodstream infections continuing to impact children. Rapid identification of causative agents and timely administration of targeted therapy can positively impact patient outcomes and improve antibiotic stewardship. The BioFire® Blood Culture Identification 2 (BCID2) Panel (BioFire Diagnostics, LLC), an updated version of the FDA-cleared BioFire® FilmArray® Blood Culture Identification (BCID) Panel, designed for use on positive blood cultures (PBCs), assesses 43 analytes, including 17 novel analytes (8 bacterial, 2 fungal, and 7 antimicrobial resistance genes), with a similar turnaround time. Methods De-identified residual PBCs for which clinician-ordered testing per standard of care (SoC) had been performed were enrolled and tested with an Investigation-Use-Only version of the BCID2 Panel. Only one positive bottle per patient was enrolled. Results of BCID2 and BCID were compared. Results 116 PBCs (48 aerobic and 68 anaerobic) were evaluated using the BioFire BCID2 Panel and results were compared to the BioFire BCID Panel. Of the 116 cases, 103 were positive on both the BioFire BCID2 Panel and the BioFire BCID Panel. Ten cases were negative on both tests. While the two panels showed 97% agreement, three cases were discrepant. Using culture (SoC) as the tiebreaker, two cases were false positive and one case was false negative on the BioFire BCID Panel. In all three cases, results from culture and the BioFire BCID2 Panel were in agreement. As expected, no organisms were detected on the BioFire BCID2 Panel in PBCs from 10% (12/116) of PBC bottles where culture identified only organisms that are not part of the panel menu. With the BioFire BCID2 Panel’s expanded platform, two cases identified as Enterobacteriaceae on the BioFire BCID Panel were identified to the genus level on the BioFire BCID2 Panel; 31 cases detected to the genus level on the BioFire BCID Panel were identified to the species level on the BioFire BCID2 Panel. Conclusion Overall, the BioFire BCID2 Panel performed well against the BioFire BCID Panel for identification of bloodstream pathogens and provided additional discrimination of some pathogens to the genus or species level. Data presented are from assays that have not been cleared or approved for diagnostic use. Disclosures All Authors: No reported disclosures

scholarly journals 11. Evaluation of the Bact/alert® VIRTUO™ in Terms of Time to Detection, Performance, Workflow Efficiency and Impact on Patient Management, Compared to the BACTEC™ FX Automated Blood Culture System

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S7-S7
Author(s):  
Ana V Halperin ◽  
José Luis Cortés Cuevas ◽  
Juan Antonio Del Castillo Polo ◽  
Miriam Cuesta ◽  
Sergio Talens ◽  
...  
Keyword(s):  
Blood Culture ◽  
Large Scale ◽  
Clinical Performance ◽  
Bloodstream Infections ◽  
Blood Cultures ◽  
Causative Organism ◽  
Research Support ◽  
Hands On ◽  
Time To Detection ◽  
Research Grant

Abstract Background Bloodstream infections are associated with high rates of morbidity and mortality, therefore prompt identification and antimicrobial susceptibility testing of the causative organism(s) are critical. We compared the microbiological/clinical performance of BacT/ALERT®-VIRTUO™-(BioMerieux) to that of the BACTEC™FX-(BD) instrument, with time-to-detection (TTD, from loading into system until positivity) as the primary outcome. Secondary microbiological outcomes were positivity and contamination rates, hands-on-time, turn-around-time (TAT) and time-to-identification. Methods We performed a prospective cross-over study using blood cultures from patients (&gt;18 years) suspected of bacteremia/fungemia, localized in different wards into two strata (Stratum-1: Emergency Department-ED-; Stratum-2: in-hospital patients). Testing was performed in BACTEC™-PlusAerobic/F and BACTEC-Lytic/10-Anaerobic/F bottles and incubated in BACTEC™FX, or BacT/ALERT®FA-Plus and FN-Plus bottles and incubated in VIRTUO™. Initially, each strata was randomly assigned to one of the incubators and then alternated every 2-weeks for 6 months (October-16th-2018 to April-16th-2019). All samples were processed in parallel with the same work-flow from the moment they were flagged positive. Maximum incubation time was 5 days. Results We included a total of 4782 extractions (9510 bottles) in VIRTUO and 5139 (10193 bottles) in BACTEC. The median age was 67 years for both groups and the samples were equally distributed for each ward (ED: VIRTUO 80.9%, BD 76.4%). The number of blood cultures with at least one positive extraction was 873(18.3%) for VIRTUO and 802(15.6%) for BACTEC (p=0.0003). TTD and proportion of aerobic/anaerobic bottles is shown in Table. Hands-on-time was reduced by 15 minutes/day when using VIRTUO. Table Conclusion We have compared on a large scale and in a “real world” setting the performance of two automatic blood culture incubators. TTD was significantly lower for the VIRTUO incubated samples, with differences in both systems depending on the type of bottle (aerobic vs. anaerobic). The number of positive results was significantly higher for the VIRTUO incubated samples, which might impact antimicrobial prescription and clinical outcomes. Disclosures Ana V. Halperin, MD, Biomérieux (Grant/Research Support) José Luis Cortés Cuevas, MD, biomerieux (Research Grant or Support)biomerieux (Research Grant or Support) Juan Antonio Del Castillo Polo, MD, Biomérieux (Research Grant or Support) Sergio Talens, n/a, Biomerieux (Research Grant or Support) Robert Birch, n/a, bioMerieux Inc. (Employee) Rafael Cantón, PharmD PhD, Biomérieux (Grant/Research Support)

Sign in / Sign up

Export Citation Format

Share Document