scholarly journals Multi-center Evaluation of the Cepheid Xpert® Xpress SARS-CoV-2/Flu/RSV Test

2020 ◽  
Author(s):  
Heba H. Mostafa ◽  
Karen C. Carroll ◽  
Rachel Hicken ◽  
Gregory J. Berry ◽  
Ryhana Manji ◽  
...  
Keyword(s):  
Public Health ◽  
Los Angeles ◽  
Influenza A ◽  
Respiratory Virus ◽  
Medical Center ◽  
Standard Of Care ◽  
Nucleic Acid Amplification ◽  
Nasopharyngeal Swab ◽  
Influenza B ◽  
Syncytial Virus

With the approach of respiratory virus season in the Northern Hemisphere, clinical microbiology and public health laboratories will need rapid diagnostic assays to distinguish SARS-CoV-2 from influenza and respiratory syncytial virus (RSV) infections for diagnosis and surveillance. In this study, the clinical performance of the Xpert® Xpress SARS-CoV-2/Flu/RSV test (Cepheid, Sunnyvale, CA, USA) for nasopharyngeal swab specimens was evaluated in four centers: Johns Hopkins Medical Microbiology Laboratory, Northwell Health Laboratories, NYC Public Health Laboratory, and Los Angeles County/University of Southern California (LAC+USC) Medical Center. A total of 319 nasopharyngeal swab specimens, positive for SARS-CoV-2 (n = 75), influenza A (n = 65), influenza B (n = 50), RSV (n = 38), or negative (n = 91) by the standard of care nucleic acid amplification tests at each site were tested using the Cepheid panel test. The overall positive percent agreement for the SARS-CoV-2 target was 98.7% (n= 74/75) and the negative agreement was 100% (n= 91) with all other analytes showing 100% total agreement (n= 153). Standard of care tests to which the Cepheid panel was compared included the Cepheid Xpert Xpress SARS-CoV-2, Cepheid Xpert Xpress Flu/RSV, the GenMark ePlex respiratory panel, the BioFire Respiratory panels 2.1 and v1.7, the DiaSorin Simplexa COVID-19 Direct, and the Hologic Panther Fusion SARS-CoV-2 assays. The Xpert Xpress SARS-CoV-2/Flu/RSV test showed high sensitivity and accuracy for all analytes included in the test. This test will provide a valuable clinical diagnostic and public health solution for detecting and differentiating SARS-CoV-2, influenza A and B, and RSV infections during the current respiratory virus season.

scholarly journals Rapid disappearance of influenza following the implementation of COVID-19 mitigation measures in Hamilton, Ontario

2021 ◽  
Vol 47 (04) ◽  
pp. 202-208
Author(s):  
Kevin Zhang ◽  
Avika Misra ◽  
Patrick J Kim ◽  
Seyed M Moghadas ◽  
Joanne M Langley ◽  
...  
Keyword(s):  
Public Health ◽  
Influenza A ◽  
Respiratory Virus ◽  
Respiratory Viruses ◽  
Mitigation Measures ◽  
Nasopharyngeal Swab ◽  
Health Measures ◽  
Bayesian Linear Regression ◽  
Syncytial Virus ◽  
The Impact

