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Date Published: 25/08/2023
Abstract Views: 227
Views pdf: 161
DOI: https://doi.org/10.51298/vmj.v529i1.6258
Issue
Vol. 529 No. 1 (2023)
Section
Các bài báo
How to Cite
Vũ, Q. H., Nguyễn, T. B. T., & Nguyễn, T. H. (2023). RESEARCH OF PRODUCTION PROCESS AND EVALUATION OF HOMOGENEITY AND STABILITY IN LYOPHILIZED PLASMA APPLIED OF PROTHROMBIN TIME FOR COAGULATION LABORATORY EXTERNAL QUALITY ASSESSMENT. Vietnam Medical Journal, 529(1). https://doi.org/10.51298/vmj.v529i1.6258

RESEARCH OF PRODUCTION PROCESS AND EVALUATION OF HOMOGENEITY AND STABILITY IN LYOPHILIZED PLASMA APPLIED OF PROTHROMBIN TIME FOR COAGULATION LABORATORY EXTERNAL QUALITY ASSESSMENT

Quang Huy Vũ1,, Thị Bích Thảo Nguyễn2, Thị Hồng Nguyễn3
1 Van Lang University
2 University of Medicine and Pharmacy at Ho Chi Minh City
3 Can Tho University of Medicine - Pharmacy

Main Article Content

Abstract

Objective: Development of the production process of lyophilized plasma-containing Prothrombin Time. Evaluation of homogeneity and stability of samples after production according to ISO 13528:2015 and ISO guide 35 for coagulation laboratory external quality assessment. Methods: Experimental study on the production process of lyophilized plasma-containing Prothrombin. The fresh frozen plasma is collected from Blood Transfusion Hematology Hospital - Ho Chi Minh City, Vietnam and tested negative for HBV, HCV, and HIV,... Adjust Prothrombin Time levels as desired. Evaluate the homogeneity and stability of lyophilized plasma by an average comparison test (Oneway ANOVA) and t-test. Results: The lyophilized plasma-containing Prothrombin Time in post-production batches under transport conditions were achieve homogeneity and stability for a minimum of 7 days. Samples are stable under storage conditions of -20oC and 2 – 8oC for a minimum of 10 weeks. Conclusion: The Quality control center of the medical laboratory of the University of Medicine and Pharmacy at Ho Chi Minh City (QCCUMP) has produced Prothrombin Time lyophilized from fresh frozen plasma with minimum stability of 10 weeks. Production samples that achieve homogeneity and stability according to the criteria of ISO 13528:2015 and ISO guide 35 meet the proficiency testing scheme

Article Details

Keywords

Prothrombin Time, PT test, homogeneity, stability lyophilized plasma, external quality assessment, coagualation laboratory, quality control center.

References

Cunningham MT, et al. Quality assurance in hemostasis: the perspective from the College of American Pathologists proficiency testing program. Semin Thromb Hemost. Apr 2007; 33(3):250-8.
2. Jones P. Haemophilia: a global challenge. Haemophilia. Jan 1995;1(1):11-3.
3. Jennings I, et al. Stability of coagulation proteins in lyophilized plasma. International Journal of Laboratory Hematology. 2015; 37(4): 495-502.
4. International Standard Organization (2015). "ISO 13528 Statistical methods for use in proficiency testing by interlaboratory comparison”, Geneva, Switzerland, First edition.
5. Skinner MW. Haemophilia: provision of factors and novel therapies: World Federation of Hemophilia goals and achievements. British journal of haematology. 2011;154(6):704-714.
6. Srivastava A. Delivery of haemophilia care in the developing world. Haemophilia. 1998;4:33-40.
7. Susai SR, et al. Evidence that complement and coagulation proteins are mediating the clinical response to omega-3 fatty acids: A mass spectrometry-based investigation in subjects at clinical high-risk for psychosis. Transl Psychiatry. Oct 28 2022;12(1):454.
8. Yuan H, Gao Z, Zhang J, et al. Homogeneity and Stability Evaluation of External Quality Assessment Control Materials for Four Coagulation Tests. Clin Lab. May 1 2021;67(5).