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1.
Trials ; 21(1): 828, 2020 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-33023671

RESUMO

OBJECTIVES: Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. • To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge. TRIAL DESIGN: Randomised, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent plasma or standard of care. PARTICIPANTS: High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorised in 4 groups: • Group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. • Group 2, chronic immunosuppression not meeting the criteria of group 1. • Group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1µg/mL. • Group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2. Observation time for all patients is expected to be at least 3 months after entry into the study. Patients receive convalescent plasma for two days (day 1 and day 2) or standard of care. For patients in the standard arm, cross over is allowed from day 10 in case of not improving or worsening clinical condition. Nose/throat swabs for determination of viral load are collected at day 0 and day 1 (before first CP administration) and subsequently at day 2, 3, 5, 7, 10, 14, 28 or until discharge. Serum for SARS-Cov-2 diagnostic is collected at baseline and subsequently at day 3, 7, 14 and once during the follow-up period (between day 35 and day 84). There is a regular follow-up of 3 months. All discharged patients are followed by regular phone calls. All visits, time points and study assessments are summarized in the Trial Schedule (see full protocol Table 1). All participating trial sites will be supplied with study specific visit worksheets that list all assessments and procedures to be completed at each visit. All findings including clinical and laboratory data are documented by the investigator or an authorized member of the study team in the patient's medical record and in the electronic case report forms (eCRFs). INTERVENTION AND COMPARATOR: This trial will analyze the effects of convalescent plasma from recovered subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection. Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment. In addition, eligible patients have a confirmed SARS-CoV-2 infection and O2 saturation ≤ 94% while breathing ambient air. Patients are randomised to receive (experimental arm) or not receive (standard arm) convalescent plasma in two bags (238 - 337 ml plasma each) from different donors (day 1, day 2). A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition. MAIN OUTCOMES: Primary endpoints: The main purpose of the study is to assess the time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of a SARS-CoV-2 infection or standard of care. Secondary endpoints: • Overall survival, defined as the time from randomisation until death from any cause 28-day, 56-day and 84-day overall survival rates. • SARS-CoV-2 viral clearance and load as well as antibody titres. • Requirement mechanical ventilation at any time during hospital stay (yes/no). • Time until discharge from randomisation. • Viral load, changes in antibody titers and cytokine profiles are analysed in an exploratory manner using paired non-parametric tests (before - after treatment). RANDOMISATION: Upon confirmation of eligibility (patients must meet all inclusion criteria and must not meet exclusion criteria described in section 5.3 and 5.4 of the full protocol), the clinical site must contact a centralized internet randomization system ( https://randomizer.at/ ). Patients are randomized using block randomisation to one of the two arms, experimental arm or standard arm, in a 1:1 ratio considering a stratification according to the 4 risk groups (see Participants). BLINDING (MASKING): The study is open-label, no blinding will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total number of 174 patients is required for the entire trial, n=87 per group. TRIAL STATUS: Protocol version 1.2 dated 09/07/2020. A recruitment period of approximately 9 months and an overall study duration of approximately 12 months is anticipated. Recruitment of patients starts in the third quarter of 2020. The study duration of an individual patient is planned to be 3 months. After finishing all study-relevant procedures, therapy, and follow-up period, the patient is followed in terms of routine care and treated if necessary. Total trial duration: 18 months Duration of the clinical phase: 12 months First patient first visit (FPFV): 3rd Quarter 2020 Last patient first visit (LPFV): 2nd Quarter 2021 Last patient last visit (LPLV): 3rd Quarter 2021 Trial Report completed: 4th Quarter 2021 TRIAL REGISTRATION: EudraCT Number: 2020-001632-10, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE , registered on 04/04/2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). The eCRF is attached (Additional file 3).