Background: Public health measures, such as physical distancing and closure of schools and non-essential services, were rapidly implemented in Canada to interrupt the spread of the coronavirus disease 2019 (COVID-19). We sought to investigate the impact of mitigation measures during the spring wave of COVID-19 on the incidence of other laboratory-confirmed respiratory viruses in Hamilton, Ontario. Methods: All nasopharyngeal swab specimens (n=57,503) submitted for routine respiratory virus testing at a regional laboratory serving all acute-care hospitals in Hamilton between January 2010 and June 2020 were reviewed. Testing for influenza A and B, respiratory syncytial virus, human metapneumovirus, parainfluenza I–III, adenovirus, and rhinovirus/enterovirus was done routinely using a laboratory-developed polymerase chain reaction multiplex respiratory viral panel. A Bayesian linear regression model was used to determine the trend of positivity rates of all influenza samples for the first 26 weeks of each year from 2010 to 2019. The mean positivity rate of Bayesian inference was compared with the weekly reported positivity rate of influenza samples in 2020. Results: The positivity rate of influenza in 2020 diminished sharply following the population-wide implementation of COVID-19 interventions. Weeks 12–26 reported 0% positivity for influenza, with the exception of 0.1% reported in week 13. Conclusion: Public health measures implemented during the COVID-19 pandemic were associated with a reduced incidence of other respiratory viruses and should be considered to mitigate severe seasonal influenza and other respiratory virus pandemics.

scholarly journals Rapid disappearance of influenza following the implementation of COVID-19 mitigation measures in Hamilton, Ontario

2020 ◽  
Author(s):  
Kevin Zhang ◽  
Avika Misra ◽  
Patrick J. Kim ◽  
Seyed M. Moghadas ◽  
Joanne M. Langley ◽  
...  
Keyword(s):  
Public Health ◽  
Influenza A ◽  
Respiratory Virus ◽  
Respiratory Viruses ◽  
Mitigation Measures ◽  
Nasopharyngeal Swab ◽  
Health Measures ◽  
Syncytial Virus ◽  
Novel Coronavirus ◽  
The Impact

AbstractBackgroundPublic health measures, such as social distancing and closure of schools and non-essential services, were rapidly implemented in Canada to interrupt the spread of the novel coronavirus disease 2019 (COVID-19).ObjectiveWe sought to investigate the impact of mitigation measures during the spring wave of COVID-19 on the incidence of other laboratory-confirmed respiratory viruses in Hamilton, Ontario.MethodsAll nasopharyngeal swab specimens (n = 57,503) submitted for routine respiratory virus testing at a regional laboratory serving all acute-care hospitals in Hamilton, Ontario between January 2010 and June 2020 were reviewed. Testing for influenza A/B, respiratory syncytial virus, human metapneumovirus, parainfluenza I–III, adenovirus and rhinovirus/enterovirus was done routinely using a laboratory-developed polymerase chain reaction multiplex respiratory viral panel. A Bayesian linear regression model was used to determine the trend of positivity rates of all influenza samples for the first 26 weeks of each year from 2010 to 2019. The mean positivity rate of Bayesian inference was compared with the weekly reported positivity rate of influenza samples in 2020.ResultsThe positivity rate of influenza in 2020 diminished sharply following the population-wide implementation of COVID-19 interventions. Weeks 12-26 reported 0% positivity for influenza, with the exception of 0.1% reported in week 13.ConclusionsPublic health measures implemented during the COVID-19 pandemic were associated with a reduced incidence of other respiratory viruses and should be considered to mitigate severe seasonal influenza and other respiratory virus pandemics.

scholarly journals The Panther Fusion System with Open Access Functionality for Laboratory-Developed Tests for Influenza A Virus Subtyping

2020 ◽  
Vol 58 (6) ◽  
Author(s):  
Kathleen A. Stellrecht ◽  
Jesse L. Cimino ◽  
Vincente P. Maceira
Keyword(s):  
Open Access ◽  
Influenza A ◽  
Limit Of Detection ◽  
Turnaround Time ◽  
Nucleic Acid Amplification ◽  
Influenza B ◽  
Fusion System ◽  
Valuable Complement ◽  
Syncytial Virus

