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Random access molecular diagnostics – Increased efficiency in laboratory workflow and translation of reduced result turnaround time to patient benefit
Abstracts / Journal of Clinical Virology 82S (2016) S1–S142
Reference [1] E. Brown, S. Lawson, C. Welbon, J. Gnanandarajah, J. Li, M.P. Murtaugh, E.A. Nelson, R.M. Molina, J.J. Zimmerman, R.R. Rowland, Y. Fang, Antibody response to porcine reproductive and respiratory syndrome virus (PRRSV) nonstructural proteins and implications for diagnostic detection and differentiation of PRRSV types I and II, Clin. Vaccine Immunol. 16 (2009) 628–635. [2] J.Q. Chu, X.M. Hu, M.C. Kim, C.S. Park, M.H. Jun, Development and validation of a recombinant nucleocapsid protein-based ELISA for detection of the antibody to porcine reproductive and respiratory syndrome virus, J. Microbiol. 47 (2009) 582–588.
http://dx.doi.org/10.1016/j.jcv.2016.08.091 Abstract no: 52 Presentation at ESCV 2016: Poster 52 Random access molecular diagnostics – Increased efficiency in laboratory workflow and translation of reduced result turnaround time to patient benefit G. Clark ∗ , L. Anderson-Cable, M. Diggle Nottingham University Hospitals NHS Trust, United Kingdom The advent of molecular diagnostics for infectious diseases was accompanied by the ability to drastically reduce the time taken to produce a diagnostic result, with tangible benefits to the patient pathway such as rapid administration of treatment and timely infection control intervention. However, the majority of molecular diagnostic platforms for the diagnosis of infectious disease are reliant upon batch processing in order to maximise cost effectiveness or due to limited availability of staff. This batch processing workflow limits the possible reductions in result turnaround time and thus potential benefits to the patient pathway. The DxN VERIS System by Beckman Coulter is a random access, real-time PCR analyser for the combined extraction and quantitative analysis of pathogen nucleic acid in clinical samples. The system is designed to reduce staff hands on time and enable realtime testing of clinical samples. In order to evaluate potential reductions in turnaround time to result, improvements in laboratory workflow and the opportunity to re-optimise the skill mix of laboratory staff the DxN VERIS System was evaluated in parallel with current testing methodologies at the Nottingham University Hospitals Microbiology department. Of the four assays selected for comparison (HIV, hepatitis B, hepatitis C and CMV quantitation), significant reductions were demonstrated across all. Average turnaround time reductions ranged from 36 h for CMV results, to 190 h for hepatitis B results and in most cases with VERIS analysis a result would have been made available to the requesting clinician on the same day as the sample request. The issue of how result turnaround time directly affects the patient is often not considered when evaluating a diagnostic platform, but is becoming more important with recent initiatives to implement timely and appropriate antimicrobial treatment and necessary infection control precautions. The evaluation at Nottingham University Hospitals investigated this aspect further, evaluating individual patient cases and demonstrating how a reduction in turnaround time via random access testing could directly translate to a positive impact on the patient care pathway. Random access testing facilitates increased efficiency in the patient’s care, timely intervention with appropriate antiviral therapy and prompt decisions for future patient management. http://dx.doi.org/10.1016/j.jcv.2016.08.092
S47
Abstract no: 54 Presentation at ESCV 2016: Poster 53 Real-time multiplex PCR system detection of viruses and bacteria in blood from febrile infants <90 days of age A. Hemmert 1,∗ , B. Kensinger 1 , E. Lo 1 , J. Oblad 1 , G. Storch 2 , D. Schnadower 2 , R. Selvarangan 3 , F. Hassan 3 , L. Heuschen 3 , D. Thomas 4 , K. Newcomer 4 , J. Yi 5 , R. Jerris 5 , K. Stephens 5 , A. Leber 6 , D. Cohen 6 , J. Daly 7 , S. Holt 7 , K. Bouzac 1 , R. Crisp 1 1
BioFire Diagnostics, LLC, Salt Lake City, UT, USA Washington University School of Medicine, St. Louis, MO, USA 3 Children’s Mercy Hospital, Kansas City, MO, USA 4 Indiana University School of Medicine, IN, USA 5 Emory University School of Medicine, Atlanta, GA, USA 6 Nationwide Children’s Hospital, Columbus, OH, USA 7 Primary Children’s Hospital, Salt Lake City, UT, USA 2
