scholarly journals Independent side-by-side validation and comparison of four serological platforms for SARS-CoV-2 antibody testing

Author(s):  
Bernd Jahrsdörfer ◽  
Joris Kroschel ◽  
Carolin Ludwig ◽  
Victor Max Corman ◽  
Tatjana Schwarz ◽  
...  

Abstract Highly sensitive and specific platforms for the detection of anti-SARS-CoV-2 antibodies are becoming increasingly important for (1) evaluating potential SARS-CoV-2 convalescent plasma donors, (2) studying the spread of SARS-CoV-2 infections and (3) identifying individuals with seroconversion. This study provides a comparative validation of four anti-SARS-CoV-2 platforms. Unique feature of this study is the use of a representative cohort of COVID-19-convalescent patients with mild-to-moderate disease course. All platforms showed significant correlations with a SARS-CoV-2 plaque-reduction-neutralization test, with highest sensitivities for the Euroimmun and the Roche platforms, suggesting their preferential use for screening of persons at increased risk of SARS-CoV-2 infections.

Transfusion ◽  
2021 ◽  
Author(s):  
Steven J. Drews ◽  
Dana V. Devine ◽  
Janet McManus ◽  
Emelissa Mendoza ◽  
Kathy Manguiat ◽  
...  

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hitoshi Kawasuji ◽  
Yoshitomo Morinaga ◽  
Hideki Tani ◽  
Miyuki Kimura ◽  
Hiroshi Yamada ◽  
...  

AbstractAdaptive immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) dynamics remain largely unknown. The neutralizing antibody (NAb) levels in patients with coronavirus disease 2019 (COVID-19) are helpful for understanding the pathology. Using SARS-CoV-2 pseudotyped virus, serum sample neutralization values in symptomatic COVID-19 patients were measured using the chemiluminescence reduction neutralization test (CRNT). At least two sequential serum samples collected during hospitalization were analyzed to assess NAbs neutralizing activity dynamics at different time points. Of the 11 patients, four (36.4%), six (54.5%), and one (9.1%) had moderate, severe, and critical disease, respectively. Fifty percent neutralization (N50%-CRNT) was observed upon admission in 90.9% (10/11); all patients acquired neutralizing activity 2–12 days after onset. In patients with moderate disease, neutralization was observed at earliest within two days after symptom onset. In patients with severe-to-critical disease, neutralization activity increased, plateauing 9–16 days after onset. Neutralization activity on admission was significantly higher in patients with moderate disease than in patients with severe-to-critical disease (relative % of infectivity, 6.4% vs. 41.1%; P = .011). Neutralization activity on admission inversely correlated with disease severity. The rapid NAb response may play a crucial role in preventing the progression of COVID-19.


2014 ◽  
Vol 52 (5) ◽  
pp. 435-440 ◽  
Author(s):  
Hee-Jung Lee ◽  
Kyung-Il Min ◽  
Ki Hoon Park ◽  
Hyo Jung Choi ◽  
Min-Kyoung Kim ◽  
...  

2014 ◽  
Vol 21 (11) ◽  
pp. 1581-1588 ◽  
Author(s):  
Piotr Kardas ◽  
Mohammadreza Sadeghi ◽  
Fabian H. Weissbach ◽  
Tingting Chen ◽  
Lea Hedman ◽  
...  

ABSTRACTJC polyomavirus (JCPyV) can cause progressive multifocal leukoencephalopathy (PML), a debilitating, often fatal brain disease in immunocompromised patients. JCPyV-seropositive multiple sclerosis (MS) patients treated with natalizumab have a 2- to 10-fold increased risk of developing PML. Therefore, JCPyV serology has been recommended for PML risk stratification. However, different antibody tests may not be equivalent. To study intra- and interlaboratory variability, sera from 398 healthy blood donors were compared in 4 independent enzyme-linked immunoassay (ELISA) measurements generating >1,592 data points. Three data sets (Basel1, Basel2, and Basel3) used the same basic protocol but different JCPyV virus-like particle (VLP) preparations and introduced normalization to a reference serum. The data sets were also compared with an independent method using biotinylated VLPs (Helsinki1). VLP preadsorption reducing ≥35% activity was used to identify seropositive sera. The results indicated that Basel1, Basel2, Basel3, and Helsinki1 were similar regarding overall data distribution (P= 0.79) and seroprevalence (58.0, 54.5, 54.8, and 53.5%, respectively;P= 0.95). However, intra-assay intralaboratory comparison yielded 3.7% to 12% discordant results, most of which were close to the cutoff (0.080 < optical density [OD] < 0.250) according to Bland-Altman analysis. Introduction of normalization improved overall performance and reduced discordance. The interlaboratory interassay comparison between Basel3 and Helsinki1 revealed only 15 discordant results, 14 (93%) of which were close to the cutoff. Preadsorption identified specificities of 99.44% and 97.78% and sensitivities of 99.54% and 95.87% for Basel3 and Helsinki1, respectively. Thus, normalization to a preferably WHO-approved reference serum, duplicate testing, and preadsorption for samples around the cutoff may be necessary for reliable JCPyV serology and PML risk stratification.


