1887
Perspective Open Access

Abstract

Monkeypox was declared a public health emergency of international concern by the World Health Organization (WHO) on 23 July 2022. Between 1 January and 23 July 2022, 16,016 laboratory confirmed cases of monkeypox and five deaths were reported to WHO from 75 countries on all continents. Public health authorities are proactively identifying cases and tracing their contacts to contain its spread. As with COVID-19, PCR is the only method capable of being deployed at sufficient speed to provide timely feedback on any public health interventions. However, at this point, there is little information on how those PCR assays are being standardised between laboratories. A likely reason is that testing is still limited on a global scale and that detection, not quantification, of monkeypox virus DNA is the main clinical requirement. Yet we should not be complacent about PCR performance. As testing requirements increase rapidly and specimens become more diverse, it would be prudent to ensure PCR accuracy from the outset to support harmonisation and ease regulatory conformance. Lessons from COVID-19 should aid implementation with appropriate material, documentary and methodological standards offering dynamic mechanisms to ensure testing that most accurately guides public health decisions.

Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2022.27.32.2200497
2022-08-11
2024-04-16
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2022.27.32.2200497
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/27/32/eurosurv-27-32-3.html?itemId=/content/10.2807/1560-7917.ES.2022.27.32.2200497&mimeType=html&fmt=ahah

References

  1. Zumla A, Valdoleiros SR, Haider N, Asogun D, Ntoumi F, Petersen E, et al. Monkeypox outbreaks outside endemic regions: scientific and social priorities. Lancet Infect Dis. 2022;22(7):929-31.  https://doi.org/10.1016/S1473-3099(22)00354-1  PMID: 35636447 
  2. Huggett JF, Benes V, Bustin SA, Garson JA, Harris K, Kammel M, et al. Cautionary note on contamination of reagents used for molecular detection of SARS-CoV-2. Clin Chem. 2020;66(11):1369-72.  https://doi.org/10.1093/clinchem/hvaa214  PMID: 32894756 
  3. MacKay MJ, Hooker AC, Afshinnekoo E, Salit M, Kelly J, Feldstein JV, et al. The COVID-19 XPRIZE and the need for scalable, fast, and widespread testing. Nat Biotechnol. 2020;38(9):1021-4.  https://doi.org/10.1038/s41587-020-0655-4  PMID: 32820257 
  4. Shchelkunov SN, Shcherbakov DN, Maksyutov RA, Gavrilova EV. Species-specific identification of variola, monkeypox, cowpox, and vaccinia viruses by multiplex real-time PCR assay. J Virol Methods. 2011;175(2):163-9.  https://doi.org/10.1016/j.jviromet.2011.05.002  PMID: 21635922 
  5. Saijo M, Ami Y, Suzaki Y, Nagata N, Iwata N, Hasegawa H, et al. Diagnosis and assessment of monkeypox virus (MPXV) infection by quantitative PCR assay: differentiation of Congo Basin and West African MPXV strains. Jpn J Infect Dis. 2008;61(2):140-2. PMID: 18362406 
  6. Maksyutov RA, Gavrilova EV, Shchelkunov SN. Species-specific differentiation of variola, monkeypox, and varicella-zoster viruses by multiplex real-time PCR assay. J Virol Methods. 2016;236:215-20.  https://doi.org/10.1016/j.jviromet.2016.07.024  PMID: 27477914 
  7. Luciani L, Inchauste L, Ferraris O, Charrel R, Nougairède A, Piorkowski G, et al. A novel and sensitive real-time PCR system for universal detection of poxviruses. Sci Rep. 2021;11(1):1798.  https://doi.org/10.1038/s41598-021-81376-4  PMID: 33469067 
  8. Li Y, Zhao H, Wilkins K, Hughes C, Damon IK. Real-time PCR assays for the specific detection of monkeypox virus West African and Congo Basin strain DNA. J Virol Methods. 2010;169(1):223-7.  https://doi.org/10.1016/j.jviromet.2010.07.012  PMID: 20643162 
  9. Li Y, Olson VA, Laue T, Laker MT, Damon IK. Detection of monkeypox virus with real-time PCR assays. J Clin Virol. 2006;36(3):194-203.  https://doi.org/10.1016/j.jcv.2006.03.012  PMID: 16731033 
  10. Kulesh DA, Loveless BM, Norwood D, Garrison J, Whitehouse CA, Hartmann C, et al. Monkeypox virus detection in rodents using real-time 3′-minor groove binder TaqMan assays on the Roche LightCycler. Lab Invest. 2004;84(9):1200-8.  https://doi.org/10.1038/labinvest.3700143  PMID: 15208646 
  11. International Organization for Standardization (ISO). In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide. ISO 17822:2020. Geneva: ISO; 2020. Available from: https://www.iso.org/standard/67022.html
  12. World Health Organization (WHO). Laboratory testing for the monkeypox virus: Interim guidance. Geneva: WHO; 2022. Available from: https://www.who.int/publications/i/item/WHO-MPX-laboratory-2022.1
  13. Isidro J, Borges V, Pinto M, Sobral D, Santos JD, Nunes A, et al. Phylogenomic characterization and signs of microevolution in the 2022 multi-country outbreak of monkeypox virus. Nat Med. 2022.  https://doi.org/10.1038/s41591-022-01907-y  PMID: 35750157 
  14. Evans D, Cowen S, Kammel M, O’Sullivan DM, Stewart G, Grunert HP, et al. The dangers of using Cq to quantify nucleic acid in biological samples: a lesson from COVID-19. Clin Chem. 2021;68(1):153-62.  https://doi.org/10.1093/clinchem/hvab219  PMID: 34633030 
  15. Whale AS, von der Heide EK, Kohlenberg M, Brinckmann A, Baedker S, Karalay O, et al. Digital PCR can augment the interpretation of RT-qPCR Cq values for SARS-CoV-2 diagnostics. Methods. 2022;201:5-14.  https://doi.org/10.1016/j.ymeth.2021.08.006  PMID: 34454016 
  16. Vierbaum L, Wojtalewicz N, Grunert HP, Lindig V, Duehring U, Drosten C, et al. RNA reference materials with defined viral RNA loads of SARS-CoV-2-A useful tool towards a better PCR assay harmonization. PLoS One. 2022;17(1):e0262656.  https://doi.org/10.1371/journal.pone.0262656  PMID: 35051208 
  17. Centers for Disease Control and Prevention (CDC). Test procedure: Non-variola Orthopoxvirus generic real-time PCR test. Atlanta: CDC; 2022. Available from: https://www.cdc.gov/poxvirus/monkeypox/pdf/PCR-Diagnostic-Protocol-508.pdf
  18. Adler H, Gould S, Hine P, Snell LB, Wong W, Houlihan CF, et al. Clinical features and management of human monkeypox: a retrospective observational study in the UK. Lancet Infect Dis. 2022;22(8):1153-62.  https://doi.org/10.1016/S1473-3099(22)00228-6  PMID: 35623380 
  19. International Organization for Standardization (ISO). In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods. ISO/TS 5798:2022. Geneva: ISO; 2020. Available from: https://www.iso.org/standard/81712.html?browse=tc
  20. International Bureau of Weights and Measures (BIPM). A roadmap to metrology readiness for infectious disease pandemic response. Sèvres Cedex: BIPM; 2022. Available from: https://bit.ly/3uRpXHm
/content/10.2807/1560-7917.ES.2022.27.32.2200497
Loading

Data & Media loading...

Supplementary data

Submit comment
Close
Comment moderation successfully completed
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error