scholarly journals Molecular Point-of-care Testing for Influenza A/B and Respiratory Syncytial Virus: Workflow Parameters for the ID Now™ and cobas® Liat® Systems

2020 ◽  
Vol 13 (2) ◽  
pp. 370
Author(s):  
S. Young ◽  
J. Phillips ◽  
C. Griego-Fullbright ◽  
A. Wagner ◽  
P. Jim ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Influenza A ◽  
Point Of Care ◽  
Point Of Care Testing ◽  
Syncytial Virus

scholarly journals Detection of Influenza A and B Viruses and Respiratory Syncytial Virus by Use of Clinical Laboratory Improvement Amendments of 1988 (CLIA)-Waived Point-of-Care Assays: a Paradigm Shift to Molecular Tests

2018 ◽  
Vol 56 (7) ◽  
Author(s):  
Marwan M. Azar ◽  
Marie L. Landry
Keyword(s):  
Respiratory Syncytial Virus ◽  
Antiviral Therapy ◽  
Influenza A ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Molecular Tests ◽  
Syncytial Virus ◽  
Clinical Laboratory Improvement Amendments

ABSTRACT An accurate laboratory diagnosis of influenza, respiratory syncytial virus (RSV), and other respiratory viruses can help to guide patient management, antiviral therapy, infection prevention strategies, and epidemiologic monitoring. Influenza has been the primary driver of rapid laboratory testing due to its morbidity and mortality across all ages, the availability of antiviral therapy, which must be given early to have an effect, and the constant threat of new pandemic strains. Over the past 30 years, there has been an evolution in viral diagnostic testing, from viral culture to rapid antigen detection, and more recently, to highly sensitive nucleic acid amplification tests (NAAT), as well as a trend to testing at the point of care (POC). Simple rapid antigen immunoassays have long been the mainstay for POC testing for influenza A and B viruses and respiratory syncytial virus (RSV) but have been faulted for low sensitivity. In 2015, the first POC NAAT for the detection of influenza was approved by the Food and Drug Administration (FDA), ushering in a new era. In 2017, the FDA reclassified rapid influenza diagnostic tests (RIDTs) from class I to class II devices with new minimum performance standards and a requirement for annual reactivity testing. Consequently, many previously available RIDTs can no longer be purchased in the United States. In this review, recent developments in Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived testing for respiratory virus infections will be presented, with the focus on currently available FDA-cleared rapid antigen and molecular tests primarily for influenza A and B viruses and RSV.

scholarly journals Impact of a multiplex PCR point-of-care test for influenza A/B and respiratory syncytial virus on an acute pediatric hospital ward

2018 ◽  
Vol 91 (4) ◽  
pp. 331-335 ◽  
Author(s):  
Andres I. Vecino-Ortiz ◽  
Simon D. Goldenberg ◽  
Sam T. Douthwaite ◽  
Chih-Yuan Cheng ◽  
Rebecca E. Glover ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Multiplex Pcr ◽  
Influenza A ◽  
Point Of Care ◽  
Hospital Ward ◽  
Pediatric Hospital ◽  
Point Of Care Test ◽  
Syncytial Virus

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 Diagnostic and economic evaluation of a point-of-care test for respiratory syncytial virus

2020 ◽  
Vol 6 (3) ◽  
pp. 00018-2020
Author(s):  
A. Joy Allen ◽  
Andrea Gonzalez-Ciscar ◽  
Clare Lendrem ◽  
Jana Suklan ◽  
Karen Allen ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Diagnostic Accuracy ◽  
Influenza A ◽  
Diagnostic Yield ◽  
Point Of Care ◽  
Cost Savings ◽  
Sample Type ◽  
Standard Laboratory ◽  
Point Of Care Test ◽  
Syncytial Virus

