scholarly journals Clinical characteristics and antibody response to SARS-CoV-2 spike 1 protein using VITROS Anti-SARS-CoV-2 antibody tests in COVID-19 patients in Japan

2021 ◽  
Vol 70 (4) ◽  
Author(s):  
Mayu Nagura-Ikeda ◽  
Kazuo Imai ◽  
Katsumi Kubota ◽  
Sakiko Noguchi ◽  
Yutaro Kitagawa ◽  
...  

Introduction. Serological tests for COVID-19 are important in providing results for surveillance and supporting diagnosis. Investigating the serological response in COVID-19 patients with different disease severity is important for assessing the clinical utility of serological assays. Gap Statement. However, few studies have investigated the clinical utility of antibody assays for COVID-19 or differences in antibody response in association with disease severity. Aim. The study aimed to evaluate the clinical characteristics and clinical utility of VITROS SARS-CoV-2 antibody tests according to COVID-19 severity in patients in Japan. Methodology. We analysed 255 serum specimens from 130 COVID-19 patients and examined clinical records and laboratory data. Presence of total (IgA, IgM, and IgG) and specific IgG antibody for the spike 1 antigen of SARS-CoV-2 was determined using VITROS Anti-SARS-CoV-2 antibody tests. Results. Overall, 98 (75.4 %) and 32 (24.6 %) patients had mild and severe COVID-19, respectively. On admission, 76 (58.5 %) and 45 (34.6 %) patients were positive for total and IgG antibody assays. Among 91 patients at discharge, 90 (98.9 %) and 81 (89.0 %) were positive for total and IgG antibody, respectively. Clinical background and laboratory findings on admission, but not the prevalence or concentration of total or IgG antibody, were associated with disease prognosis. Total and IgG antibody intensities were significantly higher in severe cases than in mild cases in serum collected >11 days after onset, but not within 10 days. Conclusion. VITROS Anti-SARS-CoV-2 total and IgG assays will be useful as supporting diagnostic and surveillance tools and for evaluation of humoral immune response to COVID-19. Optimal prediction of disease prognosis is made from considering both clinical history and laboratory findings.

2020 ◽  
Author(s):  
Mayu Nagura-Ikeda ◽  
Kazuo Imai ◽  
Katsumi Kubota ◽  
Sakiko Noguchi ◽  
Yutaro Kitagawa ◽  
...  

Abstract Background: We evaluated clinical characteristics and the clinical utility of VITROS SARS-CoV-2 antibody tests according to COVID-19 severity in patients in Japan. Methods: We analyzed 255 serum specimens from 130 COVID-19 patients and examined clinical records and laboratory data. Presence of total (IgA, IgM, and IgG) and specific IgG antibody for the spike 1 antigen of SARS-CoV2 was determined using VITROS Anti-SARS-CoV-2 antibody tests. Findings: Overall, 98 (75.4%) and 32 (24.6%) patients had mild and severe COVID-19, respectively. On admission, 76 (58.5%) and 45 (34.6%) patients were positive for total and IgG antibody assays. Among 91 patients at discharge, 90 (98.9%) and 81 (89.0%) patients were positive for total and IgG antibody, respectively. Clinical background and laboratory findings on admission, but not the prevalence or concentration of total or IgG antibody, were associated with disease prognosis. Total and IgG antibody intensity were significantly higher in severe cases than in mild cases in serum collected after 11 days from onset, but not within 10 days. Conclusion: VITROS Anti-SARS-CoV-2 Total and IgG assays will be useful as supporting diagnostic and surveillance tools and for evaluation of humoral immune response to COVID-19. Clinical background and laboratory findings are preferable predictors of disease prognosis.


2020 ◽  
Vol 48 (9) ◽  
pp. 030006052095683
Author(s):  
Yeyu Cai ◽  
Jiayi Liu ◽  
Haitao Yang ◽  
Mian Wang ◽  
Qingping Guo ◽  
...  

