Evaluation of the Alere i Influenza A&amp;B Nucleic Acid Amplification Test by Use of Respiratory Specimens Collected in Viral Transport Medium

Bell, J. Jeremiah; Selvarangan, Rangaraj

doi:10.1128/jcm.01639-14

Cited by 52 publications

(36 citation statements)

References 26 publications

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“…Nie et al evaluated the Alere i system with the FilmArray respiratory panel (RP) (BioFire Diagnostics, Salt Lake City, UT) using frozen NP swabs in viral transport media, using the Prodesse ProFluϩ assay (Gen-Probe, San Diego, CA) for discrepant analysis (9). Bell and Selvarangan reported similar findings comparing the results of Alere i system to those of viral culture, with discrepant analysis by the Prodesse ProFluϩ assay in their pediatric study (10). Validating performance parameters with UTM means continued use of a common collection system currently in place in our laboratory and the availability of additional specimens without having to collect additional samples for subsequent testing, which may be necessary to clarify respiratory diagnoses, such as coinfections, or address specific infection control requirements (1, 2, 11).…”

supporting

confidence: 64%

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

Chapin

Flores-Cortez

2015

J Clin Microbiol

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bData 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. R apid and accurate diagnoses of influenza prompt necessary infection control, public health notification, tracking, and accurate administration of antiviral therapy. During the pandemic H1N1 outbreak of 2009, the performance of rapid antigen detection tests for influenza was shown to be inferior to the performance of molecular methods, with sensitivity ranging from 10% to 70% (1-3). Rapid molecular testing was not available in many hospitals, clinics, and physician offices due to either cost of equipment or cost of reagents, use of complex molecular diagnostics requiring skilled technologists to perform testing, and/or slow turnaround time to results (2, 4, 5). Recently, the Alere i influenza A&B assay (Alere, Scarborough, ME) became a FDA-cleared molecular test for detection of influenza viruses A and B.The Alere i influenza A&B system (Alere i system) is a rapid, semiautomated in vitro diagnostic test for the detection and differentiation of influenza A virus and influenza B virus with objective results available in less than 15 min. The Alere i system incorporates isothermal nucleic acid amplification technology using primers and fluorescent probes specific for amplification of RNA targets for influenza A and B virus in samples from patients presenting with influenza-like illness (ILI). The test is performed with an Alere i instrument and three test components: sample receiver, containing elution buffer, test base with two sealed reaction tubes containing a lyophilized pellet containing reagents for amplification of target RNA, and a transfer cartridge for transferring the eluted sample to test base. The Alere i influenza A&B test is intended for direct nasal swab specimen testing for influenza A and B viral infections in conjunction with clinical and epidemiological risk factors. Similar to the earlier IQuum Liat influenza A/B assay (Roche Diagnostics, Indianapolis, IN), the Alere i system was developed to address the unmet clinical need for rapid point-of-care testing of influenza at clinical sites with low test volume and limited easy-to-use molecular technology. Performance characteristics of such devices are lacking, as well as comparisons to traditional PCR methods.The Alere i influenza A&B assay is equipped with sterile-foamtipped applicator swabs (Puritan Medical Products LLC, Guilford, ME) for fresh specimen collection; however, rayon or flocked nasal swabs have been validated for use by Alere. Speci...

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supporting

confidence: 64%

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

Chapin

Flores-Cortez

2015

J Clin Microbiol

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“…The present study evaluated the performance of Alere iNAT against existing RIDTs using RT‐PCR as the reference standard for the detection of influenza viruses on clinical specimens collected from patients with an ILI. Others have previously compared Alere iNAT against RT‐PCR and/or viral culture using prospectively collected or frozen samples . Overall, Alere iNAT has demonstrated superior performance to the other RIDTs, particularly in the detection of influenza B.…”

Section: Discussionmentioning

confidence: 99%

“…The lack of paediatric samples may have also lowered the observed sensitivity of all RIDTs tested; previous meta‐analyses have suggested improved RIDT sensitivity of up to 13% in children as they generally have higher viral loads and prolonged viral shedding compared to adults . A recent study of Alere iNAT performance in children and adolescents reported sensitivities and specificities of 88·8% and 98·3%, respectively, for influenza A and 100% and 100%, respectively, for influenza B compared to RT‐PCR …”

Section: Discussionmentioning

confidence: 99%

Detection of influenza A and B with the Alere^™ i Influenza A & B: a novel isothermal nucleic acid amplification assay

Hazelton

Gray

et al. 2015

Influenza Resp Viruses

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BackgroundRapid influenza diagnostic tests (RIDTs) have an important role in clinical decision-making; however, the performances of currently available assays vary widely.ObjectivesWe evaluated the performance of the Alere™ i Influenza A&B (Alere™ iNAT), a rapid isothermal nucleic acid amplification assay that has recently received FDA clearance, for the detection of influenza A and B viruses during the Australian influenza season of 2013. Results were compared to two other RIDTs tested in parallel; Quidel Sofia® Influenza A+B fluorescent immunoassay (FIA) and Alere™ BinaxNOW® Influenza A & B immunochromatographic (ICT) assay.MethodsA total of 202 paired nasopharyngeal swabs collected from patients ≥16 years old with an influenza-like illness (ILI) were eluted in 2 ml of universal transport medium (UTM) that was used to perform all three RIDTs in parallel. Reverse-transcription polymerase chain reaction (RT-PCR) was used as the reference standard.ResultsCompared to RT-PCR, Alere™ iNAT detected 77·8% influenza A positive samples versus 71·4% and 44·4% for the Quidel Sofia® Influenza A+B FIA and BinaxNOW® Influenza A & B ICT assay, respectively. For influenza B, Alere™ iNAT detected 75% of those positive by RT-PCR, versus 33·3% and 25·0% for Sofia® and BinaxNOW®, respectively. The specificity of Alere™ iNAT was 100% for influenza A and 99% for influenza B.ConclusionsAlere™ i Influenza A&B is a promising new rapid influenza diagnostic assay with potential point-of-care applications.

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“…an independent conclusion about the assay performance. Other studies report a sensitivity of Alere TM Influenza A&B of 73%-99% for influenza-A, 97%-100% for influenza-B; and specificity of 95%-100% for influenza-A, and 100% for influenza-B [9][10][11].…”

Section: The Overall Low Number Of Influenza-b In Both Test Series LImentioning

confidence: 97%

Diagnostic performance of near-patient testing for influenza

Beckmann

Hirsch

2015

Journal of Clinical Virology

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Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Test by Use of Respiratory Specimens Collected in Viral Transport Medium

Cited by 52 publications

References 26 publications

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

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

Detection of influenza A and B with the Alere^™ i Influenza A & B: a novel isothermal nucleic acid amplification assay

Diagnostic performance of near-patient testing for influenza

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Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Test by Use of Respiratory Specimens Collected in Viral Transport Medium

Cited by 52 publications

References 26 publications

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

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

Detection of influenza A and B with the Alere™ i Influenza A & B: a novel isothermal nucleic acid amplification assay

Diagnostic performance of near-patient testing for influenza

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Product

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Detection of influenza A and B with the Alere^™ i Influenza A & B: a novel isothermal nucleic acid amplification assay