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Background: To optimize management strategies and predict the long-term clinical course in patients with chronic hepatitis B (CHB), non-invasive tests to determine the degree of hepatic fibrosis have been developed.Aims: We aimed to conduct a large-scale external validation of a simple, non-invasive test called P2/MS using CHB patients and to compare it to other non-invasive tests for the prediction of histological cirrhosis.Methods: From 2006 to 2009, we enrolled a total of 521 consecutive CHB patients who underwent liver biopsy. Fibrosis stage was assessed according to the Metavir scoring system by a single pathologist who was unaware of the patients' histories.Results: For predictions of significant (p>or=2) and severe (p>or=3) fibrosis and cirrhosis (p=4), the areas under the receiver operating characteristic curves were 0.801, 0.856, and 0.906, respectively. In predicting cirrhosis, we found that diagnostic values were comparable to age-spleen platelet ratio index (0.931, p=0.063), spleen-platelet ratio index (0.923, p=0.145), age-platelet index (0.914, p=0.670), and FIB-4 (0.898. p=0.597) and had better outcomes than the aspartate aminotransferase (AST)-platelet ratio index (0.780, p<0.001), and AST-alanine aminotransferase ratio index (0.729, p<0.001). The cut-off points of P2/MS>83 and P2/MS<30 provided 91.1% of negative predictive value and 91.3% of positive predictive value, respectively. Based on these results, liver biopsies could be avoided in 67.0% of the population. These cut-offs were validated internally using bootstrap resampling methods, which showed good agreement.Conclusions: P2/MS is a simple, accurate, and inexpensive method with comparable outcomes to other non-invasive tests and may reduce the need for liver biopsy in the majority of CHB patients. [ABSTRACT FROM AUTHOR]