Department for Infectious Disease Epidemiology, Bernhard-Nocht-Institute for Tropical Medicine, Hamburg, Germany.
East African Community (EAC), Arusha, Tanzania.
Microbiol Spectr. 2023 Jun 15;11(3):e0489522. doi: 10.1128/spectrum.04895-22. Epub 2023 Apr 3.
The clinical performance of two rapid antigen tests for the diagnosis of Severe Acute Respiratory Coronavirus (SARS-CoV-2) were regionally evaluated in East African populations. Swabs were collected from 1,432 individuals from five Partner States of the East African Community (Tanzania, Uganda, Burundi, Rwanda and South Sudan). The two rapid antigen tests (Bionote NowCheck COVID-19 Ag and SD Biosensor STANDARD Q COVID-19 Ag) were evaluated against the detection of SARS-CoV-2 RNA by the Reverse Transcription PCR (RT-PCR) gold standard. Of the concordant results with both RT-PCR and rapid antigen test data (862 for Bionote and 852 for SD Biosensor), overall clinical sensitivity was 60% and 50% for the Bionote NowCheck and the SD Biosensor STANDARD Q, respectively. Stratification by viral load, including samples with RT-PCR cycle thresholds (Ct) of <25, improved sensitivity to 90% for both rapid diagnostic tests (RDTs). Overall specificity was good at 99% for both antigen tests. Taken together, the clinical performance of both Ag-RDTs in real world settings within the East African target population was lower than has been reported elsewhere and below the acceptable levels for sensitivity of >80%, as defined by the WHO. Therefore, the rapid antigen test alone should not be used for diagnosis but could be used as part of an algorithm to identify potentially infectious individuals with high viral load. Accurate diagnostic tests are essential to both support the management and containment of outbreaks, as well as inform appropriate patient care. In the case of the SARS-CoV-2 pandemic, antigen Rapid Diagnostic Tests (Ag-RDTs) played a major role in this function, enabling widespread testing by untrained individuals, both at home and within health facilities. In East Africa, a number of SARS-CoV-2 Ag-RDTs are available; however, there remains little information on their true test performance within the region, in the hands of the health workers routinely carrying out SARS-CoV-2 diagnostics. This study contributes test performance data for two commonly used SARS-CoV-2 Ag-RDTs in East Africa, which will help inform the use of these RDTs within the region.
两种快速抗原检测试剂用于诊断严重急性呼吸冠状病毒(SARS-CoV-2)的临床性能在东非人群中进行了区域性评估。从东非共同体的五个伙伴国家(坦桑尼亚、乌干达、布隆迪、卢旺达和南苏丹)的 1432 个人中采集了拭子。两种快速抗原检测试剂(Bionote NowCheck COVID-19 Ag 和 SD Biosensor STANDARD Q COVID-19 Ag)与逆转录聚合酶链反应(RT-PCR)金标准检测 SARS-CoV-2 RNA 进行了比较。在与 RT-PCR 和快速抗原检测数据一致的结果中(Bionote 为 862 例,SD Biosensor 为 852 例),Bionote NowCheck 和 SD Biosensor STANDARD Q 的总体临床灵敏度分别为 60%和 50%。按病毒载量分层,包括 RT-PCR 循环阈值(Ct)<25 的样本,两种快速诊断检测(RDT)的灵敏度提高到 90%。两种抗原检测的总体特异性均为 99%。总的来说,在东非目标人群的真实环境中,两种 Ag-RDT 的临床性能均低于其他地方的报告,低于世界卫生组织(WHO)定义的>80%灵敏度的可接受水平。因此,单独的快速抗原检测不应用于诊断,但可以作为一种算法的一部分,用于识别具有高病毒载量的潜在传染性个体。准确的诊断检测对于支持疾病的管理和控制以及提供适当的患者护理都至关重要。在 SARS-CoV-2 大流行期间,抗原快速诊断检测(Ag-RDTs)在这一功能中发挥了重要作用,使未经培训的人员能够在家中和医疗机构中进行广泛的检测。在东非,有多种 SARS-CoV-2 Ag-RDT 可供使用;然而,关于这些 RDT 在该地区的实际检测性能,即在常规进行 SARS-CoV-2 诊断的卫生工作者手中的情况,仍然知之甚少。本研究提供了两种在东非常用的 SARS-CoV-2 Ag-RDT 的测试性能数据,这将有助于为该地区使用这些 RDT 提供信息。