ABSTRACT Nucleic acid amplification tests, such as PCR, are the method of choice for respiratory virus testing, due to their superior diagnostic accuracy and fast turnaround time. The Panther Fusion (Fusion; Hologic) system has an array of highly sensitive in vitro diagnostic (IVD) real-time PCR assays for respiratory viruses, including an assay for influenza A (FluA) virus, influenza B (FluB) virus, and respiratory syncytial virus (RSV) (FFABR assay). The Fusion system has Open Access functionality to perform laboratory-developed tests (LDTs) alongside IVD assays. We developed two LDTs for FluA virus strain typing on the Panther Fusion instrument, enabling side-by-side testing with the FFABR assay. The LDT-FAST assay uses proprietary primers and probes designed by Hologic for the Prodesse ProFAST+ (PFAST) assay. The exWHO-FAST assay is an expanded redesign of the WHO-recommended reverse transcriptase PCRs (RT-PCRs). To evaluate the performance of these two LDTs, 110 FluA virus-positive samples were tested. Of these, 104 had been subtyped previously; 54 were H3, 46 were 09H1, and 4 were fsH1. All were appropriately subtyped by both LDTs. Of the untyped FluA virus samples, three were subtyped as H3 by both LDTs and two were subtyped as H3 by the LDT-FAST assay only. The sample not subtyped by either LDT was retested with the FFABR assay and was now negative. Limit-of-detection (LOD) analyses were performed with five FluA virus strains. The LDT-FAST LODs were similar to the FFABR assay LODs, while the exWHO-FAST LODs were higher for two H3N2 strains, findings that were explained by analysis of primer/probe homology. In conclusion, either FluA virus typing assay would be a valuable complement to the Panther Fusion respiratory menu given the performance of these LDTs, the system’s full automation, and the ability to split eluates for both IVD and LDT testing.

scholarly journals Performance of a Novel Point-of-Care Molecular Assay for Detection of Influenza A and B Viruses and Respiratory Syncytial Virus (Enigma MiniLab) in Children with Acute Respiratory Infection

2015 ◽  
Vol 54 (1) ◽  
pp. 212-215 ◽  
Author(s):  
Sam T. Douthwaite ◽  
Charlotte Walker ◽  
Elisabeth J. Adams ◽  
Catherine Mak ◽  
Andres Vecino Ortiz ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Influenza A ◽  
Respiratory Virus ◽  
Point Of Care ◽  
Influenza B Virus ◽  
Influenza B ◽  
Molecular Assay ◽  
B Virus ◽  
Syncytial Virus ◽  
Virus Influenza

The performance of the Enigma MiniLab assay for influenza A and B viruses and respiratory syncytial virus (RSV) was compared to a centralized laboratory respiratory virus panel. The positive and negative percent agreement for influenza A virus, influenza B virus, and RSV were 79.2% (95% confidence interval [95% CI], 57.8 to 92.9%) and 99.4% (95% CI, 98.4 to 99.9), 100% (95% CI, 47.8 to 100%) and 100% (95% CI, 99.3 to 100%), 98.5% (95% CI, 94.6 to 99.8%) and 94.5% (95% CI, 91.9 to 96.4%), respectively.

scholarly journals Utility and Challenges of a Multi-pathogen Diagnostic Platform for Characterizing Public Health Threats of Severe Acute Respiratory Infections in Six Countries

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S17-S18
Author(s):  
Jennifer Milucky ◽  
Keyword(s):  
Public Health ◽  
Influenza A ◽  
Age Distribution ◽  
Simultaneous Detection ◽  
Case Fatality ◽  
Influenza B ◽  
Upper Respiratory Tract ◽  
Severe Acute Respiratory Infection ◽  
Syncytial Virus ◽  
Multiple Pathogens

