Aim: The prothrombin time (PT) activity value, which is an essential factor in the Child-Pugh classification of liver disease, has not yet been standardized, causing confusion in the evaluation of hepatic reserve. The results of Child-Pugh classification were verified with the reagents used in Japan for PT measurement.
Methods: The PT activity value (%) was measured with seven types of reagents in 147 patients with liver disease who gave their consent, from January 2014 to December 2016, and the hepatic reserve was compared based on the results from each reagent.
Results: The seven types of PT measurement reagents verified covered 72.9% of the testing facilities in Japan. The average PT activity value of the same sample using the seven reagents was from 76.6 ± 19.2 (%) to 89.2 ± 20.2 (%), with a maximum deviation of 12.6%. A significant difference was found in the results from each measurement reagent in the statistical analysis (p<0.001). Moreover, in the Child-Pugh classification of the 147 cases, a maximum of 8 cases of Child-Pugh class A divergence from 88 cases to 96 cases were observed, depending on the reagent used to measure the PT activity value.
Conclusions: Our results indicate that, based on the PT measurement reagents used by many facilities in Japan, the results from the same sample may differ, and the subsequent Child-Pugh classification, which is indispensable for the treatment of liver disease, may also vary according to the PT measurement reagent used.
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