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Background & Aims Currently available HDV PCR assays are characterized by considerable run-to-run and inter-laboratory variability. Hence, we established a quantitative RT-PCR assay on the open channel of a fully automated PCR platform (cobas6800, Roche) offering improved consistency and reliability. Methods A primer/probe-set targeting a highly conserved region upstream of the HDV-antigen was adapted for use on the cobas6800. The lower limit of detection (LOD) was determined using a dilution panel of the HDV WHO standard (n=21/dilution). Linearity and inclusivity were tested by preparing 10-fold dilution series (genotypes (GT) 1-8 cell culture-derived; n=5/dilution). Patient samples containing a variety of bloodborne viral pathogens were tested to confirm exclusivity (n=60). Results LOD of the HDV Utility-Channel assay (HDV_UTC) was determined as 3.86 IU/ml (95%-CI:2.95-5.05 IU/ml) with a linear range from 10-10ˆ8 IU/ml (GT1). Linear relationships were observed for all HDV GT with slopes ranging from -3.481 to -4.134 cycles/log and R2 from 0.918 to 0.994. Inter-run and intra-run variability was 0.3 and 0.6 Ct (3xLOD), respectively. No false-positive results were observed. To evaluate clinical performance, 110 serum samples of anti-HDV-Ab+ patients were analyzed using the HDV_UTC and CE-IVD RoboGene assay. 58/110 and 49/110 samples were concordant positive or negative, respectively (overall agreement 97,3%). Quantitative comparison demonstrated a strong correlation (r:0.922; 95%-CI:0.869-0.954; p-value:<0.0001). Conclusion The use of highly automated, sample-to-result solutions for molecular diagnostics holds many inherent benefits over manual workflows, including improved reliability, reproducibility and dynamic scaling of testing capacity. The assay we established showed excellent analytical and clinical performance, with inclusivity for all HDV GT and a limit of quantification of 10 IU/ml, making it a sensitive new tool for HDV screening and viral load monitoring. Lay Summary The hepatitis delta virus (HDV) causes a severe form of inflammation in the liver. We developed a tool for molecular diagnostics, a polymerase chain reaction HDV assay that showed great performance. It can be used to improve diagnosis of HDV, as well as for monitoring of treatment success. The assay allows for quantification of the virus in the tested samples and is performed on a fully automated platform (cobas6800), which provides various benefits including less hands-on time and excellent comparability of test results.
Lisa Sophie Pflüger; Dominik Nörz; Tassilo Volz; Katja Giersch; Annika Giese; Nora Goldmann; Dieter Glebe; Jan-Hendrik Bockmann; Susanne Pfefferle; Maura Dandri; Julian Schulze Zur Wiesch; Marc Lütgehetmann. Clinical establishment of a laboratory developed quantitative HDV PCR assay on the cobas6800 high-throughput system. JHEP Reports 2021, 1 .
AMA StyleLisa Sophie Pflüger, Dominik Nörz, Tassilo Volz, Katja Giersch, Annika Giese, Nora Goldmann, Dieter Glebe, Jan-Hendrik Bockmann, Susanne Pfefferle, Maura Dandri, Julian Schulze Zur Wiesch, Marc Lütgehetmann. Clinical establishment of a laboratory developed quantitative HDV PCR assay on the cobas6800 high-throughput system. JHEP Reports. 2021; ():1.
Chicago/Turabian StyleLisa Sophie Pflüger; Dominik Nörz; Tassilo Volz; Katja Giersch; Annika Giese; Nora Goldmann; Dieter Glebe; Jan-Hendrik Bockmann; Susanne Pfefferle; Maura Dandri; Julian Schulze Zur Wiesch; Marc Lütgehetmann. 2021. "Clinical establishment of a laboratory developed quantitative HDV PCR assay on the cobas6800 high-throughput system." JHEP Reports , no. : 1.
Critical Coronavirus disease 2019 (COVID-19) developed in a 7-year-old girl with a history of dystrophy, microcephaly, and central hypothyroidism. Starting with gastrointestinal symptoms, the patient developed severe myocarditis followed by progressive multiple organ failure complicated by Pseudomonas aeruginosa bloodstream infection. Intensive care treatment consisting of invasive ventilation, drainage of pleural effusion, and high catecholamine therapy could not prevent the progression of heart failure, leading to the implantation of venoarterial extracorporeal life support (VA-ECLS) and additional left ventricle support catheter (Impella® pump). Continuous venovenous hemofiltration (CVVH) and extracorporeal hemadsorption therapy (CytoSorb®) were initiated. Whole exome sequencing revealed a mutation of unknown significance in DExH-BOX helicase 30 (DHX30), a gene encoding a RNA helicase. COVID-19 specific antiviral and immunomodulatory treatment did not lead to viral clearance or control of hyperinflammation resulting in the patient’s death on extracorporeal life support-(ECLS)-day 20. This fatal case illustrates the potential severity of pediatric COVID-19 and suggests further evaluation of antiviral treatment strategies and vaccination programs for children.
Sofia Apostolidou; Theresa Harbauer; Peter Lasch; Daniel Biermann; Maja Hempel; Marc Lütgehetmann; Susanne Pfefferle; Jochen Herrmann; André Rüffer; Konrad Reinshagen; Rainer Kozlik-Feldmann; Anna Gieras; Inga Kniep; Jun Oh; Dominique Singer; Chinedu Ebenebe; Robin Kobbe. Fatal COVID-19 in a Child with Persistence of SARS-CoV-2 Despite Extensive Multidisciplinary Treatment: A Case Report. Children 2021, 8, 564 .
AMA StyleSofia Apostolidou, Theresa Harbauer, Peter Lasch, Daniel Biermann, Maja Hempel, Marc Lütgehetmann, Susanne Pfefferle, Jochen Herrmann, André Rüffer, Konrad Reinshagen, Rainer Kozlik-Feldmann, Anna Gieras, Inga Kniep, Jun Oh, Dominique Singer, Chinedu Ebenebe, Robin Kobbe. Fatal COVID-19 in a Child with Persistence of SARS-CoV-2 Despite Extensive Multidisciplinary Treatment: A Case Report. Children. 2021; 8 (7):564.