1976 ◽  
Vol 4 (5) ◽  
pp. 437-442
Author(s):  
G Gerna ◽  
R W Chambers

A new plaque assay for the quantitation of varicella-zoster virus and a plaque reduction neutralization test for the determination of neutralizing antibody titer have been developed using the indirect immunoperoxidase technique. As compared with the classical plaque assay using a solid overlay, the test gives earlier results since plaque counting can be performed on day 3 after the inoculation of cell cultures. In six patients with zoster infection, neutralizing antibody titers ranged from 1:20 to 1:40 before the onset of infection and reached high levels (1:320 to 1:5,120) during the convalescent phase of the disease. Complement-fixing (CF) titers were all negative (less than 1:8) in prezoster serum samples from the same patients and ranged from 1:128 to 1:2,048 in the convalescent-phase sera. In the two cases in which late serum samples were available, neutralizing antibody titers matched the preillness levels, whereas CF titers dropped to undetectable levels. Neither neutralizing nor CF antibody was detected in two sera from individuals with no history of varicella-zoster infection. No differences in virus titers or neutralizing antibody titers were observed between the immunoperoxidase and the classical plaque assays. The appropriate characterization of reagent specificity is required before routine application of the test.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Priyatharsan Yoganathan ◽  
Jean-Benoit Rossel ◽  
Sebastian Bruno Ulrich Jordi ◽  
Yannick Franc ◽  
Luc Biedermann ◽  
...  

Abstract Background Genetic variations within the regulatory region of the gene encoding NOD-like receptor pyrin domain containing 3 (NLRP3) have been associated with Crohn’s Disease (CD). NLRP3 is part of the NLRP3-inflammasome that mediates the maturation of IL-1β and IL-18. Carrying the major allele of the single nucleotide polymorphisms (SNPs) rs10733113, rs4353135 and rs55646866 is associated with an increased risk for CD. We here studied the impact of these polymorphisms on clinical characteristics in patients of the Swiss IBD Cohort Study (SIBDCS). Methods We included 981 Crohn’s disease (CD) patients and 690 ulcerative colitis (UC) patients of the SIBDCS. We analyzed whether three CD-associated NLRP3 polymorphisms have an impact on the clinical disease course in these patients. Results In CD patients presence of the major allele (G) of rs10733113 was associated with less surgeries and lower maximal CDAI and a similar trend was observed for rs55646866 and rs4353135. Presence of the major allele of all three SNPs was negatively correlated to maximal CDAI. In UC patients homozygous genotype for the major allele (CC) for rs55646866 was associated with a higher age at diagnosis and a higher MTWAI index. Homozygous genotype for the major allele of all three polymorphisms was associated with a higher number of ambulatory visits and longer hospital stays. Conclusions In CD patients presence of the major allele of all three polymorphisms was associated with markers of a less severe disease course, while in UC the homozygous genotype for all major alleles suggested a more severe disease activity.


2021 ◽  
pp. jrheum.201671
Author(s):  
Philip J. Mease ◽  
Leonard H. Calabrese ◽  
Kristina Callis Duffin ◽  
Rebecca H. Haberman ◽  
Rodrigo Firmino ◽  
...  

The coronavirus disease 2019 (COVID-19; caused by SARS-CoV-2) pandemic has affected the healthcare system on a global scale, and we utilized the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2020 annual meeting to examine how COVID-19 might affect patients with psoriatic disease (PsD) and the clinicians who care for them. Pressing issues and concerns identified included whether having psoriasis increased the risk of acquiring COVID-19, vaccine safety, and the acceptability of telehealth. The general message from rheumatologists, dermatologists, infectious disease specialists, and patient research partners was that data did not suggest that having PsD or its treatment significantly increased risk of infection or more severe disease course, and that the telehealth experience was a success overall.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S012-S012
Author(s):  
M D Wewer ◽  
M Zhao ◽  
A Nordholm-Carstensen ◽  
J B Seidelin ◽  
J Burisch