Assuntos
Anticorpos Antivirais/sangue , Betacoronavirus , Infecções por Coronavirus , Pandemias , Plasma/imunologia , Pneumonia Viral , Idoso , Betacoronavirus/imunologia , Betacoronavirus/isolamento & purificação , Ensaios Clínicos Fase II como Assunto , Convalescença , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/terapia , Feminino , Humanos , Imunização Passiva/métodos , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Estudos Multicêntricos como Assunto , Pneumonia Viral/diagnóstico , Pneumonia Viral/imunologia , Pneumonia Viral/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco Ajustado , Índice de Gravidade de Doença
2.
PLoS Med ; 17(10): e1003358, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33001967

RESUMO

BACKGROUND: Loss of smell and taste are commonly reported symptoms associated with coronavirus disease 2019 (COVID-19); however, the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in people with acute loss of smell and/or taste is unknown. The study aimed to determine the seroprevalence of SARS-CoV-2 antibodies in a community-based population with acute loss of smell and/or taste and to compare the frequency of COVID-19 associated symptoms in participants with and without SARS-CoV-2 antibodies. It also evaluated whether smell or taste loss are indicative of COVID-19 infection. METHODS AND FINDINGS: Text messages, sent via primary care centers in London, United Kingdom, invited people with loss of smell and/or taste in the preceding month, to participate. Recruitment took place between 23 April 2020 and 14 May 2020. A total of 590 participants enrolled via a web-based platform and responded to questions about loss of smell and taste and other COVID-19-related symptoms. Mean age was 39.4 years (SD ± 12.0) and 69.1% (n = 392) of participants were female. A total of 567 (96.1%) had a telemedicine consultation during which their COVID-19-related symptoms were verified and a lateral flow immunoassay test that detected SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies was undertaken under medical supervision. A total of 77.6% of 567 participants with acute smell and/or taste loss had SARS-CoV-2 antibodies; of these, 39.8% (n = 175) had neither cough nor fever. New loss of smell was more prevalent in participants with SARS-CoV-2 antibodies, compared with those without antibodies (93.4% versus 78.7%, p < 0.001), whereas taste loss was equally prevalent (90.2% versus 89.0%, p = 0.738). Seropositivity for SARS-CoV-2 was 3 times more likely in participants with smell loss (OR 2.86; 95% CI 1.27-6.36; p < 0.001) compared with those with taste loss. The limitations of this study are the lack of a general population control group, the self-reported nature of the smell and taste changes, and the fact our methodology does not take into account the possibility that a population subset may not seroconvert to develop SARS-CoV-2 antibodies post-COVID-19. CONCLUSIONS: Our findings suggest that recent loss of smell is a highly specific COVID-19 symptom and should be considered more generally in guiding case isolation, testing, and treatment of COVID-19. TRIALS REGISTRATION: ClinicalTrials.gov NCT04377815.


Assuntos
Anticorpos Antivirais/sangue , Infecções por Coronavirus/complicações , Transtornos do Olfato/virologia , Pneumonia Viral/complicações , Distúrbios do Paladar/virologia , Adulto , Betacoronavirus , Técnicas de Laboratório Clínico , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/imunologia , Feminino , Humanos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Londres , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/imunologia , Testes Imediatos , Soroconversão , Estudos Soroepidemiológicos , Envio de Mensagens de Texto
4.
Artigo em Inglês | MEDLINE | ID: mdl-33014893

RESUMO

Objective: To explore the diagnostic value of serum severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid (N) protein assay in the early stages of SARS-COV-2 infection. Methods: Serum N protein level in SARS-COV-2 infected patients and non-SARS-COV-2 infected population was measured by enzyme-linked immunosorbent assay (ELISA) double antibody sandwich assay. Colloidal gold immunochromatography assay was used to detect serum N protein antibodies in the above populations. Results: Fifty cases of SARS-CoV-2 nucleic acid-positive and SARS-CoV-2 antibody-negative patients had a serum N protein positivity rate of 76%. Thirty-seven patients who were positive for serum SARS-CoV-2 antibody after infection had a serum SARS-CoV-2 N protein positivity rate of 2.7%. Serum N protein test results of 633 non-SARS-COV-2 infected patients, including pregnant women, patients with other respiratory infections, and individuals with increased rheumatoid factor were all negative, with serum N protein concentration <10.00 pg/mL at 100% specificity. Using SPSS 19.0 to calculate the receiver operating characteristic curve, the area under the curve was determined to be 0.9756 (95% confidence interval 0.9485-1.000, p < 0.0001), and sensitivity and specificity were 92% (95% confidence interval 81.16-96.85%) and 96.84% (95% confidence interval 95.17-97.15%), respectively. The best CUT-OFF value was 1.850 pg/mL. Conclusion: The measurement of serum SARS-COV-2 N protein has a high diagnostic value for infected patients before the antibody appears and shortens the window period of serological diagnosis. It is recommended that the manufacturer establish two different CUT-OFF values according to the purpose of the application. One CUT-OFF value is used for the diagnosis of clinical SARS-COV-2 infection, and the other is used to screen out as many suspected cases as possible.


