Abstract

In order to compare the last version of the Respiratory Virus Panel (RVP) Fast assay for human Adenovirus (hAdv) detection with a specific real-time polymerase chain reaction (qPCR), which is considered the gold standard for hAdv detection, nasopharyngeal samples collected from 309 children (age range, four months to eight years) with respiratory tract infection were tested using the RVP Fast v2 assay (Luminex Molecular Diagnostics, Inc., Toronto, ON, Canada) and a specific TaqMan qPCR to identify hAdv DNA. The RVP Fast v2 assay detected 30/61 (49.2%) hAdv infections that had been identified by real-time qPCR, demonstrating a significantly lower detection rate (p < 0.001). The sensitivity of the RVP Fast v2 assay in comparison to qPCR was lower in younger children (42.9% vs. 57.7%; Cohen’s kappa coefficient, 0.53); in samples with co-infections (40.0% vs. 56.7%; Cohen’s kappa coefficient, 0.52); and in samples with hAdv type C (45.9% vs. 57.1%; Cohen’s kappa coefficient, 0.60). Samples with lower viral loads were associated with a significantly lower sensitivity of the RVP Fast v2 assay (35.1% vs. 68.2%, p = 0.01; Cohen’s kappa coefficients, 0.49). The RVP Fast v2 assay has important limitations for the detection of hAdv and cannot be used to evaluate whether hAdvs are the main etiologic agent responsible for an outbreak or when epidemiological studies are performed.

Highlights

  • Epidemics of different respiratory viruses simultaneously occur every winter season [1]

  • The Respiratory Virus Panel (RVP) Fast v2 assay detected 30/61 (49.2%) of human Adenovirus (hAdv) infections that had been identified by qPCR, demonstrating a significantly lower detection rate (p < 0.001)

  • No case was identified that resulted in a positive RVP Fast v2 test and a negative qPCR test

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Summary

Introduction

Epidemics of different respiratory viruses simultaneously occur every winter season [1]. Direct comparisons of the RVP Fast assay with qPCR have shown that discordant results can occur for some viruses, with reduced sensitivity of the RVP Fast assay observed mainly in samples with low viral load [2,6]. This explains why the first RVP Fast Assay version was cleared by the Food and Drug Administration for the detection of only eight viruses and subtypes and for application only to nasopharyngeal swabs, leaving other specimens to be validated by the individual laboratories. This study compared the sensitivity and specificity of the last version of the RVP Fast assay (the v2 version) for human Adenovirus (hAdv) detection with those of qPCR, which is considered the gold standard

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