Phillips S, Granade T C, Pau C P, Candal D, Hu D J, Parekh B S
HIV Immunology and Diagnostics Branch, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
Clin Diagn Lab Immunol. 2000 Jul;7(4):698-9. doi: 10.1128/CDLI.7.4.698-699.2000.
We evaluated six rapid tests for their sensitivity and specificity in diagnosing human immunodeficiency virus type 1 (HIV-1) infection using 241 specimens (172 HIV-1 positive, 69 HIV-1 negative) representing different HIV-1 subtypes (A [n = 40], B [n = 47], C [n = 28], E [n = 42], and F [n = 7]). HIVCHEK, Multispot, RTD and SeroStrip were 100% sensitive and specific. Capillus failed to identify two of eight subtype C specimens (overall sensitivity of 98. 85%), while the SUDS test (the only test approved by the Food and Drug Administration) gave false-positive results for 5 of 69 seronegative specimens (specificity of 93.24%). Our results suggest that although rapid tests perform well in general, it may be prudent to evaluate a rapid test for sensitivity and specificity in a local population prior to its widespread use.
我们使用241份标本(172份HIV-1阳性,69份HIV-1阴性)评估了六种快速检测方法在诊断1型人类免疫缺陷病毒(HIV-1)感染方面的敏感性和特异性,这些标本代表了不同的HIV-1亚型(A [n = 40]、B [n = 47]、C [n = 28]、E [n = 42]和F [n = 7])。HIVCHEK、Multispot、RTD和SeroStrip的敏感性和特异性均为100%。Capillus未能识别出8份C亚型标本中的2份(总体敏感性为98.85%),而SUDS检测(唯一经美国食品药品监督管理局批准的检测方法)在69份血清阴性标本中有5份出现假阳性结果(特异性为93.24%)。我们的结果表明,尽管快速检测总体表现良好,但在广泛使用之前,先在当地人群中评估快速检测的敏感性和特异性可能是谨慎之举。