Assuntos
Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Proteínas do Nucleocapsídeo/sangue , Pneumonia Viral/diagnóstico , Anticorpos Antivirais/sangue , Betacoronavirus/isolamento & purificação , Biomarcadores/sangue , Infecções por Coronavirus/sangue , Ensaio de Imunoadsorção Enzimática/métodos , Feminino , Humanos , Masculino , Pandemias , Pneumonia Viral/sangue , Gravidez , Sensibilidade e Especificidade
5.
G Ital Nefrol ; 37(5)2020 Oct 05.
Artigo em Italiano | MEDLINE | ID: mdl-33026198

RESUMO

We report the brief experience of the Nephrology Center located in a "no-COVID" Hospital in Massa Marittima. We describe the actions taken to prevent the transmission of the virus SARS-CoV-2 among hemodialysis patients and healthcare workers and the methods for diagnosing COVID-19, with particular attention to serological tests and nasopharyngeal swabs in asymptomatic subjects. The detection of IgM and IgG antibodies through the serological test performed on 34 patients, all negative for nasopharyngeal swabs, showed positivity in 41,18% of cases. These have been classified as false positives following repeated negative nasopharyngeal swabs, the evaluation of clinical and epidemiological history and of clinical manifestations and, finally, a second serological test performed after 18 days, which resulted negative for all patients. Interpreting serological tests is not easy; the strategies for diagnosis should include clinical and epidemiological history and clinical manifestations, as well as the results of confirmation tests and the evaluation over a precise observation period. Otherwise, there is a risk of considering as protected by antibodies subjects that are in fact false positives.


Assuntos
Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Técnicas de Laboratório Clínico , Infecções por Coronavirus/diagnóstico , Unidades Hospitalares de Hemodiálise/estatística & dados numéricos , Pandemias , Pneumonia Viral/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças Assintomáticas , Betacoronavirus/isolamento & purificação , Reações Falso-Positivas , Feminino , Humanos , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Imunoglobulina M/sangue , Imunoglobulina M/imunologia , Itália , Masculino , Pessoa de Meia-Idade , Nasofaringe/virologia , Guias de Prática Clínica como Assunto , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade
6.
G Ital Nefrol ; 37(5)2020 Oct 05.
Artigo em Italiano | MEDLINE | ID: mdl-33026199

