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Date Published: 30/03/2023
Abstract Views: 190
Views PDF: 102
DOI: https://doi.org/10.51298/vmj.v524i2.4858
Issue
Vol. 524 No. 2 (2023)
Section
Các bài báo
How to Cite
Vũ , Q. H. ., Lê, T. K. V. ., Văng , T. T. L. ., Trần , T. M. Q., & Trần , N. N. . (2023). PERFECTING THE PRODUCTION PROCESS OF LYOPHILIZED BLOOD PLASMA CONTAINING HBV-DNA AND EVALUATION THE EFFICIENCY OF ESTABLISHING QUANTITATIVE HBV-DNA EXTERNAL QUALITY ASSESSMENT PROGRAM FROM YEAR 2019 TO 2021. Vietnam Medical Journal, 524(2). https://doi.org/10.51298/vmj.v524i2.4858

PERFECTING THE PRODUCTION PROCESS OF LYOPHILIZED BLOOD PLASMA CONTAINING HBV-DNA AND EVALUATION THE EFFICIENCY OF ESTABLISHING QUANTITATIVE HBV-DNA EXTERNAL QUALITY ASSESSMENT PROGRAM FROM YEAR 2019 TO 2021

Quang Huy Vũ 1, Thị Kiều Vân Lê1, Thị Trúc Linh Văng 1, Thị Mỹ Qui Trần 1, Nhật Nguyên Trần 1
1 University of Medicine and Pharmacy at Ho Chi Minh City

Main Article Content

Abstract

Objectives: Perfecting the production processof lyophilized blood plasma containing HBV-DNA use in External Quality Assessment. Evaluation the efficiency of establishing quantiative HBV-DNA external quality assessment program from 2019 to 2021. Method: Empirical research of HBV-DNA positive plasma and Descriptive Statistics for the efficiency of establishing quantiative HBV-DNA external quality assessment program from 2019 to 2021. Result: Completed the procedure for producing HBV-DNA external quality assessment sample: evaluate the dilution efficiency according to designated deviation ±0,5log10 copies/mL approved interval, sample batcthes achieving homologous solution volume are distributed (CV<1%). The number of laboratories participate in quantiative HBV-DNA external quality assessment program increase annually (2019: 20 units, 2020: 26 units; 2021: 33 units). Annually participated units present high quality result (above >95%), (2019: 96,67%, 2020: 97,38%; 2021: 96,88%). Conclusion: Lyophilized blood plasma containing HBV-DNA product procedure is completed. Numbers of participated laboratories increase over years, ratio of certificated laboratories constantly reach above 95%.

Article Details

Keywords

External Quality Assessment, HBV-DNA, lyophilized blood plasma

References

1. Bộ Y tế (2019), Về việc ban hành hướng dẫn chẩn đoán, điều trị bệnh viêm gan vi rút B, trang 27.
2. Vũ Quang Huy (2017), Quy trình thử nghiệm sản xuất mẫu ngoại kiểm định lượng HBV-DNA, Tạp chí Y Học Tp. Hồ Chí Minh, Thành phố Hồ Chí Minh, trang 216-222.
3. Vũ Quang Huy, Trần Thị Mỹ Qui (2021), Đánh giá tính đồng nhất và độ ổn định mẫu HBV DNA đông khô theo tiêu chuẩn về mẫu ngoại kiểm, Tạp chí y học Việt Nam (ISSN: 1859 – 1868), tập 507, tháng 10, số 2, 2021, 140 – 144.
4. International Organization for Standardization (2015), ISO 13528:2015 Statistical methods for use in proficiency testing by interlaboratory comparisons, Geneva.
5. WHO (2015), Guidelines for the Prevention, Care and Treatment of Persons with Chronic Hepatitis B Infection. Geneva, 13-44.
6. JF Fryer, R Minhas, T Dougall, et al. (2016), "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, WHO ECBS Report 2016, WHO/BS/2016.2291, pp. 1-41.
7. RW de Almeida, MP Espírito-Santo, PSF Sousa, et al. (2015), "Hepatitis B virus DNA stability in plasma samples under short-term storage at 42° C", Brazilian Journal of Medical and Biological Research, 48 (6), pp. 553-556.
8. World Health Organization (2006), Recommendations for the preparation, characterization and establishment of international and other biological reference standards (revised 2004), WHO Technical Report, Series No 932, pp. 73-131.