Evaluation of the homogeneity and stability of the external quality control panel for influenza viruses by Realtime Rt-PCR in laboratory conditions in Pasteur Institute in Ho Chi Minh City

Abstract

To enhance influenza surveillance activities in Vietnam, the Department of Medical Examination and Treatment Administration, in collaboration with the U.S. CDC, implemented influenza case surveillance at healthcare facilities. To assess the quality of testing performed at these facilities, the proficiency testing panels for the influenza virus were prepared and distributed by the Pasteur Institute in Ho Chi Minh City. These panels were prepared according to the ISO 17043:2011 standard, and their quality was assessed according to the ISO 13528:2022 standard, focusing on two key criteria: homogeneity and stability. Experimental research was conducted in the laboratory on prepared panels. Homogeneity was evaluated based on the results of 10 panels. Stability was assessed using 3 panels under different conditions: freeze-thaw cycles and storage at 2 – 8°C for 48 – 72 hours after freezing (transport conditions). The panels met the homogeneity criteria. Stability was maintained after 28 days of study under all conditions. The panels met the quality requirements according to ISO 13528:2022 and can be used in proficiency testing programs for determining influenza virus in practice.