RESUMO

Lombardy was violently hit by Covid-19 between the end of February and the beginning of March 2020. On 09.05.2020 there were 81225 total registered Covid-19+ cases (8051 / million inhabitants) with 14924 deaths (1479 deaths / million inhabitants). The province of Cremona presented a higher number of Covid-19+ cases and a worse relative mortality than the already high regional average. Patients on regular hemodialysis treatment present a high risk of infection due to the co-pathologies present, while healthcare workers may represent a risk for themselves and for the patients, due to the treatment environment and the close contact with them. All patients and healthcare workers of the Dialysis Center in Crema were evaluated (oro-pharyngeal swab for viral RNA research, qualitative anti-Covid-19 antibodies, quantitative IgG antibodies, co-pathologies), regardless of the symptomatology, over a 60-day period. Hemodialysis patients have a risk of infection that is 12.7 times that of the local population, while healthcare workers outperform the patients for Covid-positivity (30.3% vs 21.6%). Lethality in infected patients is high (31% of Covid-19+ subjects), while it is zero among healthcare professionals. The antibody response (qualitative and quantitative) in Covid-19+ patients is adequate, when compared to that of Covid-19+ healthcare staff. In our Center, the most critical phase lasted about 45 days but, thanks to the measures taken, it was possible to make the dialysis area Covid-free, as it remains after 128 days.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Falência Renal Crônica/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Diálise Renal , Adulto , Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Betacoronavirus/isolamento & purificação , Técnicas de Laboratório Clínico , Comorbidade , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/prevenção & controle , Infecção Hospitalar/prevenção & controle , Emergências , Feminino , Pessoal de Saúde , Unidades Hospitalares de Hemodiálise/estatística & dados numéricos , Humanos , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Transmissão de Doença Infecciosa do Profissional para o Paciente/prevenção & controle , Itália/epidemiologia , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Orofaringe/virologia , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Risco , Taxa de Sobrevida
7.
G Ital Nefrol ; 37(5)2020 Oct 05.
Artigo em Italiano | MEDLINE | ID: mdl-33026203

RESUMO

We report the case of a 93-year-old woman on haemodialysis treatment for more than 30 months and with multiple comorbidities who recovered from a Covid-19 infection without any significant clinical problems. The patient has shown a delay in viral clearance with swab test negativization (confirmed) after 33 days; after testing positive again, she has resulted persistently negative, (confirmed after 49 days). After the first negative swab, IgG and IgM antibodies have been found; these have remained persistently positive after a month. As well as highlighting an unexpected resilience in an extremely fragile context, the analysis of this case draws attention to patients' management and, potentially, to the need to arrange dialysis treatments in isolation for some time after their "laboratory recovery".


Assuntos
Betacoronavirus , Infecções por Coronavirus/complicações , Pandemias , Pneumonia Viral/complicações , Diálise Renal , Sobreviventes , Idoso de 80 Anos ou mais , Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Betacoronavirus/isolamento & purificação , Calcitriol/uso terapêutico , Técnicas de Laboratório Clínico , Comorbidade , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Quimioterapia Combinada , Feminino , Heparina/uso terapêutico , Humanos , Hidroxicloroquina/uso terapêutico , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Nasofaringe/virologia , Inibidores da Agregação de Plaquetas/uso terapêutico , Pneumonia Viral/diagnóstico , Pneumonia Viral/tratamento farmacológico , Fatores de Tempo
8.
IEEE Pulse ; 11(5): 28-31, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33064642

RESUMO

An at-home test for coronavirus disease 2019 (COVID-19) could be released commercially as early as August, according to Scanwell Health of Los Angeles. A combination of a finger-prick blood sample and a smart-phone app, the test is designed to detect the presence of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The company hopes to receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) by the end of summer, and make its first commercially available tests soon after.


Assuntos
Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Pneumonia Viral/diagnóstico , Técnicas de Laboratório Clínico/instrumentação , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/imunologia , Humanos , Aplicativos Móveis , Pandemias , Participação do Paciente/métodos , Pneumonia Viral/epidemiologia , Pneumonia Viral/imunologia , Estados Unidos/epidemiologia
9.
Biochem Med (Zagreb) ; 30(3): 030901, 2020 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-33071558

