Owens D K, Holodniy M, McDonald T W, Scott J, Sonnad S
Section of General Internal Medicine, VA Palo Alto Health Care System, CA 94304, USA.
JAMA. 1996 May 1;275(17):1342-8.
To evaluate the sensitivity and specificity of the polymerase chain reaction (PCR) for the diagnosis of infection with human immunodeficiency virus (HIV) in infants.
We used studies published between 1988 and 1994 identified in a literature search of 17 databases, including MEDLINE.
Studies were included if DNA amplification by PCR was performed on peripheral blood mononuclear cells from infants or children.
Two investigators independently extracted data. The study design was assessed independently by 2 investigators who were blinded to study results.
Thirty-two studies met the inclusion criteria and were analyzed. The median reported sensitivity was 91.6% (range, 31%-100%), and the median specificity was 100% (range, 50%-100%). A summary receiver operating characteristic curve based on all 32 studies indicated that PCR has a maximum joint sensitivity and specificity between 93.2% and 94.9%. Subgroup analysis indicated that the joint sensitivity and specificity was significantly (P = .04) higher in older infants (98.2%) than in neonates (aged < or = 30 days; 93.3%). For infants at low risk of perinatal transmission (probability of transmission, 8.3%), the positive predictive value for PCR is 55.8% in neonates and 83.2% in older infants. A negative PCR result reduces the probability of HIV infection to less than 3%. No studies met all criteria for study design.
Although PCR is one of the best available tests for diagnosis of HIV infection in neonates and infants, it is not definitive. Therefore, PCR should be interpreted with the aid of careful clinical follow-up examinations. The sensitivity and specificity of PCR in neonates is lower than in older infants, which results in a low positive predictive value; however, negative tests are informative. Delaying the use of PCR until after the neonatal period or repeating PCR on independent samples obtained 30 to 60 days later will reduce test errors.
评估聚合酶链反应（PCR）诊断婴儿感染人类免疫缺陷病毒（HIV）的敏感性和特异性。
我们使用了在对包括MEDLINE在内的17个数据库进行文献检索时确定的1988年至1994年发表的研究。
如果对婴儿或儿童外周血单核细胞进行了PCR DNA扩增，则纳入研究。
两名研究人员独立提取数据。两名对研究结果不知情的研究人员独立评估研究设计。
32项研究符合纳入标准并进行了分析。报告的中位敏感性为91.6%（范围31%-100%），中位特异性为100%（范围50%-100%）。基于所有32项研究的汇总受试者工作特征曲线表明，PCR的最大联合敏感性和特异性在93.2%至94.9%之间。亚组分析表明，年龄较大婴儿的联合敏感性和特异性（98.2%）显著高于新生儿（年龄≤30天；93.3%）（P = 0.04）。对于围产期传播风险较低的婴儿（传播概率为8.3%），PCR在新生儿中的阳性预测值为55.8%，在年龄较大婴儿中为83.2%。PCR阴性结果可将HIV感染概率降低至3%以下。没有研究符合研究设计的所有标准。
尽管PCR是诊断新生儿和婴儿HIV感染的最佳可用检测方法之一，但并非决定性方法。因此，应借助仔细的临床随访检查来解释PCR结果。PCR在新生儿中的敏感性和特异性低于年龄较大婴儿，导致阳性预测值较低；然而，阴性检测结果具有参考价值。将PCR的使用推迟到新生儿期之后，或在30至60天后对独立样本重复进行PCR，将减少检测误差。
