Abstract

MIYARES, Maelys et al. Validation of the technique of determination of total proteins by microcoomassie method to double wave longitude for the sample of Finished Product of hepatitis C core antigen. Vaccimonitor [online]. 2013, vol.22, n.2, pp.14-18. ISSN 1025-028X.

A formulation was obtained for a vaccinal candidate of hepatitis C virus (VHC) in the CIGB. It is a plasmid for the immunization with DNA contianing the genes of the three structural antigens of the virus, blended with a recombinant truncated variant of the protein of the core of the VHC, as molecular adjuvant. Both compounds were formulated in separate vials and were mixed at the moment of the immunization. In the laboratory of Development-analytic the technique of determination of total proteins was validated by the microcoomassie method for the sample of Finished Product (FP) of Hepatitis C core antigen (HCVcoreAg). The validated parameters were: Specificity, Linearity and Range, Accuracy, Precision, Stability of the FP sample under two different conditions of storage. The method was specific for the quantification of the HCcAg without interferences of sample placebo of FP to superior dilutions at 1:8. The curve of the microcoomassie for the FP was lineal in the range of work of 5-40 µg/mL. It demonstrated the accuracy of the method (100±10% recovery). In the evaluation of the system, the established acceptance criteria were completed for Precision: Repeatability (CV £ 5%) and Intermediate Precision (CV £ 10%). Temperatures studied in stability did not cause alteration in HCcAg concentration, and the FP can be stored for 15 days. Validation was satisfactory. The method is adequate to quantify the sample of the FP. This result allows us to comply with the specifications established for this product.

Keywords : hepatitis C; Microomasie; validation.

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