Evaluation of Alere i Influenza A&amp;B for Rapid Detection of Influenza Viruses A and B

Nie, Shaoping; Roth, Richard B.; Stiles, Jeffrey; Mikhlina, Albina; Lu, Xuedong; Tang, Yi‐Wei; Babady, N. Esther

doi:10.1128/jcm.01132-14

Cited by 112 publications

(105 citation statements)

References 26 publications

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“…The sensitivity of the Alere test of 71.3% for detection of influenza A virus that we observed was lower than that reported by others (6)(7)(8)(9). Three of these previous reports compared it to the Xpert Flu A/B (Cepheid, Sunnyvale, CA) assay (7)(8)(9), and one compared it to the FilmArray assay (6) as we did.…”

Section: Discussioncontrasting

confidence: 60%

“…These samples were thawed once and retested concurrently with both study tests in batches ranging from 3 to 11 samples by a single medical technologist using a single Alere instrument and a single Liat instrument in our clinical laboratory. The Alere, Liat, and FilmArray tests were performed as previously described (6,11,12). The FilmArray test uses nested, multiplex PCR and melting curve analysis for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids in respiratory samples.…”

Section: Methodsmentioning

confidence: 99%

“…The Alere test is intended to be used for direct nasal swabs (CLIA complexity, waived) and for nasal and nasopharyngeal swabs eluted in viral transport medium (CLIA complexity, moderate). The Alere test has reported sensitivities and specificities of from 80 to 99.3% and from 62.5 to 100%, respectively, for detection of influenza A virus and from 45.2 to 97.6% and 53.6 to 100%, respectively, for detection of influenza B virus (5)(6)(7)(8)(9). The comparator assays included viral culture in one study and other nucleic acid amplification tests in the remaining studies.…”

mentioning

confidence: 99%

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Direct Comparison of Alere i and cobas Liat Influenza A and B Tests for Rapid Detection of Influenza Virus Infection

2016

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We compared two rapid, point-of care nucleic acid amplification tests for detection of influenza A and B viruses (Alere i [Alere] and cobas Liat [Roche Diagnostics]) with the influenza A and B virus test components of the FilmArray respiratory panel (BioFire Diagnostics) using 129 respiratory specimens collected in universal viral transport medium (80 influenza A virus and 16 influenza B virus positive) from both adult and pediatric patients. The sensitivities of the Alere test were 71.3% for influenza A virus and 93.3% for influenza B virus, with specificities of 100% for both viruses. The sensitivities and specificities of the Liat test were 100% for both influenza A and B viruses. The poor sensitivity of the Alere test for detection of influenza A virus was likely due to a study set that included many low-positive samples that were below its limit of detection. Influenza is a significant cause of morbidity and mortality worldwide. Although the diagnosis is often made by clinical signs and symptoms alone, laboratory testing may be needed to guide antiviral therapy, determine isolation precautions, and provide epidemiologic data, since many different respiratory viruses can cause influenza-like illness. The laboratory diagnosis of influenza has evolved from the use of culture and antigen detection tests to nucleic acid amplification tests that are now considered the new gold standard.Until recently, point-of-care diagnostic testing has been limited to rapid antigen tests based on chromatographic immunoassay technology designed in simple-to-use formats with results available in Ͻ30 min. The chromatographic immunoassays typically have suffered from moderate to low sensitivity; however, recent improvements in test chemistries and instrument readout of results have improved their performance characteristics (1-4). Currently, there are two CLIA-waived, FDA-cleared nucleic acid amplification tests designed to be performed as point-of-care tests by nonlaboratory personnel, the Alere i (Alere, Scarborough, MA) and cobas Liat (Roche Diagnostics, Indianapolis IN) influenza A and B tests. These tests hold promise to significantly improve near-patient diagnostic testing for influenza and may facilitate true practice changes in how clinicians manage these patients.The Alere test is semiautomated and uses an isothermal nicking enzyme amplification reaction and fluorescently labeled molecular beacons to amplify and detect a region of the polymerase basic protein 2 gene in influenza A virus, a region of the polymerase acid protein gene in influenza B virus, and an internal control in less than 15 min (5). The Alere test is intended to be used for direct nasal swabs (CLIA complexity, waived) and for nasal and nasopharyngeal swabs eluted in viral transport medium (CLIA complexity, moderate). The Alere test has reported sensitivities and specificities of from 80 to 99.3% and from 62.5 to 100%, respectively, for detection of influenza A virus and from 45.2 to 97.6% and 53.6 to 100%, respectively, for detection of influenza B vir...

