Lauer B A, Masters H A, Wren C G, Levin M J
J Clin Microbiol. 1985 Nov;22(5):782-5. doi: 10.1128/jcm.22.5.782-785.1985.
A new enzyme-linked immunosorbent assay (ELISA) respiratory syncytial virus antigen detection kit (Ortho Diagnostics, Inc., Raritan, N.J.) was compared with virus culture and with the indirect fluorescent antibody test (FAT) by using fresh nasal washings from children with suspected respiratory syncytial virus infection. Both uncentrifuged nasal washings and pellets from centrifuged split specimens were examined by ELISA. The ELISA was considered positive when the optical density was greater than the mean background optical density plus 0.15. Specimens positive by ELISA but negative by culture and FAT were reexamined in an ELISA blocking assay. Of 337 uncentrifuged specimens, 124 (37%) were positive by culture, 107 (32%) were positive by FAT, and 166 (49%) were positive by ELISA. Blocking assays showed that 21 of 30 (70%) of the seemingly false-positive ELISA tests were, in fact, true-positives and that the cultures and FATs were falsely negative. A patient specimen was considered positive when it was positive by virus culture, FAT, or blocking assay. The sensitivity, specificity, and positive predictive value of the ELISA test were 88, 94, and 95%, respectively. Centrifugation of nasal washings raised the sensitivity from 88 to 92% but reduced the specificity from 94 to 81%. We conclude that the Ortho ELISA test of uncentrifuged nasal washings is more sensitive than virus culture or indirect FAT and is highly specific.
采用来自疑似呼吸道合胞病毒感染儿童的新鲜鼻腔冲洗液,将一种新型酶联免疫吸附测定(ELISA)呼吸道合胞病毒抗原检测试剂盒(奥索诊断公司,新泽西州拉里坦)与病毒培养法以及间接荧光抗体试验(FAT)进行比较。ELISA检测了未离心的鼻腔冲洗液以及离心后的分离标本的沉淀物。当光密度大于平均背景光密度加0.15时,ELISA被判定为阳性。对ELISA检测呈阳性但病毒培养和FAT检测呈阴性的标本,采用ELISA阻断试验重新检测。在337份未离心的标本中,124份(37%)病毒培养呈阳性,107份(32%)FAT检测呈阳性,166份(49%)ELISA检测呈阳性。阻断试验表明,30份看似ELISA假阳性检测结果中的21份(70%)实际上为真阳性,而病毒培养和FAT检测结果为假阴性。当患者标本通过病毒培养、FAT或阻断试验呈阳性时,该标本被判定为阳性。ELISA检测的灵敏度、特异性和阳性预测值分别为88%、94%和95%。鼻腔冲洗液离心后,灵敏度从88%提高到92%,但特异性从94%降至81%。我们得出结论,未离心鼻腔冲洗液的奥索ELISA检测比病毒培养或间接FAT检测更敏感,且具有高度特异性。