五种快速 HIV 检测试剂（口腔液或指端全血）在医疗环境中的实时比较：敏感性评估。
Sensitivity of five rapid HIV tests on oral fluid or finger-stick whole blood: a real-time comparison in a healthcare setting.
机构信息
Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.
出版信息
PLoS One. 2010 Jul 19;5(7):e11581. doi: 10.1371/journal.pone.0011581.
BACKGROUND
Health authorities in several countries recently recommended the expansion of human immunodeficiency virus (HIV) antibody testing, including the use of rapid tests. Several HIV rapid tests are now licensed in Europe but their sensitivity on total blood and/or oral fluid in routine healthcare settings is not known.
METHODS AND FINDINGS
200 adults with documented HIV-1 (n=194) or HIV-2 infection (n=6) were prospectively screened with five HIV rapid tests using either oral fluid (OF) or finger-stick whole blood (FSB). The OraQuick Advance rapid HIV1/2 was first applied to OF and then to FSB, while the other tests were applied to FSB, in the following order: Vikia HIV 1/2, Determine HIV 1-2, Determine HIV-1/2 Ag/Ab Combo and INSTI HIV-1/HIV-2. Tests negative on FSB were repeated on paired serum samples. Twenty randomly selected HIV-seronegative subjects served as controls, and the results were read blindly. Most patients had HIV-1 subtype B infection (63.3%) and most were on antiretroviral therapy (68.5%). Sensitivity was 86.5%, 94.5%, 98.5%, 94.9%, 95.8% and 99% respectively, with OraQuick OF, OraQuick FSB, Vikia, Determine, Determine Ag/Ab Combo and INSTI (p<0.0001). OraQuick was less sensitive on OF than on FSB (p=0.008). Among the six patients with three or more negative tests, two had recent HIV infection and four patients on antiretroviral therapy had undetectable plasma viral load. When patients positive in all the tests were compared with patients who had at least one negative test, only a plasma HIV RNA level<200 cp/ml was significantly associated with a false-negative result (p=0.009). When the 33 rapid tests negative on FSB were repeated on serum, all but six (5 negative with OraQuick, 1 with INSTI) were positive. The sensitivity of OraQuick, Determine and Determine Ag/Ab Combo was significantly better on serum than on FSB (97.5%, p=0.04; 100%, p=0.004; and 100%, p=0.02, respectively).
CONCLUSION
When evaluated in a healthcare setting, rapid HIV tests were less sensitive on oral fluid than on finger-stick whole blood and less sensitive on finger-stick whole blood than on serum.
背景
最近，一些国家的卫生当局建议扩大人类免疫缺陷病毒（HIV）抗体检测，包括使用快速检测。目前已有几种 HIV 快速检测在欧洲获得许可，但在常规医疗保健环境中，它们对全血和/或口腔液的敏感性尚不清楚。
方法和发现
200 名经证实患有 HIV-1（n=194）或 HIV-2 感染（n=6）的成年人前瞻性地使用五种快速 HIV 检测，分别使用口腔液（OF）或指尖全血（FSB）。OraQuick 快速 HIV1/2 首先应用于 OF，然后应用于 FSB，而其他检测则按以下顺序应用于 FSB：Vikia HIV 1/2、Determine HIV 1-2、Determine HIV-1/2 Ag/Ab Combo 和 INSTI HIV-1/HIV-2。FSB 检测阴性者，重复检测配对血清样本。20 名随机选择的 HIV 血清阴性者作为对照，结果盲法读取。大多数患者感染 HIV-1 亚型 B（63.3%），大多数接受抗逆转录病毒治疗（68.5%）。OraQuick OF、OraQuick FSB、Vikia、Determine、Determine Ag/Ab Combo 和 INSTI 的敏感性分别为 86.5%、94.5%、98.5%、94.9%、95.8%和 99%（p<0.0001）。OraQuick 在 OF 上的敏感性低于 FSB（p=0.008）。在六位三次或以上检测均为阴性的患者中，两位患者近期感染了 HIV，四位接受抗逆转录病毒治疗的患者血浆病毒载量无法检测到。当所有检测均为阳性的患者与至少有一次检测为阴性的患者进行比较时，仅血浆 HIV RNA 水平<200 cp/ml 与假阴性结果显著相关（p=0.009）。当 33 次 FSB 检测阴性的快速检测在血清中重复检测时，除了 6 次（5 次 OraQuick 阴性，1 次 INSTI 阴性）外，其余均为阳性。OraQuick、Determine 和 Determine Ag/Ab Combo 在血清中的敏感性明显优于 FSB（97.5%，p=0.04；100%，p=0.004；和 100%，p=0.02，分别）。
结论
在医疗保健环境中评估时，快速 HIV 检测在口腔液中的敏感性低于指尖全血，在指尖全血中的敏感性低于血清。
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