scholarly journals An international multicenter examination of MOG antibody assays

2019 ◽  
Author(s):  
Markus Reindl ◽  
Kathrin Schanda ◽  
Mark Woodhall ◽  
Fiona Tea ◽  
Sudarshini Ramanathan ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Excellent Agreement ◽  
Blood Donors ◽  
Clinical Care ◽  
Myelin Oligodendrocyte Glycoprotein ◽  
Antibody Assays ◽  
National Testing ◽  
International Testing ◽  
International Multicenter ◽  
Good Agreement

AbstractObjectivesTo compare the reproducibility of 11 antibody assays for IgG and IgM myelin oligodendrocyte glycoprotein antibodies (MOG-IgG, MOG-IgM) from five international centers.MethodsThe following samples were analyzed: MOG-IgG clearly positive sera (n=39), MOG-IgG low positive sera (n=39), borderline negative sera (n=13), clearly negative sera (n=40), and healthy blood donors (n=30). As technical controls, 18 replicates (9 MOG-IgG positive and 9 negative) were included. All samples and controls were re-coded, aliquoted, and distributed to the five testing centers which performed the following antibody assays: five live and one fixed immunofluorescence cell-based assays (CBA-IF, five MOG-IgG, one MOG-IgM), three live flow cytometry cell-based assays (FACS-CBA, all MOG-IgG), and two enzyme-linked immunosorbent assays (ELISA, both MOG-IgG).ResultsWe found excellent agreement (96%) between the live CBAs for MOG-IgG for samples previously identified as clearly positive or negative from four different national testing centers. The agreement was lower with fixed CBA-IF (90%) and the ELISA showed no concordance with CBAs for detection of human MOG-IgG. All CBAs showed excellent inter-assay reproducibility. The agreement of MOG-IgG CBAs for borderline negative (77%) and particularly low positive (33%) samples was less good. Finally, most samples from healthy blood donors (97%) were negative for MOG-IgG in all CBAs.ConclusionLive MOG-IgG CBAs showed excellent agreement for high positive and very good agreement for negative samples at four international testing centers. Low positive samples were more frequently discordant than in similar assays for other autoantigens. Further research is needed to improve international standardization for clinical care.

scholarly journals International multicenter examination of MOG antibody assays

2020 ◽  
Vol 7 (2) ◽  
pp. e674 ◽  
Author(s):  
Markus Reindl ◽  
Kathrin Schanda ◽  
Mark Woodhall ◽  
Fiona Tea ◽  
Sudarshini Ramanathan ◽  
...  
Keyword(s):  
Excellent Agreement ◽  
Blood Donors ◽  
Clinical Care ◽  
Myelin Oligodendrocyte Glycoprotein ◽  
Antibody Assays ◽  
National Testing ◽  
International Testing ◽  
Ig G ◽  
International Multicenter ◽  
Aquaporin 4 Antibody

ObjectiveTo compare the reproducibility of 11 antibody assays for immunoglobulin (Ig) G and IgM myelin oligodendrocyte glycoprotein antibodies (MOG-IgG and MOG-IgM) from 5 international centers.MethodsThe following samples were analyzed: MOG-IgG clearly positive sera (n = 39), MOG-IgG low positive sera (n = 39), borderline negative sera (n = 13), clearly negative sera (n = 40), and healthy blood donors (n = 30). As technical controls, 18 replicates (9 MOG-IgG positive and 9 negative) were included. All samples and controls were recoded, aliquoted, and distributed to the 5 testing centers, which performed the following antibody assays: 5 live and 1 fixed immunofluorescence cell-based assays (CBA-IF, 5 MOG-IgG, and 1 MOG-IgM), 3 live flow cytometry cell-based assays (CBA-FACS, all MOG-IgG), and 2 ELISAs (both MOG-IgG).ResultsWe found excellent agreement (96%) between the live CBAs for MOG-IgG for samples previously identified as clearly positive or negative from 4 different national testing centers. The agreement was lower with fixed CBA-IF (90%), and the ELISA showed no concordance with CBAs for detection of human MOG-IgG. All CBAs showed excellent interassay reproducibility. The agreement of MOG-IgG CBAs for borderline negative (77%) and particularly low positive (33%) samples was less good. Finally, most samples from healthy blood donors (97%) were negative for MOG-IgG in all CBAs.ConclusionsLive MOG-IgG CBAs showed excellent agreement for high positive and negative samples at 3 international testing centers. Low positive samples were more frequently discordant than in a similar comparison of aquaporin-4 antibody assays. Further research is needed to improve international standardization for clinical care.

542 Expansion of cytotoxic NK Cells from PBMCs using individualized cytokine combination

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A578-A578
Author(s):  
Andreia Maia ◽  
Joana Lerias ◽  
Markus Maeurer ◽  
Mireia Castillo-Martin
Keyword(s):  
Flow Cytometry ◽  
Nk Cells ◽  
Natural Killer ◽  
Peripheral Blood ◽  
Blood Donors ◽  
Nk Cell ◽  
Tumour Cells ◽  
List Type ◽  
Mhc I ◽  
Cytokine Combination

