Chemiluminescent immunoassay technology: what does it change in autoantibody detection?

Cinquanta, Luigi; Fontana, Desrè Ethel; Bizzaro, Nicola

doi:10.1007/s13317-017-0097-2

Cited by 199 publications

(150 citation statements)

References 73 publications

(50 reference statements)

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“…The RLUs are proportional to the concentration of isoluminol conjugate bound to the human IgG or IgM antibodies. Additional details are described elsewhere 15 .…”

Section: Methodsmentioning

confidence: 99%

Seroprevalences of autoantibodies and anti-infectious antibodies among Ghana’s healthy population

Katz

Luca

Dzudzor

et al. 2020

Sci Rep

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Autoantibodies, which are antibodies that target self-epitopes, have considerable diagnostic, prognostic and predictive value in specific autoimmune diseases. Various infectious agents have been linked via numerous mechanisms to the formation of different autoantibodies. Therefore, estimating the prevalence of autoantibodies and anti-infectious antibodies in different populations is of high importance. Different genetic and environmental pressures, such as these found in Ghana's different geographical provinces, may affect the prevalence of autoantibodies. In this study, we assessed the seroprevalence of a diverse panel of autoantibodies and anti-infectious antibodies among the healthy Ghanaian population and investigated possible environmental and genetic predispositions for autoantibodies and autoimmunity. The sera of 406 healthy individuals were obtained from Greater Accra, Upper West, Eastern and Volta regions. Multiplexed assay and chemiluminescent immunoassay techniques were utilized to assess the presence of a panel of autoantibodies and anti-infectious antibodies. We found a high prevalence of anti-HSV-1 IgG (91-100%), anti-EBNA IgG (81-93%) and anti-EBV-VCA IgG (97-100%) antibodies. The prevalence of ANA (at least one of: anti-dsDNA; antichromatin; anti-ribosomal-P; anti-Ro/SSA; anti-La/SSB; anti-centromere B; anti-Sm; anti-Sm/RNP; anti-Scl-70; anti-Jo1; anti-DFS70) was estimated at 14%. An inverse association between anti-HSV-2 antibodies and ANA (p = 0.044; adjusted OR = 0.398; CI [0.162-0.975]) was found, after adjusting for differences in gender, age, and familial history of autoimmune diseases. A trend towards reduced seroprevalence of anti-dsDNA antibodies among subjects who were positive for anti-HSV-2 antibodies was also noted (p = 0.1). In conclusion, the inverse association between anti-HSV-2 antibodies and ANA positivity suggests a possible protective role of HSV-2 infection against autoimmunity.Currently, the etiology of autoimmune diseases (AIDs) is not completely understood. Many variables are thought to play a role in the development of these diseases, including genetic, immunological, hormonal and environmental factors 1 . These various factors and the interactions between them, which constitute the "Mosaic of Autoimmunity", may contribute to autoimmunity by different mechanisms. One of these mechanisms is associated with the loss of self-tolerance 2 .Infectious agents, which are members of the environmental pebble of the mosaic, can induce loss of tolerance through various mechanisms, such as: (1) Epitope spreading, i.e. development of an autoimmune response mediated by autoreactive T-cells and expansion of the auto-reactive B-cell repertoire to endogenous epitopes, following

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“…The RLUs are proportional to the concentration of isoluminol conjugate bound to the human IgG or IgM antibodies. Additional details are described elsewhere 15 .…”

Section: Methodsmentioning

confidence: 99%

Seroprevalences of autoantibodies and anti-infectious antibodies among Ghana’s healthy population

Katz

Luca

Dzudzor

et al. 2020

Sci Rep

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“…Therefore, diagnostic laboratories are increasingly shifting to fully automated random-access systems with focus on bead-based chemiluminescence technology. 8 The objective of this study was to evaluate the performance characteristics of a novel standardized anti-PLA2R ChLIA, and to determine if this assay can close the sensitivity gap between ELISA and RC-IFA.…”

mentioning

confidence: 99%

Development of a Standardized Chemiluminescence Immunoassay for the Detection of Autoantibodies Against Human M-Type Phospholipase A2 Receptor in Primary Membranous Nephropathy

