Objective This study aims to prepare and evaluate the homogeneity,stability,and repeatability of HIV-1 viral load proficiency testing materials(PTMs)based on 8E5 cells.Methods Four groups of proficiency testing materials for HIV-1 viral load with concentrations of 106,105,104,and 103copies/ml were obtained by 10-fold gradient dilution of 8E5 cell supernatant,and the viral load analyzer was applied to detect the viral copy numbers and its conversion into lg value.The mean((x)),standard deviation(s),coefficient of variation(CV),and trend were calculated to evaluate the homogeneity,stability,and repeatability of PTMs.Results In the homogeneity evaluation experiment of the four concentration gradients,the CVs of the PTMs in each concentration group were 1.2％,2.6％,1.8％,and 3.2％,respectively.In the stability evaluation experiment,the detection results did not change with the prolongation of time during the 5-month evaluation period for each group of PTMs at-20 ℃(P＞0.05).Meanwhile,the results did not change with time during the 5-week evaluation period for each group of PTMs at 4 ℃(P＞0.05).However,the results decreased with time during the 15-day evaluation period for each group of PTMs at 25 ℃(P＜0.05).In evaluating the effect of freeze-thaw times,the number of repeated freeze-thaws had little effect on the PTMs,whose detection results fluctuated within the range of((x)±2s).Conclusions In this study,the PTMs based on 8E5 cells had good homogeneity and stability under the storage conditions of-20 ℃ and 4 ℃ and could be used as a quality control for HIV-1 viral load capacity validation.
Human immunodeficiency virus 1Viral loadRNA8E5 cellsProficiency testing
NETL
NSTL
万方数据
