Khadir A, Coutlée F, Saint-Antoine P, Olivier C, Voyer H, Kessous-Elbaz A
Département de Microbiologie et Maladies Infectieuses, Hôpital Notre-Dame, Montréal, PQ, Canada.
J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Jul 1;9(3):257-63.
We report here the clinical evaluation of Amplicor polymerase chain reaction (PCR) assay for the detection of the human immunodeficiency virus type 1 (HIV-1) in peripheral blood mononuclear cells (PBMCs). Results obtained with Amplicor HIV-1 test were compared to serological status and a standard PCR assay using SK38/SK39 and oligomer hybridization with SK19. A panel of 208 well-characterized specimens was analyzed, including PBMC lysates from 47 antibody-negative high-risk individuals, eight antibody-negative low-risk subjects, two subjects with acute retroviral disease, 35 asymptomatic seropositive subjects (59 samples) with CD4 counts > 400/mm3, 31 patients (46 samples) with AIDS-related complex (ARC), 30 patients (40 specimens) with AIDS, and six seropositive patients with unknown clinical status. Amplicor demonstrated a specificity of 100% and a sensitivity of 98.7%. Of the two false-negative samples with Amplicor, one was negative for beta-globin amplification, whereas a dilution of the other sample turned positive for HIV-1. Inhibitors of Taq polymerase were thus believed to be responsible for the negative results. This study demonstrates that commercialized nonisotopic PCR assays reach adequate levels of sensitivity and specificity for diagnosis of HIV-1 infection and could be considered in clinical situations in which serology is not helpful.
我们在此报告用于检测外周血单核细胞（PBMC）中1型人类免疫缺陷病毒（HIV-1）的Amplicor聚合酶链反应（PCR）检测法的临床评估。将Amplicor HIV-1检测法所得结果与血清学状态以及使用SK38/SK39的标准PCR检测法和与SK19的寡聚物杂交法进行比较。分析了一组208个特征明确的标本，包括来自47名抗体阴性高危个体、8名抗体阴性低危个体的PBMC裂解物，2名急性逆转录病毒病患者，35名CD4计数>400/mm³的无症状血清阳性个体（59份样本），31名艾滋病相关综合征（ARC）患者（46份样本），30名艾滋病患者（40份标本），以及6名临床状态不明的血清阳性患者。Amplicor检测法的特异性为100%，敏感性为98.7%。在Amplicor检测法的两份假阴性样本中，一份β-珠蛋白扩增呈阴性，而另一份样本稀释后HIV-1检测呈阳性。因此认为Taq聚合酶抑制剂是导致阴性结果的原因。本研究表明，商业化的非同位素PCR检测法在诊断HIV-1感染方面达到了足够的敏感性和特异性水平，在血清学无助的临床情况下可以考虑使用。
