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      Serological chemiluminescence immunoassay for the diagnosis of SARS‐CoV‐2 infection

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          Abstract

          Objective

          Dynamic monitoring of the concentration variation of IgM and IgG in patients with SARS‐CoV‐2 infections and exploring their diagnostic value for coronavirus disease‐19 (COVID‐19).

          Methods

          A total of 15 patients with SARS‐CoV‐2 infection were enrolled as the COVID‐19 group, and 50 patients were enrolled as the control group. The concentrations of SARS‐CoV‐2‐specific antibodies (IgM and IgG) were detected by a chemiluminescence immunoassay (CLIA).

          Results

          According to the cutoff value recommended by the manufacturer (cutoff = 10 AU/mL), the sensitivity, specificity, Youden index (YI), positive predictive value (PPV), and negative predictive value (NPV) of IgM were 60%, 100%, 60%, 100%, and 89.29%, respectively; and 86.67%, 100%, 86.67%, 100%, and 96.15%, respectively, for IgG. We reassessed the cutoff value of IgM. When the cutoff value for SARS‐CoV‐2 IgM was 1.83 AU/mL, the sensitivity, specificity, YI, PPV, and NPV were 93.33%, 98%, 91.33%, 93.33%, and 98%, respectively. During dynamic monitoring of the concentrations of IgM and IgG in COVID‐19 patients, we found the shortest times before a patient became IgM and IgG seropositive after symptom onset were 1.5 and 2 days, respectively. The longest times were 7 and 8 days, respectively. The positive rates of SARS‐CoV‐2 IgM and IgG both reached 100% in 8‐14 days after symptom onset.

          Conclusion

          The IgM cutoff value of 1.83 AU/mL for the diagnosis of COVID‐19 was much better than the cutoff suggested by the manufacturer. SARS‐CoV‐2 infection can be ruled out if antibodies against SARS‐CoV‐2 are still undetectable 14 days after symptom onset.

          Abstract

          The new cutoff of IgM improve the diagnostic value. Considering the high diagnostic efficiency of IgG, we chose the day on which the SARS‐CoV‐2 IgG was close to 10.00 AU/mL. Then, we collected IgM data on the same day to select new cutoff values. When the cutoff value of IgM was 1.83 AU/mL, we obtained the maximum YI.

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          A Novel Coronavirus from Patients with Pneumonia in China, 2019

          Na Zhu, Dingyu Zhang, Wenling Wang … (2020)
          Summary In December 2019, a cluster of patients with pneumonia of unknown cause was linked to a seafood wholesale market in Wuhan, China. A previously unknown betacoronavirus was discovered through the use of unbiased sequencing in samples from patients with pneumonia. Human airway epithelial cells were used to isolate a novel coronavirus, named 2019-nCoV, which formed a clade within the subgenus sarbecovirus, Orthocoronavirinae subfamily. Different from both MERS-CoV and SARS-CoV, 2019-nCoV is the seventh member of the family of coronaviruses that infect humans. Enhanced surveillance and further investigation are ongoing. (Funded by the National Key Research and Development Program of China and the National Major Project for Control and Prevention of Infectious Disease in China.)
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            Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study

            Xiaobo Yang, Yuan Yu, Jiqian Xu … (2020)
            Summary Background An ongoing outbreak of pneumonia associated with the severe acute respiratory coronavirus 2 (SARS-CoV-2) started in December, 2019, in Wuhan, China. Information about critically ill patients with SARS-CoV-2 infection is scarce. We aimed to describe the clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia. Methods In this single-centered, retrospective, observational study, we enrolled 52 critically ill adult patients with SARS-CoV-2 pneumonia who were admitted to the intensive care unit (ICU) of Wuhan Jin Yin-tan hospital (Wuhan, China) between late December, 2019, and Jan 26, 2020. Demographic data, symptoms, laboratory values, comorbidities, treatments, and clinical outcomes were all collected. Data were compared between survivors and non-survivors. The primary outcome was 28-day mortality, as of Feb 9, 2020. Secondary outcomes included incidence of SARS-CoV-2-related acute respiratory distress syndrome (ARDS) and the proportion of patients requiring mechanical ventilation. Findings Of 710 patients with SARS-CoV-2 pneumonia, 52 critically ill adult patients were included. The mean age of the 52 patients was 59·7 (SD 13·3) years, 35 (67%) were men, 21 (40%) had chronic illness, 51 (98%) had fever. 32 (61·5%) patients had died at 28 days, and the median duration from admission to the intensive care unit (ICU) to death was 7 (IQR 3–11) days for non-survivors. Compared with survivors, non-survivors were older (64·6 years [11·2] vs 51·9 years [12·9]), more likely to develop ARDS (26 [81%] patients vs 9 [45%] patients), and more likely to receive mechanical ventilation (30 [94%] patients vs 7 [35%] patients), either invasively or non-invasively. Most patients had organ function damage, including 35 (67%) with ARDS, 15 (29%) with acute kidney injury, 12 (23%) with cardiac injury, 15 (29%) with liver dysfunction, and one (2%) with pneumothorax. 37 (71%) patients required mechanical ventilation. Hospital-acquired infection occurred in seven (13·5%) patients. Interpretation The mortality of critically ill patients with SARS-CoV-2 pneumonia is considerable. The survival time of the non-survivors is likely to be within 1–2 weeks after ICU admission. Older patients (>65 years) with comorbidities and ARDS are at increased risk of death. The severity of SARS-CoV-2 pneumonia poses great strain on critical care resources in hospitals, especially if they are not adequately staffed or resourced. Funding None.
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              Transmission of 2019-nCoV Infection from an Asymptomatic Contact in Germany

