Medical Microbiology, Canadian Blood Services, Toronto, Ontario.
Can J Infect Dis Med Microbiol. 2005 Jan;16(1):26-30. doi: 10.1155/2005/515063.
HIV diagnostic testing has come a long way since its inception in the early 1980s. Current enzyme immunoassays are sensitive enough to detect antibody as early as one to two weeks after infection. A variety of other assays are essential to confirm positive antibody screens (Western blot, polymerase chain reaction [PCR]), provide an adjunct to antibody testing (p24 antigen, PCR), or provide additional information for the clinician treating HIV-positive patients (qualitative and quantitative PCR, and genotyping). Most diagnostic laboratories have complex testing algorithms to ensure accuracy of results and optimal use of laboratory resources. The choice of assays is guided by the initial screening results and the clinical information provided by the physician; both are integral to the laboratory's ability to provide an accurate laboratory diagnosis. Laboratories should also provide specific information on specimen collection, storage and transport so that specimen integrity is not compromised, thereby preserving the accuracy of laboratory results. Point of Care tests have become increasingly popular in the United States and some places in Canada over the past several years. These tests provide rapid, on-site HIV results in a format that is relatively easy for clinic staff to perform. However, the performance of these tests requires adherence to good laboratory quality control practices, as well as the backup of a licensed diagnostic laboratory to provide confirmation and resolution of positive or indeterminate results. Laboratory quality assurance programs and the participation in HIV proficiency testing programs are essential to ensure that diagnostic laboratories provide accurate, timely and clinically relevant laboratory results.
自 20 世纪 80 年代初问世以来,HIV 诊断检测技术已经取得了长足的进步。目前的酶免疫分析法足够灵敏,能够在感染后一到两周内检测到抗体。各种其他检测方法对于确认阳性抗体筛查(免疫印迹法、聚合酶链反应 [PCR])、为抗体检测提供辅助(p24 抗原、PCR)或为治疗 HIV 阳性患者的临床医生提供额外信息(定性和定量 PCR 以及基因分型)至关重要。大多数诊断实验室都有复杂的测试算法,以确保结果的准确性和实验室资源的最佳利用。检测方法的选择取决于初始筛查结果和医生提供的临床信息;这两者都是实验室提供准确实验室诊断的能力的重要组成部分。实验室还应提供有关标本采集、存储和运输的具体信息,以确保标本完整性不受损害,从而保持实验室结果的准确性。在过去几年中,美国和加拿大的一些地方越来越多地使用即时检测(Point-of-care testing)。这些测试提供了快速、现场的 HIV 结果,其格式相对易于诊所工作人员执行。然而,这些测试的性能需要遵守良好的实验室质量控制实践,以及许可诊断实验室的备份,以提供阳性或不确定结果的确认和解决。实验室质量保证计划和参与 HIV 能力验证计划对于确保诊断实验室提供准确、及时和临床相关的实验室结果至关重要。