Purpose To investigate associations between the clinical characteristics and incubation periods of patients infected with coronavirus disease 2019 (COVID-19) in Wuhan, China. Methods Complete clinical and epidemiological data from 149 patients with COVID-19 at a hospital in Hunan Province, China, were collected and retrospectively analyzed. Results Analysis of the distribution and receiver operator characteristic curve of incubation periods showed that 7 days was the optimal cut-off value to assess differences in disease severity between groups. Patients with shorter (≤7 days) incubation periods (n = 79) had more severe disease, longer durations of hospitalization, longer times from symptom onset to discharge, more abnormal laboratory findings, and more severe radiological findings than patients with longer (>7 days) incubation periods. Regression and correlation analyses also showed that a shorter incubation period was associated with longer times from symptom onset to discharge. Conclusion The associations between the incubation periods and clinical characteristics of COVID-19 patients suggest that the incubation period may be a useful marker of disease severity and prognosis.


2021 ◽  
Author(s):  
Lisa Florin ◽  
Karel Maelegheer ◽  
Wouter Vandewal ◽  
Dirk Bernard ◽  
Johan Robbrecht

Abstract Objective In this study, the performance of 2 commercially available SARS-CoV-2 antibody assays is evaluated. Methods The Siemens SARS-CoV-2 Total (COV2T) and IgG (COV2G) antibody tests were evaluated on a Siemens Atellica IM1300 analyzer. Imprecision was assessed with the CLSI EP15 protocol using positive controls. Ninety control group specimens were analyzed for specificity, and 175 specimens from 58 patients with polymerase chain reaction–confirmed SARS-CoV-2 were measured for the sensitivity and kinetics of the antibody response. Results Within-run and total imprecision were acceptable for both assays. Both tests showed a specificity of 100%. Sensitivity earlier in the disease state was greater for the COV2T assay than for the COV2G assay, but sensitivity >14 days after onset of symptoms approached 100% for both. For all patients, antibody titers remained above the seroconversion cutoff for all follow-up specimens. Conclusion This study shows acceptable performance for both the Siemens COV2T and COV2G test, although seroconversion occurs earlier with the COV2T test.


2021 ◽  
Author(s):  
Judith Kannenberg ◽  
Carolin Schnurra ◽  
Nina Reiners ◽  
Reinhard Henschler ◽  
Raymund Buhmann ◽  
...  

SARS-CoV-2-specific IgM antibodies wane during the first three months after infection and IgG antibody levels decline. This may limit the ability of antibody tests to identify previous SARS CoV-2 infection at later time points. To examine if the sensitivity of antibody tests falls off, we compared the sensitivity of two nucleoprotein-based antibody tests, the Roche Elecsis II Anti-SARS-CoV-2 and the Abbott SARS-CoV-2 IgG assay and three glycoprotein-based tests, the Abbott SARS-CoV-2 IgG II Quant, Siemens Atellica IM COV2T and Euroimmun SARS-CoV-2 assay with 56 sera obtained 6-8 months after SARS-CoV-2 infection. The sensitivity of the Roche, Abbott SARS-CoV-2 IgG II Quant and Siemens antibody assays was 94.6 % (95% confidence interval (CI) 85.1-98.9 %), 98.2 % (95% CI: 90.4-99.9 %) and 100 % (95% CI: 93.6-100 %). The sensitivity of the N-based Abbott SARS-CoV-2 IgG and the glycoprotein-based Euroimmun ELISA was 48.2 % (95% CI: 34.7-62.0 %) and 83.9 % (95% CI: 71.7-92.4 %). The nucleoprotein-based Roche and the glycoprotein-based Abbott RBD and Siemens tests were more sensitive than the N-based Abbott and the Euroimmun antibody tests (p=0.0001 to p=0.039). The N-based Abbott antibody test was less sensitive 6-8 months than 4-10 weeks after SARS-CoV-2 infection (p = 0.0002). The findings show that most SARS CoV-2 antibody assays correctly identified previous infection 6-8 months after infection. The sensitivity of pan-Ig antibody tests was not reduced at 6-8 months when IgM antibodies have usually disappeared. However, one of the nucleoprotein-based antibody tests significantly lost sensitivity over time.


