Validation of the titration method for the human immunodeficiency virus type 1

[摘要] BACKGROUND: viral quantification is essential to demonstrate biological product safety during the validation of the production process.OBJECTIVE: to evaluate the accuracy, linearity and detection limit of a titration method for the human immunodeficiency virus type 1. METHODS: the titration was performed by calculating the end-point dilution method, through the cytopathic effect assay and the determination of Ag p24 production by an enzyme immunoassay. Mean infective dose in cultured cells per milimeter was estimated by Reed and Muench´s method.RESULTS: the accuracy of the method was similar to that of the reference titration, the variation coefficient figures for accuracy (repeatability and intermediate accuracy) were lower than 5 % and 10 %, respectively, the linearity showed adequate correlation coefficient and the detection limit was determined in the 10-12 dilution CONCLUSIONS: the evaluated method was suitable for viral quantification

[学科分类] 传染病学

[关键词] viral titration;validation;human immunodeficiency virus type 1