RESUMO

Introduction: The 2019 Coronavirus disease (COVID-19) has been characterized as a pandemic, representing a serious global public health emergency. Serological tests have been proposed as reliable tools for detecting Coronavirus SARS-CoV-2 antibodies in infected patients, especially for surveillance or epidemiological purposes. The aim of this study is to evaluate the agreement between the IgM/IgG rapid assays, based on lateral flow immunochromatographic assay, and the fully automated 2019-nCoV IgM and IgG, based on chemiluminescence immunoassay. Materials and methods: SARS-CoV-2 antibodies were measured with the BIOSYNEX COVID-19 BSS IgM/IgG test (BIOSYNEX, Illkirch-Graffenstaden, France) and the MAGLUMI CLIA (IgM and IgG) (SNIBE - Shenzhen New Industries Biomedical Engineering, Shenzhen, China) in 70 serum samples from patients with PCR-confirmed diagnosis. The strength of the agreement of the two methods was calculated by using the Cohen Kappa index. Results: The results showed a good grade of concordance between the two immunoassays with a Cohen's kappa coefficient of 0.71 (95%CI: 0.54-0.87) for IgG SARS-CoV-2 antibodies and 0.70 (95%CI: 0.53-0.87) for IgM SARS-CoV-2 antibodies. In addition, the rapid assays BIOSYNEX COVID-19 BSS for detecting SARS-CoV-2 antibodies showed a positive likelihood ratio (LR) of 10.63 (95%CI: 2.79-40.57) for IgG and a LR of 6.79 (95%CI: 2.93-15.69) for IgM. Conclusion: Our results suggest that the immunochromatographic rapid IgM/IgG test and the chemiluminescence IgM and IgG immunoassay have a good degree of concordance, suggesting that both could be considered as useful tools for epidemiologic surveillance.


Assuntos
Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Pandemias , Pneumonia Viral/diagnóstico , Idoso , Feminino , Humanos , Imunoensaio , Medições Luminescentes , Masculino , Pessoa de Meia-Idade , Vigilância da População , Reprodutibilidade dos Testes
10.
J Hematol Oncol ; 13(1): 131, 2020 10 02.
Artigo em Inglês | MEDLINE | ID: mdl-33008453

RESUMO

SARS-CoV-2 has infected millions of people worldwide, but little is known at this time about second infections or reactivation. Here, we report a case of a 55-year-old female undergoing treatment for CD20+ B cell acute lymphoblastic leukemia who experienced a viral reactivation after receiving rituximab, cytarabine, and dasatinib. She was initially hospitalized with COVID-19 in April and developed a high antibody titer with two negative nasal polymerase chain reaction (PCR) swabs for SARS-CoV-2 on discharge. After recovery, she resumed treatment in June for her leukemia, which included rituximab, cytarabine, and dasatinib. She promptly lost her COVID-19 antibodies, and her nasal PCR turned positive in June. She developed a severe COVID-19 pneumonia with lymphopenia, high inflammatory markers, and characteristic bilateral ground-glass opacities on chest CT, requiring high-flow nasal cannula and transfer to the intensive care unit. She received steroids, anticoagulation, and convalescent plasma, and within 48 h she was off oxygen. She was discharged home in stable condition several days later. Given the short time frame from leukemia treatment to PCR positivity and the low case rate in mid-June in New York City, reinfection appears to have been unlikely and SARS-CoV-2 reactivation is a possible explanation. This case illustrates the risks of treating recently recovered COVID-19 patients with immunosuppressive therapy, particularly lymphocyte- and antibody-depleting therapy, and raises new questions about the potential of SARS-CoV-2 reactivation.


Assuntos
Betacoronavirus/genética , Infecções por Coronavirus/imunologia , Citarabina/uso terapêutico , Imunossupressores/uso terapêutico , Pneumonia Viral/imunologia , Leucemia-Linfoma Linfoblástico de Células Precursoras B/tratamento farmacológico , Rituximab/uso terapêutico , Doença Aguda , Anticorpos Antivirais/sangue , Anticorpos Antivirais/imunologia , Anticoagulantes/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/terapia , Infecções por Coronavirus/virologia , Citarabina/efeitos adversos , Feminino , Humanos , Imunização Passiva , Imunossupressores/efeitos adversos , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/virologia , Reação em Cadeia da Polimerase , Recidiva , Rituximab/efeitos adversos , Esteroides/uso terapêutico , Resultado do Tratamento
11.
PLoS One ; 15(10): e0240502, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33035234