Chicago/Turabian StyleSofia Apostolidou; Theresa Harbauer; Peter Lasch; Daniel Biermann; Maja Hempel; Marc Lütgehetmann; Susanne Pfefferle; Jochen Herrmann; André Rüffer; Konrad Reinshagen; Rainer Kozlik-Feldmann; Anna Gieras; Inga Kniep; Jun Oh; Dominique Singer; Chinedu Ebenebe; Robin Kobbe. 2021. "Fatal COVID-19 in a Child with Persistence of SARS-CoV-2 Despite Extensive Multidisciplinary Treatment: A Case Report." Children 8, no. 7: 564.
New SARS-CoV-2 variants with increased transmissibility, like B.1.1.7, first detected in England or B.1.351, first detected in South Africa, have caused considerable concern worldwide. In order to contain the spread of these lineages, it is of utmost importance to have rapid, sensitive and high-throughput detection methods at hand. A set of RT-qPCR assays was modified for a diagnostic SARS-CoV-2 multiplex assay including detection of the del-HV69/70 and N501Y mutations on the cobas6800 platform. Analytical sensitivity was assessed for both wild-type SARS-CoV-2 and B.1.1.7 lineage by serial dilution. For clinical performance, a total of 176 clinical samples were subjected to the test and results compared to a commercial manual typing-PCR assay and next generation sequencing as gold standard. The multiplex assay was highly sensitive for detection of SARS-CoV-2 RNA in clinical samples, with an LoD of 6.16 cp/ml (CI: 4.00–8.31). LoDs were slightly higher for detection of the HV69/70 deletion (85.92, CI: 61–194.41) and the N501Y SNP (105.99 cp/ml, CI: 81.59 – 183.66). A total of 176 clinical samples were tested with the assay, including 50 samples containing SARS-CoV-2 of the B.1.1.7 lineage, one containing B.1.351 and 85 non-B.1.1.7/B.1.351 lineage, of which three also harbored a HV69/70 deletion. All were correctly identified by the multiplex assay. We describe here a highly sensitive, fully automated multiplex PCR assay for the simultaneous detection of the del-HV69/70 and N501Y mutations that can distinguish between B.1.1.7 and other lineages. The assay allows for high-throughput screening for currently relevant variants in clinical samples prior to sequencing.
Dominik Nörz; Moritz Grunwald; Flaminia Olearo; Nicole Fischer; Martin Aepfelbacher; Susanne Pfefferle; Marc Lütgehetmann. Evaluation of a fully automated high-throughput SARS-CoV-2 multiplex qPCR assay with built-in screening functionality for del-HV69/70- and N501Y variants such as B.1.1.7. Journal of Clinical Virology 2021, 141, 104894 .
AMA StyleDominik Nörz, Moritz Grunwald, Flaminia Olearo, Nicole Fischer, Martin Aepfelbacher, Susanne Pfefferle, Marc Lütgehetmann. Evaluation of a fully automated high-throughput SARS-CoV-2 multiplex qPCR assay with built-in screening functionality for del-HV69/70- and N501Y variants such as B.1.1.7. Journal of Clinical Virology. 2021; 141 ():104894.
Chicago/Turabian StyleDominik Nörz; Moritz Grunwald; Flaminia Olearo; Nicole Fischer; Martin Aepfelbacher; Susanne Pfefferle; Marc Lütgehetmann. 2021. "Evaluation of a fully automated high-throughput SARS-CoV-2 multiplex qPCR assay with built-in screening functionality for del-HV69/70- and N501Y variants such as B.1.1.7." Journal of Clinical Virology 141, no. : 104894.
With great interest, we read the recent article by Zhen and Berry1Zhen W. Berry G.J. Development of a new multiplex real-time RT-PCR assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection.J Mol Diagn. 2020; 22: 1367-1372Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar presenting a novel first-line diagnostic quantitative PCR assay for SARS-CoV-2 detection, targeting the viral S gene. Following reports of increasing abundance of SARS-CoV-2 variants, such as VOC202012/01 in Britain and 501.V2 in South Africa, a number of single nucleotide polymorphisms and in-frame deletions within the S gene have come into the spotlight in recent weeks.2Kemp S. Harvey W. Lytras S. Carabelli A. Robertson D. Gupta R. Recurrent emergence and transmission of a SARS-CoV-2 spike deletion H69/V70. bioRxiv. 2021..https://www.biorxiv.org/content/10.1101/2021.01.27.428516v1.full.pdfDate: 2021Google Scholar These mutations are increasingly attracting attention due to their potential consequences for infection control and vaccination programs.
Dominik Nörz; Susanne Pfefferle; Moritz Grunwald; Nicole Fischer; Martin Aepfelbacher; Marc Lütgehetmann. Modifying a Diagnostic SARS-CoV-2 Spike PCR to Turn a Del69/70 Dropout into a Discriminatory On-Target Assay. The Journal of Molecular Diagnostics 2021, 23, 777 -778.
AMA StyleDominik Nörz, Susanne Pfefferle, Moritz Grunwald, Nicole Fischer, Martin Aepfelbacher, Marc Lütgehetmann. Modifying a Diagnostic SARS-CoV-2 Spike PCR to Turn a Del69/70 Dropout into a Discriminatory On-Target Assay. The Journal of Molecular Diagnostics. 2021; 23 (6):777-778.
Chicago/Turabian StyleDominik Nörz; Susanne Pfefferle; Moritz Grunwald; Nicole Fischer; Martin Aepfelbacher; Marc Lütgehetmann. 2021. "Modifying a Diagnostic SARS-CoV-2 Spike PCR to Turn a Del69/70 Dropout into a Discriminatory On-Target Assay." The Journal of Molecular Diagnostics 23, no. 6: 777-778.