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Section: Discussioncontrasting

confidence: 60%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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Direct Comparison of Alere i and cobas Liat Influenza A and B Tests for Rapid Detection of Influenza Virus Infection

2016

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“…The package insert provided prior to FDA approval did not call for repeat testing of such samples, and this has subsequently been added. In 2014, Nie et al (9) and Bell and Selvarangan (10) reported high sensitivity and specificity ranges of 87.2% to 93.3% and 93.3% to 100% for influenza A virus, and 97.4% to 100% and 100% for influenza B virus, respectively. 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).…”

mentioning

confidence: 99%

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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“…Commercial assays particularly suited to near patient or the point-of-care setting have also been introduced, including the Alere I Influenza A&B (Alere, Stockport, United Kingdom) (8)(9)(10) and Cobas Liat Influenza A/B (Roche, Pleasanton, CA) (11) assays. These have both obtained CLIA (Clinical Laboratory Improvement Amendments) waiver, allowing use of the assay in nontraditional laboratory sites, such as emergency departments, clinic rooms, and pharmacy clinics (12).…”

mentioning

confidence: 99%

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

et al. 2016

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eThe 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. Influenza virus and respiratory syncytial virus (RSV) infections are common causes of acute respiratory illness resulting in high rates of hospitalizations and lost work or school days (1, 2). Rapid testing has an important role in clinical decision making and could facilitate the rational prescription of antivirals, reduce unnecessary pathology testing and antimicrobial therapy, and allow appropriate institution of infection control and public health interventions.Previously commercially available rapid tests were based on lateral flow or fluorescent immunochromatographic technology detecting the presence of viral nucleoproteins. However, the performance of such tests is disappointing, with relatively poor sensitivities compared with PCR (3). Consequently, negative samples cannot confidently exclude infection and must be further tested with more-sensitive assays. Additionally, a recent randomized controlled trial evaluating the impact of these rapid tests on prescribing and clinical outcomes found little evidence to support their use (4).Highly sensitive molecular assays for the detection of influenza virus and RSV have become commercially available and include the GeneXpert (5), Simplexa (6), and Prodesse (7) assays, which all detect influenza A and B viruses and RSV. Commercial assays particularly suited to near patient or the point-of-care setting have also been introduced, including the Alere I Influenza A&B (Alere, Stockport, United Kingdom) (8-10) and Cobas Liat Influenza A/B (Roche, Pleasanton, CA) (11) assays. These have both obtained CLIA (Clinical Laboratory Improvement Amendments) waiver, allowing use of the assay in nontraditional laboratory sites, such as emergency departments, clinic rooms, and pharmacy clinics (12).The Enigma MiniLab influenza A/B & RSV assay obtained CE-IVD (in vitro diagnostics) designation in January 2014 and is available across Europe. The assay is fully automated, accepting nasopharyngeal swabs directly into a disposable cartridge. Magnetic bead purification and concentration are followed by fluorogenic reverse transcriptase PCR for the qualitative detection of influenza A virus (matrix gene), influenza B virus (nonstructural gene), and RSV (fusion gene). The assay has a running time of 90 min. The system requires less than 2 min of hands-on time and is scalable, with each module operating independently and on demand, meaning that up to six tests can be run concurrently (12). Figure 1 shows the platform in a single-module configuration.We investigated the diagnostic accuracy, ...

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Evaluation of Alere i Influenza A&B for Rapid Detection of Influenza Viruses A and B

Cited by 112 publications

References 26 publications

Direct Comparison of Alere i and cobas Liat Influenza A and B Tests for Rapid Detection of Influenza Virus Infection

Direct Comparison of Alere i and cobas Liat Influenza A and B Tests for Rapid Detection of Influenza Virus Infection

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

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

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