RESUMO

BACKGROUND: A greater understanding of the antibody response to SARS-CoV-2 in an infected population is important for the development of a vaccination. AIM: To investigate SARS-CoV-2 IgA and IgG antibodies in Thai patients with differing severities of COVID-19. METHODS: Plasma from the following patient groups was examined: 118 adult patients with confirmed SARS-CoV-2 infections, 49 patients under investigation (without confirmed infections), 20 patients with other respiratory infections, and 102 healthy control patients. Anti-SARS-CoV-2 enzyme-linked immunosorbent assay (ELISA) from EUROIMMUN was performed to assess for IgA and IgG antibodies. The optical density (OD) ratio cutoff for a positive result was 1.1 for IgA and 0.8 for IgG. Additionally, the association of the antibody response with both the severity of disease and the date after onset of symptoms was analyzed. RESULTS: A total of 289 participants were enrolled and 384 samples analyzed from March 10 to May 31, 2020. Patients were categorized, based on their clinical manifestations, as mild (n = 59), moderate (n = 27), or severe (n = 32). The overall sensitivity of IgA and IgG from the samples collected after day 7 of the symptoms was 87.9% (95% CI: 79.8-93.6) and 84.8% (95% CI: 76.2-91.3), respectively. Compared to the mild group, the severe group had significantly higher levels of spike 1 (S1) antigen-specific IgA and IgG. All patients in the moderate and severe groups had S1-specific IgG, while 20% of the patients in the mild group did not have any IgG detected after two weeks after the onset of symptoms. Interestingly, in the severe group, the SARS-CoV-2 IgG level was significantly higher in males than females (p = 0.003). CONCLUSION: The serological test for SARS-CoV-2 has a high sensitivity more than two weeks after the onset of illness. Additionally, the serological response differs among patients based on sex as well as the severity of infection.


Assuntos
Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Infecções por Coronavirus/patologia , Pneumonia Viral/patologia , Adulto , Idoso , Formação de Anticorpos , Betacoronavirus/genética , Betacoronavirus/isolamento & purificação , Estudos de Casos e Controles , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/virologia , Ensaio de Imunoadsorção Enzimática , Feminino , Humanos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/imunologia , Pneumonia Viral/virologia , RNA Viral/genética , RNA Viral/metabolismo , Reação em Cadeia da Polimerase em Tempo Real , Índice de Gravidade de Doença , Fatores Sexuais , Glicoproteína da Espícula de Coronavírus/imunologia
13.
BMC Infect Dis ; 20(1): 749, 2020 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-33050892

RESUMO

BACKGROUND: Two months after the outbreak of coronavirus disease 2019 (COVID-19) in Wuhan, China, tens of thousands of hospitalized patients had recovered, and little is known about the follow-up of the recovered patients. METHODS: The clinical characteristics, reverse transcriptase-polymerase chain reaction (RT-PCR) results from throat swab specimens and the results of serological COVID-19 rapid diagnostic test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were retrospectively reviewed for a total of 758 recovered patients who were previously hospitalized in 17 hospitals and quarantined at 32 rehabilitation stations in Wuhan, China. RESULTS: In total, 59 patients (7.78%) had recurrent positive findings for COVID-19 on RT-PCR from throat swabs. With regard to antibody detection, 50/59 (84.75%) and 4/59 (6.78%) patients had positive IgG or dual positive IgG/IgM RDT results, respectively. CONCLUSIONS: Some patients who had been quarantined and had subsequently recovered from COVID-19 had recurrent positive RT-PCR results for SARS-CoV-2, and the possibility of transmission of the virus by recovered patients needs further investigation. TRIAL REGISTRATION: Current Controlled Trials ChiCTR2000033580 , Jun 6th 2020. Retrospectively registered.


