Article Sidebar

PDF (Tiếng Việt)
Published: 2024-07-10
Abstract Views: 237
Views PDF (Tiếng Việt): 32
DOI: https://doi.org/10.52163/yhc.v65iCD5.1283
Issue
Vol. 65 No. CĐ 5
Section
Articles
How to Cite
Phúc, H. T. D. ., Hưng, N. V. ., Vân, . L. T. K. ., Viễn, . N. T. ., Tùng, P. N. ., Diễm, N. T. N. ., Phương, N. T. B. ., & Chương, . L. V. . (2024). 37. EVALUATION OF THE STABILITY OF LYOPHILIZED PLASMA SAMPLE IN THE PROFICIENCY TESTING SCHEME FOR DETECTING ANTIGENS OF NS1 VIRUS DENGUE. Vietnam Journal of Community Medicine, 65(CĐ 5). https://doi.org/10.52163/yhc.v65iCD5.1283

37. EVALUATION OF THE STABILITY OF LYOPHILIZED PLASMA SAMPLE IN THE PROFICIENCY TESTING SCHEME FOR DETECTING ANTIGENS OF NS1 VIRUS DENGUE

Huynh Thi Diem Phuc1, Nguyen Van Hung1, Le Thi Kieu Van1, Nguyen Tien Vien1, Pham Nguyen Tung1, Nguyen Thi Ngoc Diem2, Nguyen Thi Be Phuong1, Le Van Chuong1
1 University of Medicine and Pharmacy at Ho Chi Minh City
2 University of Medicine and Pharmacy at Ho Chi Minh Cit

Main Article Content

Abstract

Objective: Evaluate the stability of lyophilized plasma items to detect Dengue virus NS1 antigen according to ISO/IEC 17043:2023 and ISO 13528:2022 standards for application in proficiency testing (PT) scheme.


Method: Experimental research. Lyophilized plasma items including 2 batches: batch A (positive samples for Dengue virus NS1 antigen), batch B (negative samples for Dengue virus NS1 antigen) after being checked for homogeneity, will be evaluated for short-term and long-term stability according to ISO 13528. Select a random sample through Microsoft Excel 16 software. Use one-way analysis of variance (One-way ANOVA) to evaluate the homogeneity of the samples.


Results: At short-term conditions (transportation time), the items are stable up to 7 days. At longterm conditions, when stored at -20o C, 0o C, 2 - 8o C, the items are stable up to 90 days.


Conclusion: The lyophilized plasma item to detect Dengue virus NS1 antigen achieved stability during transportation and storage conditions to meet ISO/IEC 17043:2023 and ISO 13528:2022 standards for application in proficiency testing scheme.

Article Details

Keywords

Proficiency testing, NS1, Dengue virus, Dengue fever, stability

References

[1] Bộ Y tế, Quyết định 2760/QĐ-BYT ngày 04/7/2023 về việc ban hành hướng dẫn chẩn đoán, điều trị sốt xuất huyết Dengue, 2023
[2] World Health Organization and Unicef. Handbook for clinical management of Dengue, 2012.
[3] Shrivastava A, Dash PK, Tripathi NK et al, Evaluation of a commercial Dengue NS1 enzyme-linked immunosorbent assay for early diagnosis of dengue infection. Indian J Med Microbiol, 2011; 29(1):51-5.
[4] ISO/IEC 17043:2023 - General requirements for the competence of proficiency testing providers.
[5] ISO 13528:2022 - Statistical methods for use in proficiency testing by interlaboratory comparison.
[6] Ammann C, Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products. AAPS PharmSciTech. 2011;12(4):1264-75.
[7] Fryer J, Minhas R, Dougall T et al., Collaborative study to evaluate the proposed WHO 4th international standard for hepatitis B virus (HBV) DNA for nucleic acid amplification technique (NAT)-based assays. World Health Organization. 2016; WHO ECBS Report 2016, WHO/BS/2016.2291:pp. 1-41.
[8] Poe A, Duong NT, Bedi K et al., Stability of hepatitis C virus RNA and anti-HCV antibody in air-dried and freeze-dried human plasma samples. J Virol Methods. 2018;253:53-5.