Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Department of Laboratory Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
J Mol Diagn. 2021 Jan;23(1):10-18. doi: 10.1016/j.jmoldx.2020.10.007. Epub 2020 Oct 26.
The prevalence and clinical relevance of viremia in patients with coronavirus disease 2019 (COVID-19) have not been well studied. A prospective cohort study was designed to investigate blood viral load and clearance kinetics in 52 patients (median age, 62 years; 31 [59.6%] male) and explore their association with clinical features and outcomes based on a novel one-step RT droplet digital PCR (RT-ddPCR). By using one-step RT-ddPCR, 92.3% (48 of 52) of this cohort was quantitatively detected with viremia. The concordance between the blood and oropharyngeal swab tests was 60.92% (53 of 87). One-step RT-ddPCR was tested with a 3.03% false-positive rate and lower 50% confidence interval of detection at 54.026 copies/mL plasma. There was no reduction in the blood viral load in all critical patients, whereas the general and severe patients exhibited a similar ability to clear the viral load. The viral loads in critical patients were significantly higher than those in their general and severe counterparts. Among the 52 study patients, 30 (58%) were discharged from the hospital. Among half of the 30 discharged patients, blood viral load remained positive, of which 76.9% (10 of 13) completely cleared their blood viral load at follow-up. Meanwhile, none of their close contacts had evidence of infection. Quantitative determination of the blood viral test is of great clinical significance in the management of patients with coronavirus disease 2019.
新型冠状病毒病（COVID-19）患者的病毒血症的流行情况及其临床相关性尚未得到很好的研究。本研究设计了一项前瞻性队列研究，旨在通过新型一步法 RT 微滴数字 PCR（RT-ddPCR），调查 52 例患者（中位年龄 62 岁；31 例[59.6%]为男性）的血液病毒载量和清除动力学，并探讨其与临床特征和结局的关系。通过使用一步法 RT-ddPCR，该队列中 92.3%（52 例中的 48 例）可定量检测到病毒血症。血液和咽拭子检测的一致性为 60.92%（87 例中的 53 例）。一步法 RT-ddPCR 的假阳性率为 3.03%，检测下限的 50%置信区间为 54.026 拷贝/ml 血浆。所有危重症患者的血液病毒载量均未降低，而普通型和重型患者清除病毒载量的能力相似。危重症患者的病毒载量明显高于普通型和重型患者。在 52 例研究患者中，30 例（58%）出院。在出院的 30 例患者中，有一半的血液病毒载量仍为阳性，其中 76.9%（13 例中的 10 例）在随访时完全清除了血液病毒载量。同时，他们的密切接触者均无感染证据。血液病毒检测的定量测定对 COVID-19 患者的管理具有重要的临床意义。
