Evaluation Of HIV Antibody Test Strategy Currently Used In China And Preparation Of Quality Control Specimens Based On Filter Paper

To evaluate the HIV antibody test strategy and study the serological characterization of indeterminate Western Blot results of HIV antibody confirmation, find a new way to verify the HIV antibody indeterminate results and provide references for editing"National Guideline for Detection of HIV/AIDS". The study is divided to three chapters.Chapter 1: Cross-sectional study on the HIV testObjective: To analysis data about the serological characterization of HIV antibody test based on large clinical samples and reveals the frequency of primary screening of HIV antibody, population character and its pathology distribution. Methods: retrospect analysis on the 90289 clinical HIV test data during 2002 to 2008 in WJ General Hospital was used. Stratified analysis of the S/CO value based on the 81085 HIV antibody samples was monitored. Out patient's reasons and distribution patterns was analyzed based on HIV positive samples. Furthermore, the history of HIV positive patients including transfusion and surgery were also analyzed. Results: 1,HIV positive frequency and indeterminate rate in different population was different. The value of indeterminate ration on HIV infection indication was only 6.3%。HIV antibody reactive results from Cross-sectional analysis increase with time and the number of patients except on 2007. HIV antibody indeterminate ratio is the highest among clinical patients, while the ratio was relatively low in new recruits, there was no indeterminate results in drug abuser population. The population of liver transplant, bone break patients and skin disease patients shows higher HIV indeterminate rate compared with that of physical examination population. The average S/CO value in real HIV antibody positive sample was relatively higher than HIV indeterminate patients. HIV antibody positive occurrence in male is significantly higher than female. There were no significant differences in HIV positive occurrence among children, mid-youth and elderly populations. Conclusion :1,The efficiency of HIV antibody test strategy varied significantly among different human population. The current detection strategy is more reliable in high-risk population, thus other detection strategy should be employed in low risk population, for example, high specific detection methods. The main outpatient reason for HIV positive people is pre-surgery examination and consultation. HIV infection people are mainly comprised of young and middle-aged male by drug abuse and sex dissemination, sex dissemination ratio exceeds blood dissemination. 2,The current HIV test procedure effect in our country has changed significantly, the primary HIV antibody detection accuracy is significantly higher since 2007. So reexamination of specific population should be canceled to lower analysis cost and simplified operation procedure. 3,The application effect of current HIV detection strategy vary among different population, which shows high accuracy rate in high risk population. Also, HIV indeterminate distribution significance varies among different population, among which, unspecific reaction is the most important factors affecting low risk population. Based on this, different strategy can be used among different population. For example, standard follow-up procedure can still be used to low risk population, while negative consultant or supplemental virus load detection can be handled at the same time. For high risk population, earlier HIV infection diagnosis standard should be established instead of follow-up or supplemental virus load detection..4,Some immunology abnormal factors,such as RF positive,ANA positive,anti-TP positive may be increase unspecific reaction of primary screening of HIV antibody.Chapter 2:Characterization and Verification of HIV Antibody IndeterminateObjective : To study the serological characterization of HIV antibody indeterminate results, identify a new method to verify the HIV antibody indeterminate results. Methods: Line immunoassay, HIV viral load test and western blotting were monitored in 31 cases from HIV antibody indeterminate. Results: WB results showed that 44.3% indeterminate HIV antibody samples were p24 monoband, 13.6% were gp160 monoband, 17% were gp160 with p24, 8% were p17 with p24 .4 out of 31 cases was diagnosed as HIV primary infection. Line immunoassay and HIV RNA viral load showed 4 serological changes, which were confirmed to be HIV-positive. The other 27 cases without serological changes were approved to be HIV-negative. The specificity of LIA was 82.9%. P24 antigen was negative in all the 31 cases, including the cases, which was confirmed as HIV-positive later. Of all 31 originally indeterminate cases, viral loads were tested in 30 cases. Positive result was found in 3 cases, which were approved to be HIV-positive later. No viral loads were detected in the other 27 cases (0.05). HIV dried plasma spot specimens may be suit for the demands of internal quality control due to their stability and homogeneity. The specimens of dried plasmas spot (DPS) on filter paper and the plasma control– specimens were tested about antibodies of the human immunodeficiency virus with ELISA assay. There was no difference between two groups (P > 0.05). Conclusion : The HIV specimens of dried plasmas spot (DPS) on filter paper can replace traditional liquid control in clinic Lab.