So far, only a few reports about reinfections with SARS-CoV-2 have been published, and they often lack detailed immunological and virological data. We report about a SARS-CoV-2 reinfection with a genetically distinct SARS-CoV-2 variant in an immunocompetent female healthcare worker that has led to a mild disease course. No obvious viral escape mutations were observed in the second virus variant. The infectious virus was shed from the patient during the second infection episode despite the presence of neutralizing antibodies in her blood. Our data indicate that a moderate immune response after the first infection, but not a viral escape, did allow for reinfection and live virus shedding.
Thomas Brehm; Susanne Pfefferle; Ronald von Possel; Robin Kobbe; Dominik Nörz; Stefan Schmiedel; Adam Grundhoff; Flaminia Olearo; Petra Emmerich; Alexis Robitaille; Thomas Günther; Platon Braun; Gabriele Andersen; Johannes Knobloch; Marylyn Addo; Ansgar Lohse; Martin Aepfelbacher; Nicole Fischer; Julian Schulze Zur Wiesch; Marc Lütgehetmann. SARS-CoV-2 Reinfection in a Healthcare Worker Despite the Presence of Detectable Neutralizing Antibodies. Viruses 2021, 13, 661 .
AMA StyleThomas Brehm, Susanne Pfefferle, Ronald von Possel, Robin Kobbe, Dominik Nörz, Stefan Schmiedel, Adam Grundhoff, Flaminia Olearo, Petra Emmerich, Alexis Robitaille, Thomas Günther, Platon Braun, Gabriele Andersen, Johannes Knobloch, Marylyn Addo, Ansgar Lohse, Martin Aepfelbacher, Nicole Fischer, Julian Schulze Zur Wiesch, Marc Lütgehetmann. SARS-CoV-2 Reinfection in a Healthcare Worker Despite the Presence of Detectable Neutralizing Antibodies. Viruses. 2021; 13 (4):661.
Chicago/Turabian StyleThomas Brehm; Susanne Pfefferle; Ronald von Possel; Robin Kobbe; Dominik Nörz; Stefan Schmiedel; Adam Grundhoff; Flaminia Olearo; Petra Emmerich; Alexis Robitaille; Thomas Günther; Platon Braun; Gabriele Andersen; Johannes Knobloch; Marylyn Addo; Ansgar Lohse; Martin Aepfelbacher; Nicole Fischer; Julian Schulze Zur Wiesch; Marc Lütgehetmann. 2021. "SARS-CoV-2 Reinfection in a Healthcare Worker Despite the Presence of Detectable Neutralizing Antibodies." Viruses 13, no. 4: 661.
SARS-CoV-2 molecular diagnostics is facing material shortages and long turnaround times due to exponential increase of testing demand. We evaluated the analytic performance and handling of four rapid Antigen Point of Care Tests (AgPOCTs) I-IV (Distributors: (I) Roche, (II) Abbott, (III) MEDsan and (IV) Siemens). 100 RT-PCR negative and 84 RT-PCR positive oropharyngeal swabs were prospectively collected and used to determine performance and accuracy of these AgPOCTs. Handling was evaluated by 10 healthcare workers/users through a questionnaire. The median duration from symptom onset to sampling was 6 days (IQR 2–12 days). The overall respective sensitivity were 49.4 % (CI95 %: 38.9–59.9), 44.6 % (CI95 %: 34.3–55.3), 45.8 % (CI95 %: 35.5–56.5) and 54.9 % (CI95 %: 43.4−65.9) for tests I, II, III and IV, respectively. In the high viral load subgroup (containing >106 copies of SARS-CoV-2 /swab, n = 26), AgPOCTs reached sensitivities of 92.3 % or more (range 92.3 %–100 %). Specificity was 100 % for tests I, II (CI95 %: 96.3–100 for both tests) and IV (CI95 %: 96.3–100) and 97 % (CI95 %: 91.5–98.9) for test III. Regarding handling, test I obtained the overall highest scores, while test II was considered to have the most convenient components. Of note, users considered all assays, with the exception of test I, to pose a significant risk for contamination by drips or spills. Besides some differences in sensitivity and handling, all four AgPOCTs showed acceptable performance in high viral load samples. However, due to the significantly lower sensitivity compared to RT-qPCR, a careful consideration of pro and cons of AgPOCT has to be taken into account before clinical implementation.
Flaminia Olearo; Dominik Nörz; Fabian Heinrich; Jan Peter Sutter; Kevin Roedl; Alexander Schultze; Julian Schulze Zur Wiesch; Platon Braun; Lisa Oestereich; Benno Kreuels; Dominic Wichmann; Martin Aepfelbacher; Susanne Pfefferle; Marc Lütgehetmann. Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR. Journal of Clinical Virology 2021, 137, 104782 -104782.
AMA StyleFlaminia Olearo, Dominik Nörz, Fabian Heinrich, Jan Peter Sutter, Kevin Roedl, Alexander Schultze, Julian Schulze Zur Wiesch, Platon Braun, Lisa Oestereich, Benno Kreuels, Dominic Wichmann, Martin Aepfelbacher, Susanne Pfefferle, Marc Lütgehetmann. Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR. Journal of Clinical Virology. 2021; 137 ():104782-104782.
Chicago/Turabian StyleFlaminia Olearo; Dominik Nörz; Fabian Heinrich; Jan Peter Sutter; Kevin Roedl; Alexander Schultze; Julian Schulze Zur Wiesch; Platon Braun; Lisa Oestereich; Benno Kreuels; Dominic Wichmann; Martin Aepfelbacher; Susanne Pfefferle; Marc Lütgehetmann. 2021. "Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR." Journal of Clinical Virology 137, no. : 104782-104782.
