MMWR Morb Mortal Wkly Rep. 2002 Nov 22;51(46):1051-2.
On November 7, 2002, the Food and Drug Administration announced approval of the OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies, Inc., Bethlehem, Pennsylvania) for use by trained personnel as a point-of-care test to aid in the diagnosis of infection with human immunodeficiency virus type 1 (HIV-1). OraQuick is a simple, rapid test that can detect antibodies to HIV in fingerstick whole blood specimens and provide results in as little as 20 minutes [corrected]. The test has been categorized as moderate complexity under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). A second FDA-approved moderate-complexity rapid HIV test, Single Use Diagnostic System for HIV-1 (Abbott-Murex Inc., Norcross, Georgia), remains available in the United States for use with serum or plasma specimens.
2002年11月7日，美国食品药品监督管理局宣布批准OraQuick快速HIV-1抗体检测（由宾夕法尼亚州伯利恒市的OraSure Technologies公司生产），供经过培训的人员用作即时检验，以辅助诊断1型人类免疫缺陷病毒（HIV-1）感染。OraQuick是一种简单、快速的检测方法，能够在手指采血的全血样本中检测出HIV抗体，最短只需20分钟[已修正]即可得出结果。根据1988年《临床实验室改进修正案》（CLIA），该检测被归类为中等复杂程度。美国还有另一种经美国食品药品监督管理局批准的中等复杂程度的快速HIV检测方法，即HIV-1一次性诊断系统（由佐治亚州诺克罗斯市的雅培-默克公司生产），可用于血清或血浆样本检测。
