The development of In-House internal quality control material for HBs Antigen and HCV Antibody in blood by rapid test at Jainadnarendra hospital.

Abstract

     This research was experimental research aimed to study the appropriate method for preparing quality control substances that can be produced and used by themselves for internal quality control of hepatitis B and hepatitis C virus testing in blood with a rapid test kit, and to evaluate quality control samples from a medical technology laboratory by testing the stability of the developed quality control substances stored at 4 degrees Celsius with 0.1% Sodium azide as a preservative. The tests were performed with quality test strips, both HBs Ag, Anti-HCV (qualitative analysis method), at 2 levels for 90 days, once a day/week, and data were collected to test the stability of the quality control substances at 2-8 degrees Celsius compared to storage at -20 degrees Celsius. At -20 degrees Celsius, the tests were performed only at Chaiyaphum Narenthon Hospital. The data were analyzed using descriptive statistics.

     The results of the study found that the development of internal quality control substances by using donor blood plasma, which has been confirmed to be negative or positive and left over from routine disposal, was inactivated and used a preservative to reduce contamination, and then sent for comparison between 10 laboratories in the Chai Nat network, testing once a week. The results of the efficiency test of the developed quality control sample compared to commercially produced quality control substances showed no difference and were stable at 2-8 degrees Celsius for at least 12 weeks, indicating that the developed quality control sample can be used as a quality control sample for the rapid test kit for HBs Ag and Anti-HCV in blood. It is also a model for other hospitals to reduce the cost of quality operations and support the goals according to the strategic plan to be achieved.