Regulatory status: For research use only, not for use in diagnostic procedures.

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Serum, plasma
Intended Use
This kit is used for the qualitative detection of novel coronavirus IgM antibodies in human serum or plasma in vitro.
This kit is stored at 2 ~ 8 °C, the validity period is 6 months.
Avoid freezing and use within the validity period.
Production date, valid until the label.
General Description
The new coronavirus belongs to the beta coronavirus of the genus β, which has an envelope, the particles are round or oval, often polymorphic, and the diameter is 60-140nm. Its genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. Current research shows that it has more than 85% homology with bat SARS-like coronavirus (bat-SLCoVZC45).
In vitro isolation and culture, 2019-nCoV can be found in human respiratory epithelial cells in about 96 hours, while it takes about 6 days to isolate and culture in Vero E6 and Huh-7 cell lines. Based on current epidemiological investigations, the incubation period is generally 7 days, with a maximum of 14 days. Main symptoms are fever, fatigue, and dry cough. A few patients have symptoms such as nasal congestion, runny nose, and diarrhea. In severe cases, dyspnea occurs more than a week later. In severe cases, acute respiratory distress syndrome, septic shock, difficult to correct metabolic acidosis, and coagulation dysfunction develop rapidly. It is worth noting that in the course of severe and critically ill patients, there may be moderate to low fever, even without obvious fever. Some patients showed only low fever, mild fatigue, and no pneumonia and recovered after 1 week. In the early stages of the disease, the total number of white blood cells in the peripheral blood was normal or decreased, the lymphocyte count decreased, and some patients had increased liver enzymes, muscle enzymes, and myoglobin. Most patients have elevated C-reactive protein (CRP) and erythrocyte sedimentation rate and normal procalcitonin. In severe cases, D-dimer increases and peripheral blood lymphocytes progressively decrease. New coronavirus nucleic acids can be detected in throat swabs, sputum, lower respiratory tract secretions, and blood. [1] Serum antibody testing helps confirm the infection status of a case.


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A combined approach of MALDI-TOF mass spectrometry and multivariate analysis as a potential tool for the detection of SARS-CoV-2 virus in nasopharyngeal swabs


Authors: Rocca, Maria Florencia; Zintgraff, Jonathan Cristian; Dattero, Maria Elena; Santos, Leonardo Silva; Ledesma, Martin; Vay, Carlos; Prieto, Monica; Benedetti, Estefania; Avaro, Martin; Russo, Mara; Nachtigall, Fabiane Manke; Baumeister, Elsa

Coronavirus disease 2019, known as COVID-19, is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The early, sensitive and specific detection of SARS-CoV-2 virus is widely recognized as the critical point in responding to the ongoing outbreak. Currently, the diagnosis is based on molecular real time RT-PCR techniques, although their implementation is being threatened due to the extraordinary demand for supplies worldwide. That is why the development of alternative and/or complementary tests becomes so relevant. Here, we exploit the potential of mass spectrometry technology combined with machine learning algorithms, for the detection of COVID-19 positive and negative protein profiles directly from nasopharyngeal swabs samples. According to the preliminary results obtained, accuracy = 67.66 %, sensitivity = 61.76 %, specificity = 71.72 %, and although these parameters still need to be improved to be used as a screening technique, mass spectrometrybased methods coupled with multivariate analysis showed that it is an interesting tool that deserves to be explored as a complementary diagnostic approach due to the low cost and fast performance. However, further steps, such as the analysis of a large number of samples, should be taken in consideration to determine the applicability of the method developed.

COVID-19 and the liver


Authors: Jothimani, Dinesh; Venugopal, Radhika; Abedin, Mohammed Forhad; Kaliamoorthy, Ilankumaran; Rela, Mohamed

The current coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has become a major public health crisis over the past few months. Overall case fatality rates range between 2-6%; however, the rates are higher in the elderly and those with underlying comorbidities like diabetes, hypertension and heart disease. Recent reports showed that about 2-11% of patients with COVID-19 had underlying chronic liver disease. During the previous SARS epidemic, around 60% of patients were reported to develop various degrees of liver damage. In the current pandemic, hepatic dysfunction has been seen in 14-53% of patients with COVID-19, particularly in those with severe disease. Cases of acute liver injury have been reported and are associated with higher mortality. Hepatic involvement in COVID-19 could be related to the direct cytopathic effect of the virus, an uncontrolled immune reaction, sepsis or drug-induced liver injury. The postulated mechanism of viral entry is through the host angiotensin-converting enzyme 2 (ACE2) receptors that are abundantly present in type 2 alveolar cells. Interestingly, ACE2 receptors are expressed in the gastrointestinal tract, vascular endothelium and cholangiocytes of the liver. The effects of COVID-19 on underlying chronic liver disease require detailed evaluation and, with data currently lacking, further research is warranted in this area. (C) 2020 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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