| ObjectiveLaboratory detection of recent human immunodeficiency virus type 1(HIV-1)is one of the key and difficult issues in HIV/AIDS prevention and control.In order to further explore the feasibility of detecting recent HIV-1 infection by using a recombinant antigen-based capture enzyme immunoassays(RCEIA),and preliminarily calculate the technical parameters in estimating HIV-1 incidence,longitudinal plasma specimens from HIV-1 seroconverting individuals were tested for calculating the certain threshold(cutoff)value and mean duration of recent infection(MDRI)on RCEIA,these results were compared with those by using the BED HIV-1 capture enzyme immunoassay(BED CEIA)and limiting antigen avidity enzyme immunoassay(LAg-Avidity EIA),respectively.The results of 4 RCEIA kits(RCEIA-07,RCEIA-03,RCEIA-19 and RCEIA-22)were compared to further screen the recombinant antigen.Methods1.A total of 160 longitudinal plasma specimens collected from 45 HIV-1 seroconverting individuals from 2 cohorts were used in this study.2.These specimens were tested by using each RCEIA kit,BED CEIA and LAg-Avidity EIA,respectively,to obtain optical density(OD)values and normalized optical density(ODn)values.3.The ODn values of each RCEIA kit were plotted against the estimated days post-seroconversion.4.Statistical Program for Social Sciences(SPSS,version 22.0)was used to obtain certain threshold(cutoff)value and mean durations of recent infection(MDRI)for each RCEIA kit.5.Analyzed the relevance and difference of the ODn values on 4 RCEIA kits.6.Analyzed the relevance of the ODn values between each RCEIA kit and BED CEIIA or LAg-Avidity EIA.Results1.Quality control of 4 RCEIA kits:Coefficient of variation for 1 calibrator specimen and 3 positive controls were 7.0%-8.9%for raw OD values,and coefficient of variation for the positive controls were 3.1%-7.7%for ODn values from 14 plate runs by using RCEIA-07.The coefficient of variation for 1 calibrator specimen and 3 positive controls were less than 15%and 10%for raw OD values and ODn value by using the other 3 RCEIA kits,respectively.2.The relationship between ODn values for RCEIA kits and estimated days post-seroconversion:The ratio of HIV-specific IgG to total IgG,as measured by RCEIA-07,increased in almost all individuals over time,while there was heterogeneity of kinetics among individual responses.At the early stage of post-conversion,the distribution of ODn values were closer,and the difference of ODn values increased gradually over time.The relationships between the ODn values for other 3 RCEIA kits and estimated days post-seroconversion were similar to that for RCEIA-07,while some ODn values were different,and the distinction of them for HIV-1 longitudinal plasma specimens was RCEIA-03>RCEIA-07>RCEIA-22>RCEIA-19.3.Optimal cutoff and MDRI for 4 RCEIA kits:The optimal cutoff was ODn value of 0.8,0.7,0.6 and 0.5 for RCEIA-07,RCEIA-03,RCEIA-19 and RCEIA-22,respectively,while the MDRI was 197,197,197,113 days for them,respectively.The difference between the proportion false recent for each RCEIA kit and that for BED CEIA was not statistically significant(P>0.05),the difference between the proportion false recent for each RCEIA kit and that for LAg-Avidity EIA was also not statistically significant(P>0.05).4.Relevance between the detection of 4 RCEIA kits:The ODn values for RCEIA-07 and RCEIA-03 showed a linear relevance,and Spearman relevance coefficient was 0.986,P<0.001.There was a linear relevance between RCEIA-07 and RCEIA-19,and Spearman relevance coefficient was 0.971,P<0.001.There was a linear relevance between RCEIA-07 and RCEIA-22,and Spearman relevance coefficient was 0.984,P<0.001.There was a linear relevance between RCEIA-03 and RCEIA-19,and Spearman relevance coefficient was 0.978,P<0.001.There was a linear relevance between RCEIA-03 and RCEIA-22,and Spearman relevance coefficient was 0.977,P<0.001.There was a linear relevance between RCEIA-19 and RCEIA-22,and Spearman relevance coefficient was 0.979,P<0.001.5.Comparison of the difference of the detection of the 4 RCEIA kits:The difference of the detection of the ODn values for the 4 RCEIA kits was statistically significant(F=94.87,P<0.001).Among them,there was no statistically significant difference between the ODn values for RCEIA-07 and RCEIA-22.There were statistically significant differences between the ODn values for RCEIA-07 and RCEIA-03,RCEIA-07 and RCEIA-19,RCEIA-03 and RCEIA-19,RCEIA-03 and RCEIA-22,and RCEIA-19 and RCEIA-22.The difference of detection was the ODn values for RCEIA-07=RCEIA-22>>RCEIA-03>RCEIA-19.6.Relevance of the detection between 4 RCEIA kits and BED CEIA:There was a linear relevance between the ODn values for RCEIA-07 and BED CEIA,and Spearman relevance coefficient was 0.835,P<0.001.There was a linear relevance between the ODn values for RCEIA-03 and BED CEIA,and Spearman relevance coefficient was 0.842,P<0.001.There was a linear relevance between the ODn values for RCEIA-19 and BED CEIA,and Spearman relevance coefficient was 0.850,P<0.001.There was a linear relevance between the ODn values for RCEIA-22 and BED CEIA,and Spearman relevance coefficient was 0.846,P<0.001.7.Relevance of the detection between the 4 RCEIA kits and LAg-Avidity EIA:There was a linear relevance between the ODn values for RCEIA-07 and LAg-Avidity EIA,and Spearman relevance coefficient was 0.794,P<0.001.There was a linear relevance between the ODn values for RCEIA-03 and LAg-Avidity EIA,and Spearman relevance coefficient was 0.836,P<0.001.There was a linear relevance between the ODn values for RCEIA-19 and LAg-Avidity EIA,and Spearman relevance coefficient was 0.832,P<0.001.There was a linear relevance between the ODn values for RCEIA-22 and LAg-Avidity EIA,and Spearman relevance coefficient was 0.814,P<0.001.Conclusions1.The recombinant antigen-based capture enzyme immunoassay(RCEIA)kits showed well stability。2.The 4 RCEIA kits could discriminate recent and long time HIV-1 infection at population level.3.Limited data shown that the optimal cutoff was ODn value of 0.8,0.7,0.6 and 0.5 for RCEIA-07,RCEIA-03,RCEIA-19 and RCEIA-22,respectively,while the MDRI was 197,197,197,113 days for them,respectively.The difference between the proportion false recent for each RCEIA kit and that for BED CEIA or LAg-Avidity EIA was not statistically significant.4.The ODn values for 4 RCEIA kits were strongly revelated with each other,but there were some differences.RCEIA-07 and RCEIA-03 are preferred for further evaluation,and RCEIA-19 and RCEIA-22 could be considered to be excluded.5.The ODn values for each RCEIA kit were strongly revelated with BED CEIA and LAg-Avidity EIA,respectively. |
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