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RESEARCH ARTICLE (Open Access)

External quality control processes for infectious disease testing

Wayne Dimech https://orcid.org/0000-0003-3425-9419 A , Guiseppe Vincini https://orcid.org/0000-0003-0972-0066 A and Belinda McEwan https://orcid.org/0000-0003-1631-316X B
+ Author Affiliations
- Author Affiliations

A National Serology Reference Laboratory, Melbourne, Vic., Australia. Email: wayne@nrlquality.org.au, joe@nrlquality.org.au

B Royal Hobart Hospital, Pathology, Hobart, Tas., Australia. Email: belinda.mcewan@ths.tas.gov.au

Microbiology Australia 45(1) 41-43 https://doi.org/10.1071/MA24013
Published: 4 March 2024

© 2024 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of the ASM. This is an open access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND)

References

Dimech W (2021) The standardization and control of serology and nucleic acid testing for infectious diseases. Clin Microbiol Rev 34, e00035-21.
| Crossref | Google Scholar | PubMed |

Prechl J (2021) Why current quantitative serology is not quantitative and how systems immunology could provide solutions. Biol Futur 72, 37-44.
| Crossref | Google Scholar | PubMed |

Baylis S, et al. (2021) Standardization of Diagnostic Assays. In Encyclopedia of Virology. Vol. 5, 4th edn. pp. 52–63. Elsevier.

Dimech WJ et al. (2023) Time to address quality control processes applied to antibody testing for infectious diseases. Clin Chem Lab Med 61, 205-212.
| Crossref | Google Scholar | PubMed |

International Organization for Standardization (2022) Medical laboratories — requirements for quality and competence. ISO 15189:2022. ISO, Geneva, Switzerland. https://www.iso.org/standard/76677.html

National Association of Testing Authorities, Australia (2023) General Accreditation Criteria: ISO 15189 Standard Application Document. NATA. https://nata.com.au/files/2021/05/ISO-15189-Application-Document-Medical-Testing-Supplementary-Requirements-for-Accreditation.pdf

Therapeutic Goods Administration (2020) Classification of IVD medical devices. Version 3.0, December 2020. Australian Government, Canberra, ACT, Australia. https://www.tga.gov.au/sites/default/files/classification-ivd-medical-devices.pdf

Vincini GA, Dimech WJ (2023) What is the best external quality control sample for your laboratory? Clin Chem Lab Med 61, e50-e52.
| Crossref | Google Scholar | PubMed |

Dimech W et al. (2015) Determination of quality control limits for serological infectious disease testing using historical data. Clin Chem Lab Med 53, 329-336.
| Crossref | Google Scholar | PubMed |

10  National Pathology Accreditation Advisory Council (2018) Requirements for Quality Control, External Quality Assurance and Method Evaluation, 6th edn. Commonwealth of Australia, Department of Health, Canberra, ACT, Australia. https://www.safetyandquality.gov.au/publications‐and‐resources/resource‐library/requirements‐quality‐control‐external‐quality‐assurance‐and‐method‐evaluation‐sixth‐edition‐2018

11  Westgard JO (1994) Selecting appropriate quality-control rules. Clin Chem 40, 499-501.
| Google Scholar | PubMed |

12  Westgard JO (2003) Internal quality control: planning and implementation strategies. Ann Clin Biochem 40, 593-611.
| Crossref | Google Scholar | PubMed |

13  Dimech W et al. (2018) Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing. Clin Chem Lab Med 56, 1970-1978.
| Crossref | Google Scholar | PubMed |

14  Public Health England (2021) UK Standards for Microbiology Investigations: quality assurance in the diagnostic virology and serology laboratory. Standards Unit, National Infection Service, London, UK. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1005438/Q_2i8.pdf