A Multi-Laboratory Evaluation of Commercial Monkeypox Virus Molecular Tests

Erster, Oran; Levy, Itzchak; Kabat, Areej; Mannasse, Batya; Levy, Virginia; Assraf, Hadar; Azar, Roberto; Ben-Zvi, Haim; Bradenstein, Ritta; Bunder, Olga; Fadeela, Ayman; Keren-Naus, Ayelet; Peretz, Avi; Roif-Kaminsky, Diana; Saleh, Lolu; Schreiber, Licita; Schwartz, Orna; Shaked‐Mishan, Pninit; Sorek, Nadav; Strauss, Merav; Steinberg, Rosalie; Treygerman, Orit; Zisman‐Rozen, Simona; Yishai, Ruth; Tejman-Yarden, Noa; Mendelson, Ella; Sofer, Danit

doi:10.1128/spectrum.00225-23

Microbiol Spectr

2023

DOI: 10.1128/spectrum.00225-23

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A Multi-Laboratory Evaluation of Commercial Monkeypox Virus Molecular Tests

Oran Erster

Itzchak Levy

Areej Kabat

et al.

Abstract: To the best of our knowledge, this study is the first methodical evaluation of commercial kits designed for Monkeypox virus detection. This was done by performing the same tests using the same sample set in multiple laboratories, simultaneously, on a national scale.

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Cited by 2 publications

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Analytical and clinical evaluation of a novel real-time PCR-based detection kit for Mpox virus

Bunse,

Ziel,

Hagen

et al. 2024

Med Microbiol Immunol

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Outbreaks of emerging diseases, like Mpox in 2022, pose unprecedented challenges to global healthcare systems. Although Mpox cases globally decreased since the end of 2022, numbers are still significant in the African Region, European Region, Region of the Americas, and Western Pacific Region. Rapid and efficient detection of infected individuals by precise screening assays is crucial for successful containment. In these assays, analytical and clinical performance must be assessed to ensure high quality. However, clinical studies evaluating Mpox virus (MPXV) detection kits using patient-derived samples are scarce. This study evaluated the analytical and clinical performance of a new diagnostic MPXV real-time PCR detection kit (Sansure Monkeypox Virus Nucleic Acid Diagnostic Kit) using patient-derived samples collected in Germany during the MPXV clade IIb outbreak in 2022. Our experimental approach determined the Limit of Detection (LoD) to less than 200 cp/mL using whole blood samples and samples derived from vesicles or pustules. Furthermore, we tested potentially inhibiting substances and pathogens with homologous nucleic acid sequences or similar clinical presentation and detected no cross-reactivity or interference. Following this, the assay was compared to a CE-marked test in a clinical performance study and achieved a diagnostic sensitivity of 100.00% and diagnostic specificity of 96.97%. In summary, the investigated real-time PCR assay demonstrates high analytical performance and concurs with the competitor device with high specificity and sensitivity.

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Analytical and clinical evaluation of a novel real-time PCR-based detection kit for Mpox virus

Bunse,

Ziel,

Hagen

et al. 2024

Med Microbiol Immunol

View full text Add to dashboard Cite

show abstract

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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A Multi-Laboratory Evaluation of Commercial Monkeypox Virus Molecular Tests

Abstract: To the best of our knowledge, this study is the first methodical evaluation of commercial kits designed for Monkeypox virus detection. This was done by performing the same tests using the same sample set in multiple laboratories, simultaneously, on a national scale.

Cited by 2 publications

References 18 publications

Analytical and clinical evaluation of a novel real-time PCR-based detection kit for Mpox virus

Analytical and clinical evaluation of a novel real-time PCR-based detection kit for Mpox virus

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

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