Lot-to-lot difference: a new approach to evaluate regression studies

Chun Yee Lim, Corey Markus, Tze Ping Loh

Research output: Contribution to journalLetterpeer-review

Abstract

Dear editor

A new (candidate) reagent lot can produce systematic differences in measurements when compared to the existing reagent lot. This can be attributed to differences in manufacturing processes, storage, transport and laboratory processing. It is important for laboratories to identify such differences and ensure they fall within an a priori defined acceptance criteria before deploying them for routine clinical use. This assessment is commonly performed by paired measurements of remainder clinical samples (ideally) spanning the analytical measurement range assayed with the existing and candidate reagent lots. Linear regression in various forms can then be applied on the paired results, which derive coefficients for slope (proportional difference) and intercept (constant difference). The advantage of using linear regression approaches is that assessment of lot-to-lot changes are investigated across the measurement range and not select concentrations...
Original languageEnglish
Number of pages2
JournalScandinavian Journal of Clinical and Laboratory Investigation
DOIs
Publication statusPublished - 15 Dec 2022

Keywords

  • Laboratory procedures
  • reagents
  • consistency
  • measurement
  • linear regression
  • lot-to-lot variance

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