Multicenter Evaluation of the BIOFIRE Blood Culture Identification 2 Panel for Detection of Bacteria, Yeasts, and Antimicrobial Resistance Genes in Positive Blood Culture Samples.

Diagnostic tools that can rapidly identify and characterize microbes growing in blood cultures are important components of clinical microbiology practice because they help to provide timely information that can be used to optimize patient management. This publication describes the bioMérieux BIOFIRE Blood Culture Identification 2 (BCID2) Panel clinical study that was submitted to the U.S. Food & Drug Administration. Results obtained with the BIOFIRE BCID2 Panel were compared to standard-of-care (SoC) results, sequencing results, PCR results, and reference laboratory antimicrobial susceptibility testing results to evaluate the accuracy of its performance. Results for 1,093 retrospectively and prospectively collected positive blood culture samples were initially enrolled, and 1,074 samples met the study criteria and were included in the final analyses. The BIOFIRE BCID2 Panel demonstrated an overall sensitivity of 98.9% (1,712/1,731) and an overall specificity of 99.6% (33,592/33,711) for Gram-positive bacteria, Gram-negative bacteria and yeast targets which the panel is designed to detect. One hundred eighteen off-panel organisms, which the BIOFIRE BCID2 Panel is not designed to detect, were identified by SoC in 10.6% (114/1,074) of samples. The BIOFIRE BCID2 Panel also demonstrated an overall positive percent agreement (PPA) of 97.9% (325/332) and an overall negative percent agreement (NPA) of 99.9% (2,465/2,767) for antimicrobial resistance determinants which the panel is designed to detect. The presence or absence of resistance markers in Enterobacterales correlated closely with phenotypic susceptibility and resistance. We conclude that the BIOFIRE BCID2 Panel produced accurate results in this clinical trial.

Direct MALDI-TOF MS and Antimicrobial Susceptibility Testing of Positive Blood Cultures Using the FASTTM System and FAST-PBC Prep Cartridges-Performance Evaluation in a Clinical Microbiology Laboratory Serving High-Risk Patients.

Bloodstream infections are a leading cause of morbidity and mortality. The rapid diagnostic testing of positive blood cultures (PBCs) shortens times to effective therapy and the de-escalation of broad-spectrum empiric therapy. This is the first study examining the Qvella FASTTM System for the rapid (~20 min) purification of microorganisms directly from PBCs using BacT/Alert® FA/FAN bottles in the bioMérieux Virtuo instrument. We compared the performance of the FASTTM System Liquid ColonyTM (LC), for immediate downstream ID and phenotypic AST, to standard workflow involving colonies obtained by overnight subculture. The LC yielded a concordant species ID by VITEK MS in 121/138 (87.7%) samples, identifying 32 different Gram-positive and Gram-negative species with 3/123 (2.6%) discordances. Compared to standard workflow, direct AST of the LC using VITEK® 2 yielded 98.4% categorical agreement and 98.0% essential agreement. Very major error, major error, and minor error rates were 1.0%, 0.0%, and 1.8%, respectively, for Gram-negative organisms; and 1.9%, 0.2%, and 1.2%, respectively, for Gram-positive organisms. The median times from positive blood culture flag to results by FASTTM System for ID and AST were 7.8 h and 15.7 h, respectively, versus 22.4 h and 36.6 h for standard workflow, respectively. In conclusion, the FASTTM System provides reliable results for direct ID and AST from PBCs with significantly decreased turnaround times.

Lightweight UV-C disinfection system.

UV-C exposure is an effective disinfectant for a range of bacteria and viruses. As such, UV-C treatment, in combination with a chemical wipe, is a common cleaning protocol in medical facilities. Given the increase in severe bacterial and viral agents in society, having access to environmentally friendly disinfectant methods is of increasing interest. In response, we designed, constructed, and validated a UV-C disinfection system from readily accessible components. To improve the UV-C intensity, the enclosure interior was coated with chrome paint. The system is validated using Bacillus cereus, a gram-positive endospore-forming bacteria.

Statistical 3D Distribution Analysis of Prostate Cancers in Korean Using Digital Processing Techniques.

OBJECTIVES: Several researchers have shown that three dimensional (3D) distribution analysis of prostate cancer is helpful when initiating needle biopsy procedures. Knowledge regarding the distribution of prostate cancer could enhance understanding of the pathophysiology involved and improve detection of these malignancies. We propose utilizing digital processing techniques to analyze prostate cancer distribution in a 3D setting. METHODS: Pre-made radical prostatectomy sample slices were digitized with a resolution of 76 dpi. Slices of each sample were aligned and registered by deformation algorithm and interpolated for analysis of relative distribution statistics. We analyzed 80 samples saved in electronic medical record and compared the detection rate of preoperative needle biopsies and radical prostatectomies using our 3D analysis technique. RESULTS: The statistical 3D distribution of prostate cancer was evaluated using a 36-sector process. Results were represented in the following two ways: distribution of a single patient, and statistical distribution of prostate cancers of multiple patients. The overall concordance rate was 62.7% between the two methods; therefore a technique is needed which can raise this percentage. CONCLUSIONS: We suggest using the normalization method to develop a software tool which permits reconstruction of the 3D distribution of prostate cancer from 2D legacy images and reduces the loss of image quality as well. This application will facilitate detection of prostate cancer by aiding in the determination of the most effective clinical position via partial sampling with decreased patient inconvenience.

Limited sampling of radical prostatectomy specimens with excellent preservation of prognostic parameters of prostate cancer.

CONTEXT: The widespread use of the serum prostate-specific antigen test has increased the early detection of prostate cancer and consequently reduced grossly definable prostate cancers. OBJECTIVE: To find the most efficient gross sampling method for radical prostatectomy specimens not only preserving important prognostic factors but also being cost effective. DESIGN: We initially analyzed clinicopathologic features of the entire prostate sections from 148 radical prostatectomy specimens, which then were used to examine the impact of 5 partial sampling methods on tumor stage, Gleason score, extraprostatic extension, resection margin status, and paraffin block numbers. The methods included submission of (1) alternative slices, (2) alternative slices plus biopsy-positive posterior quarters, (3) every posterior half, (4) every posterior half plus one midanterior half, and (5) alternative slices plus peripheral 3-mm rim of the remaining prostate. RESULTS: Prostate cancers and their extraprostatic extension and resection margin involvement were commonly located in the right posterior portion of the prostate. Method 5 was most efficient, detecting all cases with extraprostatic extension and resection margin involvement and reducing 25% of paraffin blocks compared with the entire sampling of the prostate. The Gleason scores were retained in most of cases, except reversal of the primary and secondary Gleason grade component in only 2 cases (1%). Only 4 cases (3%) were downstaged within the same T2 stage. CONCLUSIONS: These results demonstrate that sampling of alternative slices plus peripheral rim of the remaining prostate is the most efficient partial sampling method for radical prostatectomy specimens.