Background: Fever in infants (<90 days old) is a common medical problem that accounts for a large proportion of pediatric emergency department visits. Because the symptoms displayed are often non-specific, it is difficult to distinguish between viral syndromes, serious bacterial infection (SBI), or non-infectious causes of fever. Clinicians currently rely on a combination of patient history, physical examination, and laboratory findings to identify patients that are at a high or low risk of SBI. While this methodology is intended to reduce unnecessary testing/treatment, most febrile infants still receive extensive evaluation as well as hospital admission until a bacterial infection can be ruled out. A rapid, easy-to-use, comprehensive diagnostic test could benefit patient care in this vulnerable population by potentially reducing antibiotic use or influencing hospital admission decisions. To aid in the etiological identification for this non-specific syndrome, BioFire Diagnostics is developing the FilmArray® Febrile Infant (FI) Panel for use on the FilmArray System. The FilmArray FI Panel simultaneously tests for six bacteria and ten viruses using 200 L of blood. Two minutes of hands-on time are required and comprehensive results are returned in about an hour. Materials and methods: 245 blood specimens from infants, ≤90 days, with either a fever (reported temperature > 38.0 ◦ C) or a blood/CSF culture where an SBI was suspected, were evaluated in this study. This study was approved by each participating sites institutional review board (IRB). Residual standard of care (SOC) specimens as well as prospectively collected samples were tested. Each blood sample was divided into two 250 L aliquots for FilmArray FI testing and independent comparator PCR testing. FilmArray FI results were compared to SOC laboratory results as well as verified with independent PCR comparator assays. Any discrepancies between the FilmArray FI Panel and comparator PCR were investigated with additional bi-directional PCR sequencing. Results: There were 80 detections of virus or bacteria, across the 245 blood specimens (33% positivity). Seventy-nine percent (79%, 63/80) were viruses and 21% were bacteria (17/80). The most frequently detected virus was enterovirus (17), followed by human herpesvirus 6 (16) and adenovirus (7). The most frequently detected bacteria were Streptococcus agalactiae (6), Escherichia coli (4), and Staphylococcus aureus (3). Blood culture identified 17 bacteria, seven of which were common skin contaminants such as Coagulase-negative Staphylococcus. FilmArray FI and blood culture were in agreement of 4 of 8 shared results. Dual viral and bacterial infections were observed in eight samples. The FilmArray FI Panel
Reference [1] E. Brown, S. Lawson, C. Welbon, J. Gnanandarajah, J. Li, M.P. Murtaugh, E.A. Nelson, R.M. Molina, J.J. Zimmerman, R.R. Rowland, Y. Fang, Antibody response to porcine reproductive and respiratory syndrome virus (PRRSV) nonstructural proteins and implications for diagnostic detection and differentiation of PRRSV types I and II, Clin. Vaccine Immunol. 16 (2009) 628–635. [2] J.Q. Chu, X.M. Hu, M.C. Kim, C.S. Park, M.H. Jun, Development and validation of a recombinant nucleocapsid protein-based ELISA for detection of the antibody to porcine reproductive and respiratory syndrome virus, J. Microbiol. 47 (2009) 582–588.
http://dx.doi.org/10.1016/j.jcv.2016.08.091 Abstract no: 52 Presentation at ESCV 2016: Poster 52 Random access molecular diagnostics – Increased efficiency in laboratory workflow and translation of reduced result turnaround time to patient benefit G. Clark ∗ , L. Anderson-Cable, M. Diggle Nottingham University Hospitals NHS Trust, United Kingdom The advent of molecular diagnostics for infectious diseases was accompanied by the ability to drastically reduce the time taken to produce a diagnostic result, with tangible benefits to the patient pathway such as rapid administration of treatment and timely infection control intervention. However, the majority of molecular diagnostic platforms for the diagnosis of infectious disease are reliant upon batch processing in order to maximise cost effectiveness or due to limited availability of staff. This batch processing workflow limits the possible reductions in result turnaround time and thus potential benefits to the patient pathway. The DxN VERIS System by Beckman Coulter is a random access, real-time PCR analyser for the combined extraction and quantitative analysis of pathogen nucleic acid in clinical samples. The system is designed to reduce staff hands on time and enable realtime testing of clinical samples. In order to evaluate potential reductions in turnaround time to result, improvements in laboratory workflow and the opportunity to re-optimise the skill mix of laboratory staff the DxN VERIS System was evaluated in parallel with current testing methodologies at the Nottingham University Hospitals Microbiology department. Of the four