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目的研究艾滋病病毒(HIV)抗体蛋白印迹试验不确定标本的血清学特征,比较血清学和核酸定量方法对不确定结果的鉴别效果,为HIV抗体不确定结果的随访处置和诊断提供依据。方法以安徽省艾滋病确证中心实验室2003-2014年确证为“HIV抗体不确定”并有随访结果的298例标本为研究对象。对首次和随访标本同时进行蛋白印迹试验和必要的核酸检测,结合流行病学史资料来判定标本HIV感染的真实状况;对感染组和非感染组样本的筛查、确证和核酸结果进行比较和验证。结果1)不确定标本中发现28例HIV感染者,其中血清阳转24例,带型不进展但核酸持续阳性者4例。2)不确定结果中,未感染组和感染组标本酶联免疫吸附试验S/CO均值有显著性差异;蛋白印迹试验条带强度越强,感染风险越高,所有gp160gp120带型后续随访全部为HIV感染者;胶体金检测不确定标本的敏感性和特异性分别为96.4%和88.5%。3)病毒载量检测不确定标本的敏感性和特异性分别为96.4%和99.6%,随访检测敏感性和特异性均达100%。结论1)针对env带的不确定标本预示有较大的感染风险,尤其是gp160gp120和gp160p24两种带型,须做进一步的随访和鉴别诊断;2)不确定结果随访8周以上带型不进展也不能完全判为阴性,应当视情况采用核酸方法鉴别诊断;3)病毒载量检测是鉴别不确定标本的有效方法,当结果为低拷贝或与流行病学资料(或抗体结果)相悖时,要考虑假阳性和假阴性的可能。
Objective To study the serological characteristics of indeterminate samples of HIV antibody in Western blotting and to compare the discriminating effect of uncertainties with serological and nucleic acid quantification methods and to provide basis for the follow-up and diagnosis of HIV antibody indeterminate results. Methods A total of 298 specimens confirmed as “Uncertain HIV antibody” from 2003 to 2014 in Center of HIV / AIDS Confirmatory Center of Anhui Province were followed up. The first and follow-up specimens at the same time Western blot test and the necessary nucleic acid detection, combined with the history of epidemiological data to determine the true status of HIV infection samples; infected and non-infected samples screening, validation and nucleic acid results were compared and verification. Results (1) Twenty-eight cases of HIV-1 were found in uncertain samples, including 24 cases of seroconversion to seroconversion, 4 cases of non-progressing serotypes and persistent positive nucleic acid. 2) In the uncertain results, there was a significant difference in S / CO mean of enzyme-linked immunosorbent assay between uninfected group and infected group. The stronger the intensity of Western blotting test band, the higher the risk of infection. All subsequent follow-up of gp160gp120 banding was HIV infection; the sensitivity and specificity of colloidal gold detection of uncertain specimens were 96.4% and 88.5%. 3) The sensitivity and specificity of the detection of the virus load were 96.4% and 99.6% respectively. The sensitivity and specificity of follow-up detection reached 100%. Conclusion 1) Uncertain samples targeting env band indicate higher risk of infection, especially gp160gp120 and gp160p24 two types, further follow-up and differential diagnosis should be done; 2) Uncertainty results follow-up more than 8 weeks with no progress Can not be completely negative, it should be based on the use of nucleic acid differential diagnosis; 3) viral load test is to identify uncertain samples of an effective method, when the result is low copy or with epidemiological data (or antibody results) contrary, To consider the possibility of false positives and false negatives.