The abnormal reaction data-detecting function of the automated biochemical analyzer was useful to prevent erroneous total-bilirubin measurement and to identify monoclonal proteins.

ABSTRACT

BACKGROUND: Recently, to detect abnormal reactions and failures of the device in biological analysis, a reaction data monitoring system has been provided for automated biochemical analyzers. We investigated the usefulness of this function for total-bilirubin (T-Bil) measurement in routine testing. METHODS: Abnormal reactions of T-Bil were detected in the reaction data over time based on the following items whether the absorbance variance after mixing of the first reagent and sample exceeds the cut-off value. RESULTS: In the cases in which the abnormal reaction was observed, the absorbance rapidly rose because of turbidity after mixing the sample with Reagent-1. The measured value was higher than the actual T-Bil level, for which the analyzer showed a warning mark with the output data. When this particular serum sample was subjected to immunofixation electrophoresis, the presence of a monoclonal protein was confirmed. We encountered seven similar cases out of 30,731 samples. CONCLUSIONS: The reaction data monitoring system of the automated biochemical analyzers was useful to prevent false reports (misdiagnosis) due to unpredictable problems during T-Bil measurement. It was also suggested that detection of false reaction with a reagent may be a clue to find a new pathology, such as monoclonal gammopathy.