Development of production process of dengue NS1 antigen panel for external quality assessment of dengue NS1 rapid test

Abstract

Rapid test results to detect NS1 antigen of Dengue virus are widely used in diagnosis as well as prevention of the dengue fever epidemic. In order to meet the demand of medical laboratories for more EQA, this study was conducted to develop the production process of Dengue NS1 antigen panel for external quality assessment of Dengue NS1 rapid test. The panel was produced from the three pool plasma samples of patients with Dengue fever in the National Dengue Control Program, collected in 2019 and stored at PIHCM, and two negative plasma samples from Hematology and Blood Transfusion hospital at
Ho Chi Minh city. Samples were characterized by Dengue virus real-time RT-PCR, SD Dengue NS1 Ag ELISA and some different brands of NS1 rapid tests. Samples are stored frozen and freeze-dried. The panels were evaluated for homogeneity and stability according to the guidelines of ISO 13528: 2015. The lyophilized samples were shipped to 23 laboratories for external quality assessment of Dengue NS1 test and the results were in high agreement with Pasteur Institute results