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      Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity

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          Abstract

          Objective

          With the current SARS-CoV2 outbreak, countless tests need to be performed on potential symptomatic individuals, contacts and travellers. The gold standard is a quantitative polymerase chain reaction (qPCR)–based system taking several hours to confirm positivity. For effective public health containment measures, this time span is too long. We therefore evaluated a rapid test in a high-prevalence community setting.

          Study design

          Thirty-nine randomly selected individuals at a COVID-19 screening centre were simultaneously tested via qPCR and a rapid test. Ten previously diagnosed individuals with known SARS-CoV-2 infection were also analysed.

          Methods

          The evaluated rapid test is an IgG/IgM–based test for SARS-CoV-2 with a time to result of 20 min. Two drops of blood are needed for the test performance.

          Results

          Of 49 individuals, 22 tested positive by repeated qPCR. In contrast, the rapid test detected only eight of those positive correctly (sensitivity: 36.4%). Of the 27 qPCR-negative individuals, 24 were detected correctly (specificity: 88.9%).

          Conclusion

          Given the low sensitivity, we recommend not to rely on an antibody-based rapid test for public health measures such as community screenings.

          Highlights

          • There is an urgent need for rapid testing for Sars-CoV-2 to guarantee a sufficient outbreak management.
          • The tested IgG/IgM rapid test shows a low sensitivity in a community screening setting.
          • Other antibody- or antigen-based tests should be tested for their usefullness in this setting for better outbreak control.

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          Most cited references 7

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          Clinical Characteristics of Coronavirus Disease 2019 in China

          Abstract Background Since December 2019, when coronavirus disease 2019 (Covid-19) emerged in Wuhan city and rapidly spread throughout China, data have been needed on the clinical characteristics of the affected patients. Methods We extracted data regarding 1099 patients with laboratory-confirmed Covid-19 from 552 hospitals in 30 provinces, autonomous regions, and municipalities in mainland China through January 29, 2020. The primary composite end point was admission to an intensive care unit (ICU), the use of mechanical ventilation, or death. Results The median age of the patients was 47 years; 41.9% of the patients were female. The primary composite end point occurred in 67 patients (6.1%), including 5.0% who were admitted to the ICU, 2.3% who underwent invasive mechanical ventilation, and 1.4% who died. Only 1.9% of the patients had a history of direct contact with wildlife. Among nonresidents of Wuhan, 72.3% had contact with residents of Wuhan, including 31.3% who had visited the city. The most common symptoms were fever (43.8% on admission and 88.7% during hospitalization) and cough (67.8%). Diarrhea was uncommon (3.8%). The median incubation period was 4 days (interquartile range, 2 to 7). On admission, ground-glass opacity was the most common radiologic finding on chest computed tomography (CT) (56.4%). No radiographic or CT abnormality was found in 157 of 877 patients (17.9%) with nonsevere disease and in 5 of 173 patients (2.9%) with severe disease. Lymphocytopenia was present in 83.2% of the patients on admission. Conclusions During the first 2 months of the current outbreak, Covid-19 spread rapidly throughout China and caused varying degrees of illness. Patients often presented without fever, and many did not have abnormal radiologic findings. (Funded by the National Health Commission of China and others.)
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            Evidence of SARS-CoV-2 Infection in Returning Travelers from Wuhan, China