Author(s):  
Paul Naaber ◽  
Kaidi Hunt ◽  
Jaana Pesukova ◽  
Liis Haljasmagi ◽  
Pauliina Rumm ◽  
...  

Background. High number of SARS-CoV-2 antibody tests are available in different formats, detect different types of antibodies, and use different target proteins. Sensitivity of these tests varies and could be also related to clinical symptoms and testing time. Methods. Serum samples from 97 COVID-19 patients and 100 controls were tested with 9 antibody tests (SNIBE, Epitope, Euroimmun, Roche, Abbott, DiaSorin, Biosensor, LIPS N, and LIPS S-RBD). The results were analyzed in context of clinical data. Findings. Positivity rate was of tests was following: N-LIPS test (91.8% cases), Epitope (85.6%), Abbott and in-house LIPS S-RBD (both 84.5%), Roche (83.5%), Euroimmun (82.5%), DiaSorin (81.4%), SNIBE (70.1%), and Biosensor (64.9%). Agreement between tests varied (71-95%). Correlation between patient symptoms score and antibody value was test-dependent: varied from strongest in LIPS N (rho=0.41; p<0.001) to nonsignificant (LIPS S-RBD). Testing time from symptoms influenced sensitivity in some tests more than anothers. Interpretation. Sensitivity of tests varied highly and combination of different tests may improve it. Relation of results to symptoms and testing time was test-dependent. Thus, some antibody tests seems to be more sensitive to detect antibodies early and in asymptomatic patients than others. Funding. Study was funded by SYNLAB Estonia and Estonian Research Council grant PRG377.


2021 ◽  
Author(s):  
Marc Emmenegger ◽  
Sreedhar Saseendran Kumar ◽  
Vishalini Emmenegger ◽  
Thomas Buettner ◽  
Peter Schierack ◽  
...  

Antiphospholipid antibodies (aPL), assumed to cause antiphospholipid syndrome (APS), are notorious for their heterogeneity and detect phospholipids and phospholipid-binding proteins. The persistent presence of Lupus anticoagulant and/or aPL against cardiolipin and/or β2 glycoprotein I have been shown to be independent risk factors for vascular thrombosis and pregnancy morbidity in APS. Among others, viral infections have been proposed to trigger the production of aPL while mostly being considered non-pathogenic. Yet, the potential pathogenicity of infection-associated aPL has gained momentum since an increasing number of patients infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been described with coagulation abnormalities and hyperinflammation, together with the presence of aPL. Here, we present data from a multicentric, mixed-severity study including three cohorts of individuals who contracted SARS-CoV-2 as well as non-infected blood donors. We simultaneously measured 10 different criteria and non-criteria aPL (IgM and IgG) by using a line immunoassay. Further, IgG antibody response against three SARS-CoV-2 proteins was investigated using tripartite automated blood immunoassay technology. Our analyses revealed that select non-criteria aPL are enriched concomitant to or after an infection with SARS-CoV-2. Linear mixed-effect models suggest an association of aPL to prothrombin (PT) with the strength of the antibody response against SARS-CoV-2 and further influenced by SARS-CoV-2 disease severity and sex of the individuals. In conclusion, our study is the first to report an association between disease severity, anti-SARS-CoV-2 immunoreactivity and aPL against PT in patients with SARS-CoV-2.


2021 ◽  
Vol 3 (10) ◽  
Author(s):  
Girish Chandra Dash ◽  
Debaprasad Parai ◽  
Hari Ram Choudhary ◽  
Annalisha Peter ◽  
Usha Kiran Rout ◽  
...  

