ABSTRACT
ObjectivesTo assess the real-world diagnostic accuracy of the Livzon point-of-care rapid test for antibodies to SARS-COV-2 DesignProspective cohort study SettingDistrict general hospital in England Participants173 Patients and 224 hospital staff with a history of COVID-19 symptoms, and who underwent PCR and/or reference antibody testing for COVID-19. InterventionsThe Livzon point-of-care (POC) lateral flow immunoassay rapid antibody test (IgM and IgG) was conducted at least 7 days after onset of symptoms and compared to the composite reference standard of PCR for SARS-COV-2 plus reference laboratory testing for antibodies to SARS-COV-2. The SARS-CoV-2 RT-PCR was tested using the available molecular technology during the study time (PHE laboratories, GeneXpert(R) system Xpert, Xpress SARS-CoV-2 and Source bioscience laboratory). All molecular platforms/assays were PHE/NHSE approved. The reference antibody test was the Elecsys Anti-SARS-CoV-2 assay (Roche diagnostics GmBH). Main outcome measuresSensitivity and specificity of the rapid antibody test ResultsThe reference antibody test was positive in 190/268 (70.9%) of participants with a history of symptoms suggestive of COVID-19; in the majority (n=312) the POC test was taken 35 days or more after onset of symptoms. The POC antibody test had an overall sensitivity of 90.1% (292/328, 95% CI 86.3 - 93.1) and specificity of 100% (68/68, 95% CI 94.7 - 100) for confirming prior SARS-CoV-2 infection when compared to the composite reference standard. Sensitivity was 97.8% (89/92, 95% CI 92.3% to 99.7%) in participants who had been admitted to hospital and 84.4% (124/147, 95% CI 77.5% to 89.8%) in those with milder illness who had never been seen in hospital. ConclusionsThe Livzon point-of-care antibody test had comparable sensitivity and specificity to the reference laboratory antibody test, so could be used in clinical settings to support decision-making about patients presenting with more than 10 days of symptoms of COVID-19. What is already known on this topic- Presence of IgG and IgM antibodies to SARS-COV-2 indicates that the person was infected at least 7 days previously and is usually no longer infectious. - Rapid point-of-care tests for antibodies to SARS-COV-2 are widely available, cheap and easy to use - Preliminary evaluations suggested that rapid antibody tests may have insufficient accuracy to be useful for testing individual patients. What this study adds- The rapid point-of-care test for antibodies to SARS-COV-2 was 90.1% sensitive and 100% specific compared to reference standards for prior infection with COVID-19. - This is comparable to reference antibody tests - The point-of-care test evaluated in this study could be used to support clinical decision-making in real time, for patients presenting with symptoms of possible COVID-19 with at least 10 days of symptoms.
Subject(s)
COVID-19ABSTRACT
Background: Germ Defence (https://germdefence.org/) is a freely available website providing behavioural advice for infection control within households, using behaviour change techniques. This observational study reports current infection control behaviours in the home in UK and international users of the website, and examine how they might be improved to reduce the spread of COVID-19. Method: 28,285 users sought advice from four website pathways (to protect themselves generally, to protect others if the user was showing symptoms, to protect themselves if household members were showing symptoms, and to protect a household member who is at high risk) and completed outcome measures of current infection control behaviours within the home (self-isolation, social distancing, putting shopping/packages aside, wearing face-covering, cleaning and disinfecting, handwashing), and intentions to change these behaviours. Results: Current user behaviours mean scores varied across all infection control measures but were between 'sometimes' and 'quite often', except handwashing ('very often'). Behaviours were similar regardless of the website pathway used. After using Germ Defence, users recorded intentions to improve infection control behaviour across all website pathways and for all behaviours. Conclusions: Self-reported infection control behaviours other than handwashing are lower than is optimal for infection prevention, although reported handwashing is much higher. The advice using behaviour change techniques in Germ Defence led to intentions to improve these behaviours. This has been shown previously to reduce the incidence, severity and transmission of infections. These findings suggest that promoting Germ Defence within national and local public health guidance could reduce COVID-19 transmission.