Abstract Background Perianal Crohn’s disease (pCD) has a major negative impact on patients’ quality of life and is complex to treat. Despite its putative high frequency and burden for patients, only a few studies have investigated the incidence, disease course and associated cancer-risk in a population-based setting. The aim was to assess the incidence and course of pCD in adult patients with CD within a 19-year period. Specifically, describing changes in medical and surgical management as well as rates of cancer. Methods The cohort comprised all individuals &gt;18 years diagnosed with CD in Denmark between 1 January 1997 and 31 December 2015. Patients were identified in the National Patient Registry. Chi-square test, Mann–Whitney–Wilcoxon test and multivariate Cox regression analysis were used. Results A total of 1,697/9,739 (17%) patients with CD were found to have pCD. Perianal fistulas were the most common manifestation accounting for 943 (56%) cases. The onset of pCD before CD diagnosis occurred in 32%. The overall incidence of pCD was 20/1,000 patient-years. The incidence of pCD remained stable over time. More patients with pCD were treated with immunomodulators (70%) and biologics (35%) than those without pCD (51%, p &lt; 0.001 and 15%, p &lt; 0.001, respectively). Defunctioning stoma was performed in 157/943 (17%) of perianal fistula patients. Stoma formation in relation to resection was performed in 112/943 (12%) of perianal fistula patients. Patients with pCD were found to have a significantly increased risk of undergoing major abdominal surgery compared with patients without pCD (hazard ratio: 1.52, 95% CI: 1.40 to 1.65, p &lt; 0.001). The incidence rate ratios of anal and rectal cancer in pCD patients were 12.46 (95% CI: 5.07 to 30.59, p &lt; 0.001) and 2.41 (95% CI: 1.31 to 4.42, p = 0.003) respectively, when compared with non-IBD matched controls. The incidence rate ratio of anal and rectal cancer in pCD patients was 2.36 (95% CI: 0.86 to 6.50, p = 0.09) and 1.35 (95% CI: 0.68 to 2.68, p = 0.38) respectively, when compared with CD patients without pCD. Conclusion In this nationwide study, 17% of the CD patients developed pCD. The continuing high incidence of pCD suggests a limited disease-modifying effect of biologics. Patients with pCD were at increased risk of undergoing major surgery compared with non-pCD patients. The risk of rectal or anal cancer was increased in patients with pCD compared with non-IBD matched controls. These findings encourage surveillance of rectal and anal cancer.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S280-S281
Author(s):  
M Attauabi ◽  
M Zhao ◽  
F Bendtsen ◽  
J Burisch

Abstract Background Several studies have shown an association between inflammatory bowel diseases [IBD] and immune-mediated diseases [IMIDs], but data on the impact of co-occurring IMIDs on IBD course are inconsistent. The aim of this study was to investigate the impact of co-occurring IMIDs on IBD phenotype and disease course. Methods PubMed and EMBASE were searched from database inception through December 2018 and updated in October 2019 for studies reporting prevalences or odds, risks or hazard ratios of IBD-related disease outcomes in patients with and without co-existing IMIDs. Meta-analyses were performed to estimate summary prevalences and risks of the outcomes which included disease extension, IBD-related surgery and hospitalisation, malignancy, mortality and need of medication (biologic therapy, steroids and immunomodulators). IMIDs were stratified into primary sclerosing cholangitis [PSC] and ‘IMIDs other than PSC’. Results A total of 93 studies comprising 14,307 IBD patients with IMIDs and 3,409,914 IBD patients without IMIDs were included in the study. Summary risks and prevalences with 95% confidence intervals for each outcome are presented in figures 1 and 2, respectively. The following results are all significant (p &lt; 0.05). Compared with patients without co-occurring IMIDs, patients with ulcerative colitis [UC] and co-occurring IMIDs other than PSC more frequently received immunomodulators and steroids, and patients with Crohn’s disease [CD] and concomitant IMIDs other than PSC more often received biologic therapy. UC patients with co-existing IMIDs other than PSC more often underwent IBD-related surgery, while patients with CD and PSC received fewer surgeries. In addition, UC patients with co-occurring PSC were at increased risk for having extensive colitis, pancolitis, and malignancies. Patients with UC and PSC had a higher mortality rate, but no difference was found among patients with IMIDs other than PSC. PSC did not influence hospitalisation rates among IBD patients. Conclusion This meta-analysis found that IBD patients with co-existing IMIDs have a different disease course than patients without concomitant IMIDs. This study emphasises the importance of multidisciplinary care of IBD and that physicians caring for IBD patients need to be aware of IMIDs as a prognostic factor.


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