Hyperinflammation contributes to lung injury and subsequent acute respiratory distress syndrome with high mortality in patients with severe coronavirus disease 2019 (COVID-19). To understand the underlying mechanisms involved in lung pathology, we investigated the role of the lung-specific immune response. We profiled immune cells in bronchoalveolar lavage fluid and blood collected from patients with severe COVID-19 and patients with bacterial pneumonia not associated with viral infection. By tracking T cell clones across tissues, we identified clonally expanded tissue-resident memory-like TH17 cells (TRM17 cells) in the lungs even after viral clearance. These TRM17 cells were characterized by a potentially pathogenic cytokine expression profile of IL17A and CSF2 (GM-CSF). Interactome analysis suggests that TRM17 cells can interact with lung macrophages and cytotoxic CD8+ T cells, which have been associated with disease severity and lung damage. High IL-17A and GM-CSF protein levels in the serum of patients with COVID-19 were associated with a more severe clinical course. Collectively, our study suggests that pulmonary TRM17 cells are one potential orchestrator of the hyperinflammation in severe COVID-19.
Yu Zhao; Christoph Kilian; Jan-Eric Turner; Lidia Bosurgi; Kevin Roedl; Patricia Bartsch; Ann-Christin Gnirck; Filippo Cortesi; Christoph Schultheiß; Malte Hellmig; Leon U.B. Enk; Fabian Hausmann; Alina Borchers; Milagros N. Wong; Hans-Joachim Paust; Francesco Siracusa; Nicola Scheibel; Marissa Herrmann; Elisa Rosati; Petra Bacher; Dominik Kylies; Dominik Jarczak; Marc Lütgehetmann; Susanne Pfefferle; Stefan Steurer; Julian Schulze Zur Wiesch; Victor G. Puelles; Jan-Peter Sperhake; Marylyn M. Addo; Ansgar W. Lohse; Mascha Binder; Samuel Huber; Tobias B. Huber; Stefan Kluge; Stefan Bonn; Ulf Panzer; Nicola Gagliani; Christian F. Krebs. Clonal expansion and activation of tissue-resident memory-like TH17 cells expressing GM-CSF in the lungs of patients with severe COVID-19. Science Immunology 2021, 6, eabf6692 .
AMA StyleYu Zhao, Christoph Kilian, Jan-Eric Turner, Lidia Bosurgi, Kevin Roedl, Patricia Bartsch, Ann-Christin Gnirck, Filippo Cortesi, Christoph Schultheiß, Malte Hellmig, Leon U.B. Enk, Fabian Hausmann, Alina Borchers, Milagros N. Wong, Hans-Joachim Paust, Francesco Siracusa, Nicola Scheibel, Marissa Herrmann, Elisa Rosati, Petra Bacher, Dominik Kylies, Dominik Jarczak, Marc Lütgehetmann, Susanne Pfefferle, Stefan Steurer, Julian Schulze Zur Wiesch, Victor G. Puelles, Jan-Peter Sperhake, Marylyn M. Addo, Ansgar W. Lohse, Mascha Binder, Samuel Huber, Tobias B. Huber, Stefan Kluge, Stefan Bonn, Ulf Panzer, Nicola Gagliani, Christian F. Krebs. Clonal expansion and activation of tissue-resident memory-like TH17 cells expressing GM-CSF in the lungs of patients with severe COVID-19. Science Immunology. 2021; 6 (56):eabf6692.
Chicago/Turabian StyleYu Zhao; Christoph Kilian; Jan-Eric Turner; Lidia Bosurgi; Kevin Roedl; Patricia Bartsch; Ann-Christin Gnirck; Filippo Cortesi; Christoph Schultheiß; Malte Hellmig; Leon U.B. Enk; Fabian Hausmann; Alina Borchers; Milagros N. Wong; Hans-Joachim Paust; Francesco Siracusa; Nicola Scheibel; Marissa Herrmann; Elisa Rosati; Petra Bacher; Dominik Kylies; Dominik Jarczak; Marc Lütgehetmann; Susanne Pfefferle; Stefan Steurer; Julian Schulze Zur Wiesch; Victor G. Puelles; Jan-Peter Sperhake; Marylyn M. Addo; Ansgar W. Lohse; Mascha Binder; Samuel Huber; Tobias B. Huber; Stefan Kluge; Stefan Bonn; Ulf Panzer; Nicola Gagliani; Christian F. Krebs. 2021. "Clonal expansion and activation of tissue-resident memory-like TH17 cells expressing GM-CSF in the lungs of patients with severe COVID-19." Science Immunology 6, no. 56: eabf6692.
Background: SARS-CoV-2 molecular diagnostics is facing material shortages and long turnaround times due to exponential increase of testing demand. Objective: We evaluated the analytic performance and handling of four rapid Antigen Point of Care Tests (AgPOCTs) I-IV (Distributors: (I) Roche, (II) Abbott, (III) MEDsan and (IV) Siemens). Methods: 100 RT-PCR negative and 84 RT-PCR positive oropharyngeal swabs were prospectively collected and used to determine performance and accuracy of these AgPOCTs. Handling was evaluated by 10 healthcare workers/users through a questionnaire. Results: The median duration from symptom onset to sampling was 6 days (IQR 2-12 days). The overall relative sensitivity was 49.4%, 44.6%, 45.8% and 54.9 % for tests I, II, III and IV, respectively. In the high viral load subgroup (containing >106 copies of SARS-CoV-2 /swab, n=26), AgPOCTs reached sensitivities of 92.3% or more (range 92.3%-100%). Specificity was 100% for tests I, II and IV and 97% for test III. Regarding handling, test I obtained the overall highest scores, while test II was considered to have the most convenient components. Of note, users considered all assays, with the exception of test I, to pose a significant risk for contamination by drips or spills. Discussion: Besides some differences in sensitivity and handling, all four AgPOCTs showed acceptable performance in high viral load samples. However, due to the significantly lower sensitivity compared to RT-qPCR, a careful consideration of pro and cons of AgPOCT has to be taken into account before clinical implementation.
Flaminia Olearo; Dominik Noerz; Fabian Heinrich; Jan Peter Sutter; Kevin Roedel; Alexander Schultze; Julian Schulze Zur Wiesch; Platon Braun; Lisa Oesterreich; Benno Kreuels; Dominic Wichmann; Martin Aepfelbacher; Susanne Pfefferle; Marc Luetgehetmann. Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR. 2020, 1 .