Assuntos
Betacoronavirus/genética , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Reação em Cadeia da Polimerase Via Transcriptase Reversa/métodos , Síndrome Respiratória Aguda Grave/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Antivirais/sangue , Criança , China/epidemiologia , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/fisiopatologia , Infecções por Coronavirus/transmissão , Infecções por Coronavirus/virologia , Feminino , Seguimentos , Humanos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/fisiopatologia , Pneumonia Viral/transmissão , Pneumonia Viral/virologia , Estudos Retrospectivos , Fatores de Risco , Síndrome Respiratória Aguda Grave/fisiopatologia , Síndrome Respiratória Aguda Grave/virologia , Adulto Jovem
14.
Biosens Bioelectron ; 169: 112643, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33007615

RESUMO

Detection of antibodies to upper respiratory pathogens is critical to surveillance, assessment of the immune status of individuals, vaccine development, and basic biology. The urgent need for antibody detection tools has proven particularly acute in the COVID-19 era. We report a multiplex label-free antigen microarray on the Arrayed Imaging Reflectometry (AIR) platform for detection of antibodies to SARS-CoV-2, SARS-CoV-1, MERS, three circulating coronavirus strains (HKU1, 229E, OC43) and three strains of influenza. We find that the array is readily able to distinguish uninfected from convalescent COVID-19 subjects, and provides quantitative information about total Ig, as well as IgG- and IgM-specific responses.


Assuntos
Anticorpos Antivirais/sangue , Infecções por Coronavirus/sangue , Coronavirus/isolamento & purificação , Vírus da Influenza A/isolamento & purificação , Influenza Humana/sangue , Pneumonia Viral/sangue , Betacoronavirus/isolamento & purificação , Técnicas Biossensoriais/instrumentação , Técnicas Biossensoriais/métodos , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/virologia , Desenho de Equipamento , Células HEK293 , Humanos , Influenza Humana/diagnóstico , Influenza Humana/virologia , Coronavírus da Síndrome Respiratória do Oriente Médio/isolamento & purificação , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/virologia , Análise Serial de Proteínas/instrumentação , Análise Serial de Proteínas/métodos , Vírus da SARS/isolamento & purificação , Sensibilidade e Especificidade
15.
Epidemiol Infect ; 148: e214, 2020 09 18.
Artigo em Inglês | MEDLINE | ID: mdl-32943130

RESUMO

In March 2020, China had periodically controlled the coronavirus disease-19 (COVID-19) epidemic. We reported the results of health screening for COVID-19 among returned staff of a hospital and conducted a summary analysis to provide valuable experience for curbing the COVID-19 epidemic and rebound. In total, 4729 returned staff from Zhongnan Hospital of Wuhan University, Wuhan, China were examined for COVID-19, and the basic information, radiology and laboratory test results were obtained and systematically analysed. Among the 4729 employees, medical staff (62.93%) and rear-service personnel (30.73%) were the majority. The results of the first physical examination showed that 4557 (96.36%) were normal, 172 (3.64%) had abnormal radiological or laboratory test results. After reexamination and evaluation, four were at high risk (asymptomatic infections) and were scheduled to transfer to a designated hospital, and three were at low risk (infectivity could not be determined) and were scheduled for home isolation observation. Close contacts were tracked and managed by the Center for Disease Control and Prevention (CDC) in China. Asymptomatic infections are a major risk factor for returning to work. Extensive health screening combined with multiple detection methods helps to identify asymptomatic infections early, which is an important guarantee in the process of returning to work.


Assuntos
Infecções Assintomáticas/epidemiologia , Infecções por Coronavirus/diagnóstico , Recursos Humanos em Hospital/estatística & dados numéricos , Pneumonia Viral/diagnóstico , Retorno ao Trabalho , Adolescente , Adulto , Anticorpos Antivirais/sangue , Betacoronavirus , China/epidemiologia , Técnicas de Laboratório Clínico , Feminino , Hospitais , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Fatores de Risco , Adulto Jovem
17.
Emerg Microbes Infect ; 9(1): 2157-2168, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32940547

