Fundamental study of thyroid hormone measurement reagent using the fully automated chemiluminescent enzyme immunoanalyzer Accuraseed

Abstract

Pretesting before medical practice is becoming prevalent from the viewpoints of prompt initiation of treatment and reduction of burden on patients. To investigate the possibility of expediting the process from sample collection to result reporting, the basic performances of TSH, FT4, and FT3 were determined by chemiluminescent enzyme immunoassay on an automatic analyzer named Accuraseed, which can finish one measurement in 10 min. We also report on the comparison of rapidity between Accuraseed and the routine modular device, ARCHITECT, and Lumipulse. We evaluated the reproducibility (simultaneous, day difference), correlation, minimum detection sensitivity, linearity, and influence of coexisting substances as basic performances of these three thyroid assays. As a result, the regression equation slope (Accuraseed shows a decreasing tendency) and one diverging sample were found to correlate with the routine modular, but in all other investigations such as simultaneous reproducibility and minimum detection sensitivity, good results were obtained. For the divergent sample observed in the FT3 assay, it is considered to be influenced by heterophilic antibodies according to the observation of measured value behavior after PEG treatment. In the comparative study of rapidity, the time from applying a sample rack with five samples (three assays per sample) into the analyzer to the result output of Accuraseed and the routine modular, ARCHITECT, and Lumipulse was measured. As a result, the time until the first result output of ARCHITECT was about 5 min and that of the Accuraseed was about 7 min. The time to reporting the results of all the five samples (15 tests) is 15 min for Accuraseed, and the times to reporting for the routine modular, ARCHITECT, and Lumipulse are 27, 33, and 37 min, respectively. Our results indicate the possibility of shortening TAT using Accuraseed.