β2-M Applied In HIV Efficacy Monitoring Of Anti-virus Therapy As A Biomarker

ObjectiveThis study was designed to explore the feasibility of beta-2 microglobulin (β2-M) as a potential biomarker in aided-diagnosis of human immunodeficiency viral (HTV) infection and the efficacy monitoring of highly active antiretroviral therapy (HAART) for HTV.SubjectTotal 3145 patients with serum/whole blood samples were collected, which included 2998 new diagnosed HIV patients and 147 normal controls. Among all the 2998 HIV patients,110 cases(group I) did not receive HAART treatment,819 cases (Group II) received HAART treatment, and 1069 cases(Group III) received irregular HAART.Material and methodsCD4 and CD8 fluorescence monoclonal antibodies (BD) were used to analyze cell counts using flow cytometers; NASBA-PCR and Immune turbidity method were performed to detect HTV RNA and β2-M levels in blood samples. SPSS 17.0 statistical software was adopted to compare the difference among these 3 groups by SNK method, and the correlation analysis was conducted by Pearson correlation analysis. ROC curve was drafted and Under the Curve Area was used to test the diagnostic value of β2-M. The sensitivity, specificity, positive expectation, and negative expectation of β2-M were calculated by using HIV-RNA as the reference system.Results1.β2-M levelThere are no significant difference in β2-M level between group I which were the initial diagnosed as HIV, and group Ⅱ, which received routine HAART treatment and work well (P>0.05). However,β2-M level showed significant different between group I and control group and but didn’t receive any treatment and group Ⅲ which received irregular HAART treatment (P<0.001).2. CD4+, CD8+ counting, CD4+/CD8+ ratioCD4+, CD8+ and CD4+/CD8+ ratios of group Ⅰ, group Ⅱ, group Ⅲ are as followed:331.00±184.07/μl,1024.00±520.21/μl and 0.32±0.16 in group I; 321.00±178.67/μl,758.10±428.40/μl,0.42±0.22 in group IIand 259.00±209.00/μl,771.3±435.70/μl,0.34±0.15 in group Ⅲ, respectively, which showed significantly different (P<0.001)3. HIV-RNA copy numberHTV-RNA copy number was detected with 257 HIV patients and the media copy number is 3.56×104 copies/ml. There are no significant difference in HTV-RNA copy number between sex and age, but in ethnic the difference obviously.4. Correlation analysisβ2-M concentration showed significantly negative correlation with CD4+、CD8+及 CD4+/CD8+ ratio with correlation coefficient (R) were-0.452 (P<0.01),-0.151 (P<0.05) and -0.276 (P<0.05) respectively. However, (32-M concentration positively correlated with HIV RNA (r= 0.582, P<0.001).5 Clinical detection efficiency evaluationHIV-RNA copy number was used as the standard of clinical diagnosis, and the results were fitted with the results of β2-M to draft ROC curve. The area under the ROC curve was 0.691 (95%CI=0.631-0.747). According to the optimal cut-off point of ROC curve, the sensitivity and specificity of were 68.00% and 59.87%, respectively, with β2-M concentration 2.9 as cutoff value.ConclusionFor all AIDS patients treated with HAART, β2-M showed significantly correlation with CD4+, CD8+, HIV RNA and had a good diagnostic value, with the sensitivity and specificity of 68.00% and 59.87% respectively, when β2-M concentration cutoff value were 2.9. β2-M can be used as a biomarker for the prediction of HIV progression and anti-retroviral HAART therapy of HIV infection.