Abstract Background Pneumonia causes significant morbidity and mortality worldwide. Comprehensive etiology studies of pneumonia in adults are limited; however, new diagnostics enable simultaneous detection of multiple pathogens in respiratory specimens. Characterizing the public health threat of severe acute respiratory infection (SARI) may enhance global health security. We studied potential etiologies of SARI among adults in six countries over a 12-month period using multi-pathogen diagnostics. Methods We enrolled SARI cases (acute onset of fever and cough, requiring hospitalization, in an adult) from Global Disease Detection sites in Bangladesh, China, Egypt, Guatemala, Kenya, and Thailand and healthy frequency-matched controls (2 controls: 5 cases) by time (onset), age group (18–49, 50–64, 65+ years), and catchment area. Demographics, clinical data, and nasopharyngeal and oropharyngeal specimens were collected from cases and controls. Specimens were tested for 16 viruses and 14 bacteria using Taqman® Array Card, which uses real-time reverse transcriptase polymerase chain reaction. Results We enrolled 2,388 cases and 1,135 controls from Oct 2013 through Oct 2015. Age distribution (Figure) and seasonality varied by site: enrollment peaked in summer months in Bangladesh, Thailand, and China, and in winter months in Egypt, but was stable throughout the year in Guatemala and Kenya. Case fatality rate across all study locations was 2.3% (range 0–7.0%). One or more pathogens was detected in 76% of cases and in 67% of controls; ≥2 pathogens were detected in 42% of cases and 37% of controls. Pathogens more commonly detected among cases than controls included influenza A (OR 13.3, CI 7.0–25.2; 12.8% of cases vs. 1.1% of controls), influenza B (OR: 27.0, CI 8.6–84.8; 8.1% vs. 0.3%), and respiratory syncytial virus (RSV) (OR: 9.4, CI 3.4–25.8; 4.0% vs. 0.4%). Conclusion In this SARI study, frequent detection of multiple pathogens in the oro- and nasopharynx of both cases and controls made etiology attribution difficult. Influenza and RSV, however, were likely to be causes of SARI. Because upper respiratory tract specimens may not accurately reflect disease in the lung, better specimens are needed to determine pneumonia etiology, particularly for bacteria. Disclosures All authors: No reported disclosures.

scholarly journals 1791. Novel Metabolomics Approach for the Diagnosis of Respiratory Viruses Directly from Nasopharyngeal Specimens

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S660-S660
Author(s):  
Catherine Hogan ◽  
Anthony T Le ◽  
Justin Mak ◽  
Malaya Kumar. Sahoo ◽  
Tina Cowan ◽  
...  
Keyword(s):  
Host Cell ◽  
Influenza A ◽  
Component Analysis ◽  
Respiratory Viruses ◽  
Primary Component ◽  
Nasopharyngeal Swab ◽  
Influenza B ◽  
Compound Identification ◽  
Influenza A H1n1 ◽  
Syncytial Virus

Abstract Background Respiratory virus infections are important causes of morbidity and mortality among pediatric and adult patients. These viruses infect respiratory epithelial cells, where they may induce specific metabolite alterations. As a proof-of-concept, we investigate the novel use of liquid chromatography (LC) combined with quadrupole time-of-flight mass spectrometry (Q-TOF) for the study of host cell metabolite alterations to diagnose and differentiate respiratory viruses. Methods We studied nasopharyngeal swab samples positive for respiratory viruses by the eSensor Respiratory Viral Panel (GenMark Diagnostics, Carlsbad, CA). Banked, frozen samples (−80°C) stored in viral transport media were retrieved and thawed. Aliquots of 100 μL were centrifuged at 13.3 × g for 15 minutes, and the filtrate was analyzed by Agilent 6545 Quadrupole LC/Q-TOF (Agilent Technologies, Santa Clara, CA). Compounds were separated using a novel column arrangement based on hydrophobicity and charge using a quaternary solvent manager, followed by accurate mass analysis by LC/Q-TOF. Agilent Mass Profiler 3D principal component analysis was performed, and compound identification was completed using the METLIN metabolite database. Results A total of 235 specimens were tested by LC/Q-TOF, including 195 positive specimens [including adenovirus, coronavirus, influenza A H1N1 and H3N2, influenza B, human metapneumovirus, parainfluenza viruses 1, 2, 3, and 4, respiratory syncytial virus (RSV), and rhinovirus] as well as 40 negative clinical specimens. LC/Q-TOF primary component analysis (PCA) allowed preliminary identification of key metabolites that distinguished all virus-positive specimens compared with the negative group, and differentiated respiratory viruses from one another including between influenza A 2009 H1N1 and H3N2 subtypes (Figure 1). Conclusion Preliminary data from our LC/Q-TOF analysis show that respiratory viruses exhibit different host cell metabolomic profiles that allow viral differentiation to the species level, and for influenza A virus, the subtype level. This metabolomic approach has substantial potential for diagnostic applications in infectious diseases directly from patient samples, and may be eventually adapted for point-of-care testing. Disclosures All authors: No reported disclosures.