              Camilla Rothe, Mirjam Schunk, Peter Sothmann … (2020)
              To the Editor: The novel coronavirus (2019-nCoV) from Wuhan is currently causing concern in the medical community as the virus is spreading around the world. 1 Since identification of the virus in late December 2019, the number of cases from China that have been imported into other countries is on the rise, and the epidemiologic picture is changing on a daily basis. We are reporting a case of 2019-nCoV infection acquired outside Asia in which transmission appears to have occurred during the incubation period in the index patient. A 33-year-old otherwise healthy German businessman (Patient 1) became ill with a sore throat, chills, and myalgias on January 24, 2020. The following day, a fever of 39.1°C (102.4°F) developed, along with a productive cough. By the evening of the next day, he started feeling better and went back to work on January 27. Before the onset of symptoms, he had attended meetings with a Chinese business partner at his company near Munich on January 20 and 21. The business partner, a Shanghai resident, had visited Germany between January 19 and 22. During her stay, she had been well with no signs or symptoms of infection but had become ill on her flight back to China, where she tested positive for 2019-nCoV on January 26 (index patient in Figure 1) (see Supplementary Appendix, available at NEJM.org, for details on the timeline of symptom development leading to hospitalization). On January 27, she informed the company about her illness. Contact tracing was started, and the above-mentioned colleague was sent to the Division of Infectious Diseases and Tropical Medicine in Munich for further assessment. At presentation, he was afebrile and well. He reported no previous or chronic illnesses and had no history of foreign travel within 14 days before the onset of symptoms. Two nasopharyngeal swabs and one sputum sample were obtained and were found to be positive for 2019-nCoV on quantitative reverse-transcriptase–polymerase-chain-reaction (qRT-PCR) assay. 2 Follow-up qRT-PCR assay revealed a high viral load of 108 copies per milliliter in his sputum during the following days, with the last available result on January 29. On January 28, three additional employees at the company tested positive for 2019-nCoV (Patients 2 through 4 in Figure 1). Of these patients, only Patient 2 had contact with the index patient; the other two patients had contact only with Patient 1. In accordance with the health authorities, all the patients with confirmed 2019-nCoV infection were admitted to a Munich infectious diseases unit for clinical monitoring and isolation. So far, none of the four confirmed patients show signs of severe clinical illness. This case of 2019-nCoV infection was diagnosed in Germany and transmitted outside Asia. However, it is notable that the infection appears to have been transmitted during the incubation period of the index patient, in whom the illness was brief and nonspecific. 3 The fact that asymptomatic persons are potential sources of 2019-nCoV infection may warrant a reassessment of transmission dynamics of the current outbreak. In this context, the detection of 2019-nCoV and a high sputum viral load in a convalescent patient (Patient 1) arouse concern about prolonged shedding of 2019-nCoV after recovery. Yet, the viability of 2019-nCoV detected on qRT-PCR in this patient remains to be proved by means of viral culture. Despite these concerns, all four patients who were seen in Munich have had mild cases and were hospitalized primarily for public health purposes. Since hospital capacities are limited — in particular, given the concurrent peak of the influenza season in the northern hemisphere — research is needed to determine whether such patients can be treated with appropriate guidance and oversight outside the hospital.
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                Author and article information

                Contributors
                Wu Junqi:
                ORCID: https://orcid.org/0000-0002-4134-8797
                jhwujunqi@sina.com
                Journal
                Journal ID (nlm-ta): J Clin Lab Anal
                Journal ID (iso-abbrev): J. Clin. Lab. Anal
                Journal ID (doi): 10.1002/(ISSN)1098-2825
                Journal ID (publisher-id): JCLA
                Title: Journal of Clinical Laboratory Analysis
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 0887-8013
                ISSN (Electronic): 1098-2825
                Publication date (Electronic): 16 July 2020
                Electronic Location Identifier: e23466
                Affiliations
                [ 1 ] Department of Clinical Laboratory Jinhua Municipal Central Hospital Jinhua China
                [ 2 ] Department of Central Laboratory Jinhua Municipal Central Hospital Jinhua China
                Author notes
                [*] [* ] Correspondence

                Wu Junqi, Department of Clinical Laboratory, Jinhua Municipal Central Hospital, Jinhua 321000, China.

                Email: jhwujunqi@ 123456sina.com

                Author information
                https://orcid.org/0000-0002-9090-7380
                https://orcid.org/0000-0001-7541-3801
                https://orcid.org/0000-0002-4134-8797
                Article
                Publisher ID: JCLA23466
                DOI: 10.1002/jcla.23466
                PMC ID: 7404627
                PubMed ID: 32671890
                SO-VID: 6dcff26f-f10d-458f-87a3-da470d8538c7
                Copyright © © 2020 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 31 March 2020
                Date revision received : 21 May 2020
                Date accepted : 02 June 2020
                Page count
                Figures: 1, Tables: 3, Pages: 6, Words: 7385
                Funding
                Funded by: Special scientific research project for emergency prevention and control of pneumonia of new coronavirus infections in Jinhua City (Key)
                Award ID: 2020XG‐02
                Categories
                Subject: Research Article
                Subject: Research Articles
                Custom metadata
                source-schema-version-number 2.0
                edited-state corrected-proof
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.8.6 mode:remove_FC converted:05.08.2020

                ScienceOpen disciplines: Clinical chemistry
                Keywords: antibody,covid‐19,diagnostic value,sars‐cov‐2
                Data availability:
                ScienceOpen disciplines: Clinical chemistry
                Keywords: antibody, covid‐19, diagnostic value, sars‐cov‐2

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