Serology is the primary means for identifying patients with HIV infection and Acquired Immunodeficiency Syndrome (AIDS). Testing of serum by serologic methods has been extensively used since 1985, not only for clinical diagnosis but also for epidemiological surveillance and donor screening in blood banks. Fast serological diagnostic techniques are now being developed, using urine and oral fluid, as an alternative for anti-HIV antibody screening, and many parallel studies are proving its accuracy. The purpose of this study was to evaluate the sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of the ImmunoComb II HIV 1&2 Saliva((R)) test from Orgenics (Dot-ELISA) compared to the routine exams (ELISA and Western Blot) of HIV positive/AIDS patients, undergoing antiretroviral treatment or not, in different stages of the disease's evolution, and compared to serologic testing of known HIV negative patients by the use of serum ELISA (blood donors). To accomplish this, patients of the Immunogenic Deficiencies Control Center (CCDI) and voluntary blood donors of the Blood Bank Center of the Medical School of Sã:o Paulo/Federal University of São Paulo (EPM-UN I FESP) were evaluated. Sensitivity of Dot-ELISA in oral fluid was 100%, specificity 97.08%, PPV 96.66% and NPV 100%. The method used in this case study was shown to be highly sensitive and specific, being useful particularly in epidemiological surveillance and screening.

译文

:血清学是鉴定HIV感染和后天免疫机能丧失综合症(AIDS)患者的主要手段。自1985年以来,通过血清学方法进行血清检测已广泛用于临床诊断,还用于血库中的流行病学监测和供体筛查。现在正在开发一种快速的血清学诊断技术,使用尿液和口腔液体作为抗HIV抗体筛查的替代方法,许多平行研究证明了其准确性。这项研究的目的是评估Orgenics(Dot-ELISA)进行的ImmunoComb II HIV 1&2 Saliva(R)测试的敏感性,特异性,准确性,阳性预测值(PPV)和阴性预测值(NPV),与在疾病发展的不同阶段中接受或未接受抗逆转录病毒治疗的HIV阳性/ AIDS患者的常规检查(ELISA和Western Blot),并与使用血清ELISA(献血者)的已知HIV阴性患者的血清学检测进行比较。为此,对S&atilde:o Paulo /圣保罗联邦大学医学院(EPM-UN I FESP)的免疫原性缺乏症控制中心(CCDI)的患者和血液库中心的自愿献血者进行了评估。 Dot-ELISA在口腔液中的敏感性为100%,特异性为97.08%,PPV为96.66%,NPV为100%。该案例研究中使用的方法显示出高度的敏感性和特异性,特别适用于流行病学监测和筛查。

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