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Validation and verification of automated urine particle analysers
  1. Giuseppe Enrico Bignardi
  1. Correspondence to Dr Giuseppe Enrico Bignardi, South of Tyne and Wear Pathology, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, Tyne and Wear (UK), NE9 6SX and Microbiology Department, Sunderland Royal Hospital, Kayll Road, Sunderland SR4 7TP, UK; Giuseppe.Bignardi{at}chsft.nhs.uk

Abstract

There is often uncertainty on how validation and verification of newly introduced tests should be conducted, and there is a real risk of verification becoming a meaningless ritual, rather than a useful exercise. This article reviews the literature and makes recommendations regarding the validation and verification of automated urine particles analysers. A generic practical approach to verification is also recommended. For many analysers, the accuracy of white blood cells, epithelial cells and bacterial counts is corroborated by a number of independent evaluations; thus, any verification laboratory work could be significantly scaled down. Conversely, in the scenario that automated urine microscopy is used as a screening test to reduce the number of urines cultured, the extremely variable performance reported in the literature requires a full-scale verification to define the optimal cut-off values that give a sensitivity of >98% with the local settings and circumstances. With some analysers, the risk of carry-over also needs to be assessed, as part of the verification process, and exclusion criteria (urines requiring culture regardless of the microscopy results) need to be well defined, as there are patients or specimen types for which the performance of microscopy as a screening test may not be adequate.

  • URINE
  • AUTOMATION
  • INFECTIONS

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Footnotes

  • Handling editor Slade Jensen

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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