Respiratory syncytial virus is a common cause of bronchiolitis. Historically, point-of-care tests have involved antigen detection technology with limited sensitivity. The aim of this study was to prospectively evaluate the diagnostic accuracy and model the economic impact of the Roche cobas® Liat® point-of-care influenza A/B and respiratory syncytial virus test.The “DEC-RSV” study was a multi-centre, prospective, observational study in children under 2 years presenting with viral respiratory symptoms. A nasopharyngeal aspirate sample was tested using the point-of-care test and standard laboratory-based procedures. The primary outcome was accuracy of respiratory syncytial virus detection. The cost implications of adopting a point-of-care test were modelled using study data.A total of 186 participants were recruited, with both tests performed on 177 samples. The point-of-care test was invalid for 16 samples (diagnostic yield 91%) leaving 161 available for primary analysis. After resolving discrepancies, the cobas® Liat® respiratory syncytial virus test had 100.00% (95% CI 96.07%–100.00%) sensitivity and 98.53% (95% CI 92.08%–99.96%) specificity. Median time to result was 0.6 h (interquartile range (IQR) 0.5–1) for point-of-care testing and 28.9 h (IQR 26.3–48.1) for standard laboratory testing. Estimated non-diagnostic cost savings for 1000 patients, based on isolation decision-making on point-of-care test result, were £57 010, which would increase to £94 847 when cohort nursing is used.In young children the cobas® Liat® point-of-care respiratory syncytial virus test has high diagnostic accuracy using nasopharyngeal aspirates (currently an off-licence sample type). Time to result is clinically important and was favourable compared to laboratory-based testing. The potential exists for cost savings when adopting the point-of-care test.

scholarly journals Molecular point-of-care testing for influenza A/B and respiratory syncytial virus: comparison of workflow parameters for the ID Now and cobas Liat systems

2019 ◽  
Author(s):  
Stephen Young ◽  
Jamie Phillips ◽  
Christen Griego-Fullbright ◽  
Aaron Wagner ◽  
Patricia Jim ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Influenza A ◽  
Point Of Care ◽  
Turnaround Time ◽  
Walk Away ◽  
Molecular Tests ◽  
Syncytial Virus ◽  
Improve Patient Management ◽  
Parallel Workflow ◽  
Improve Patient

ABSTRACTAimsPoint-of-care (POC) tests for influenza and respiratory syncytial virus (RSV) offer the potential to improve patient management and antimicrobial stewardship. Studies have focused on performance; however, no workflow assessments have been published comparing POC molecular tests. This study compared the Liat and ID Now systems workflow, to assist end-users in selecting an influenza and/or RSV POC test.MethodsStaffing, walk-away, and turnaround time (TAT) of the Liat and ID Now systems were determined using 40 nasopharyngeal samples, positive for influenza or RSV. The ID Now system requires separate tests for influenza and RSV, so parallel (two instruments) and sequential (one instrument) workflows were evaluated.ResultsThe ID Now ranged 4.1–6.2 minutes for staffing, 1.9–10.9 minutes for walk-away and 6.4–15.8 minutes for TAT per result. The Liat ranged 1.1–1.8 minutes for staffing, 20.0–20.5 minutes for walk-away and 21.3–22.0 minutes for TAT. Mean walk-away time comprised 38.0% (influenza positive) and 68.1% (influenza negative) of TAT for ID Now and 93.7% (influenza/RSV) for Liat. The ID Now parallel workflow resulted in medians of 5.9 minutes for staffing, 9.7 minutes for walk-away, and 15.6 minutes for TAT. Assuming prevalence of 20% influenza and 20% RSV, the ID Now sequential workflow resulted in medians of 9.4 minutes for staffing, 17.4 minutes for walk-away, and 27.1 minutes for TAT.ConclusionsThe ID Now and Liat systems offer different workflow characteristics. Key considerations for implementation include value of both influenza and RSV results, clinical setting, staffing capacity, and instrument(s) placement.

scholarly journals Common cold in Team Finland during 2018 Winter Olympic Games (PyeongChang): epidemiology, diagnosis including molecular point-of-care testing (POCT) and treatment

