RT Journal Article
SR Electronic
T1 Validation and verification of automated urine particle analysers
JF Journal of Clinical Pathology
JO J Clin Pathol
FD BMJ Publishing Group Ltd and Association of Clinical Pathologists
SP 94
OP 101
DO 10.1136/jclinpath-2016-203958
VO 70
IS 2
A1 Giuseppe Enrico Bignardi
YR 2017
UL http://jcp.bmj.com/content/70/2/94.abstract
AB 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.