Search

Introduction: The ARIES® HSV 1&2 Assay is a new FDA cleared real-time PCR test for detection and differentiation of HSV-1 and HSV-2 DNA from cutaneous and mucocutaneous lesions. The test is performed on the ARIES® System, an automated sample to answer real-time PCR instrument that provides a closed system and simple workflow for performing molecular testing.Areas covered: This article reports the clinical performance of the ARIES® HSV 1&2 Assay assessed on 1963 prospectively collected specimens. Assay sensitivities were 91.1–95% (cutaneous) and 97–98.5% (mucocutaneous), and specificities were 88.8–94.2% (cutaneous) and 93.2–95.4% (mucocutaneous), as compared to the ELVIS® HSV test system.Expert commentary: Detection of HSV DNA by PCR is rapid and more sensitive than traditional culture and immunoassay methods and is being widely adopted in many laboratory settings. Sample to answer molecular platforms like ARIES® will enable routine and non-molecular labs to perform sensitive and rapid molecular t...

Health-care and public health professionals rely on accurate, real-time monitoring of infectious diseases for outbreak preparedness and response. Early detection of outbreaks is improved by systems that are pathogen-specific. We describe a system, FilmArray®Trend, for rapid disease reporting that is syndrome-based but pathogen-specific. Results from a multiplex molecular diagnostic test are sent directly to a cloud database.www.syndromictrends.compresents these data in near real-time. Trend preserves patient privacy by removing or obfuscating patient identifiers. We summarize the respiratory pathogen results, for 20 organisms from 344,000 patient samples acquired as standard of care testing over the last four years from 20 clinical laboratories in the United States. The majority of pathogens show influenza-like seasonality, rhinovirus has fall and spring peaks and adenovirus and bacterial pathogens show constant detection over the year. Interestingly, the rate of pathogen co-detections, on average 7.7%, matches predictions based on the relative abundance of organisms present.

Background Culture-based bacterial identification is important in the management of infections, but can be a laborious effort and can be limited by prior antibiotic (abx) use. There is limited data on the clinical value and effective implementation of 16s ribosomal RNA PCR (16s). The objective is to describe cases in which 16s was used in suspected infections. Methods Descriptive analysis of all culture-negative cases of suspected infections in a large tertiary hospital where 16s was utilized from January 1, 2014 to Jul 13, 2016, was performed as part of an IRB-approved study. Test was performed by an outside laboratory when requested by an ID specialist, and bacterial cultures were negative (-) for at least 72 hours in sterile body fluid or tissue specimens. Results 16s was used in 70 cases: 24/70 (34.3%) were positive (+) with 20 (83.3%) having received prior antibiotics. At least 1change in abx plan was made in 17 (70.8%) cases: 14 changed to narrower spectrum and 6 in duration. Among (−) 16s, 14/36 (30.4%) had at least 1change in abx plan (8/14 stopping abx, 4/14 to narrower spectrum). Fever (> T 100.3F) within 24 hours of admission was more common in (+) vs. (-) 16s (9/24 vs. 3/46, P = 0.01). Number of abx changes was higher in (+) than (-) 16s (1.6 ± 1.2 [SD] vs. 0.8 ± 0.9 [SD], P = 0.004). Rate of empiric non-targeted antibiotic use after ID consult, was not different in (+) vs (−)16s (0.6 ± 0.4 vs. 0.7 ± 0.4, P = 0.34). Hospital stay was longer with (+) vs (−) 16s (12.7 ± 7.4 [SD] vs. 8.4 ± 5.3 [SD] days, P = 0.007).This was probably affected by the underlying diagnoses and illness severity. Mean turnaround time for results was 10.8 days (3–25, range). Yield of test was high in empyema (80%). Many of the isolated organisms were Streptococcus sp. and anaerobes. Conclusion 16s in culture-negative specimens can lead to specific microbiologic diagnosis in 34% of cases despite 80% receiving antibiotics prior to sampling. Changes in abx plan occurred in 44% of all cases. Within (-) 16s results, 30.4% had a change in abx plan, 17.4% having discontinued abx. Streptococcus sp. and anaerobes were the commonly isolated organisms and with highest test yield in empyema.16s has clinical utility that may be even greater if the turnaround time is shortened. Disclosures All authors: No reported disclosures.

Background: Health care and public health professionals rely on accurate, real-time monitoring of infectious diseases for outbreak preparedness and response. Early detection of outbreaks is improved by systems that are comprehensive and specific with respect to the pathogen but are rapid in reporting the data. It has proven difficult to implement these requirements on a large scale while maintaining patient privacy. Objective: The aim of this study was to demonstrate the automated export, aggregation, and analysis of infectious disease diagnostic test results from clinical laboratories across the United States in a manner that protects patient confidentiality. We hypothesized that such a system could aid in monitoring the seasonal occurrence of respiratory pathogens and may have advantages with regard to scope and ease of reporting compared with existing surveillance systems. Methods: We describe a system, BioFire Syndromic Trends, for rapid disease reporting that is syndrome-based but pathogen-specific. Deidentified patient test results from the BioFire FilmArray multiplex molecular diagnostic system are sent directly to a cloud database. Summaries of these data are displayed in near real time on the Syndromic Trends public website. We studied this dataset for the prevalence, seasonality, and coinfections of the 20 respiratory pathogens detected in over 362,000 patient samples acquired as a standard-of-care testing over the last 4 years from 20 clinical laboratories in the United States. Results: The majority of pathogens show influenza-like seasonality, rhinovirus has fall and spring peaks, and adenovirus and the bacterial pathogens show constant detection over the year. The dataset can also be considered in an ecological framework; the viruses and bacteria detected by this test are parasites of a host (the human patient). Interestingly, the rate of pathogen codetections, on average 7.94% (28,741/362,101), matches predictions based on the relative abundance of organisms present. Conclusions: Syndromic Trends preserves patient privacy by removing or obfuscating patient identifiers while still collecting much useful information about the bacterial and viral pathogens that they harbor. Test results are uploaded to the database within a few hours of completion compared with delays of up to 10 days for other diagnostic-based reporting systems. This work shows that the barriers to establishing epidemiology systems are no longer scientific and technical but rather administrative, involving questions of patient privacy and data ownership. We have demonstrated here that these barriers can be overcome. This first look at the resulting data stream suggests that Syndromic Trends will be able to provide high-resolution analysis of circulating respiratory pathogens and may aid in the detection of new outbreaks.