Utility of a Viral Vesicular Panel Multiplex Polymerase Chain Reaction Assay for the Diagnosis of Monkeypox, Herpes Simplex, and Varicella Zoster Viruses

Wilber, Eli; Rebolledo, Paulina A.; Kasinathan, Vyjayanti; Merritt, Stephanie M.; Titanji, Boghuma K; Aldred, Bruce; Kandiah, Sheetal; Ray, Susan M.; Sheth, Anandi N.; Colasanti, Jonathan; Wang, Yun F.

doi:10.1093/ofid/ofad140

Cited by 5 publications

(7 citation statements)

References 9 publications

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“…To our knowledge, this is the third published study to report results on the QIAstat-Dx assay. In the study by Wilber et al [10], QIAstat-Dx allowed researchers to detect MPXV clade II in 36 of 47 samples, whereas the comparator (Mpox Virus DNA Qualitative Real-Time PCR assay; Quest Diagnostics, Chantilly, VA, USA) detected MPXV clade II in 37 of 47 samples, thus resulting in a positive agreement of 97.3% (36/37 samples). The sample with a discordant result had a Ct value with the Quest Diagnostics assay near the limit of detection, suggesting a sample's viral load below the limit of detection of the QIAstat-Dx assay.…”

Section: Discussionmentioning

confidence: 99%

“…The diagnosis of mpox based on clinical presentation alone may be difficult, especially in atypical presentation cases [6]. Therefore, it is important not only to differentiate the two MPXV clades from each other, but also MPXV from other orthopoxviruses (MPXV is a double-stranded DNA virus belonging to the genus Orthopoxvirus [OPX]) [7][8][9] or other vesicular disease-causing viruses such as herpes simplex virus 1 and 2 (HSV-1/HSV-2), human herpesvirus 6 (HHV6), enterovirus (EV), or varicella zoster virus (VZV) [10,11]. The speed of diagnosis, achievable through a point-of-care testing (POCT) molecular assay, may be important, especially if the surge in mpox cases requires easier detection and timely control at the local level to decrease the global spread of the disease [4].…”

Section: Introductionmentioning

confidence: 99%

“…To date, the QIAstat-Dx viral vesicular panel assay (Qiagen, Germantown, MD, USA), which launched on the market in September 2022 (https://www.rapidmicrobiology.com/ news/monkeypox-health-emergency-qiagen-launches-syndromic-test-panel; accessed on 11 September 2023) is the only commercially available real-time PCR assay to be both a POCT (approximately 1 h of reaction time required) and a multitarget panel (MPXV and five other vesicular disease-causing viruses included) assay. It should be noted that the assay (hereafter referred to as QIAstat-Dx assay) is a research use only (RUO) assay whose clinical utility for the detection of MPXV (and other (co)-infecting viruses) has been shown in two evaluation studies published so far [10,11]. In one of these studies [11], human samples other than skin lesion material, which remains the preferred clinical sample based on the WHO's mpox laboratory testing guidelines [12], were used.…”

Section: Introductionmentioning

confidence: 99%

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Performance of a Novel Real-Time PCR-Based Assay for Rapid Monkeypox Virus Detection in Human Samples

Liotti,

Marchetti,

Falletta

et al. 2023

Microorganisms

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The ongoing epidemic of mpox, namely human monkeypox virus (MPXV) infection, requires rapid and reliable laboratory diagnosis. We report on the QIAstat-Dx viral vesicular panel PCR assay that allows the detection of (within 75 min) six vesicular disease-causing viruses, including MPXV. We analyzed 168 clinical samples, known to be positive (51 samples) or negative (117 samples) for MPXV clade II, obtained from patients at their mpox diagnosis or follow-up. QIAstat assay results were compared to those of a MPXV-specific reference PCR assay. The QIAstat assay detected MPXV (clade II) in 51 (100%) of 51 samples and did not detect MPXV in 117 (100%) of 117 samples, resulting in a positive or negative agreement of 100% (95% CI, 93.0–100) and 100% (95% CI, 96.8–100), respectively. Of the 20 patients diagnosed with mpox, 18 (90.0%) had at least a vesicular swab and 1 (5.0%) had only an oropharyngeal swab positive for MPXV. At mpox follow-ups, 2 (10.0%) of 20 patients had first-time positive whole blood samples. Thirteen MPXV-negative samples were positive for mpox-mimicking viruses. Our findings show the excellent performance of the QIAstat-Dx assay for MPXV detection in clinical samples. Further studies are needed before considering a large-scale application of the QIAstat-Dx assay.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Performance of a Novel Real-Time PCR-Based Assay for Rapid Monkeypox Virus Detection in Human Samples