AMA StyleFlaminia Olearo, Dominik Noerz, Fabian Heinrich, Jan Peter Sutter, Kevin Roedel, Alexander Schultze, Julian Schulze Zur Wiesch, Platon Braun, Lisa Oesterreich, Benno Kreuels, Dominic Wichmann, Martin Aepfelbacher, Susanne Pfefferle, Marc Luetgehetmann. Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR. . 2020; ():1.
Chicago/Turabian StyleFlaminia Olearo; Dominik Noerz; Fabian Heinrich; Jan Peter Sutter; Kevin Roedel; Alexander Schultze; Julian Schulze Zur Wiesch; Platon Braun; Lisa Oesterreich; Benno Kreuels; Dominic Wichmann; Martin Aepfelbacher; Susanne Pfefferle; Marc Luetgehetmann. 2020. "Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR." , no. : 1.
Key Points Patients with acute leukemia present with a prolonged and severe course of COVID-19, which is paralleled by high rates of viremia. Low-intensive chemotherapy seems to be more feasible in patients with acute myeloid leukemia and concomitant SARS-CoV-2 infection.
Susanne Ghandili; Susanne Pfefferle; Kevin Roedl; Piet Sonnemann; Panagiotis Karagiannis; Olaf Boenisch; Stefan Kluge; Stefan Schmiedel; Harald Ittrich; Holger Rohde; Marc Lütgehetmann; Katja Weisel; Carsten Bokemeyer; Dominic Wichmann; Walter Fiedler; Dominik Jarczak; Franziska Modemann. Challenges in treatment of patients with acute leukemia and COVID-19: a series of 12 patients. Blood Advances 2020, 4, 5936 -5941.
AMA StyleSusanne Ghandili, Susanne Pfefferle, Kevin Roedl, Piet Sonnemann, Panagiotis Karagiannis, Olaf Boenisch, Stefan Kluge, Stefan Schmiedel, Harald Ittrich, Holger Rohde, Marc Lütgehetmann, Katja Weisel, Carsten Bokemeyer, Dominic Wichmann, Walter Fiedler, Dominik Jarczak, Franziska Modemann. Challenges in treatment of patients with acute leukemia and COVID-19: a series of 12 patients. Blood Advances. 2020; 4 (23):5936-5941.
Chicago/Turabian StyleSusanne Ghandili; Susanne Pfefferle; Kevin Roedl; Piet Sonnemann; Panagiotis Karagiannis; Olaf Boenisch; Stefan Kluge; Stefan Schmiedel; Harald Ittrich; Holger Rohde; Marc Lütgehetmann; Katja Weisel; Carsten Bokemeyer; Dominic Wichmann; Walter Fiedler; Dominik Jarczak; Franziska Modemann. 2020. "Challenges in treatment of patients with acute leukemia and COVID-19: a series of 12 patients." Blood Advances 4, no. 23: 5936-5941.
Stroke and central nervous system dysfunction are cardinal symptoms in critically ill corona virus disease 19 (COVID-19) patients. In an autopsy series of 32 COVID-19 patients, we investigated whether carotid arteries were infected with SARS-CoV-2 by employing genomic, virologic, histochemical and transcriptomic analyses. We show that SARS-CoV-2 productively infects and modulates vascular responses in carotid arteries. This finding has far reaching implications for the understanding and clinical treatment of COVID-19.
Susanne Pfefferle; Thomas Guenther; Victor Puelles; Fabian Heinrich; Dominik Noerz; Manja Czech-Sioli; Alexander Carstens; Susanne Krasemann; Milagros Wong; Lisa Oestereich; Tim Magnus; Lena Allweiss; Caroline Edler; Ann-Sophie Schroeder; Maura Dandri; Tobias Huber; Markus Glatzel; Klaus Pueschel; Adam Grundhoff; Marc Luetgehetmann; Martin Aepfelbacher; Nicole Fischer. SARS-CoV-2 infects carotid arteries: implications for vascular disease and organ injury in COVID-19. 2020, 1 .
AMA StyleSusanne Pfefferle, Thomas Guenther, Victor Puelles, Fabian Heinrich, Dominik Noerz, Manja Czech-Sioli, Alexander Carstens, Susanne Krasemann, Milagros Wong, Lisa Oestereich, Tim Magnus, Lena Allweiss, Caroline Edler, Ann-Sophie Schroeder, Maura Dandri, Tobias Huber, Markus Glatzel, Klaus Pueschel, Adam Grundhoff, Marc Luetgehetmann, Martin Aepfelbacher, Nicole Fischer. SARS-CoV-2 infects carotid arteries: implications for vascular disease and organ injury in COVID-19. . 2020; ():1.
Chicago/Turabian StyleSusanne Pfefferle; Thomas Guenther; Victor Puelles; Fabian Heinrich; Dominik Noerz; Manja Czech-Sioli; Alexander Carstens; Susanne Krasemann; Milagros Wong; Lisa Oestereich; Tim Magnus; Lena Allweiss; Caroline Edler; Ann-Sophie Schroeder; Maura Dandri; Tobias Huber; Markus Glatzel; Klaus Pueschel; Adam Grundhoff; Marc Luetgehetmann; Martin Aepfelbacher; Nicole Fischer. 2020. "SARS-CoV-2 infects carotid arteries: implications for vascular disease and organ injury in COVID-19." , no. : 1.