scholarly journals Comparative Seasonal Respiratory Virus Epidemic Timing in Utah

Viruses ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 275
Author(s):  
Zayne Y. Callahan ◽  
Trevor K. Smith ◽  
Celeste Ingersoll ◽  
Rebecca Gardner ◽  
E. Kent Korgenski ◽  
...  
Keyword(s):  
Influenza A ◽  
Respiratory Virus ◽  
Local Level ◽  
Late Summer ◽  
Influenza B ◽  
Viral Interference ◽  
Early Fall ◽  
Syncytial Virus ◽  
Time Specific ◽  
Epidemic Timing

Previous studies have found evidence of viral interference between seasonal respiratory viruses. Using laboratory-confirmed data from a Utah-based healthcare provider, Intermountain Health Care, we analyzed the time-specific patterns of respiratory syncytial virus (RSV), influenza A, influenza B, human metapneumovirus, rhinovirus, and enterovirus circulation from 2004 to 2018, using descriptive methods and wavelet analysis (n = 89,462) on a local level. The results showed that RSV virus dynamics in Utah were the most consistent of any of the viruses studied, and that the other seasonal viruses were generally in synchrony with RSV, except for enterovirus (which mostly occurs late summer to early fall) and influenza A and B during pandemic years.

scholarly journals Post-pandemic influenza A/H1N1pdm09 is associated with more severe outcomes than A/H3N2 and other respiratory viruses in adult hospitalisations

2019 ◽  
Vol 147 ◽  
Author(s):  
C. A. Minney-Smith ◽  
L. A. Selvey ◽  
A. Levy ◽  
D. W. Smith
Keyword(s):  
Clinical Outcomes ◽  
Influenza A ◽  
Respiratory Virus ◽  
Respiratory Illness ◽  
Respiratory Viruses ◽  
Influenza B ◽  
Virus Infections ◽  
Icu Admission ◽  
Hospitalised Patients ◽  
Syncytial Virus

Abstract This study compares the frequency and severity of influenza A/H1N1pdm09 (A/H1), influenza A/H3N2 (A/H3) and other respiratory virus infections in hospitalised patients. Data from 17 332 adult hospitalised patients admitted to Sir Charles Gairdner Hospital, Perth, Western Australia, with a respiratory illness between 2012 and 2015 were linked with data containing reverse transcription polymerase chain reaction results for respiratory viruses including A/H1, A/H3, influenza B, human metapneumovirus, respiratory syncytial virus and parainfluenza. Of these, 1753 (10.1%) had test results. Multivariable regression analyses were conducted to compare the viruses for clinical outcomes including ICU admission, ventilation, pneumonia, length of stay and death. Patients with A/H1 were more likely to experience severe outcomes such as ICU admission (OR 2.5, 95% CI 1.2–5.5, P = 0.016), pneumonia (OR 3.0, 95% CI 1.6–5.7, P < 0.001) and lower risk of discharge from hospital (indicating longer lengths of hospitalisation; HR 0.64 95% CI 0.47–0.88, P = 0.005), than patients with A/H3. Patients with a non-influenza respiratory virus were less likely to experience severe clinical outcomes than patients with A/H1, however, had similar likelihood when compared to patients with A/H3. Patients hospitalised with A/H1 had higher odds of severe outcomes than patients with A/H3 or other respiratory viruses. Knowledge of circulating influenza strains is important for healthcare preparedness.

