ISSN 2410-7751 (Print)
ISSN 2410-776X (Online)

"Biotechnologia Acta" V. 9, No 4, 2016
https://doi.org/10.15407/biotech9.04.035
Р. 35-41 , Bibliography 10, English
Universal Decimal Classification: 616.097.578.828.519.874.2

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

T. Y. Trokhymchuk¹, E. N. Chumak¹, L. N. Moysa¹, V.A.Shevchuk², L. A. Ganova², V. G. Serdyuk¹, N.Ya. Spivak²

¹PJSC «SPC» Diaproph-Med», Kyiv
² Zabolotny Institute of Microbiology and Virology, Kyiv

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.

Key words: accelerated storage method, the Arrhenius equation, immune enzyme analysis, HIV diagnosis, combined test kit.

© Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine, 2016