Introduction. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody responses remain poorly understood and the clinical utility of serological testing is still unclear. Aim. To understand the relationship between the antibody response to SARS-CoV-2 infection and the demographics and cycle threshold (C t) values of confirmed RT-PCR patients. Methodology. A total of 384 serum samples were collected from individuals between 4–6 weeks after confirmed SARS-CoV-2 infection and tested for the development of immunoglobulin class G (IgG) against SARS-CoV-2. The C t values, age, gender and symptoms of the patients were correlated with the development of antibodies. Results. IgG positivity was found to be 80.2 % (95 % CI, 76.2–84.2). Positivity increased with a decrease in the C t value, with the highest (87.6 %) positivity observed in individuals with C t values <20. The mean (±sd) C t values for IgG positives and negatives were 23.34 (±6.09) and 26.72 (±7.031), respectively. No significant difference was found for demographic characteristics such as age and sex and symptoms and antibody response. The current study is the first of its kind wherein we have assessed the correlation of the RT-PCR C t with the development of IgG against SARS-CoV-2. Conclusion. Although C t values might not have any relation with the development of symptoms, they are associated with the antibody response among SARS-CoV-2-infected individuals.


2021 ◽  
Vol 17 (12) ◽  
pp. e1010118
Author(s):  
Marc Emmenegger ◽  
Sreedhar Saseendran Kumar ◽  
Vishalini Emmenegger ◽  
Tomas Malinauskas ◽  
Thomas Buettner ◽  
...  

Antiphospholipid antibodies (aPL), assumed to cause antiphospholipid syndrome (APS), are notorious for their heterogeneity in targeting phospholipids and phospholipid-binding proteins. The persistent presence of Lupus anticoagulant and/or aPL against cardiolipin and/or β2 glycoprotein I have been shown to be independent risk factors for vascular thrombosis and pregnancy morbidity in APS. aPL production is thought to be triggered by–among other factors–viral infections, though infection-associated aPL have mostly been considered non-pathogenic. Recently, the potential pathogenicity of infection-associated aPL has gained momentum since an increasing number of patients infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been described with coagulation abnormalities and hyperinflammation, together with the presence of aPL. Here, we present data from a multicentric, mixed-severity study including three cohorts of individuals who contracted SARS-CoV-2 as well as non-infected blood donors. We simultaneously measured 10 different criteria and non-criteria aPL (IgM and IgG) by using a line immunoassay. Further, IgG antibody response against three SARS-CoV-2 proteins was investigated using tripartite automated blood immunoassay technology. Our analyses revealed that selected non-criteria aPL were enriched concomitant to or after an infection with SARS-CoV-2. Linear mixed-effects models suggest an association of aPL with prothrombin (PT). The strength of the antibody response against SARS-CoV-2 was further influenced by SARS-CoV-2 disease severity and sex of the individuals. In conclusion, our study is the first to report an association between disease severity, anti-SARS-CoV-2 immunoreactivity, and aPL against PT in patients with SARS-CoV-2.


Diagnosis ◽  
2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Diletta Onorato ◽  
Giovanni Carpenè ◽  
Giuseppe Lippi ◽  
Mairi Pucci

AbstractThe worldwide spread of coronavirus disease 2019 (COVID-19) has generated a global health crisis and more than a million deaths so far. Epidemiological and clinical characteristics of COVID-19 are increasingly reported, along with its potential relationship with overweight and/or obesity. Therefore, we aim here to review the current scientific literature on the impact of overweight and/or obesity among hospitalized patients who have developed severe or critical forms of COVID-19. Following PRISMA guidelines, our literature search identified over 300 scientific articles using the keywords “obesity” and “COVID-19”, 22 of which were finally selected for reporting useful information on the association between overweight/obesity and disease severity. In particular, in 11 out of the 14 studies (79%) which evaluated the association between obesity and disease severity providing also a risk estimate (i.e., the odd ratio; OR), the OR value was constantly >2. Although the studies were found to be heterogeneous in terms of design, population, sample size and endpoints, in most cases a significant association was found between obesity and the risk of progressing to severe COVID-19 illness, intensive care unit admission and/or death. We can hence conclude that an increased body mass index shall be considered a negative prognostic factor in patients with COVID-19, and more aggressive prevention or treatment shall hence be reserved to overweight and/or obese patients.


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