ObjectivesWe used viral genomics to deeply analyze the first SARS-CoV-2 infection clusters in the metropolitan region of Hamburg, Germany. Epidemiological analysis and contact tracing together with a thorough investigation of virus variant patterns revealed low and high infection dose transmissions to be involved in transmission events.MethodsInfection control measures were applied to follow up contract tracing. Metagenomic RNA- and SARS-CoV-2 amplicon sequencing was performed from 25 clinical samples for sequence analysis and variant calling.ResultsThe index patient acquired SARS-CoV-2 in Italy and after his return to Hamburg transmitted it to 2 out of 132 contacts. Virus genomics and variant pattern clearly confirms the initial local cluster. We identify frequent single nucleotide polymorphisms at positions 241, 3037, 14408, 23403 and 28881 previously described in Italian sequences and now considered as one major genotype in Europe. While the index patient showed a single nucleotide polymorphism only one variant was transmitted to the recipients. Different to the initial cluster, we observed in household clusters occurring at the time in Hamburg also intra-host viral species transmission events.ConclusionsSARS-CoV-2 variant tracing highlights both, low infection dose transmissions suggestive of fomites as route of infection in the initial cluster and high and low infection dose transmissions in family clusters indicative of fomites and droplets as infection routes. This suggests (1) single viral particle infection can be sufficient to initiate SARS-CoV-2 infection and (2) household/family members are exposed to high virus loads and therefore have a high risk to acquire SARS-CoV-2.
Susanne Pfefferle; Thomas Guenther; Robin Kobbe; Manja Czech-Sioli; Dominic Nörz; René Santer; Jun Oh; Stefan Kluge; Lisa Oestereich; Kersten Peldschus; Daniela Indenbirken; Jiabin Huang; Adam Grundhoff; Martin Aepfelbacher; Johannes K. Knobloch; Marc Luetgehetmann; Nicole Fischer. Low and high infection dose transmissions of SARS-CoV-2 in the first COVID-19 clusters in Northern Germany. 2020, 1 .
AMA StyleSusanne Pfefferle, Thomas Guenther, Robin Kobbe, Manja Czech-Sioli, Dominic Nörz, René Santer, Jun Oh, Stefan Kluge, Lisa Oestereich, Kersten Peldschus, Daniela Indenbirken, Jiabin Huang, Adam Grundhoff, Martin Aepfelbacher, Johannes K. Knobloch, Marc Luetgehetmann, Nicole Fischer. Low and high infection dose transmissions of SARS-CoV-2 in the first COVID-19 clusters in Northern Germany. . 2020; ():1.
Chicago/Turabian StyleSusanne Pfefferle; Thomas Guenther; Robin Kobbe; Manja Czech-Sioli; Dominic Nörz; René Santer; Jun Oh; Stefan Kluge; Lisa Oestereich; Kersten Peldschus; Daniela Indenbirken; Jiabin Huang; Adam Grundhoff; Martin Aepfelbacher; Johannes K. Knobloch; Marc Luetgehetmann; Nicole Fischer. 2020. "Low and high infection dose transmissions of SARS-CoV-2 in the first COVID-19 clusters in Northern Germany." , no. : 1.
Here, we describe the complete genome sequence of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain isolated from an oropharyngeal swab sample from a female patient with COVID-19 who was infected in Hamburg, northern Germany.
Susanne Pfefferle; Jiabin Huang; Dominik Nörz; Daniela Indenbirken; Marc Lütgehetmann; Lisa Oestereich; Thomas Günther; Adam Grundhoff; Martin Aepfelbacher; Nicole Fischer. Complete Genome Sequence of a SARS-CoV-2 Strain Isolated in Northern Germany. Microbiology Resource Announcements 2020, 9, 1 .
AMA StyleSusanne Pfefferle, Jiabin Huang, Dominik Nörz, Daniela Indenbirken, Marc Lütgehetmann, Lisa Oestereich, Thomas Günther, Adam Grundhoff, Martin Aepfelbacher, Nicole Fischer. Complete Genome Sequence of a SARS-CoV-2 Strain Isolated in Northern Germany. Microbiology Resource Announcements. 2020; 9 (23):1.
Chicago/Turabian StyleSusanne Pfefferle; Jiabin Huang; Dominik Nörz; Daniela Indenbirken; Marc Lütgehetmann; Lisa Oestereich; Thomas Günther; Adam Grundhoff; Martin Aepfelbacher; Nicole Fischer. 2020. "Complete Genome Sequence of a SARS-CoV-2 Strain Isolated in Northern Germany." Microbiology Resource Announcements 9, no. 23: 1.
1AbstractBackgroundThe ongoing SARS-CoV-2 pandemic presents a unique challenge for diagnostic laboratories around the world. Automation of workflows in molecular diagnostics are instrumental for coping with the large number of tests ordered by clinicians, as well as providing fast-tracked rapid testing for highly urgent cases. In this study we evaluated a SARS-CoV-2 LDT for the NeuMoDx 96 system, a fully automated device performing extraction and real-time PCR.MethodsA publicly available SARS-CoV-2 RT-PCR assay was adapted for the automated system. Analytical performance was evaluated using in-vitro transcribed RNA and clinical performance was compared to the cobas 6800-based reference assay within the lab.ResultsThe NeuMoDx-sarbeco-LDT displayed good analytical performance with an LoD of 95.55 cp/ml and no false positives during evaluation of cross-reactivity. A total of 176 patient samples were tested with both the Sarbeco-LDT and the reference assay. Positive and negative agreement were 100% and 99.2% respectively. Invalid-rate was 6.3%.ConclusionThe NeuMoDx-sarbeco-LDT showed analytical and clinical performance comparable to the cobas6800-based reference assay. Due to its random-access workflow concept and rapid time-to-result of about 80 minutes, the device is very well suited for providing fast-tracked SARS-CoV-2 diagnostics for urgent clinical samples in the hospital setting.HighlightsA publicly available SARS-CoV-2 RT-PCR assay was adapted and evaluated on the open mode of the NeuMoDx 96 system (Qiagen)The assay showed comparable analytical and clinical performance to the reference assayFast turn-around times (80 minutes) and random-access workflow of the system makes the assay well suited for urgent clinical samples.
Dominik Noerz; Nicole Fischer; Alexander Schultze; Stefan Kluge; Ulrich Mayer-Runge; Martin Aepfelbacher; Susanne Pfefferle; Marc Luetgehetmann. Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting. 2020, 1 .
