Gauge against the machine: revisiting quality for multi-targeted serology platforms

Diagnosis of infections of public health significance, such as leptospirosis, often present challenges for laboratories. To counter common challenges and ensure quality driven health responses, rigorous validation and verification processes are required. Despite such rigor, however, can one be certa...

Full description

Saved in:
Bibliographic Details
Published inPathology Vol. 55; no. 1; pp. 123 - 126
Main Authors Elias, Anthony, Tilbrook, Lynelle, Gray, Timothy, Varadhan, Hemalatha, George, C. R. Robert
Format Journal Article
LanguageEnglish
Published England Elsevier B.V 01.02.2023
Subjects
automation
quality assurance
quality control
Serology
Serology
automation
quality control
quality assurance
Online AccessGet full text

Cover

More Information
Summary:Diagnosis of infections of public health significance, such as leptospirosis, often present challenges for laboratories. To counter common challenges and ensure quality driven health responses, rigorous validation and verification processes are required. Despite such rigor, however, can one be certain laboratory reports are truly reflective of infection, given the risk of rare, but potentially very significant quality oversights? Here we present a real-world scenario where diagnosis of leptospirosis cases was compromised over a 6-year period despite quality measures suggesting a well performing serological assay. A subsequent investigation revealed this was attributed to the programming of an automated microtitration plate analyser, evading detection by both quality control and external quality assurance processes. The quality oversight provides insight into potential limitations in quality processes in multi-targeted serological platforms.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0031-3025
1465-3931
DOI:10.1016/j.pathol.2022.10.001