Performance of the Quidel Sofia rapid influenza diagnostic test during the 2012–2013 and 2013–2014 influenza seasons

Kammerer, Peter E.; Radin, Jennifer M; Hawksworth, Anthony W.; Myers, Connie A.; Brice, Gary T.

doi:10.1111/irv.12380

Cited by 11 publications

(14 citation statements)

References 12 publications

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“…Our study therefore aimed to undertake a clinical perspective‐based prospective comparative study to further characterize the new Sofia FIA test for influenza detection. With traditional RT‐PCR and virus culture assays as references, we demonstrated the superior sensitivity of the Sofia FIA over conventional RIAT for influenza type A diagnosis, similar to previous studies . We demonstrated the assay had a high negative predictive value, suggesting the Sofia FIA is sufficient to be used for disease screening applications that require an accurate and rapid diagnosis.…”

Section: Discussionsupporting

confidence: 81%

Diagnostic performance of the Sofia® influenza A+B fluorescent immunoassay in adult outpatients in Northern Taiwan

Yang

Huang

Shie

et al. 2018

Journal of Medical Virology

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To evaluate the diagnostic performance of the Sofia influenza A+B fluorescent immunoassay (Sofia FIA), we performed a prospective study at the Chang Gung Memorial Hospital in Taiwan from January 2012 to December 2013. Patients who presented at out-patient clinics or the emergency department with influenza-like illness were included. Upper respiratory tract specimens were collected from oropharynx or nasopharynx. Performance of the Sofia FIA was compared to that of the Formosa One Sure Flu A/B Rapid Test. A Real-time reverse transcriptase-polymerase chain reaction assay (RT-PCR) and/or virus culture were used as reference standards. Of the 109 enrolled patients, the sensitivity, specificity, positive, and negative predictive values of the Sofia FIA to detect influenza A virus were 82%, 89%, 77%, and 89%, respectively. These parameters were 100% when the samples were from nasopharynx. The positive predictive value for influenza B virus detection was 29%. The sensitivity of the Sofia FIA for detection of influenza A virus was 93% between days 2 and 4 after onset of symptoms. For specimens with low viral loads (RT-PCR cycle threshold between 30 and 34.9), the sensitivity of The Sofia FIA was 83% (10/12). The Sofia FIA performed effectively in detecting influenza A virus infection. With nasopharyngeal samples, the performance was comparable to RT-PCR. Although influenza viral load typically decreases with time, the Sofia FIA was sensitive enough to identify influenza infecting patients presenting after several days of illness. However, a high false positive rate limits the assay's usefulness to identify influenza B virus infection.

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Section: Discussionsupporting

confidence: 81%

Diagnostic performance of the Sofia® influenza A+B fluorescent immunoassay in adult outpatients in Northern Taiwan

Yang

Huang

Shie

et al. 2018

Journal of Medical Virology

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“…Fourth, the diagnostic sensitivity of the RIDT in actual use tends to be considerably lower than values listed on the product insert, resulting in false negatives. 25,26 Lower sensitivities, however, are tolerated in surveillance systems due to the ability to aggregate data. Finally, unanticipated technological problems were encountered, which occasionally prohibited wireless transmission.…”

Section: Discussionmentioning

confidence: 99%

“…Discussion of performance characteristics of Sofia, however, is beyond the scope of this article. 25,33,34 Although not explored systematically in this study, clinical sites may have received some added benefits from participation. As part of our usual operation, we provided weekly feedback on the circulation of influenza and other respiratory viruses in Wisconsin.…”

Section: Discussionmentioning

confidence: 99%

“…21,22 Laboratory Procedures WREN staff members trained the clinical laboratorians at each WREN site to use Quidel Sofia Influenza AϩB RIDT. 25 All laboratory procedures followed the package insert. 26 Following the usual specimen processing, the used nasal or "residual" swab was placed into a labeled VTM tube at the WREN sites.…”

Section: Clinician Surveillance Protocolmentioning

confidence: 99%

“…25,26 Sofia uses advanced immunofluorescence-based lateral-flow technology to detect influenza A and B viral nucleoprotein antigens in nasal specimens. The analyzer scans the test strip, measures the immunofluorescent signal, and displays the test results (Positive, Negative, or Invalid) on its display screen.…”

Section: Rapid Influenza Detection Testmentioning

confidence: 99%

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New Method for Real Time Influenza Surveillance in Primary Care: A Wisconsin Research and Education Network (WREN) Supported Study

et al. 2017

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Introduction:The goal of public health infectious disease surveillance systems is to provide accurate laboratory results in near-real time. When it comes to influenza surveillance, most current systems are encumbered with inherent delays encountered in the real-life chaos of medical practice. To combat this, we implemented and tested near-real-time surveillance using a rapid influenza detection test (RIDT) coupled with immediate, wireless transmission of results to public health entities.Methods

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Clinical manifestations of influenza and performance of rapid influenza diagnostic test: A university hospital setting

Phetcharakupt

Pasomsub

Kiertiburanakul

2021

Health Science Reports

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Background Rapid influenza diagnostic test (RIDT) is a diagnostic tool that detects the influenza virus nucleoprotein antigen. The RIDT is widely used in clinical practice because it is simple and cost‐effective, and provides results within 10‐15 minutes. Objective We aimed at evaluating the sensitivity and specificity of the Sofia® RIDT compared with the Luminex® multiplex polymerase chain reaction (PCR). The other goal was to determine the predicting factors for diagnosing influenza among individuals with influenza‐like illness (ILI). Method Patients with ILI who had the results of both tests were retrospectively reviewed. We determined the performances of the RIDT. Results A total of 473 patients were included with a median age of 58 (interquartile range 41‐74) years. Of these, 47.1% were male, and 16.2% were diagnosed with influenza by the RIDT or RT‐PCR's positive test. For influenza A, the RIDT showed a sensitivity of 76.3% (95% confidence interval [CI] 59.8‐88.6) and a specificity of 97.9% (95% CI 96.1‐99.0), whereas for influenza B, it showed a sensitivity of 47.1% (95% CI 23.0‐72.2) and a specificity of 97.1% (95% CI 95.2‐98.5). Patients with influenza were more likely to present with fever (81.8% vs 63.1%), cough (81.8% vs 66.1%), and rhinorrhea (41.6% vs 26.5%) compared to those without influenza ( P < 0.05, all), and had a higher proportion of pneumonia (19.5% vs 10.6%, P = 0.029) and acute respiratory distress syndrome (5.2% vs 1.5%, P = 0.063). The predicting factors for influenza among patients presented with ILI were cough (odds ratio [OR] 2.77; 95% CI 0.21‐0.81, P = 0.010), rhinorrhea (OR 1.87; 95% CI 1.03‐3.36, P = 0.037), and higher body temperature (OR 1.64; 95% CI 1.23‐2.19, P = 0.001). Conclusions The sensitivity of the RIDT for the diagnosis of influenza is fair in contrast to the specificity. Among patients with ILI, cough, rhinorrhea, and higher body temperature might be factors for predicting influenza.

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Performance of the Quidel Sofia rapid influenza diagnostic test during the 2012–2013 and 2013–2014 influenza seasons

Cited by 11 publications

References 12 publications

Diagnostic performance of the Sofia® influenza A+B fluorescent immunoassay in adult outpatients in Northern Taiwan

Diagnostic performance of the Sofia® influenza A+B fluorescent immunoassay in adult outpatients in Northern Taiwan

New Method for Real Time Influenza Surveillance in Primary Care: A Wisconsin Research and Education Network (WREN) Supported Study

Clinical manifestations of influenza and performance of rapid influenza diagnostic test: A university hospital setting

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