The Suitability of Pyrogen Test in vitro with Human Peripheral Blood Mononuclear Cell for Haemorrhagic Fever with Renal Syndrome Bivalent Vaccine

Abstract

To investigate the suitability of Pyrogen Test in vitro with Human Peripheral Blood Mononuclear Cell (PBMC) for Haemorrhagic Fever with Renal Syndrome Bivalent Vaccine, We collected 9 batches vaccines from different manufacturers. The recovery was determinated by human PBMC- IL-6 in vitro pyrogen test with spiking bacterial endotoxin. The recoveries of  batches were between 50%-200%, as the test solutions at a dilution less than the maximum valid dilution (MVD). The results showed all of the 9 batches vaccines were qualified products in pyrogen test. the human PBMC-IL-6 in vitro pyrogen test is suitable for Haemorrhagic Fever with Renal Syndrome Bivalent Vaccine to control the pyrogen.