Influenza A+B Test Kit Performance Study

Author(s):  
2021 ◽  
Vol 18 (1) ◽  
Author(s):  
David R. McIlwain ◽  
Han Chen ◽  
Maria Apkarian ◽  
Melton Affrime ◽  
Bonnie Bock ◽  
...  

Abstract Background Influenza places a significant burden on global health and economics. Individual case management and public health efforts to mitigate the spread of influenza are both strongly impacted by our ability to accurately and efficiently detect influenza viruses in clinical samples. Therefore, it is important to understand the performance characteristics of available assays to detect influenza in a variety of settings. We provide the first report of relative performance between two products marketed to streamline detection of influenza virus in the context of a highly controlled volunteer influenza challenge study. Methods Nasopharyngeal swab samples were collected during a controlled A/California/2009/H1N1 influenza challenge study and analyzed for detection of virus shedding using a validated qRT-PCR (qPCR) assay, a sample-to-answer qRT-PCR device (BioMerieux BioFire FilmArray RP), and an immunoassay based rapid test kit (Quidel QuickVue Influenza A + B Test). Results Relative to qPCR, the sensitivity and specificity of the BioFire assay was 72.1% [63.7–79.5%, 95% confidence interval (CI)] and 93.5% (89.3–96.4%, 95% CI) respectively. For the QuickVue rapid test the sensitivity was 8.5% (4.8–13.7%, 95% CI) and specificity was 99.2% (95.6–100%, 95% CI). Conclusion Relative to qPCR, the BioFire assay had superior performance compared to rapid test in the context of a controlled influenza challenge study.


2020 ◽  
Author(s):  
David R. McIlwain ◽  
Han Chen ◽  
Maria Apkarian ◽  
Melton Affrime ◽  
Bonnie Bock ◽  
...  

Abstract Background: Influenza places a significant burden on global health and economics. Individual case management and public health efforts to mitigate the spread of influenza are both strongly impacted by our ability to accurately and efficiently detect influenza viruses in clinical samples. Therefore, it is important to understand the performance characteristics of available assays to detect influenza in a variety of settings. We provide the first report of relative performance between two products marketed to streamline detection of influenza virus in the context of a highly controlled volunteer influenza challenge study. Methods: Nasopharyngeal swab samples were collected during a controlled A/California/2009/H1N1 influenza challenge study and analyzed using for detection of virus shedding using a validated qRT-PCR (qPCR) assay, a sample-to-answer qRT-PCR device (BioMerieux BioFire FilmArray RP), and an immunoassay based rapid test kit (Quidel QuickVue Influenza A+B Test).Results: Relative to qPCR, the sensitivity and specificity of the BioFire assay was 72.1% (63.7%-79.5%, 95% Confidence Interval (CI)) and 93.5% (89.3%-96.4%, 95% CI) respectively. For the QuickVue rapid test the sensitivity was 8.5% (4.8%-13.7%, 95% CI) and specificity was 99.2% (95.6%-100%, 95% CI).Conclusion: Relative to qPCR, the BioFire assay had superior performance compared to rapid test in the context of a controlled influenza challenge study.


2021 ◽  
Vol 18 (1) ◽  
Author(s):  
David R. McIlwain ◽  
Han Chen ◽  
Maria Apkarian ◽  
Melton Affrime ◽  
Bonnie Bock ◽  
...  

An amendment to this paper has been published and can be accessed via the original article.


2014 ◽  
Vol 53 (2) ◽  
pp. 706-709 ◽  
Author(s):  
Kimberle C. Chapin ◽  
Estefany J. Flores-Cortez

Data on the performance of rapid molecular point-of-care use platforms for diagnosis of influenza are lacking. We validated nasopharyngeal (NP) flocked specimens in universal transport medium (UTM) and evaluated the clinical sensitivity and specificity of the Alere i influenza A&B test compared to those of the Xpert flu A/B assay. The Alere i influenza A&B test had an overall sensitivity and specificity of 93.8% and 62.5% for influenza A, respectively, and of 91.8% and 53.6% for influenza B, respectively. The poor specificity was due to influenza virus samples determined positive for both type A and B.


2009 ◽  
Vol 45 (2) ◽  
pp. 146-149 ◽  
Author(s):  
Christine C. Ginocchio ◽  
Madhavi Lotlikar ◽  
Leon Falk ◽  
Suman Arora ◽  
Margaret Kowerska ◽  
...  

Viruses ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 2183
Author(s):  
Yuko Sakai-Tagawa ◽  
Seiya Yamayoshi ◽  
Peter J. Halfmann ◽  
Yoshihiro Kawaoka

Rapid antigen tests (RATs) for COVID-19 based on lateral flow immunoassays are useful for rapid diagnosis in a variety of settings. Although many kinds of RATs are available, their respective sensitivity has not been compared. Here, we examined the sensitivity of 27 RATs available in Japan for the detection of the SARS-CoV-2 delta variant. All of the RATs tested detected the delta variant albeit with different sensitivities. Nine RATs (ESPLINE SARS-CoV-2, ALSONIC COVID-19 Ag, COVID-19 and Influenza A+B Antigen Combo Rapid Test, ImmunoArrow SARS-CoV-2, Fuji Dri-chem immuno AG cartridge COVID-19 Ag, 2019-nCoV Ag rapid detection kit, Saliva SARS-CoV-2(2019-nCoV) Antigen Test Kit, and Rabliss SARS-CoV-2 antigen detection kit COVID19 AG) showed superior sensitivity to the isolated delta variant. Although actual clinical specimens were not examined, the detection level of most of the RATs was 7500 pfu, indicating that individuals whose test samples contained less virus than that would be considered negative. Therefore, it is important to bear in mind that RATs may miss individuals shedding low levels of infectious virus.


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