The outbreak of COVID-19 caused by a novel Coronavirus (termed SARS-CoV-2) has spread to over 210 countries around the world. Currently, reverse transcription quantitative qPCR (RT-qPCR) is used as the gold standard for diagnosis of SARS-CoV-2. However, the sensitivity of RT-qPCR assays of pharyngeal swab samples are reported to vary from 30% to 60%. More accurate and sensitive methods are urgently needed to support the quality assurance of the RT-qPCR or as an alternative diagnostic approach. A reverse transcription digital PCR (RT-dPCR) method was established and evaluated. To explore the feasibility of RT-dPCR in diagnostic of SARS-CoV-2, a total of 196 clinical pharyngeal swab samples from 103 suspected patients, 77 close contacts and 16 supposed convalescents were analyzed by RT-qPCR and then measured by the proposed RT-dPCR. For the 103 fever suspected patients, 19 (19/25) negative and 42 (42/49) equivocal tested by RT-qPCR were positive according to RT-dPCR. The sensitivity of SARS-CoV-2 detection was significantly improved from 28.2% by RT-qPCR to 87.4% by RT-dPCR. For 29 close contacts (confirmed by additional sample and clinical follow up), 16 (16/17) equivocal and 1 negative tested by RT-qPCR were positive according to RT-dPCR, which is implying that the RT-qPCR is missing a lot of asymptomatic patients. The overall sensitivity, specificity and diagnostic accuracy of RT-dPCR were 91%, 100% and 93 %, respectively. RT-dPCR is highly accurate method and suitable for detection of pharyngeal swab samples from COVID-19 suspected patients and patients under isolation and observation who may not be exhibiting clinical symptoms.

Background and Aim Currently, the number of patients with coronavirus disease 2019 (COVID-19) infection is increasing rapidly worldwide. In this study, we aimed to assess whether diabetes mellitus (DM) would increase the risk of severe infection and death in patients with COVID-19. Methods We systematically searched the PubMed, Web of Science, MedRxiv and COVID-19 academic research communication platform for studies reporting clinical severity and/or overall mortality data on DM in patients with COVID-19 published up to July 10, 2020. The primary outcome was to compare the severe infection rate and mortality rate in COVID-19 patients with and without DM, and to calculate the odds ratio ( OR ) and 95% confidence interval (CI). Results A total of 76 studies involving 31,067 patients with COVID-19 were included in our meta-analysis. COVID-19 patients with DM had higher severe infection and case-mortality rates compared with those without DM (21.4 vs. 10.6% and 28.5 vs. 13.3%, respectively, all p <0.01). COVID-19 patients with DM were at significantly elevated risk of severe infection ( OR = 2.38, 95% CI: 2.05–2.78, p <0.001) and mortality ( OR = 2.21, 95% CI: 1.83–2.66, p <0.001). Conclusion DM is associated with increased risk of severe infection and higher mortality in patients with COVID-19. Our study suggests that clinicians should pay more attention to the monitoring and treatment of COVID-19 patients with DM.

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