2019 ◽  
Vol 53 (17) ◽  
pp. 1093-1098 ◽  
Author(s):  
Maarit Valtonen ◽  
Matti Waris ◽  
Tytti Vuorinen ◽  
Erkki Eerola ◽  
Antti J Hakanen ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Common Cold ◽  
Olympic Games ◽  
Point Of Care ◽  
Influenza B ◽  
Point Of Care Testing ◽  
Staff Members ◽  
Winter Olympic Games ◽  
The Common ◽  
Syncytial Virus

ObjectivesThe common cold is the main cause of medical time loss in elite sport. Rapid diagnosis has been a challenge that may be amenable to molecular point-of-care testing (POCT).MethodsWe performed a prospective observational study of the common cold in Team Finland during the 2018 Winter Olympic Games. There were 44 elite athletes and 68 staff members. The chief physician recorded the symptoms of the common cold daily on a standardised form. Two nasal swabs were taken at the onset of symptoms. One swab was analysed within 45 min using a molecular POCT for respiratory syncytial virus and influenza A and B viruses. After the Games, the other swab was tested for 16 possible causative respiratory viruses using PCR in laboratory-based testing.Results20 out of 44 (45%) athletes and 22 out of 68 (32%) staff members experienced symptoms of the common cold during a median stay of 21 days. Eleven (26%) samples tested virus-positive using POCT. All subjects with influenza (n=6) and 32 close contacts were treated with oseltamivir. The aetiology of the common cold was finally detected in 75% of the athletes and 68 % of the staff members. Seven virus clusters were identified. They were caused by coronaviruses 229E, NL63 and OC43, influenza B virus, respiratory syncytial virus A, rhinovirus and human metapneumovirus. The virus infections spread readily within the team, most commonly within the same sport discipline.ConclusionsThe cold was indeed a common illness in Team Finland during the Winter Olympic Games. POCT proved to be clinically valuable, especially for influenza. The aetiology of the common cold was identified in most cases.

scholarly journals Molecular point-of-care testing for influenza A/B and respiratory syncytial virus: comparison of workflow parameters for the ID Now and cobas Liat systems

2019 ◽  
Vol 73 (6) ◽  
pp. 328-334 ◽  
Author(s):  
Stephen Young ◽  
Jamie Phillips ◽  
Christen Griego-Fullbright ◽  
Aaron Wagner ◽  
Patricia Jim ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Influenza A ◽  
Point Of Care ◽  
Turnaround Time ◽  
Walk Away ◽  
Molecular Tests ◽  
Syncytial Virus ◽  
Improve Patient Management ◽  
Parallel Workflow ◽  
Improve Patient

AimsPoint-of-care (POC) tests for influenza and respiratory syncytial virus (RSV) offer the potential to improve patient management and antimicrobial stewardship. Studies have focused on performance; however, no workflow assessments have been published comparing POC molecular tests. This study compared the Liat and ID Now systems workflow, to assist end-users in selecting an influenza and/or RSV POC test.MethodsStaffing, walk-away and turnaround time (TAT) of the Liat and ID Now systems were determined using 40 nasopharyngeal samples, positive for influenza or RSV. The ID Now system requires separate tests for influenza and RSV, so parallel (two instruments) and sequential (one instrument) workflows were evaluated.ResultsThe ID Now ranged 4.1–6.2 min for staffing, 1.9–10.9 min for walk-away and 6.4–15.8 min for TAT per result. The Liat ranged 1.1–1.8 min for staffing, 20.0–20.5 min for walk-away and 21.3–22.0 min for TAT. Mean walk-away time comprised 38.0% (influenza positive) and 68.1% (influenza negative) of TAT for ID Now and 93.7% (influenza/RSV) for Liat. The ID Now parallel workflow resulted in medians of 5.9 min for staffing, 9.7 min for walk-away and 15.6 min for TAT. Assuming prevalence of 20% influenza and 20% RSV, the ID Now sequential workflow resulted in medians of 9.4 min for staffing, 17.4 min for walk-away, and 27.1 min for TAT.ConclusionsThe ID Now and Liat systems offer different workflow characteristics. Key considerations for implementation include value of both influenza and RSV results, clinical setting, staffing capacity, and instrument(s) placement.

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