scholarly journals Multicenter Evaluation of the QIAstat-Dx Respiratory Panel for Detection of Viruses and Bacteria in Nasopharyngeal Swab Specimens

2020 ◽  
Vol 58 (5) ◽  
Author(s):  
Amy L. Leber ◽  
Jan Gorm Lisby ◽  
Glen Hansen ◽  
Ryan F. Relich ◽  
Uffe Vest Schneider ◽  
...  
Keyword(s):  
Influenza A ◽  
Parainfluenza Virus ◽  
Nasopharyngeal Swab ◽  
Influenza B ◽  
Respiratory Pathogens ◽  
Content Type ◽  
Percent Agreement ◽  
Influenza A H1n1 ◽  
Syncytial Virus

ABSTRACT The QIAstat-Dx Respiratory Panel (QIAstat-Dx RP) is a multiplex in vitro diagnostic test for the qualitative detection of 20 pathogens directly from nasopharyngeal swab (NPS) specimens. The assay is performed using a simple sample-to-answer platform with results available in approximately 69 min. The pathogens identified are adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus A and B, influenza A, influenza A H1, influenza A H3, influenza A H1N1/2009, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus/enterovirus, respiratory syncytial virus A and B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. This multicenter evaluation provides data obtained from 1,994 prospectively collected and 310 retrospectively collected (archived) NPS specimens with performance compared to that of the BioFire FilmArray Respiratory Panel, version 1.7. The overall percent agreement between QIAstat-Dx RP and the comparator testing was 99.5%. In the prospective cohort, the QIAstat-Dx RP demonstrated a positive percent agreement of 94.0% or greater for the detection of all but four analytes: coronaviruses 229E, NL63, and OC43 and rhinovirus/enterovirus. The test also demonstrated a negative percent agreement of ≥97.9% for all analytes. The QIAstat-Dx RP is a robust and accurate assay for rapid, comprehensive testing for respiratory pathogens.

scholarly journals Using routine testing data to understand circulation patterns of influenza A, respiratory syncytial virus and other respiratory viruses in Victoria, Australia

2019 ◽  
Vol 147 ◽  
Author(s):  
O. H. Price ◽  
S. G. Sullivan ◽  
C. Sutterby ◽  
J. Druce ◽  
K. S. Carville
Keyword(s):  
Respiratory Syncytial Virus ◽  
Influenza A ◽  
Respiratory Virus ◽  
Respiratory Viruses ◽  
Influenza B ◽  
Routine Testing ◽  
Circulation Patterns ◽  
Cross Correlations ◽  
Time Series Analyses ◽  
Syncytial Virus

Abstract Several studies have reported evidence of interference between respiratory viruses: respiratory viruses rarely reach their epidemic peak concurrently and there appears to be a negative association between infection with one respiratory virus and co-infection with another. We used results spanning 16 years (2002–2017) of a routine diagnostic multiplex panel that tests for nine respiratory viruses to further investigate these interactions in Victoria, Australia. Time series analyses were used to plot the proportion positive for each virus. The seasonality of all viruses included was compared with respiratory syncytial virus (RSV) and influenza A virus using cross-correlations. Logistic regression was used to explore the likelihood of co-infection with one virus given infection with another. Seasonal peaks were observed each year for influenza A and RSV and less frequently for influenza B, coronavirus and parainfluenza virus. RSV circulated an average of 6 weeks before influenza A. Co-infection with another respiratory virus was less common with picornavirus, RSV or influenza A infection. Our findings provide further evidence of a temporal relationship in the circulation of respiratory viruses. A greater understanding of the interaction between respiratory viruses may enable better prediction of the timing and magnitude of respiratory virus epidemics.

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