Evaluation of the Alere TM Influenza A&B test compared to CLART TM PneumoVir

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.

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Correction to: Performance of BioFire array or QuickVue influenza A + B test versus a validation qPCR assay for detection of influenza A during a volunteer A/California/2009/H1N1 challenge study

Virology Journal ◽

10.1186/s12985-021-01531-1 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

David R. McIlwain ◽

Han Chen ◽

Maria Apkarian ◽

Melton Affrime ◽

Bonnie Bock ◽

...

Keyword(s):

Influenza A ◽

Qpcr Assay ◽

Challenge Study ◽

2009 H1n1 ◽

B Test

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

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Comparison of Becton Dickinson Directigen EZ Flu A+B Test against the CDC Real-Time PCR Assay for Detection of 2009 Pandemic Influenza A/H1N1 Virus: TABLE 1.

Journal of Clinical Microbiology ◽

10.1128/jcm.02063-09 ◽

2009 ◽

Vol 48 (1) ◽

pp. 343-344 ◽

Cited By ~ 15

Author(s):

Tess Karre ◽

Hugh F. Maguire ◽

David Butcher ◽

Amy Graepler ◽

Diane Weed ◽

...

Keyword(s):

Real Time ◽

Pandemic Influenza ◽

Real Time Pcr ◽

Influenza A ◽

H1n1 Virus ◽

Pcr Assay ◽

Becton Dickinson ◽

Influenza A H1n1 ◽

B Test

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Performance of the Molecular Alere i Influenza A&B Test Compared to That of the Xpert Flu A/B Assay

Journal of Clinical Microbiology ◽

10.1128/jcm.02783-14 ◽

2014 ◽

Vol 53 (2) ◽

pp. 706-709 ◽

Cited By ~ 41

Author(s):

Kimberle C. Chapin ◽

Estefany J. Flores-Cortez

Keyword(s):

Influenza Virus ◽

Sensitivity And Specificity ◽

Influenza A ◽

Point Of Care ◽

Type A ◽

Influenza B ◽

Clinical Sensitivity ◽

Transport Medium ◽

The Poor ◽

B Test

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.

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Sofia Influenza A + B Test

Biomedical Safety & Standards ◽

10.1097/01.bmsas.0000429466.90287.7f ◽

2013 ◽

Vol 43 (8) ◽

pp. 60 ◽

Cited By ~ 1

Keyword(s):

Influenza A ◽

B Test

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Comparison of two rapid influenza A/B test kits with reference methods showing high specificity and sensitivity for influenza A infection

Journal of Medical Virology ◽

10.1002/jmv.20584 ◽

2006 ◽

Vol 78 (5) ◽

pp. 619-622 ◽

Cited By ~ 28

Author(s):

Susanne Booth ◽

Cristina Baleriola ◽

William D. Rawlinson

Keyword(s):

Influenza A ◽

High Specificity ◽

Reference Methods ◽

Specificity And Sensitivity ◽

B Test

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Clinical performance of the 3M Rapid Detection Flu A+B Test compared to R-Mix culture, DFA and BinaxNOW Influenza A&B Test

Journal of Clinical Virology ◽

10.1016/j.jcv.2009.03.018 ◽

2009 ◽

Vol 45 (2) ◽

pp. 146-149 ◽

Cited By ~ 26

Author(s):

Christine C. Ginocchio ◽

Madhavi Lotlikar ◽

Leon Falk ◽

Suman Arora ◽

Margaret Kowerska ◽

...

Keyword(s):

Rapid Detection ◽

Influenza A ◽

Clinical Performance ◽

B Test

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Comparison of the performance of the rapid antigen detection actim Influenza A&B test and RT-PCR in different respiratory specimens

Journal of Medical Microbiology ◽

10.1099/jmm.0.004358-0 ◽

2009 ◽

Vol 58 (3) ◽

pp. 365-370 ◽

Cited By ~ 20

Author(s):

B. Ghebremedhin ◽

I. Engelmann ◽

W. König ◽

B. König

Keyword(s):

Influenza A Virus ◽

Influenza A ◽

Antigen Detection ◽

Influenza B Virus ◽

Influenza B ◽

Rt Pcr ◽

Pcr Assay ◽

B Virus ◽

B Test ◽

Respiratory Specimens

Nowadays, influenza antigen detection test kits are used most frequently to detect influenza A or B virus to establish the diagnosis of influenza rapidly and initiate appropriate therapy. This study was conducted to evaluate the performance of the actim Influenza A&B test (Medix Biochemica). Overall, 473 respiratory specimens were analysed in the actim Influenza A&B test and the results were compared with those from an RT-PCR assay; 461 of these samples originated from paediatric patients aged 7 weeks to 6.5 years either with influenza-related symptoms or from the intensive care unit, and 12 samples originated from adults with underlying lung or haematological diseases. Diagnosis of influenza A or B virus could be established using the actim Influenza A&B test (9/473 samples for influenza A virus and 6/473 for influenza B virus). RT-PCR revealed 23 patients with influenza virus (13/473 for influenza A virus and 10/473 for influenza B virus). The sensitivity and specificity of the actim Influenza A&B test were 65 and 100 % compared with the RT-PCR assay. However, 32 external quality assessment samples containing seven different strains of influenza A subtypes H1N1 and H3N2 and the avian H5N1 were detected correctly by the actim Influenza A&B test. No cross-reactivity to a range of bacterial, fungal and other viral pathogens was observed. In conclusion, the actim Influenza A&B test is reliable for positive results due to its high specificity. Nevertheless, negative results from this test need to be confirmed by a more sensitive assay because of the low sensitivity observed with diagnostic samples.

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Performance of BioFire Array or QuickVue Influenza A+B Test versus a validation qPCR assay for detection of influenza A during a volunteer A/California/2009/H1N1 challenge study

10.21203/rs.3.rs-22980/v1 ◽

2020 ◽

Author(s):

David R. McIlwain ◽

Han Chen ◽

Maria Apkarian ◽

Melton Affrime ◽

Bonnie Bock ◽

...

Keyword(s):

Influenza A ◽

Rapid Test ◽

Influenza Viruses ◽

Qpcr Assay ◽

Superior Performance ◽

Qrt Pcr ◽

Challenge Study ◽

Test Kit ◽

2009 H1n1 ◽

B Test

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.

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