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Date Published: 23/12/2021
Abstract Views: 390
Views PDF: 318
DOI: https://doi.org/10.51298/vmj.v507i2.1421
Issue
Vol. 507 No. 2 (2021)
Section
Các bài báo
How to Cite
Quang Huy, V. ., & Thị Mỹ Qui, T. . (2021). EVALUATION OF HOMOGENEITY AND STABILITY OF HBV-DNA SAMPLE BY STANDARDS OF PROFICIENCY TEST ITEMS. Vietnam Medical Journal, 507(2). https://doi.org/10.51298/vmj.v507i2.1421

EVALUATION OF HOMOGENEITY AND STABILITY OF HBV-DNA SAMPLE BY STANDARDS OF PROFICIENCY TEST ITEMS

Vũ Quang Huy1,2,3,, Trần Thị Mỹ Qui1
1 University of Medicine and Pharmacy at Ho Chi Minh City
2 University Medical Center Ho Chi Minh City
3 Center for Standardization and Quality Control in Medical Laboratory of Ho Chi Minh City

Main Article Content

Abstract

Objectives: Development of a production process for lyophilized HBV DNA samples used in proficiency testing. Evaluation of the homogeneity and stability of HBV DNA lyophilized samples after production. Methods: Experimental research on HBV DNA positive plasma samples, evaluate the homogeneity and stability of lyophilized HBV DNA plasma samples by an average comparison test (Oneway ANOVA) and T-test.  Result: Lyophilized HBV DNA plasma samples with three levels of concentration achieved homogeneity and stability in transporting for 7 days. Samples achieved storage stability at -20°C for up to 150 days, at 2-8°C for 90 days, at 25°C and 37°C for 10 days (p value > 0.05). Conclusion: The procedure of lyophilized HBV DNA sample production has been successfully developed. The homogeneity and stability of produced samples meet the criteria standard of ISO 13528:2015 and ISO guide 35.

Article Details

Keywords

Evaluate, HBV DNA, lyophilized HBV DNA plasma

References

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