Dataset Information

Multicenter Clinical Evaluation of BacT/Alert Virtuo Blood Culture System.

ABSTRACT: BacT/Alert Virtuo is an advanced, automated blood culture system incorporating improved automation and an enhanced detection algorithm to shorten time to detection. A multicenter study of the investigational Virtuo system (bioMérieux, Inc., Durham, NC) compared to BacT/Alert 3D (BTA3D) for detection of bacteremia/fungemia in four bottle types, SA and FA Plus (aerobic) and SN and FN Plus (anaerobic), was performed in a clinical setting with patient samples in a matched system design clinical trial. Blood was added to paired aerobic or anaerobic bottles, with the volume in each bottle in each pair required to be ?10 ml and with the volumes required to be within 30% of each other. Of 5,709 bottle sets (52.5% aerobic pairs and 47.5% anaerobic pairs), 430 (7.5%) were positive for bacterial or fungal growth, with 342 (6.0%) clinically significant and 83 (1.5%) contaminated. A total of 3,539 sets (62.0%) were volume compliant, with 203 sets (5.7%) clinically significant. The positivity rates for volume-compliant bottle pairs determined by the two systems were comparable, with 68.7% of clinically significant isolates detected by both instruments, 15.7% by Virtuo only, and 15.7% by BTA3D only. Virtuo detected microbial growth nearly 2 h sooner overall than BTA3D (mean, 15.9 h versus 17.7 h). Shorter time to detection by Virtuo was related to organism group, with the time to detection being significantly shorter for enteric Gram-negative bacilli and enterococci (means, 3.6 h and 2.3 h shorter, respectively). This large clinical study demonstrated that the Virtuo blood culture system produced results comparable to those seen with the long-established BTA3D system, with significantly shorter time to detection.

SUBMITTER: Jacobs MR

PROVIDER: S-EPMC5527419 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Multicenter Clinical Evaluation of BacT/Alert Virtuo Blood Culture System.

Jacobs Michael R MR Mazzulli Tony T Hazen Kevin C KC Good Caryn E CE Abdelhamed Ayman M AM Lo Pauline P Shum Bianche B Roman Katharine P KP Robinson Danielle C DC

Journal of clinical microbiology 20170524 8

BacT/Alert Virtuo is an advanced, automated blood culture system incorporating improved automation and an enhanced detection algorithm to shorten time to detection. A multicenter study of the investigational Virtuo system (bioMérieux, Inc., Durham, NC) compared to BacT/Alert 3D (BTA3D) for detection of bacteremia/fungemia in four bottle types, SA and FA Plus (aerobic) and SN and FN Plus (anaerobic), was performed in a clinical setting with patient samples in a matched system design clinical tria ...[more]

PMID: 28539343

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Project description:Background: The aim of this study was to evaluate the clinical performance of VersaTrek 528 compared to BACTEC FX 400 blood culture (BC) systems. Materials and Methods: Simulated and clinically obtained BCs were used in the study. Confirmed bacterial species (n = 78), including 43 Gram-positives, 30 Gram-negatives, and 5 Candida albicans strains, were each inoculated into BC bottles. Clinically obtained BCs were subdivided into two groups, A and B. In group A were 72 BC sets (pair: aerobic and anaerobic) in which a set inoculated with 5 ml blood was processed in the VersaTrek BC system, whilst the one inoculated with 10 ml blood was processed in the FX BC system. In group B, 76 BC sets (pairs) corresponding to 152 VersaTrek bottles and 152 FX bottles were inoculated with the same volume (10 ml) of blood, and processed in each system. Results: In the simulated BC study, 90% (63/70) of the VersaTrek aerobic bottles were positive, which was higher than that of FX 400 (59/70, 84%), but was not statistically significant (P = 0.423). In contrast, FX 400 anaerobic bottles had a higher positive rate than the other BC system (84 vs. 77%), although it was statistically insignificant (P = 0.267). Time to detection of organisms in the two BCs was comparable for both aerobic (P = 0.131) and anaerobic bottles (P = 0.104). In clinical BCs of group A, FX BC system had slightly higher positive rates for both aerobic (11.1 vs. 9.7%, P = 0.312) and anaerobic (8.3 vs. 6.9%, P = 0.375) bottles. However, the difference was not statistically significant. In group B, VersaTrek aerobic bottles had a higher positive rate compared to the other BC system (10.5 vs. 5.2%, P = 0.063). In terms of positive rates of sub-studies A and B, VersaTrek and FX BC systems were comparable. Conclusion: There was no significant difference between the two BC systems in the detection of bacteria and fungi in simulated BCs. In clinical BCs, the performance of the VersaTrek BC system, with inoculation of 5 or 10 ml patient's blood, was comparable to the FX system with inoculation of 10 ml patient's blood.

Dataset Information

Multicenter Clinical Evaluation of BacT/Alert Virtuo Blood Culture System.

Publications

Multicenter Clinical Evaluation of BacT/Alert Virtuo Blood Culture System.

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