A STUDY OF THE PRODUCTION OF LYOPHILIZED PLASMA ITEMS FOR PROFICIENCY TESTING SCHEME IN DETECTING DENGUE VIRUS NS1 ANTIGEN
Main Article Content
Abstract
This study focuses on the production of lyophilized plasma items for detecting Dengue virus NS1 antigen, ensuring homogeneity in accordance with ISO 17043:2023 and ISO 13485:2022 standards for use in a proficiency testing (PT) scheme. The research was conducted using experimental methods. Two batches of lyophilized plasma items were produced: Batch 1 (positive samples for Dengue virus NS1 antigen) and Batch 2 (negative samples for Dengue virus NS1 antigen). All plasma samples were screened and confirmed negative for hepatitis B, hepatitis C, and HIV. A random sample was selected using Microsoft Excel 16 software, and homogeneity was assessed via one-way analysis of variance (One-way ANOVA). Results demonstrated that both PT batches met the homogeneity criteria, with CV % for Lot 1 and Lot 2 being 0.62 and 0.7, respectively, in compliance with the ISO standards. In conclusion, the produced lyophilized plasma items satisfy the requirements of ISO 17043 and ISO 13485, making them suitable for PT schemes in detecting Dengue virus NS1 antigen.
Keywords
Dengue hemorrhagic fever (DHF), Dengue virus antigen NS1, homogeneity, lyophilized plasma samples, Proficiency testing scheme
Article Details
References
Bhatt, S., Gething, P. W., Brady, O. J., Messina, J. P., Farlow, A. W., Moyes, C. L., Drake, J. M., Brownstein, J. S., Hoen, A. G., Sankoh, O., Myers, M. F., George, D. B., Jaenisch, T., Wint, G. R., Simmons, C. P., Scott, T. W., Farrar, J. J., & Hay, S. I. (2013). The global distribution and burden of dengue. Nature, 496(7446), 504-507. https://doi.org/10.1038/nature12060
Huynh, P. T., Nguyen, H. Q., Dao, H. M., Hoang, T. N. D., Vu, P. H. N., Vu, P. H. N., Le, M, H., Pham, T. T. H., Cao, M. T., Nguyen, V. T., & Nguyen, D. T. (2022). Xay dung quy trinh và tao bo mau ngoai kiem test nhanh phat hien khang nguyen NS1 của vius Dengue [Develop a process and create a rapid quality assessment test kit to detect NS1 antigen of Dengue virus]. Vietnam Journal of Preventive Medicine, 32(4), 139-148. https://doi.org/10.51403/0868-2836/2022/729
Organization, W. H., & UNICEF. (2012). Handbook for clinical management of dengue.
Prime Minister (2017). Quyet dinh so 2429/QD-BYT. Ban hanh Tieu chi danh gia muc chat luong phong xet nghiem y hoc [Decision No. 2429/QD-BYT. Promulgating criteria for assessing the quality level of medical laboratories].
Standardization, I. O. f. (2023). ISO/IEC 17043:2023 Conformity assessment - General requirements for the competence of proficiency testing providers.
Standardization, I. O. f. (2022). ISO/IEC 13528:2022 Statistical methods for use in proficiency testing by interlaboratory comparison.
Tran, T. M. Q. (2021). Production of lyophilized plasma samples for EQA of HBV-DNA quantity according to ISO/IEC 17043:2010 standards [Master’s theis]. University of Medicine and Pharmacy at HCMC.
Vu, Q. H., Tran, D. T., Tran, P. M. S., Le, V. C., Huynh, T. D. P., & Bui, Q. S. (2020). Establishment of an Experimental Procedure for Preparing Trial Serum Samples for the Specific Serodiagnosis of Toxocara canis for External Quality Assessment Schemes. Journal of parasitology research, 2020, 6842975. https://doi.org/10.1155/2020/6842975