Cambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID), Cambridge, UK.
Department of Medicine, University of Cambridge, Cambridge, UK.
Cell Rep Med. 2020 Sep 22;1(6):100099. doi: 10.1016/j.xcrm.2020.100099. Epub 2020 Sep 1.
Rapid COVID-19 diagnosis in the hospital is essential, although this is complicated by 30%-50% of nose/throat swabs being negative by SARS-CoV-2 nucleic acid amplification testing (NAAT). Furthermore, the D614G spike mutant dominates the pandemic and it is unclear how serological tests designed to detect anti-spike antibodies perform against this variant. We assess the diagnostic accuracy of combined rapid antibody point of care (POC) and nucleic acid assays for suspected COVID-19 disease due to either wild-type or the D614G spike mutant SARS-CoV-2. The overall detection rate for COVID-19 is 79.2% (95% CI 57.8-92.9) by rapid NAAT alone. The combined point of care antibody test and rapid NAAT is not affected by D614G and results in very high sensitivity for COVID-19 diagnosis with very high specificity.
在医院内快速诊断 COVID-19 非常重要，尽管通过 SARS-CoV-2 核酸扩增检测（NAAT），有 30%-50%的鼻/咽拭子呈阴性，这使情况变得复杂。此外，D614G 刺突突变体主导了大流行，目前尚不清楚针对这种变体设计的血清学检测对检测抗刺突抗体的表现如何。我们评估了联合使用快速抗体即时检测（POC）和核酸检测对疑似 COVID-19 疾病（无论是野生型还是 D614G 刺突突变体 SARS-CoV-2）的诊断准确性。单独使用快速 NAAT 检测 COVID-19 的总检出率为 79.2%（95%CI 57.8-92.9）。即时护理点抗体检测和快速 NAAT 的联合检测不受 D614G 的影响，对 COVID-19 的诊断具有非常高的敏感性和特异性。
