Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK.
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Lancet Infect Dis. 2021 Sep;21(9):e290-e295. doi: 10.1016/S1473-3099(21)00048-7. Epub 2021 Feb 23.
WHO recommends a minimum of 80% sensitivity and 97% specificity for antigen-detection rapid diagnostic tests (Ag-RDTs), which can be used for patients with symptoms consistent with COVID-19. However, after the acute phase when viral load decreases, use of Ag-RDTs might lead to high rates of false negatives, suggesting that the tests should be replaced by a combination of molecular and serological tests. When the likelihood of having COVID-19 is low, such as for asymptomatic individuals in low prevalence settings, for travel, return to schools, workplaces, and mass gatherings, Ag-RDTs with high negative predictive values can be used with confidence to rule out infection. For those who test positive in low prevalence settings, the high false positive rate means that mitigation strategies, such as molecular testing to confirm positive results, are needed. Ag-RDTs, when used appropriately, are promising tools for scaling up testing and ensuring that patient management and public health measures can be implemented without delay.
世卫组织建议抗原检测快速诊断试剂(Ag-RDT)的最低灵敏度至少为 80%,特异性至少为 97%,这些试剂可用于有 COVID-19 症状一致的患者。然而,在病毒载量下降的急性期过后,Ag-RDT 的使用可能会导致高比例的假阴性,这表明这些检测应该被分子和血清学检测的组合所取代。当 COVID-19 的可能性较低时,例如在低流行地区的无症状个体、旅行、返回学校、工作场所和大规模集会,具有高阴性预测值的 Ag-RDT 可以被有信心地用于排除感染。对于那些在低流行地区检测呈阳性的人来说,高假阳性率意味着需要采取缓解策略,例如进行分子检测以确认阳性结果。Ag-RDT 在适当使用时,是扩大检测规模的有前途的工具,可确保患者管理和公共卫生措施能够毫不拖延地实施。