AMA StyleDominik Noerz, Nicole Fischer, Alexander Schultze, Stefan Kluge, Ulrich Mayer-Runge, Martin Aepfelbacher, Susanne Pfefferle, Marc Luetgehetmann. Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting. . 2020; ():1.
Chicago/Turabian StyleDominik Noerz; Nicole Fischer; Alexander Schultze; Stefan Kluge; Ulrich Mayer-Runge; Martin Aepfelbacher; Susanne Pfefferle; Marc Luetgehetmann. 2020. "Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting." , no. : 1.
Facing the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), high-volume respiratory testing is demanded in laboratories worldwide. We evaluated the performance of a molecular assay for the detection of SARS-CoV-2 on a high-throughput platform, the cobas 6800, using the ‘open channel’ for integration of a laboratory-developed assay. We observed good analytical performance in clinical specimens. The fully automated workflow enables high-throughput testing with minimal hands-on time, while offering fast and reliable results.
Susanne Pfefferle; Svenja Reucher; Dominic Nörz; Marc Lütgehetmann. Evaluation of a quantitative RT-PCR assay for the detection of the emerging coronavirus SARS-CoV-2 using a high throughput system. Eurosurveillance 2020, 25, 2000152 .
AMA StyleSusanne Pfefferle, Svenja Reucher, Dominic Nörz, Marc Lütgehetmann. Evaluation of a quantitative RT-PCR assay for the detection of the emerging coronavirus SARS-CoV-2 using a high throughput system. Eurosurveillance. 2020; 25 (9):2000152.
Chicago/Turabian StyleSusanne Pfefferle; Svenja Reucher; Dominic Nörz; Marc Lütgehetmann. 2020. "Evaluation of a quantitative RT-PCR assay for the detection of the emerging coronavirus SARS-CoV-2 using a high throughput system." Eurosurveillance 25, no. 9: 2000152.
Background Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics. A syndromic panel testing approach like the FilmArray ME can accelerate diagnosis and therefore decrease the time to pathogen specific therapy. Yet, its clinical utility is controversial, mainly because of a remaining uncertainty in correct interpretation of results, limited data on its performance on clinical specimens and its relatively high costs. The aim of this study was to analyze clinical performance of the assay in a real life setting at a tertiary university hospital using a pragmatic and simple sample selection strategy to reduce the overall cost burden. Methods Over a period of 18 months we received 4623 CSF samples (2338 hospitalizations, 1601 individuals). FilmArray ME analysis was restricted to CSF-samples with a high pretest probability of infectious meningitis, e.g. positive Gram-stain, samples in which leukocytes and/or bacteria were evident or urgent suspicion of infection was communicated by clinicians. N = 171 samples matched to our risk criteria and were subjected to FilmArray ME analysis. Those samples were also analyzed by reference methods: culture only (n = 45), PCR only (n = 20) or both methods (n = 106). Results 56/171 (32.75%) were FilmArray ME positive. Bacterial pathogens were detected in 30/56 (53.57%), viral pathogens were detected in 27/56 (48.21%) and yeast DNA was detected in 1/56 (1.79%) of positive samples. Double detection occurred in 2/56 samples. In 52/56 (92.86%) FilmArray ME positive samples, results could be confirmed by the reference assays (sensitivity = 96.30%, specificity =96.58%). Conclusion The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis and can easily be implemented in routine diagnostic workflows. However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results. Moreover, considering the need for antimicrobial susceptibility testing, the use of molecular tests as a stand-alone diagnostic cannot be recommended.
Susanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis. BMC Infectious Diseases 2020, 20, 1 -9.
AMA StyleSusanne Pfefferle, Martin Christner, Martin Aepfelbacher, Marc Lütgehetmann, Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis. BMC Infectious Diseases. 2020; 20 (1):1-9.
Chicago/Turabian StyleSusanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. 2020. "Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis." BMC Infectious Diseases 20, no. 1: 1-9.
Background: Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics. A syndromic panel testing approach like the FilmArray ME can accelerate diagnosis and therefore decrease the time to pathogen specific therapy. Yet, its clinical utility is controversial, mainly because of a remaining uncertainty in correct interpretation of results, limited data on its performance on clinical specimens and its relatively high costs. The aim of this study was to analyze clinical performance of the assay in a real life setting at a tertiary university hospital using a pragmatic and simple sample selection strategy to reduce the overall cost burden. Methods : Over a period of 18 months we received 4,623 CSF samples (2,338 hospitalizations, 1,601 individuals). FilmArray ME analysis was restricted to CSF-samples with a high pretest probability of infectious meningitis, e.g. conspicuous positive Gram-stain, samples in which leukocytes and/or bacteria were evident or urgent suspicion of infection was communicated by clinicians. N=171 samples matched to our risk criteria and were subjected to FilmArray ME analysis. Those samples were also analyzed by reference methods: culture only (n=45), PCR only (n=20) or both methods (n=106). Results : 56/171 (32.75 %) were FilmArray ME positive. Bacterial pathogens were detected in 30/56 (53.57 %), viral pathogens were detected in 27/56 (48.21 %) and yeast DNA was detected in 1/56 (1.79 %) of positive samples. Double detection occurred in 2/56 samples. In 52/56 (92.86 %) FilmArray ME positive samples, results could be confirmed by the reference assays (sensitivity=96.30%, specificity =96.58%). Conclusion: The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis and can easily be implemented in routine diagnostic workflows. However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results. Moreover, considering the need for antimicrobial susceptibility testing, the use of molecular tests as a stand-alone diagnostic cannot be recommended.
Susanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis. 2020, 1 .
AMA StyleSusanne Pfefferle, Martin Christner, Martin Aepfelbacher, Marc Lütgehetmann, Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis. . 2020; ():1.
Chicago/Turabian StyleSusanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. 2020. "Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis." , no. : 1.
