| ObjectiveThe epidemiological investigation of the indeterminate result of HIV antibody in Fujian was to understand the detection rate and the distribution of the indeterminate result in different populations.Discusses the influence factors of indeterminate result and the effect of different testing methods to identitify indeterminate result that provide a scientific basis for differential diagnosis of indeterminate result and prevention strategy to prevent the spread of disease.Methods1.The samples of indeterminate result collection from 2015-2016 in Fujian were reviewed by WB confirmation test every month,until the result was positive or negative.If the reviewed results are still indeterminate for 3 months,we will enxtend the follow-up time to 6 months.2.The samples of indeterminate result were detected by viral nucleic qualitative detection,viral nucleic quantitative detection and HIV-1 p24 antigen assay.The samples reviewed by WB confirmation test every month,until the result was positive or negative.the final result of WB confirmed test as the “gold standar”,the identification effect of different testing methods was compared with each other.3.The samples of the indeterminate result(VNA-)were also detected for AFP,ANA,HBsAg,HCV antibody,HTLV antibody and TP antibody by enzyme-linked immunoassa,and the results were compared to that of HIV antibody negative samples.The nucleic acid sequences of HIV antibody positive and indeterminate samples(VNA+)were analyzed to compare the distribution of viral subtype.The behavior net work and resource survey of the indeterminate samples was to compared the results of WB comfirmed test and viral nucleic quantitative detection between the first case and the second generation infection case.4.Compared the results of two different confirmed test by western blot and recomLine.And compared the gp41 gene sequences with the international reference strains and normal strains of HIV antibody positive.5.According to the principle of voluntary,the patients should be carried out clinical experimental treatment,follow-up at least three months after treatment and compared the WB band patterns,clinical symptoms,CD4+ T-lymphocyte count and the result of viral nucleic quantitative detection.Results1.The epidemiological investigation of the indeterminate result of HIV antibody showed that the detection rate of indeterminate result of HIV antibody was 3.69% in Fujian.The detection rate of indeterminate result from different population were different(P<0.001).The detection rate of the indeterminate result of the blood donors(11.11%)?pregnancy/prenatal(10.39%)and other clinical patients examination(6.28%)were relatively high.2.The most common 3 kinds of WB band patterns were p24?gp160+p24 and gp160,which account for 76.19% of 210 indeterminate samples.The follow-up results showed that 80.28% indeterminate samples with only p24 were converted to HIV antibody negative.But 86.21% indeterminate samples with gp160+p24were converted to HIV antibody positive.81.25% indeterminate samples with only Gag were converted to HIV antibody negative.However 56.76% indeterminate samples with Env were converted to HIV antibody positive.As the number of WB band increased,the proportion of indeterminate samples which were converted to HIV antibody positive was increased.Moreover,the follow-up result of indeterminate result from different population were different(P<0.001).the proportion of pregnancy/ prenatal,blood donors and preoperative examination which were converted to HIV antibody nagetive was increased.But the proportion of voluntary counseling test and other clinical patients examination which were converted to HIV antibody positive was increased.3.The identification effect of different testing methods had differences.The method of viral nucleic quantitative detection(96.30%)had the highest sensitivity.And viral nucleic qualitative detection(97.85%)had the highest specificity.we should combine the results of viral nucleic quantitative detection and viral nucleic qualitative detection to have a comprehensive judgment in indeterminate samples in order to avoid the false positive and negative results.4.The samples of the indeterminate result(VNA-)and HIV antibody negative were also detected for AFP,ANA,HBsAg,HCV antibody,HTLV antibody and TP antibody by enzyme-linked immunoassa,and the results showed that the positive rates of TP antibody(12.40%)and AFP(15.70%)of indeterminate samples(VNA-)were higher than the HIV antibody negative samples which the positive rates of TP antibody and AFP were 1.77% and 0.44%,and the difference had stastistic significance(P<0.001).The positive rates of TP antibody(25%)and AFP(71.43%,10.71%)of indeterminate result in the pregnancy/prenatal and other clinical patients examination were higher than the HIV antibody negative samples,and the difference had stastistic significance(P<0.05).And the difference of distribution of viral subtype between indeterminate samples(VNA+)and HIV antibody positive sampels didn't have stastistic significance(P>0.05).The behavior net work and resource survey showed that the causes of indeterminate result may have nothing to do with the HIV viral subtype.And the cause of indeterminate result may be influenced by their own immune status.5.The study results of Compared two different confirmed test by western blot and recomLine showed that the concordance rate of gp160 by WBconfirmed test and gp41 by recomLine was 76.67%.The further study results showed that the gp41 gene of WBconfirmed test dind't have gp41 band didn't appear obvious mutation or missing.In addition,the most of cases were in the WHO clinical ? or?,and the results of CD4+ T-lymphocyte count were less than 200/?l,the results of viral nucleic acid quantitative were positive.6.By the follow-up and laboratory tests,the 55 patients were comfirmed as HIV infection.There were not false positive cases in Fujian.7.The study results showed that XC-051 HIV gene coding area didn't appearsignificant mutation.In addition,the result of viral nucleic acid quantitative was1.66×104IU/ml,and the results of CD4+ T-lymphocyte count was 9/?l.XC-051 also appear aids-related diseases and symptoms.Judging from the immunological effection,virology effection and clinical effection,the clinical experimental treatment was effective.8.According to the principle of voluntary,the 21 cases of patients were carried out clinical experimental treatment,the results showed that the clinical symptoms of 21 patient were control effectly.CD4+ T-lymphocyte count had a recovery with different degrees.And the results of viral nucleic quantitative detection declined obviously.Besides,the WB band pattern had progress with different degrees.Conclusions1.The detection rate of indeterminate result of HIV antibody is 3.69% in Fujian.The detection rate of indeterminate result from different population are different.And the detection rate of the indeterminate result of the blood donors,pregnancy/prenatal and other clinical patients examination are relatively high.2.The different WB band patterns,band number,band category and sample source indicate the different risk of HIV infection.Follow-up should be strengthened in people who have Env band(especially the band number of two or more),voluntary counseling test and other clinical patients examination to prevent the spread of disease.3.Viral nucleic quantitative detection,viral nucleic qualitative detection and the clinical experimental treatment can be used for differential diagnosis of indeterminate samples in oeder to management and control the AIDS.4.The causes of indeterminate result not only may be related to infection of treponema pallidum and the level of AFP increased but also due to the HIV infection duration and their own immune status. |
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