Establish The National Reference Standard Bank for Quality Control of HIV diagnostic products in Vietnam

Abstract

Background/Purpose: The National Reference Standard Bank used for Quality
control for HIV diagnosis biological products is designed to develop a Standard
Operation Practice, and collect HIV plasma samples at representative health
facilities in regions of Vietnam (North-Mid-South and Central Highland) in order
to establish a National Reference Standard Bank in accordance with the technical
standards of the Ministry of Health and WHO/UNAIDS regulations.
Methods: Experimental description to collect representative serum samples from
regions of Vietnam and characterize by ELISA, Western-Blot and PCR techniques
Results: The results of HIV plasma samples after collection, tested and
characterized by ELISA, Western-Blot and PCR methods giving the results as (405
positive samples with OD/CO value from 7.34-4294; 802 negative samples with
OD/CO value from 0.05-0.8; 42 difficult samples with OD/CO value from 0.089-
166.3; and 03 sets of seroconversion samples meeting the international standards).
100% of samples of National Reference Standard HIV Bank have the volume of
more than 10ml/sample and are stored in standard conditions at -70oC.
Conclusion: From the study results, the National Reference Standard Bank used
for Quality control of for HIV diagnosis biological products meets the Quality
standards regulations by the Vietnam Ministry of Health and the International
standards by WHO/UNAIDS