            To the Editor: As the number of cases of infection with the novel coronavirus (SARS-CoV-2) has continued to increase, many countries have established restrictions regarding travelers who have recently visited China. 1 With lockdown measures imposed in Hubei Province, China, 2 and a public health emergency of international concern declared by the World Health Organization, 3 foreign nationals have sought to return to their home countries from China, and public health authorities are racing to contain the spread of Covid-19 (the disease caused by SARS-CoV-2 infection) around the world. This process is complicated by epidemiologic uncertainty regarding possible transmission of the virus by asymptomatically or subclinically symptomatic infected persons. It is unclear whether persons who show no signs or symptoms of respiratory infection shed SARS-CoV-2. In this context, a group of predominantly German nationals who had stayed in Hubei Province was evacuated to Frankfurt, Germany, on February 1, 2020. They were to be transferred to Germersheim, Germany, and quarantined for 14 days, since this period is thought to be the upper limit of the incubation period of SARS-CoV-2. Screening for symptoms and clinical signs of infection was performed before their departure from China. A total of 126 travelers were allowed to board an aircraft operated by the German air force (Figure 1). During the flight, 10 passengers were isolated. Two passengers had had contact with 1 person who had a confirmed case of SARS-CoV-2 infection, 6 had reported symptoms, were deemed to be clinically symptomatic, or both, and 2 passengers had accompanied family members who had been isolated on the flight because of suspected SARS-CoV-2 infection or because of other symptoms (i.e., symptoms related to pregnancy). These 10 passengers were transferred to University Hospital Frankfurt immediately after arrival. All 10 tested negative for SARS-CoV-2 by real-time reverse-transcription–polymerase-chain-reaction (RT-PCR) assays 4 of throat swabs and sputum. The remaining 116 passengers (5 months to 68 years of age), including 23 children, were sent to the medical assessment center at Frankfurt Airport, where each was evaluated by a medical team of physicians. Each passenger was asked to report current symptoms of fever, fatigue, sore throat, cough, runny nose, muscle aches, and diarrhea, and each one was screened for signs of infection in the nose and throat. The temperature of all passengers was taken. All were afebrile except for 1 passenger who had a temperature of 38.4°C and reported dyspnea and cough. He was transferred to University Hospital Frankfurt for evaluation. However, testing to detect SARS-CoV-2 by RT-PCR of a throat swab and sputum was negative. In addition to the preplanned multistep process of screening for signs and symptoms of infection and observing the asymptomatic cohort in quarantine, we decided to offer a throat swab to test for SARS-CoV-2 in each of the 115 travelers who had passed triage. A total of 114 passengers consented to the test. Two of the 114 persons (1.8%) in this cohort of travelers who had passed the symptoms-based screening tested positive for SARS-CoV-2 by RT-PCR (cycle threshold value in the two samples, 24.39 and 30.25, respectively). Testing with a second protocol consisting of two commercial sets (LightMix Modular SARS and Wuhan CoV E-gene, and LightMix Modular Wuhan CoV RdRP-gene, both produced by TIB MOLBIOL) and retesting of the positive samples at the Institute of Virology, Philipps University Marburg, in Marburg, Germany, confirmed the results. In addition, the isolation of SARS-CoV-2 from both samples in cell culture of Caco-2 cells indicated potential infectivity (see the Supplementary Appendix, available with the full text of this letter at NEJM.org). These two persons were subsequently isolated from the cohort and transferred to the Infectious Disease Unit at University Hospital Frankfurt for further evaluation and observation on the following day. After a thorough evaluation in the hospital ward, a faint rash and minimal pharyngitis were observed in one patient. Both patients remained well and afebrile 7 days after admission. In this effort to evacuate 126 people from Wuhan to Frankfurt, a symptom-based screening process was ineffective in detecting SARS-CoV-2 infection in 2 persons who later were found to have evidence of SARS-CoV-2 in a throat swab. We discovered that shedding of potentially infectious virus may occur in persons who have no fever and no signs or only minor signs of infection.
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              Imaging and clinical features of patients with 2019 novel coronavirus SARS-CoV-2

              Background The pneumonia caused by the 2019 novel coronavirus (SARS-CoV-2, also called 2019-nCoV) recently break out in Wuhan, China, and was named as COVID-19. With the spread of the disease, similar cases have also been confirmed in other regions of China. We aimed to report the imaging and clinical characteristics of these patients infected with SARS-CoV-2 in Guangzhou, China. Methods All patients with laboratory-identified SARS-CoV-2 infection by real-time polymerase chain reaction (PCR) were collected between January 23, 2020, and February 4, 2020, in a designated hospital (Guangzhou Eighth People’s Hospital). This analysis included 90 patients (39 men and 51 women; median age, 50 years (age range, 18–86 years). All the included SARS-CoV-2-infected patients underwent non-contrast enhanced chest computed tomography (CT). We analyzed the clinical characteristics of the patients, as well as the distribution characteristics, pattern, morphology, and accompanying manifestations of lung lesions. In addition, after 1–6 days (mean 3.5 days), follow-up chest CT images were evaluated to assess radiological evolution. Findings The majority of infected patients had a history of exposure in Wuhan or to infected patients and mostly presented with fever and cough. More than half of the patients presented bilateral, multifocal lung lesions, with peripheral distribution, and 53 (59%) patients had more than two lobes involved. Of all included patients, COVID-19 pneumonia presented with ground glass opacities in 65 (72%), consolidation in 12 (13%), crazy paving pattern in 11 (12%), interlobular thickening in 33 (37%), adjacent pleura thickening in 50 (56%), and linear opacities combined in 55 (61%). Pleural effusion, pericardial effusion, and lymphadenopathy were uncommon findings. In addition, baseline chest CT did not show any abnormalities in 21 patients (23%), but 3 patients presented bilateral ground glass opacities on the second CT after 3–4 days. Conclusion SARS-CoV-2 infection can be confirmed based on the patient’s history, clinical manifestations, imaging characteristics, and laboratory tests. Chest CT examination plays an important role in the initial diagnosis of the novel coronavirus pneumonia. Multiple patchy ground glass opacities in bilateral multiple lobular with periphery distribution are typical chest CT imaging features of the COVID-19 pneumonia.
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                Author and article information

                Contributors
                Journal
                Public Health
                Public Health
                Public Health
                The Royal Society for Public Health. Published by Elsevier Ltd.
                0033-3506
                1476-5616
                18 April 2020
                18 April 2020
                Affiliations
                [a ]Institute for Hygiene and Public Health, One Health Department, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany
                [b ]Clinic for Internal Medicine, Infectious Diseases Department, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany
                [c ]Institute of Virology, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany
                Author notes
                []Corresponding author. Dr. med. Manuel Döhla, MScPH, Institute for Hygiene and Public Health, Faculty of Medicine, University Bonn, Bonn, Germany. Tel.: +49 (0) 228 287-15520; fax: +49 (0) 228 287-90-15520. manuel.doehla@ 123456ukbonn.de
                Article
                S0033-3506(20)30114-1
                10.1016/j.puhe.2020.04.009
                7165286
                © 2020 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

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                Public health

                outbreak, sars-cov-2, covid-19, coronavirus, rapid test

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