Development and Evaluation of Whole Blood Sample Panels for the External Quality Assessment Scheme for HIV Serology in Vietnam

Abstract

Strengthening testing quality assurance through External Quality Assessment (EQA) panels has been becoming popular among testing systems in Vietnam. This study aimed to development and evaluation of the EQA whole blood sample panels for HIV serology testing in Vietnam. Each EQA whole blood panel included 10 samples, which combined 6 HIV antibody- negative and 4 HIV antibody-positive samples. The results of validation showed that the sample panels achieved 100% homogeneity and stability at 30^th day under room temperature and 2 - 8^oC conditions. The negative and positive samples had no difference in hemolysis at 30th day at 4^oC (33.87mg/dl compared to 65.53mg/dl, p = 0.91) and at room temperature (144. 27mg/dl compared to 163.56mg/dl, p = 0.77), fully met the requirements for HIV antibody testing. The whole blood panels were sent to 27 HIV laboratories for piloting. 93% of the response from participants showed that the panels were easy to perform the testing and 100% of the laboratories desired to use the sample panels. The evaluation result showed that the whole blood sample panels meet the standards of EQA sample panels and could be used for HIV serology testing in facilities using finger-ptick blood specimens.