Evaluation of the molecular Xpert Xpress Flu/RSV assay vs. Alere i Influenza A &amp; B assay for rapid detection of influenza viruses

Jh, Chen; Lam, H. Y.; Yip, CC; Cheng, Vincent Chi-Chung; Chan, JF; Leung, TH; Sridhar, Siddharth; Chan, KH; Tang, BS; Yuen, Kwok‐Yung

doi:10.1016/j.diagmicrobio.2017.11.010

Cited by 28 publications

(24 citation statements)

References 21 publications

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“…P 0.05 was accepted as significant. showed 100% sensitivity for both FluA and FluB in our patients, which was close to the 100% sensitivity for FluA and 96.3% for FluB in the Hong Kong study (Chen et al, 2018). The specificity of Xpert for FluA and FluB in the two studies was also very similar.…”

Section: Discussionsupporting

confidence: 83%

“…This assay was cleared for in-vitro diagnosis in USA and Europe in 2016 but has not yet been cleared in China. The assay demonstrated high sensitivity and specificity in performance evaluation studies in the USA (Cohen et al, 2018;Ling et al, 2018), UK (Bennett et al, 2018), and Hong Kong of China (Chen et al, 2018). The data presented here also demonstrate that the Xpert assay is a suitable method for rapid and accurate identification of these causative pathogens in respiratory infections in mainland China.…”

Section: Discussionmentioning

confidence: 55%

“…The Xpert Flu/RSV assay demonstrated high sensitivity and specificity compared with other molecular methods or traditional diagnosis tests (Chen et al, 2018;Cohen et al, 2018;Ling et al, 2018). Therefore, this assay has been approved for in vitro diagnosis of FluA, FluB and RSV infection in the USA and Europe, but not in China currently.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of the Cepheid Xpert Xpress Flu/RSV assay and commercial real-time PCR for the detection of influenza A and influenza B in a prospective cohort from China

Zou

Chang

Wang

et al. 2019

International Journal of Infectious Diseases

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Background: The Xpert Xpress Flu/RSV assay is released by FDA for rapid detection of influenza A (FluA), influenza B (FluB), and respiratory syncytial virus (RSV). This study aimed to evaluate its clinical performance in comparison to that of the RT-PCR assay cleared by China FDA (CFDA-PCR). Methods: Nasopharyngeal specimens were collected from patients and tested by the two assays side by side. Discordant results were tested with a laboratory-developed real-time PCR for resolution. Viral load in the sample was quantified with a droplet digital PCR. Results: A total of 658 specimens were involved and gave 94.7%-99.1% agreement between the two assays. The Xpert assay showed higher sensitivity for FluA (100% vs. 89.8%) and FluB detection (100% vs. 95.3%), and also higher accuracy (98.9% vs. 95.7%) for FluA than the CDFA-PCR. The positive and negative predictive values (NPV) for the three viruses ranged from 90.5% to 100% in the two assays, with higher NPV for FluA and FluB in Xpert assay. Moreover, the Xpert Ct values showed a linear correlation with virus titer in specimens tested. Conclusion: Overall, the Xpert assay is a reliable and sensitive tool for the detection of FluA, FluB and RSV in our clinical settings.

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 55%

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Comparison of the Cepheid Xpert Xpress Flu/RSV assay and commercial real-time PCR for the detection of influenza A and influenza B in a prospective cohort from China

Zou

Chang

Wang

et al. 2019

International Journal of Infectious Diseases

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“…The data from this study indicates a compelling positive correlation between POCT influenza diagnostics, early initiation of targeted antiviral therapy (where indicated) and a notable reduction in antimicrobial consumption in the study cohort. In this study the performance of the ID NOW Flu A&B2 versus the GeneXpert is similar to that previously reported [16,20]. The one discordant specimen was found to have a low viral load in the nasal specimen as determined by the threshold cycle (Ct) values obtained from the GeneXpert.…”

Section: Discussionsupporting

confidence: 86%

The impact of point-of-care testing for influenza A and B on patient flow and management in a medical assessment unit of a general hospital

et al. 2020

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Objectives: Timely implementation of influenza infection control and treatment can significantly reduce the impact on Hospital resources and patient management when demand is at peak. Turnaround times of Laboratory based screening tests for the diagnosis of influenza may have an impact on the implementation of infection control measures and treatment. In this study the objectives included determining the correlation between the Abbott ID NOW point-of-care testing (POCT) instrument using the Influenza A&B2 test and the laboratory based GeneXpert Flu+RSV kit. In addition the impact of the POCT instrument on the prescription of antivirals and antibiotics was evaluated by comparing with practice when the instrument was not in place. Results:The results of the correlation study with a cohort of 54 patients revealed the Abbott ID NOW POCT has 92% sensitivity for the detection of Influenza A, while specificity was 100% for both Influenza A and B. The impact of the POCT instrument on the frequency of prescription of antivirals and amount of antibiotics consumed (33% reduction in antibiotic consumption in a cohort of 65 (2017) and 61 (2018)) was significant. In addition the average patient length of Hospital stay was significantly reduced from 5.26 days to 3.73 days.

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“…In subsequent laboratory-based studies, the Alere i influenza A & B assay was compared to another CLIA-waived NAAT (Roche cobas Liat), as well as a reference PCR. Using NPS in VTM from adults, Alere i detected 63.8% and Roche cobas Liat detected (32). Half of the samples in this study were from children.…”

Section: Nucleic Acid Detection By Molecular Amplification Assays Formentioning

confidence: 62%

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

Azar

Landry

2018

J Clin Microbiol

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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.

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Evaluation of the molecular Xpert Xpress Flu/RSV assay vs. Alere i Influenza A & B assay for rapid detection of influenza viruses

Cited by 28 publications

References 21 publications

Comparison of the Cepheid Xpert Xpress Flu/RSV assay and commercial real-time PCR for the detection of influenza A and influenza B in a prospective cohort from China

Comparison of the Cepheid Xpert Xpress Flu/RSV assay and commercial real-time PCR for the detection of influenza A and influenza B in a prospective cohort from China

The impact of point-of-care testing for influenza A and B on patient flow and management in a medical assessment unit of a general hospital

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

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