Background: Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics. A syndromic panel testing approach like the FilmArray ME can accelerate diagnosis and therefore decrease the time to pathogen specific therapy. Yet, its clinical utility is controversial, mainly because of a remaining uncertainty in correct interpretation of results, limited data on its performance on clinical specimens and its relatively high costs. The aim of this study was to analyze clinical performance of the assay in a real life setting at a tertiary university hospital using a pragmatic and simple sample selection strategy to reduce the overall cost burden. Methods: Over a period of 18 months we received 4,623 CSF samples (2,338 hospitalizations, 1,601 individuals). FilmArray ME analysis was restricted to CSF-samples with a high pretest probability of infectious meningitis, e.g. conspicuous positive Gram-stain, samples in which leukocytes and/or bacteria were evident or urgent suspicion of infection was communicated by clinicians. N=171 samples matched to our risk criteria and were subjected to FilmArray ME analysis. Those samples were also analyzed by reference methods: culture only (n=45), PCR only (n=20) or both methods (n=106). Results: 56/171 (32.75 %) were FilmArray ME positive. Bacterial pathogens were detected in 30/56 (53.57 %), viral pathogens were detected in 27/56 (48.21 %) and yeast DNA was detected in 1/56 (1.79 %) of positive samples. Double detection occurred in 2/56 samples. In 52/56 (92.86 %) FilmArray ME positive samples, results could be confirmed by the reference assays (sensitivity=96.30%, specificity =96.58%). Conclusion: The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis and can easily be implemented in routine diagnostic workflows. However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results. Moreover, considering the need for antimicrobial susceptibility testing, the use of molecular tests as a stand-alone diagnostic cannot be recommended.
Susanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis. 2019, 1 .
AMA StyleSusanne Pfefferle, Martin Christner, Martin Aepfelbacher, Marc Lütgehetmann, Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis. . 2019; ():1.
Chicago/Turabian StyleSusanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. 2019. "Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis." , no. : 1.
Background: Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics. A syndromic panel testing approach like the FilmArray ME can accelerate diagnosis and therefore decrease the time to pathogen specific therapy. Yet, its clinical utility is controversial, mainly because of a remaining uncertainty in correct interpretation of results, limited data on its performance on clinical specimens and its relatively high costs. The aim of this study was to analyze clinical performance of the assay in a real life setting at a tertiary university hospital using a pragmatic and simple sample selection strategy to reduce the overall cost burden. Methods: Over a period of 18 months we received n=4.623 CSF samples (n=2.338 hospitalizations, n=1.601 individuals). FilmArray ME analysis was restricted to CSF-samples with a high pretest probability of infectious meningitis, e.g. conspicuous Gram-stain, samples in which leukocytes and/or bacteria were evident or urgent suspicion of infection was communicated by clinicians. N=171 samples matched to our risk criteria and were subjected to FilmArray ME analysis. Those samples were also analyzed by reference methods: culture only (n=45), PCR only (n=20) or both methods (n=106). Results: 56/171 (32.75 %) were FilmArray ME positive. Bacterial pathogens were detected in 30/56 (53.57 %), viral pathogens were detected in 27/56 (48.21 %) and yeast DNA was detected in 1/56 (1.79 %) of positive samples. Double detection occurred in 2/56 samples. In 52/56 (92.86 %) FilmArray ME positive samples, results could be confirmed by the reference assays (sensitivity=96.30%, specificity =96.58%). Conclusion: The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis and can easily be implemented in routine diagnostic workflows. However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results. Moreover, considering the need for antimicrobial susceptibility testing, the use of molecular tests as a stand-alone diagnostic cannot be recommended.
Susanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis. 2019, 1 .
AMA StyleSusanne Pfefferle, Martin Christner, Martin Aepfelbacher, Marc Lütgehetmann, Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis. . 2019; ():1.
Chicago/Turabian StyleSusanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. 2019. "Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy for diagnosis of meningitis and encephalitis." , no. : 1.
Background Infectious meningitis is a serious disease and patient outcome relies on fast and reliable diagnostics. A syndromic panel testing approach like the FilmArray ME can accelerate molecular diagnostics and therefore decrease the time to pathogen specific therapy. Yet, its clinical utility is controversially discussed, mainly because of a remaining uncertainty in correct interpretation of results, limited data on its performance on clinical specimens and its comparatively high costs. Aim of this study was to analyze clinical performance of the assay in a real life setting at a tertiary university hospital using pragmatic and simple sample selection strategy to reduce overall cost burden. Methods Over a period of 18 months we received n=4.623 CSF samples (n=2.338 hospitalizations, n=1.601 individuals). FilmArray ME analysis was restricted to CSF-samples with a high pretest probability of infectious meningitis, e.g. conspicuous Gram-stain, samples in which leukocytes and/or bacteria were evident or urgent suspicion of infection was communicated by clinicians. N=171 samples matched to our risk criteria and were subjected to FilmArray ME analysis. Samples were also tested by reference methods: culture only (n=45), PCR only (n=20) or both methods (n=106). Results 56/171 (32.75%) were FilmArray ME positive. Bacterial pathogens were detected in 30/56 (53.57%) and viral pathogens were detected in 27/56 (48.21%) of positive samples. 52/56 FilmArray ME results could be confirmed by the reference assays. Conclusion The FilmArray ME assay is a fast and reliable diagnostic tool for the management of infectious meningitis and can easily be implemented in routine diagnostic workflows. However, correlation of test results and underlying clinical symptoms requires experienced users and the awareness of potentially false negative or false positive results. Moreover, considering the need for antimicrobial susceptibility testing, the use of molecular tests as stand-alone diagnostic cannot be recommended.
Susanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy. 2019, 1 .
AMA StyleSusanne Pfefferle, Martin Christner, Martin Aepfelbacher, Marc Lütgehetmann, Holger Rohde. Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy. . 2019; ():1.
Chicago/Turabian StyleSusanne Pfefferle; Martin Christner; Martin Aepfelbacher; Marc Lütgehetmann; Holger Rohde. 2019. "Implementation of the FilmArray ME panel in laboratory routine using a simple sample selection strategy." , no. : 1.