Severe sensitivity loss in an influenza A molecular assay due to antigenic drift variants during the 2014/15 influenza season

Overmeire, Yarah; Vanlaere, Elke; Hombrouck, Anneleen; Beenhouwer, H. De; Simons, Guus; Brink, Antoinette A. T. P.; Abeele, Anne‐Marie Van den; Verfaillie, Charlotte; Acker, Jos Van

doi:10.1016/j.diagmicrobio.2016.02.004

Cited by 15 publications

(14 citation statements)

References 15 publications

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“…Divergence within the MP gene of H3N2 viruses was first reported in 2013 Taiwanese viruses, with C153T, C163T, and G189T mutations affecting the WHO recommended target region [15]. It has been reported these MP mutations correlated with clade 3C.2a viruses in Europe [16]. We have demonstrated that the same is true in the USA [21].…”

Section: Discussionsupporting

confidence: 64%

“…Based on divergence from historical sequences one would have expected more mutations in the Minnesota 09H1N1 strain than in our strain. Interestingly, Overmeire et al [16] demonstrated that a C163T point mutation was pivotal in the loss of activity for the probe in a CE-marked assay from Qiagen. Indeed, the C163T mutation was seen in our viruses while a C162T mutation was observed with A/Minnesota/JB1/2013(H1N1)pdm09.…”

Section: Discussionmentioning

confidence: 99%

“…Indeed, problematic M gene mutations affecting the performance of commercial assays have been observed with A(H1N1) pdm09 viruses [12][13][14]. More recently, mutations in the MP gene of H3N2 strains have been reported in Taiwan and Belgium [15,16].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Effect of genomic drift of influenza PCR tests

Stellrecht

Nattanmai

Butt

et al. 2017

Journal of Clinical Virology

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Section: Discussionsupporting

confidence: 64%

Section: Discussionmentioning

confidence: 99%

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Effect of genomic drift of influenza PCR tests

Stellrecht

Nattanmai

Butt

et al. 2017

Journal of Clinical Virology

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“…Our sample populations offered a unique opportunity to challenge the performance of Fusion with A(H3N2) samples containing the highly problematic C163 T mutation in the M1 target region [6,7], as well as evaluate the performance among historic clades and strains of virus. Furthermore, many of these samples have been used in previous analyses of other systems, effectively enabling a multisystem analysis.…”

Section: Discussionmentioning

confidence: 99%

“…NAATs, which are rapid and have enhanced sensitivity, are considered the method of choice by many and are recommended by IDSA Guidelines [2][3][4]. However, performance differences have been observed among commercial NAATs, particularly after 2014 when sequence divergence in the matrix gene of A(H3N2) viruses emerged [5][6][7]. Especially problematic was a C163 T mutation that was first observed among 3C.2a clades of A(H3N2) [8][9][10].…”

Section: Introductionmentioning

confidence: 99%

Panther Fusion® Respiratory Virus Assays for the detection of influenza and other respiratory viruses

Stellrecht

Cimino

Wilson

et al. 2019

Journal of Clinical Virology

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Background: Nucleic acid amplification tests (NAATs), such as PCR, are preferred for respiratory virus testing, due to superior diagnostic accuracy and faster turnaround time. Panther Fusion® Respiratory Assays (Fusion), which includes FluA/B/RSV (FFABR), Paraflu and AdV/hMPV/RV, offers a modular approach to syndromic testing on a fully automated platform while improving gene targets and expanding the test menu. Objectives and study design: We evaluated Fusion using 275 consecutive nasopharyngeal specimens previously used in an analysis of five PCRs, as well as 225 archived specimens. Results: Of the combined 500 specimens, 134 were positive for influenza A (FluA), 54 for FluB, 65 for RSV, 64 for parainfluenza (PIV), 24 for adenovirus (AdV), 21 for humanmetapneumovirus (hMPV), and 40 for rhinovirus (RV) with Fusion. Of the positive samples Fusion correlated with historical results for all but one, despite multiple freeze-thaws cycles of this collection. Fusion was positive for an additional 33 samples, including 11 FluAs, 7 RSVs, 3 PIV3s, 3 AdV, 6 hMPV and 3 RVs. These samples were retested with corresponding Prodesse (Pro) assays using quadruple sample volume. This resolver test confirmed Fusion results for an additional 4 FluAs, 4 RSVs, 1 PIV3 and 3 AdVs. The sensitivity and specificity ranges of Fusion were 99-100% and 98-100%. Limit of detection (LOD) analyses were performed on a variety of Flu isolates. The LODs ranged from 2.69 to 2.99 log copies/ml and demonstrated superior LOD as compared to previously published data for some assays or to concurrent analyses with two new commercial tests.

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Influenza A virus drift variants reduced the detection sensitivity of a commercial multiplex nucleic acid amplification assay in the season 2014/15

et al. 2016

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The influenza season 2014/15 was dominated by drift variants of influenza A(H3N2), which resulted in a reduced vaccine effectiveness. It was not clear if the performance of commercial nucleic-acid-based amplification (NAT) assays for the detection of influenza was affected. The purpose of this study was to perform a real-life evaluation of two commercial NAT assays. During January-April 2015, we tested a total of 665 samples from patients with influenza-like illness using the Fast Track Diagnostics Respiratory pathogens 21, a commercial multiplex kit, (cohorts 1 and 2, n = 563 patients) and the Xpert Flu/RSV XC assay (cohort 3, n = 102 patients), a single-use cartridge system. An in-house influenza real-time RT-PCR (cohort 1) and the RealStar Influenza RT-PCR 1.0 Kit (cohort 2 and 3) served as reference tests. Compared to the reference assay, an overall agreement of 95.9 % (cohort 1), 95 % (cohort 2), and 98 % (cohort 3) was achieved. A total of 24 false-negative results were observed using the Fast Track Diagnostics Respiratory pathogens 21 kit. No false-negative results occurred using the Xpert Flu/RSV XC assay. The Fast Track Diagnostics Respiratory pathogens 21 kit and the Xpert Flu/RSV XC assay had sensitivities of 90.7 % and 100 % and specificities of 100 % and 94.1 %, respectively, compared to the RealStar 1.0 kit. Upon modification of the Fast Track Diagnostics Respiratory pathogens 21 kit, the sensitivity increased to 97.3 %. Influenza virus strains circulating during the 2014/15 season reduced the detection sensitivity of a commercial NAT assay, and continuous monitoring of test performance is therefore necessary.

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Severe sensitivity loss in an influenza A molecular assay due to antigenic drift variants during the 2014/15 influenza season

Cited by 15 publications

References 15 publications

Effect of genomic drift of influenza PCR tests

Effect of genomic drift of influenza PCR tests

Panther Fusion® Respiratory Virus Assays for the detection of influenza and other respiratory viruses

Influenza A virus drift variants reduced the detection sensitivity of a commercial multiplex nucleic acid amplification assay in the season 2014/15

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