Subject(s)
COVID-19ABSTRACT
Background: Since the outbreak of coronavirus disease 2019 (COVID-19) in January 2020, Traditional Chinese Medicine (TCM) has been fully and deeply involved in the treatment of COVID-19 in China. An increasing number of clinical trials has been registered to evaluate the effects of TCM in the prevention and therapeutic management of COVID-19.Objective: This study aims to review the existing TCM registered trials, identify promising and available TCM therapies, in order to provide reference for the global management of COVID-19. Methods: All clinical trials on TCM for COVID-19 registered in eight registry platforms worldwide were searched up to May 14, 2020. The data of registration trend, design, objective, interventions, current status, and relevant information were reviewed and summarized. Supportive information on the progress, results and potential value of the included registered trials were searched and reviewed from databases and official websites. Results: 161 TCM trials registered in three registries from January 26 to May 14 were included. 94 (58.4%) were randomized controlled trials, followed by controlled clinical trials (25, 15.5%), single-arm clinical studies (18, 11.2%) and others (24, 14.9%). 114 trials (70.8%) assessed therapeutic effects; while the remaining were for prevention, rehabilitation, and TCM syndrome epidemiology. The three most evaluated TCM interventions were Chinese herbal medicine (CHM) in the preparation forms of formulae decoction/granule (41.7%), Chinese patent medicine (24.8%) and Chinese herbal-derived injections (8.1%). The common outcomes in therapeutic trials were symptoms and signs (65.8%), time to viral clearance on PCR (50.9%), and improvement in CT images (43.9%). 78 trials (48.4%) had started recruiting and six trials (3.7%) had completed recruiting. Among the TCM interventions identified from the registered trials, the following are worthy of attention and may have the potential feasibility of being evaluated and then used worldwide due to their rigorous design, previous evidence and availability: for prevention in high-risk populations or suspected cases, moxibustion, Huoxiang Zhengqi pill and Jinye Baidu granule could be considered; for treatment, Qingfei Paidu decoction or granules in mild, moderate and severe cases, Huashi Baidu decoction, Lianhua Qingwen caplsule, Toujie Quwen granule and Xiyanping injection in mild and moderate cases, and Xuebijing injection in severe cases could be considered. For rehabilitation of cured patients, the effect of Tai Chi and Liuzijue on the patients’ lung function and quality of life deserves attention.Conclusion: A series of promising potentially effective TCM interventions including CHM formulae, Chinese patent medicines, herbal-derived injections and non-drug therapies have been identified in clinical practice and are being evaluated by registered clinical trials. Available and applicable interventions within relevant trials are worthy of worldwide attention and application, in order to contribute to the global management of COVID-19 epidemic.
Subject(s)
COVID-19ABSTRACT
Background The World Health Organization characterized the 2019 novel coronavirus disease (COVID-19) as a pandemic on March 11. Many clinical trials on COVID-19 have been registered, and we aim to review the characteristics of the trials and provide guidance for future trials to avoid duplicated effort.Methods All the studies on COVID-19 registered before Mar 3, 2020 on eight registry platforms worldwide were searched and the data of design, participants, interventions, and outcomes were extracted and analyzed. The most promising trials were screened based on study design, rationale, and resource availability.Results 393 studies registered were identified until Mar 3 2020 and 380 (96.7%) studies were from mainland China, while 3 in Japan, 3 in France, 2 in the US, and 3 were international collaborative studies. 363 studies (92.4%) recruited participants from hospitals and 266 studies (67.7%) aimed at therapeutic effect, others were for prevention, diagnosis, prognosis, etc. 202 studies (51.4%) were randomized controlled trials (RCTs). The average sample size was 1061 and ranged from 8 to 150,000 per study. 177 out of 266 therapeutic studies (66.5% ) tested Western medicines including antiviral drugs (17.7%), stem cell and cord blood therapy (10.2%), chloroquine and derivatives (8.3%), 16 (6.0%) on Chinese medicines, and 73 (27.4%) on integrated therapy of Western and Chinese medicines. 14 Chinese medicines had its clear rationale for evaluation of therapeutic effects. 31 studies among 266 therapeutic studies (11.7%) used mortality as primary outcome, while the most designed secondary outcomes were symptoms and signs (47.0%). 106 studies (27.0%) were funded by the government, and 268 (68.2%) demonstrated ethical approval. 45.5% studies (179 out of 266) had not started recruiting till Mar 3. Eight RCTs were evaluated as the most promising trials.Conclusions Majority of the studies focused on assessing therapeutics for COVID-19 but inappropriate outcome setting, delayed recruitment and insufficient numbers of new cases in China implied many studies may fail to complete. Strategies and protocols of the studies with robust and rapid data sharing from international collaboration are warranted for emergency public health events, helping to accelerate priority setting for timely evidence-based decision-making.