THE SHELF LIFE PREDICTING OF IMMUNOENZYME COMBINED TEST-SYSTEMS FOR HIV1/2 DIAGNOSTICS

摘要

The aim of the research was to determine the shelf life of the ELISA test kit DIA-HIVAg/Ab (PJSC "SPC" Diaproph-Med") intended for the determination of antibodies to HIV1/2 and p24 HIV1 antigen using accelerated storage model at elevated temperatures.It is established that the thermal inactivation process is subject to a first-order kinetic law. The dependence of the rate constants of inactivation (lnK) on temperature (1 / T) is described by the Arrhenius equation at 95% probability level (F-test). Calculated on the basis of this model, the activation energy (ΔEa) equals 23.27 kcal • mol-1. It is established that the projected shelf life of the test kit was 2 years and 1 month when stored at 4 °C in terms of reduction of its diagnostic activity by 10%.Isothermal method of accelerated storage based on the Arrhenius model can significantly save time by determining the expiration date of the test kit as early as at the stages of its development or modification. The obtained data can be used for confirmation of the diagnostic kit stability studies, in terms of long-term storage, correction recommended conditions, and for determination of test kit capability of withstanding exposure to adverse environmental factors, which may occur during transportation and storage.