Articles Vol. 65 No. CĐ 5 - NCKH 10/07/2024

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

Huynh Thi Diem Phuc1,2, Nguyen Van Hung1,2, Le Thi Kieu Van1,2, Nguyen Tien Vien1,2, Pham Nguyen Tung1,2, Nguyen Thi Ngoc Diem2,3, Nguyen Thi Be Phuong1,2, Le Van Chuong1,2
1 University of Medicine and Pharmacy at Ho Chi Minh City
2 Đại học Y Dược Thành phố Hồ Chí Minh
3 University of Medicine and Pharmacy at Ho Chi Minh Cit
Corresponding author: chuongmedtech@ump.edu.vn
DOI: 10.52163/yhc.v65iCD5.1283
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Keywords
Proficiency testing, NS1, Dengue virus, Dengue fever, stability
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.

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