Dähnrich

Saschenbrecker

Gunnarsson

et al. 2020

Kidney International Reports

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Introduction: Autoantibodies against the M-type phospholipase A2 receptor (PLA2R) are important markers in the diagnosis and monitoring of primary membranous nephropathy (pMN). For the detection of anti-PLA2R autoantibodies, a standardized recombinant cell-based indirect immunofluorescence assay (RC-IFA) and enzyme-linked immunosorbent assay (ELISA) are widely used, the former providing higher sensitivity but lacking a finely graduated quantification of antibody titers. In this study, we evaluated the diagnostic performance characteristics of a novel standardized chemiluminescence immunoassay (ChLIA) by comparison with the established anti-PLA2R test systems.Methods: Sera from 155 patients with biopsy-proven pMN and 154 disease controls were analyzed for autoantibodies against PLA2R by the novel ChLIA as well as by ELISA and RC-IFA. Results:The clinical sensitivity of the ChLIA (83.9%) was higher compared with ELISA (73.5%) and equaled that of RC-IFA (83.2%), at similar specificities ($99.4%). Among ELISA-negative pMN samples, ChLIA and RC-IFA yielded positive results in 39.0% and 36.6%, respectively. The qualitative agreement amounted to 94.5% (ChLIA vs. ELISA) and 99.4% (ChLIA vs. RC-IFA). Conclusion:The novel anti-PLA2R ChLIA outperforms the ELISA in detecting patients with pMN and demonstrates almost perfect agreement with RC-IFA. It thus presents a promising alternative tool for accurate anti-PLA2R testing, with the advantage of rapid turnaround times and fully automated randomaccess processing.

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“…value of the test in this range. Signi cant recent advances have increased the analytical range for serum tTG by 2-3 orders of magnitude [64], resulting in superior diagnostic performance in the evaluation of CD [63,65]. Timely implementation of technological advances into medical management is necessary for best-practice guidelines.…”

Section: Discussionmentioning

confidence: 99%

“…Nationwide Children's Hospital (NCH) is a referral center for evaluation and management of CD in the US. Since July of 2014, patients with differential diagnosis of CD have undergone tTG testing using QUANTA Flash® chemiluminescence assay (Inova Diagnostics, San Diego, CA) which has extended analytical range and superior performance for CD [63][64][65]. In addition, all duodenal biopsies at NCH are evaluated by experience pathologists and subject to clinicopathological consensus review.…”

Section: Clinical Settingmentioning

confidence: 99%

Value of Biopsy in a Cohort of Children with High-Titer Celiac Serologies: Observation of Dynamic Policy Differences between Europe and North America

Badizadegan¹,

Vanlandingham

Hampton

et al. 2020

Preprint

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Background: Healthcare systems implement change at different rates because of differences in incentives, organizational processes, key influencers, and management styles. A comparable set of forces may play out at the national and international levels as demonstrated in significant differences in the diagnostic management of pediatric Celiac Disease (CD) between European and North American practioners. Methods: We use retrospective clinical cohorts of 27,868 serum tissue transglutaminase (tTG) immunoglobulin A levels and 7,907 upper gastrointestinal endoscopy pathology reports to create a dataset of 793 pathology reports with matching tTG results between July 1 of 2014 and July 1 of 2018. We use this dataset to characterize histopathological findings in the duodenum, stomach and esophagus of patients as a function of serum tTG levels. In addition, we use the dataset to estimate the local and national cost of endoscopies performed in patients with serum tTG levels greater than 10 times the upper limit of normal. Results: Using evidence from a US tertiary care center, we show that in the cohort of pediatric patients with high pre-test probability of CD as determined by serum tTG levels, biopsy provides no additional diagnostic value for CD, and that it counter-intuitively introduces diagnostic uncertainty in a number of patients. We estimate that using the European diagnostic algorithms could avoid between 4,891 and 7,738 pediatric endoscopies per year in the US for evaluation of CD. Conclusions: This study considers the North American and European management guidelines for the diagnosis of pediatric CD and highlights the slow adoption in North America of evidence-based algorithms developed and applied in Europe for triage of endoscopy and biopsy. We suggest that the forces that maintain the status quo in North America go beyond medical evidence and include a variety of social and economic factors. This work contributes to the growing body of evidence that suggests that the dynamics that largely favor maintaining status quo management policies extend to clinical medicine and influence a variety of clinical decisions at the level of individual patients and the population.

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Chemiluminescent immunoassay technology: what does it change in autoantibody detection?

Cited by 199 publications

References 73 publications

Seroprevalences of autoantibodies and anti-infectious antibodies among Ghana’s healthy population

Seroprevalences of autoantibodies and anti-infectious antibodies among Ghana’s healthy population

Development of a Standardized Chemiluminescence Immunoassay for the Detection of Autoantibodies Against Human M-Type Phospholipase A2 Receptor in Primary Membranous Nephropathy

Value of Biopsy in a Cohort of Children with High-Titer Celiac Serologies: Observation of Dynamic Policy Differences between Europe and North America

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