An independent reader system that parallels critical steps of full automation capability for immunohematology testing

Abstract

IntroductionUse of fully automated solutions to perform analysis of immunohematology tests is highly desirable as it delivers an improved level of safety and security of results. However, full automation may not be feasible financially and practically in all circumstances. A solution that addresses most of the process step hazards of manual testing can assist in achieving a higher level of confidence in and safety of test results. MethodsThe study utilized a column agglutination technology (ORTHO BioVue ® System) to test a variety of samples on the ORTHO VISION ® Analyzer and compare to the reader capability of the ORTHO OPTIX™ Reader. Both direct agglutination and direct/indirect antiglobulin test methods were evaluated. The data was analysed for per cent agreement and for concordance at the lower bound 95% confidence interval. The acceptance criteria for concordance for direct agglutination was ≥ 99.4% and for indirect agglutination was ≥ 98.0% at a lower bound 95% confidence interval. ResultsThere were 13,805 columns producing 5174 interpreted tests for direct agglutination and 5998 columns producing 2958 interpreted direct/indirect antiglobulin tests evaluated. Testing demonstrated that direct agglutination and direct/indirect antiglobulin testing generated greater than 99% concordance between the fully automated instrument system and the reader. ConclusionsThe reader exceeded the approval criteria set for the study which demonstrates the capability to address the desire for a solution that moves manual testing to an enhanced level which achieves improved safety and security in immunohematology testing.