Laboratoire de Virologie, Centre Muraz, Bobo-Dioulasso, Burkina Faso.
J Clin Microbiol. 2010 Apr;48(4):1333-6. doi: 10.1128/JCM.01734-09. Epub 2010 Feb 3.
Rapid human immunodeficiency virus (HIV) antibody tests have been adopted into national guidelines for HIV testing in many countries in sub-Saharan Africa. One goal of HIV rapid testing is to minimize the occurrence of indeterminate results. From January 2005 to December 2007, plasma (or serum) samples from pregnant women in Bobo-Dioulasso (Burkina Faso, West Africa) were screened for HIV by using two rapid tests (the Determine HIV1/2 test [Abbott] and Genie II HIV-1/HIV-2 [Bio-Rad]) through a sequential algorithm prior to enrollment of HIV-1-infected women in a prevention of mother-to-child transmission (PMTCT) trial (WHO/ANRS 1289 Kesho Bora trial). Samples exhibiting indeterminate results (Determine positive and Genie II negative) were further tested with a fourth-generation HIV enzyme immunoassay (EIA) (Murex HIV Ag/Ab combination in 2005 and 2006 and Vironostika HIV Uni-Form II Ag/Ab in 2007). If positive, they were finally assessed for HIV-1 RNA (Generic HIV-1 RNA viral load assay; Biocentric). From a total of 44,653 samples tested, 597 (1.3%) showed indeterminate results. Of these, 367 could be analyzed by EIA. Only 15 (15/367, 4.1%) samples were found EIA reactive. Of these, 11 could be tested for HIV-1 RNA. All were HIV-1 RNA negative. In our clinical practice, pregnant women with such indeterminate results are now reassured during posttest counseling that they are very unlikely to be infected with HIV-1. As a consequence, such women with indeterminate results can reliably be considered negative when urgent clinical decisions (such as providing PMTCT prophylaxis) need to be taken.
在撒哈拉以南非洲的许多国家,快速人类免疫缺陷病毒 (HIV) 抗体检测已被纳入国家 HIV 检测指南。HIV 快速检测的一个目标是尽量减少不确定结果的出现。从 2005 年 1 月至 2007 年 12 月,在布基纳法索(西非博博迪乌拉索)的一项预防母婴传播 (PMTCT) 试验(世界卫生组织/非洲区域艾滋病规划署 1289 凯索博拉试验)中,对感染 HIV-1 的妇女进行入组前,对孕妇的血浆(或血清)样本使用两种快速检测方法(雅培公司的 Determine HIV1/2 检测试剂和伯乐公司的 Genie II HIV-1/HIV-2 检测试剂)进行检测,采用的是一种两步法检测策略。表现为不确定结果(Determine 试剂阳性和 Genie II 试剂阴性)的样本进一步用第四代 HIV 酶免疫分析(EIA)进行检测(2005 年和 2006 年使用 Murex HIV Ag/Ab 组合试剂,2007 年使用 Vironostika HIV Uni-Form II Ag/Ab 试剂)。如果呈阳性,最终用通用 HIV-1 RNA 病毒载量测定法(Biocentric 公司的 Generic HIV-1 RNA viral load assay)对 HIV-1 RNA 进行评估。在总共检测的 44653 个样本中,有 597 个(1.3%)显示不确定结果。其中,有 367 个可以用 EIA 进行分析。只有 15 个(367 个中的 15 个,占 15/367,4.1%)EIA 反应性样本。其中,有 11 个可以进行 HIV-1 RNA 检测。所有 HIV-1 RNA 检测均为阴性。在我们的临床实践中,对于有这种不确定结果的孕妇,在检测后咨询时,我们会告诉她们她们极不可能感染 HIV-1,从而使她们安心。因此,当需要做出紧急临床决策(如提供 PMTCT 预防)时,可可靠地将这些有不确定结果的妇女视为阴性。