assays selected for comparison (HIV, hepatitis B, hepatitis C and CMV quantitation), significant reductions were demonstrated across all. Average turnaround time reductions ranged from 36 h for CMV results, to 190 h for hepatitis B results and in most cases with VERIS analysis a result would have been made available to the requesting clinician on the same day as the sample request. The issue of how result turnaround time directly affects the patient is often not considered when evaluating a diagnostic platform, but is becoming more important with recent initiatives to implement timely and appropriate antimicrobial treatment and necessary infection control precautions. The evaluation at Nottingham University Hospitals investigated this aspect further, evaluating individual patient cases and demonstrating how a reduction in turnaround time via random access testing could directly translate to a positive impact on the patient care pathway. Random access testing facilitates increased efficiency in the patient’s care, timely intervention with appropriate antiviral therapy and prompt decisions for future patient management. http://dx.doi.org/10.1016/j.jcv.2016.08.092
S47
Abstract no: 54 Presentation at ESCV 2016: Poster 53 Real-time multiplex PCR system detection of viruses and bacteria in blood from febrile infants <90 days of age A. Hemmert 1,∗ , B. Kensinger 1 , E. Lo 1 , J. Oblad 1 , G. Storch 2 , D. Schnadower 2 , R. Selvarangan 3 , F. Hassan 3 , L. Heuschen 3 , D. Thomas 4 , K. Newcomer 4 , J. Yi 5 , R. Jerris 5 , K. Stephens 5 , A. Leber 6 , D. Cohen 6 , J. Daly 7 , S. Holt 7 , K. Bouzac 1 , R. Crisp 1 1
BioFire Diagnostics, LLC, Salt Lake City, UT, USA Washington University School of Medicine, St. Louis, MO, USA 3 Children’s Mercy Hospital, Kansas City, MO, USA 4 Indiana University School of Medicine, IN, USA 5 Emory University School of Medicine, Atlanta, GA, USA 6 Nationwide Children’s Hospital, Columbus, OH, USA 7 Primary Children’s Hospital, Salt Lake City, UT, USA 2
Background: Fever in infants (<90 days old) is a common medical problem that accounts for a large proportion of pediatric emergency department visits. Because the symptoms displayed are often non-specific, it is difficult to distinguish between viral syndromes, serious bacterial infection (SBI), or non-infectious causes of fever. Clinicians currently rely on a combination of patient history, physical examination, and laboratory findings to identify patients that are at a high or low risk of SBI. While this methodology is intended to reduce unnecessary testing/treatment, most febrile infants still receive extensive evaluation as well as hospital admission until a bacterial infection can be ruled out. A rapid, easy-to-use, comprehensive diagnostic test could benefit patient care in this vulnerable population by potentially reducing antibiotic use or influencing hospital admission decisions. To aid in the etiological identification for this non-specific syndrome, BioFire Diagnostics is developing the FilmArray® Febrile Infant (FI) Panel for use on the FilmArray System. The FilmArray FI Panel simultaneously tests for six bacteria and ten viruses using 200 L of blood. Two minutes of hands-on time are required and comprehensive results are returned in about an hour. Materials and methods: 245 blood specimens from infants, ≤90 days, with either a fever (reported temperature > 38.0 ◦ C) or a blood/CSF culture where an SBI was suspected, were evaluated in this study. This study was approved by each participating sites institutional review board (IRB). Residual standard of care (SOC) specimens as well as prospectively collected samples were tested. Each blood sample was divided into two 250 L aliquots for FilmArray FI testing and independent comparator PCR testing. FilmArray FI results were compared to SOC laboratory results as well as verified with independent PCR comparator assays. Any discrepancies between the FilmArray FI Panel and comparator PCR were investigated with additional bi-directional PCR sequencing. Results: There were 80 detections of virus or bacteria, across the 245 blood specimens (33% positivity). Seventy-nine percent (79%, 63/80) were viruses and 21% were bacteria (17/80). The most frequently detected virus was enterovirus (17), followed by human herpesvirus 6 (16) and adenovirus (7). The most frequently detected bacteria were Streptococcus agalactiae (6), Escherichia coli (4), and Staphylococcus aureus (3). Blood culture identified 17 bacteria, seven of which were common skin contaminants such as Coagulase-negative Staphylococcus. FilmArray FI and blood culture were in agreement of 4 of 8 shared results. Dual viral and bacterial infections were observed in eight samples. The FilmArray FI Panel