Evaluation of the Becton Dickinson Rapid Influenza Diagnostic Tests in Outpatients in Germany during Seven Influenza Seasons

Abstract

BackgroundAn extensive retrospective study spanning several seasons was undertaken to evaluate the diagnostic performance of the BD rapid influenza diagnostic test (RIDT) in comparison with the RT-PCR assay.MethodsA total of 2,179 respiratory samples were tested in parallel by in-house RT-PCR and the RIDT. During the 2003-2004, 2006-2007, 2007-2008, and 2008-2009 (n=1671) seasons, the BD Directigen Flu A+B test was used, and during the 2010-2011, 2011-2012 and 2012-2013 (n=508) seasons, the BD Directigen EZ Flu A+B test b was used.ResultsThe sensitivity, specificity, PPV and NPV for the BD Directigen Flu A+B test calculated for types A and B together were 39%, 99%, 98%, and 56%, respectively. For the BD Directigen EZ Flu A+B test, these values were 47%, 100%, 100%, 55%, respectively. The sensitivity of the BD Directigen Flu A+B test did not differ significantly from season to season or between types A (44%) and B (37%). The sensitivity of the BD Directigen EZ Flu A+B test calculated for type A only was 59%, which was considerably higher than the sensitivity of this test for type B (23%). The sensitivity of the RIDT was approximately 40-50% in children and teenagers, but it was only 18.% in adults aged 20 years and older. The specificity of both RIDTs was very high (>99%) during all seasons.ConclusionsDue to their rapid turnaround time, RIDTs can help guide decisions about the clinical management of influenza. Because of the high specificity, a positive result can be interpreted as a true positive, and antiviral therapy as well as appropriate measures to prevent the transmission of influenza can be initiated. The best sensitivity of the RIDT is achieved in children. However, even in this group, the RIDT will only recognize influenza infection in approximately half of the cases, and influenza should still be considered in patients with negative results; negative RIDT results must be confirmed by PCR.

Influenza and other respiratory viruses: standardizing disease severity in surveillance and clinical trials

“…Regular severity assessments over time can be combined with CP detection methodology to detect of significant changes in disease severity in cohorts. Hospital surveillance will thus become feasible in real time, as rapid-turnaround diagnostic tests are evolving [154][155][156][157]. The use of rapid diagnostic tests can then be targeted according to the local surveillance information.…”

Influenza colloidal gold method and blood routine tests combination for rapid diagnosis of influenza: a decision tree-based analysis

“…Studies have shown that the PPV range for a rapid influenza test kit is 30-80% 11,12 . Moreover, Eggers et al 13 reported that the sensitivity and NPV of a rapid influenza test were 40-50% and 55-56%, respectively. In this study, the proportion of patients who underwent routine blood tests, colloidal gold tests, and chest X-rays was 94%, 82%, and 16%, respectively.…”

Evaluation of the point-of-care Becton Dickinson Veritor™ Rapid influenza diagnostic test in Kenya, 2013–2014

“…The sensitivity of RIDTs can be substantially diminished among adults (~18%), [28] and some studies have shown even lower sensitivity among those ≥65 years (8%) [29–31], leading to underestimation of disease burden [32, 33]. …”