Centralization of multisite reagent lot-to-lot validation for Ortho Clinical Vitros chemistry instruments

Abstract

Objective: Reagent lot-to-lot comparisons are recommended by accreditation bodies to ensure that the performance of each reagent lot meets acceptable standards for quality patient results. The general approach is comprised of performing quality control (QC) and patient comparison between the old and new reagent lots and evaluating against a pre-defined criteria. Reagent lot comparison practices are often variable despite using the same instrument across different laboratories. This is costly, time consuming, and can lead to variability in acceptance criteria. While Clinical & Laboratory Standards Institute (CLSI) has a recommended guideline for reagent lot validation, it is often difficult to execute for small and rural laboratories due to limited resources. Defining the analytes required for detailed validation is important to allocate appropriate resources to ensure quality patient results. The goal of this study was to develop a standardized approach to reagent lot validation and optimize lab resources on Vitros chemistry instruments.

Design and method: This study consists of a retrospective and prospective analysis of reagent lot changes in dry slide chemistry analyzers (Ortho Clinical Diagnostics Vitros). Two years of retrospective reagent lot comparison data was obtained at a single site. A prospective study was conducted by assessing aliquots of 10 patient sample pools at 9 sites with Vitros analyzers.

Results: Of the 19 chemistry analytes evaluated, albumin, sodium, and total protein showed significant differences between reagent lots and also exceeded the pre-defined acceptance criteria.

Conclusion: For these analytes, our recommendations are to perform a comprehensive lot validation with QC and patient samples. A simple lot validation with a reflex approach comprised of initially assaying QC can be adapted for the more stable analytes to allow achieving quality patient result in a resource constraint rural environment.

Keywords: Ortho-Clinical Vitros analyzers; Reagent lot-to-lot evaluation; Standardization.