Abstract

To confirm a diagnosis of influenza at the point of care, healthcare professionals may rely on rapid influenza diagnostic tests (RIDTs). RIDTs have low to moderate sensitivity compared with viral culture or real-time reverse-transcription polymerase chain reaction (rRT-PCR). With the resurgence of the influenza A (Flu A; subtype H1N1) pandemic 2009 (pdm09) strain in the years 2013 and 2014, we evaluated the accuracy of the United State Food and Drug Administration (FDA)-approved Sofia Influenza A+B Fluorescent Immunoassay to detect epidemic Flu A(H1N1)pdm09 in specimens from the upper-respiratory tract. During a 3-month period, we collected 40 specimens that tested positive via PCR and/or culture for Flu A of the H1N1 pdm09 subtype. Of the 40 specimens, 27 tested positive (67.5%) via Sofia assay for Flu A. Of the 13 specimens with a negative result via Sofia testing, 4 had coinfection, as detected by the GenMark Diagnostics eSensor Respiratory Viral Panel. This sensitivity of the RIDT Sofia assay to detect Flu A(H1N1) pdm09 was comparable to previously reported sensitivities ranging from 10% to 75% for older RIDTs.

Highlights

  • To confirm a diagnosis of influenza at the point of care, healthcare professionals may rely on rapid influenza diagnostic tests (RIDTs)

  • Healthcare professionals rely on rapid influenza diagnostic tests (RIDTs) to aid them in the clinical management of patients, for the use of antiviral agents in respiratory infections caused by influenza.[1]

  • Antiviral treatment for illness due to influenza infection can shorten the duration of fever and other symptoms, may reduce death and the risk of complications from influenza, Abbreviations: RIDTs, rapid influenza diagnostic tests; Flu A, influenza A; pdm[09], pandemic 2009; FDA, United States Food and Drug Administration; rRT-PCR, real-time reverse-transcription polymerase chain reaction; Fluorescent Immunoassay (FIA), fluorescent immunoassay; Flu A and influenza B (Flu B), influenza B; Respiratory Viral Panel (RVP), respiratory viral panel; DFA, direct fluorescent antibody (DFA); Cycle threshold (CT), cycle threshold; CLIA, Clinical Laboratory Improvement Amendments of 1988; pos, positive; neg, negative; NA, not applicable; HRV, human rhinovirus; PIV1, parainfluenza virus 1

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Summary

Introduction

To confirm a diagnosis of influenza at the point of care, healthcare professionals may rely on rapid influenza diagnostic tests (RIDTs). Of the 13 specimens with a negative result via Sofia testing, 4 had coinfection, as detected by the GenMark Diagnostics eSensor Respiratory Viral Panel This sensitivity of the RIDT Sofia assay to detect Flu A(H1N1) pdm[09] was comparable to previously reported sensitivities ranging from 10% to 75% for older RIDTs. At points of care, healthcare professionals rely on rapid influenza diagnostic tests (RIDTs) to aid them in the clinical management of patients, for the use of antiviral agents in respiratory infections caused by influenza.[1] Antiviral treatment for illness due to influenza infection can shorten the duration of fever and other symptoms, may reduce death and the risk of complications from influenza, Abbreviations: RIDTs, rapid influenza diagnostic tests; Flu A, influenza A; pdm[09], pandemic 2009; FDA, United States Food and Drug Administration; rRT-PCR, real-time reverse-transcription polymerase chain reaction; FIA, fluorescent immunoassay; Flu B, influenza B; RVP, respiratory viral panel; DFA, direct fluorescent antibody (DFA); CT, cycle threshold; CLIA, Clinical Laboratory Improvement Amendments of 1988; pos, positive; neg, negative; NA, not applicable; HRV, human rhinovirus; PIV1, parainfluenza virus 1. January 3, 2014 January 3, 2014 January 2, 2014 December 30, 2013 January 3, 2014 December 19, 2013 December 26, 2013 December 27, 2013 December 12, 2013 November 14, 2013 December 22, 2013 December 13, 2013 November 26, 2013 November 25, 2013 December 21, 2013 January 5, 2014 January 6, 2014 January 6, 2014 January 7, 2014 January 8, 2014 January 8, 2014 January 9, 2014 February 24, 2014 February 2, 2014 February 6, 2014 February 7, 2014 January 24, 2014 January 11, 2014 February 6, 2014 February 5, 2014 February 5, 2014 January 22, 2014 January 16, 2014 January 11, 2014 January 3, 2014 January 21, 2014 February 4, 2014 February 2, 2014 February 2, 2014 January 10, 2014

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