Clinical Performance Evaluation of a Rapid Real-Time PCR Assay for Monkeypox Diagnosis: a Retrospective and Comparative Study

Peris, María Paz; Clusa, Laura; Alonso, Henar; Escolar, Cristina; Fortuño, B; Rezusta, Antonio; Milagro, Ana

doi:10.1128/spectrum.00510-23

Microbiol Spectr

2023

DOI: 10.1128/spectrum.00510-23

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Clinical Performance Evaluation of a Rapid Real-Time PCR Assay for Monkeypox Diagnosis: a Retrospective and Comparative Study

María Paz Peris

Laura Clusa

Henar Alonso

et al.

Abstract: Given that a large number of mpox outbreaks have been reported worldwide since 2022 in countries in which the disease is not endemic, the main concern for clinicians and global health systems should be to develop effective, available, and easy-to-implement diagnostic strategies to interrupt mpox transmission as soon as possible. This retrospective study demonstrates the satisfactory clinical parameters of a commercially available molecular diagnostic kit for routine testing for mpox in clinical diagnostic labo… Show more

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Cited by 3 publications

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Review of virological methods for laboratory diagnosis and characterization of monkeypox virus (MPXV): lessons learned from the 2022 Mpox outbreak

Resman Rus,

Zakotnik,

Sagadin

et al. 2024

Acta Dermatovenerologica Alpina Pannonica Et Adriatica

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Monkeypox virus (MPXV), originally endemic in West Africa (Clade II) and Central Africa (Clade I), has recently emerged worldwide and has reinforced the need for rapid and accurate MPXV diagnostics. This review presents and critically discusses the range of virological methods for laboratory diagnosis and characterization of MPXV as well as related lessons learned and practical experience gained from the 2022 Mpox global outbreak. Real-time PCR is currently considered the diagnostic gold standard and ensures accurate and timely confirmation of suspected Mpox cases based on suspicious skin lesions, and digital PCR improves the precision of MPXV DNA quantification. Whole genome sequencing reveals the diversity within the Clade IIb outbreak and highlights the role of microevolution in the adaptation of the virus to the human host. Continuous genomic surveillance is important for better understanding of human-to-human transmission and prevention of the emergence of variola virus-like strains. Traditional virological methods such as electron microscopy and virus isolation remain essential for comprehensive virus characterization, particularly in the context of vaccine and antiviral drug development. Despite the current challenges, serological tests detecting a range of anti-MPXV antibodies are important adjunct diagnostic and research tools for confirmation of late-presenting or asymptomatic MPXV cases, contact tracing, epidemiological studies, seroepidemiological surveys, and better understanding of the role of IgG and neutralizing antibodies in the immune response to infection and vaccination. A multidisciplinary approach combining advanced molecular techniques with traditional virological methods is important for rapid and reliable diagnosis, surveillance, and control of the outbreak.

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Review of virological methods for laboratory diagnosis and characterization of monkeypox virus (MPXV): lessons learned from the 2022 Mpox outbreak

Resman Rus,

Zakotnik,

Sagadin

et al. 2024

Acta Dermatovenerologica Alpina Pannonica Et Adriatica

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Diagnostic accuracy of polymerase chain reaction for detection of mpox in humans

Unnikrishnan,

Singh,

Purohit

2024

Revista Panamericana De Salud Pública

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Objective. To evaluate diagnostic accuracy of polymerase chain reaction (PCR) in detecting mpox infection in humans by pooling the estimates of sensitivity and specificity across different study settings. Methods. A systematic search was conducted in PubMed, Cochrane database, Scopus, and Google Scholar. Studies that evaluated the diagnostic accuracy of PCR test for the detection of monkeypox virus providing the sensitivity and specificity values and the total number of samples were included. The sensitivity and specificity values of PCR test were pooled for all the included studies. The meta-analysis was conducted in accordance with PRISMA guidelines using the metadta package in STATA software. A summary receiver operating characteristic (SROC) curve and forest plot were generated. The protocol was registered in PROSPERO (CRD-NIHR) database with Reference ID CRD42024590183. Results. Twelve studies were included for meta-analysis. The pooled sensitivity and specificity estimate across all the studies using a random effects model was 0.99 (95% CI [0.95, 1.00]) and 1 (95% CI [0.96, 1.00]), respectively. The SROC curve confirmed high diagnostic accuracy of PCR. The quality assessment of diagnostic accuracy studies (QUADAS) tool depicted low risk of bias. Conclusions. This systematic review and meta-analysis is the first study in the scientific literature to provide a pooling for diagnostic accuracy for PCR test for mpox and confirms it as an accurate tool in detecting the infection in humans.

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Emergency department approach to monkeypox

V. Levitt,

K. Tran,

Hraky

et al. 2023

World Journal of Emergency Medicine

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Clinical Performance Evaluation of a Rapid Real-Time PCR Assay for Monkeypox Diagnosis: a Retrospective and Comparative Study

Cited by 3 publications

References 19 publications

Review of virological methods for laboratory diagnosis and characterization of monkeypox virus (MPXV): lessons learned from the 2022 Mpox outbreak

Review of virological methods for laboratory diagnosis and characterization of monkeypox virus (MPXV): lessons learned from the 2022 Mpox outbreak

Diagnostic accuracy of polymerase chain reaction for detection of mpox in humans

Emergency department approach to monkeypox

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