Liotti,

Marchetti,

Falletta

et al. 2023

Microorganisms

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“…A multiplex approach for MPXV, VARV, and the varicella-zoster virus (VZV) identification was reported, employing [36] the unique sequences F3L, B12R, and ORF38, respectively, reducing the probability of misidentification of coexisting pathogens [37,38]. For infectious syndromes such as meningitis/encephalitis, pneumonia, and Mpox, standard multiplex pathogen panels implying RT-PCR have emerged as useful clinical tools, given the high probability of clinical overlap and coinfections with other similar viruses [39].…”

Section: Development Of Various Diagnostic Techniques (A) Development...mentioning

confidence: 99%

Mapping the Landscape of Health Research Priorities for Effective Pandemic Preparedness in Human Mpox Virus Disease

Aggarwal,

Agarwal,

Nigam

et al. 2023

Pathogens

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The global re-emergence of monkeypox (Mpox) in non-endemic regions in 2022 has highlighted the critical importance of timely virus detection and robust public health surveillance in assessing outbreaks and their impact. Despite significant Mpox research being conducted worldwide, there is an urgent need to identify knowledge gaps and prioritize key research areas in order to create a roadmap that maximizes the utilization of available resources. The present research article provides a comprehensive mapping of health research priorities aimed at advancing our understanding of Mpox and developing effective interventions for managing its outbreaks, and, as evidenced by the fact that achieving this objective requires close interdisciplinary collaboration. The key research priorities observed were identifying variants responsible for outbreaks; discovering novel biomarkers for diagnostics; establishing suitable animal models; investigating reservoirs and transmission routes; promoting the One Health approach; identifying targets for vaccination; gaining insight into the attitudes, experiences, and practices of key communities, including stigma; and ensuring equity during public health emergencies. The findings of this study hold significant implications for decision making by multilateral partners, including research funders, public health practitioners, policy makers, clinicians, and civil society, which will facilitate the development of a comprehensive plan not only for Mpox but also for other similar life-threatening viral infections.

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“…In addition, the anal swabs were analysed for the presence of MPXV using reverse transcriptase polymerase chain reaction (PCR) using the Qiagen QIAstat-Dx (QIAGEN, Hilden, Germany) analyzer and the Qiagen QIAstat-Dx Viral Vesicular Panel. The qualitative multiplex PCR panel can detect MPXV (clade 1 and 2), human herpesvirus (HHV)-1, HHV-2, HHV-3, HHV-6, and human enterovirus [13]. The analyses within this study were approved by the local ethics committee (EC 1051/2020 and EC 898/2010).…”

mentioning

confidence: 99%

No evidence of asymptomatic monkeypox infection in a highly sexually active MSM population in Austria

Grabmeier‐Pfistershammer,

Skorepa,

Breuer

et al. 2023

HIV Medicine

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BackgroundThe 2022 outbreak of monkeypox virus (MPXV) revealed new transmission routes. Incidence declined sharply in September 2022, and it remains unclear whether MPXV is circulating in asymptomatic individuals because of increased immunity.ObjectivesOur study aimed to assesss the number of asymtomatic MPXV carriers in individuals at high risk for STI.MethodsWe analysed anal samples from asymptomatic highly sexually active men who have sex with men for the presence of MPXV.ResultsWe detected a high number of concomitant sexually transmitted infections but did not find a single sample with MPXV.ConclusionsOur results indicate that the general recommendation to implement screening for MPXV is not currently justified.

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Utility of a Viral Vesicular Panel Multiplex Polymerase Chain Reaction Assay for the Diagnosis of Monkeypox, Herpes Simplex, and Varicella Zoster Viruses

Cited by 5 publications

References 9 publications

Performance of a Novel Real-Time PCR-Based Assay for Rapid Monkeypox Virus Detection in Human Samples

Performance of a Novel Real-Time PCR-Based Assay for Rapid Monkeypox Virus Detection in Human Samples

Mapping the Landscape of Health Research Priorities for Effective Pandemic Preparedness in Human Mpox Virus Disease

No evidence of asymptomatic monkeypox infection in a highly sexually active MSM population in Austria

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