Branson Bernard M
Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
Clin Infect Dis. 2007 Dec 15;45 Suppl 4:S221-5. doi: 10.1086/522541.
Diagnostic tests for human immunodeficiency virus (HIV) infection have undergone considerable evolution since the first enzyme immunoassay (EIA) and Western blot were introduced 2 decades ago. Newer methods detect infection sooner and yield results much faster. Rapid tests represent a major advance for HIV screening in the United States. Six rapid tests for detection of HIV antibody have been approved by the Food and Drug Administration (FDA) since November 2002. Four of these tests can be done in point-of-care and nonclinical settings because they use whole blood or oral fluid and are simple to perform. An assay for detection of HIV-1 RNA has been approved by the FDA to detect HIV infection before seroconversion has occurred and to confirm results of reactive screening tests; pooled testing of specimens for HIV-1 RNA has increased the cost-effectiveness of this screening tool. These new testing technologies offer unique opportunities to diagnose HIV infection among the estimated 252,000-312,000 persons in the United States who are currently unaware they are infected.
自20年前首次引入酶免疫测定法（EIA）和蛋白质印迹法以来，人类免疫缺陷病毒（HIV）感染的诊断测试经历了相当大的发展。更新的方法能更快地检测出感染情况，且出结果的速度也快得多。快速检测是美国HIV筛查的一项重大进展。自2002年11月以来，美国食品药品监督管理局（FDA）已批准了六种用于检测HIV抗体的快速检测方法。其中四种检测可以在即时护理和非临床环境中进行，因为它们使用全血或口腔液，操作简单。一种用于检测HIV-1 RNA的检测方法已获FDA批准，可在血清转化发生之前检测HIV感染，并确认反应性筛查试验的结果；对HIV-1 RNA标本进行混合检测提高了这种筛查工具的成本效益。这些新的检测技术为诊断美国约25.2万至31.2万目前未意识到自己已感染的人感染HIV提供了独特的机会。