RESUMO

This multicenter, retrospective study included 346 serum samples from 74 patients with coronavirus disease 2019 (COVID-19) and 194 serum samples from non-COVID-19 patients to evaluate the performance of five anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests, i.e. two chemiluminescence immunoassays (CLIAs): Roche Elecsys® Anti-SARS-CoV-2 Test (Roche Test) and Abbott SARS-CoV-2 IgG (Abbott Test), and three lateral flow immunoassays (LFIAs): Wondfo SARS-CoV-2 Antibody Test (Wondfo Test), ASK COVID-19 IgG/IgM Rapid Test (ASK Test), and Dynamiker 2019-nCoV IgG/IgM Rapid Test (Dynamiker Test). We found high diagnostic sensitivities (%, 95% confidence interval [CI]) for the Roche Test (97.4%, 93.4-99.0%), Abbott Test (94.0%, 89.1-96.8%), Wondfo Test (91.4%, 85.8-94.9%), ASK Test (97.4%, 93.4-99.0%), and Dynamiker Test (90.1%, 84.3-94.0%) after >21 days of symptom onset. Meanwhile, the diagnostic specificity was 99.0% (95% CI, 96.3-99.7%) for the Roche Test, 97.9% (95% CI, 94.8-99.2%) for the Abbott Test, and 100.0% (95% CI, 98.1-100.0%) for the three LFIAs. Cross-reactivity was observed in sera containing anti-cytomegalovirus (CMV) IgG/IgM antibodies and autoantibodies. No difference was observed in the time to seroconversion detection of the five serological tests. Specimens from patients with COVID-19 pneumonia demonstrated a shorter seroconversion time and higher chemiluminescent signal than those without pneumonia. Our data suggested that understanding the dynamic antibody response after COVID-19 infection and performance characteristics of different serological test are crucial for the appropriate interpretation of serological test result for the diagnosis and risk assessment of patient with COVID-19 infection.


Assuntos
Anticorpos Antivirais/imunologia , Betacoronavirus/imunologia , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/imunologia , Imunoensaio/métodos , Medições Luminescentes/métodos , Pneumonia Viral/diagnóstico , Pneumonia Viral/imunologia , Adulto , Idoso , Anticorpos Antivirais/sangue , Betacoronavirus/genética , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Reações Cruzadas/imunologia , Feminino , Humanos , Imunoensaio/normas , Medições Luminescentes/normas , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Reprodutibilidade dos Testes , Soroconversão , Testes Sorológicos , Índice de Gravidade de Doença , Taiwan/epidemiologia
18.
Cell Mol Immunol ; 17(10): 1098-1100, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32939033
20.
Emerg Microbes Infect ; 9(1): 2013-2019, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32867625

RESUMO

COVID-19 is a new respiratory illness caused by SARS-CoV-2, and has constituted a global public health emergency. Cat is susceptible to SARS-CoV-2. However, the prevalence of SARS-CoV-2 in cats remains largely unknown. Here, we investigated the infection of SARS-CoV-2 in cats during COVID-19 outbreak in Wuhan by serological detection methods. A cohort of serum samples were collected from cats in Wuhan, including 102 sampled after COVID-19 outbreak, and 39 prior to the outbreak. Fifteen sera collected after the outbreak were positive for the receptor binding domain (RBD) of SARS-CoV-2 by indirect enzyme linked immunosorbent assay (ELISA). Among them, 11 had SARS-CoV-2 neutralizing antibodies with a titer ranging from 1/20 to 1/1080. No serological cross-reactivity was detected between SARS-CoV-2 and type I or II feline infectious peritonitis virus (FIPV). In addition, we continuously monitored serum antibody dynamics of two positive cats every 10 days over 130 days. Their serum antibodies reached the peak at 10 days after first sampling, and declined to the limit of detection within 110 days. Our data demonstrated that SARS-CoV-2 has infected cats in Wuhan during the outbreak and described serum antibody dynamics in cats, providing an important reference for clinical treatment and prevention of COVID-19.


Assuntos
Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Infecções por Coronavirus/veterinária , Pandemias/veterinária , Pneumonia Viral/veterinária , Animais , Gatos , China , Infecções por Coronavirus/epidemiologia , Coronavirus Felino/imunologia , Reações Cruzadas/imunologia , Ensaio de Imunoadsorção Enzimática/métodos , Imunoglobulina G/sangue , Proteínas do Nucleocapsídeo/imunologia , Pneumonia Viral/epidemiologia , Glicoproteína da Espícula de Coronavírus/imunologia
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