BackgroundAdoptive immunotherapy relies on the use of T-cells to target tumour cells, through Major Histocompatibility Complex (MHC) Class I recognition(1). However, many tumours display alterations in the MHC-I pathway, a well-described immune evasion mechanism(2). Natural Killer (NK) cells recognize transformed cells independently from the presence of MHC-I and may be a reliable therapeutic option for patients with altered tumour MHC-I expression. The source of NK cells may be autologous or allogeneic and NK cells are also clinically relevant recipients of transgenic receptors (TCRs or antibodies) targeting tumour cells. NK cells have been categorized according to their CD56 and CD16 surface expression into different subpopulations: cytotoxic (CD56+CD16+) and regulatory (CD56brightCD16-)(3). Expanding cytotoxic NK cells is challenging, since the frequency of NK cells is low in peripheral blood(4) and there is also – at this point – not an optimal expansion protocol available.The goal of this project is to determine the best cytokine combination that facilitates expansion of cytotoxic NK cells that either target tumor cells directly or serve as recipients for transgenic receptors.MethodsPeripheral Blood Mononuclear Cells (PBMCs) were extracted using Ficoll methodology from blood donors and cultured in T25 flasks with Cell Genix Medium supplemented with 10% human serum and antibiotics. NK cells were expanded supplemented with feeder cells (ratio 1:1) and different cytokine combinations (1000 U/mL of IL-2, 10 U/ml of IL-12, 180 U/mL of IL-15 and/or 1 U/mL of IL-21) during 20 days. The immunophenotype of expanded NK cells was analyzed at days 0, 5, 10, 15 and 20 by flow cytometry. The cytotoxicity of NK cells was measured by a CD107a Assay or by a Total Cytotoxicity and Apoptosis Assay at days 10 and 20. Thirteen different cytokine combinations were tested.Results4/13 cytokine combinations produced a statistically significant increase of the absolute number of NK cells with a higher percentage of cytotoxic NK cells (figure 1). However, induction of cytotoxicity was not associated with a strong NK cell expansion. The regulatory NK cells subset (CD56brightCD16-) showed the highest percentage of CD107a-expressing cells, more than the CD56+CD16+, the most cytotoxic subpopulation of NK cells.Abstract 542 Figure 1Representative percentage of NK cells in total lymphocytes (A), CD56+CD16+ subpopulation in total NK cells (B), and CD56brightCD16- subpopulation amongst total NK cells (C) at different time points (5, 10, 15 and 20 days) expanded from PBMCs* p-value < 0.05ConclusionsThis work shows that we are able to grow and efficiently expand NK cells from PBMCs with different cytokine combinations leading to clinically relevant NK cell numbers as well as cytotoxic functions. This enables to produce NK cell products for therapy and as recipients for transgenic tumor antigen-specific receptors.AcknowledgementsThe authors would like to thank the Champalimaud Foundation Biobank, the Vivarium Facility and the Flow Cytometry Platform of the Champalimaud Centre for the Unknown.Ethics ApprovalThis study was approved by the Champalimaud Foundation Ethics Committee and by the Ethics Research Committee of NOVA Medical School of NOVA University of Lisbon.ConsentWritten informed consent was obtained from the blood donors to use their samples for research purposes.ReferencesRosenberg SA, Restifo NP, Yang JC, Morgan RA, Mark E. Adoptive cell transfer: a clinical path to effective cancer immunotherapy. Nat Rev Cancer 2008;8(4):299–308.Aptsiauri N, Ruiz-Cabello F, Garrido F. The transition from HLA-I positive to HLA-I negative primary tumors: the road to escape from T-cell responses. Curr Opin Immunol 2018;51:123–32.Di Vito C, Mikulak J, Mavilio D. On the way to become a natural killer cell. Front Immunol. 2019;10(August):1–15.Zotto G Del, Antonini F, Pesce S, Moretta F, Moretta L. Comprehensive phenotyping of human PB NK Cells by Flow Cytometry. 2020;1–9.

An electronic, unsupervised patient-reported Expanded Disability Status Scale for multiple sclerosis

2020 ◽  
pp. 135245852096881
Author(s):  
Andrew R Romeo ◽  
William M Rowles ◽  
Erica S Schleimer ◽  
Patrick Barba ◽  
Wan-Yu Hsu ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Care ◽  
Expanded Disability Status Scale ◽  
Clinical Assessments ◽  
Patient Reported ◽  
Disability Status ◽  
Two Measures ◽  
Highly Correlated ◽  
Participation In Research ◽  
Good Agreement

Background: In persons with multiple sclerosis (MS), the Expanded Disability Status Scale (EDSS) is the criterion standard for assessing disability, but its in-person nature constrains patient participation in research and clinical assessments. Objective: The aim of this study was to develop and validate a scalable, electronic, unsupervised patient-reported EDSS (ePR-EDSS) that would capture MS-related disability across the spectrum of severity. Methods: We enrolled 136 adult MS patients, split into a preliminary testing Cohort 1 ( n = 50), and a validation Cohort 2 ( n = 86), which was evenly distributed across EDSS groups. Each patient completed an ePR-EDSS either immediately before or after a MS clinician’s Neurostatus EDSS evaluation. Results: In Cohort 2, mean age was 50.6 years (range = 26–80) and median EDSS was 3.5 (interquartile range (IQR) = [1.5, 5.5]). The ePR-EDSS and EDSS agreed within 1-point for 86% of examinations; kappa for agreement within 1-point was 0.85 ( p < 0.001). The correlation coefficient between the two measures was 0.91 (<0.001). Discussion: The ePR-EDSS was highly correlated with EDSS, with good agreement even at lower EDSS levels. For clinical care, the ePR-EDSS could enable the longitudinal monitoring of a patient’s disability. For research, it provides a valid and rapid measure across the entire spectrum of disability and permits broader participation with fewer in-person assessments.

Serum antibodies to conformational and linear epitopes of myelin oligodendrocyte glycoprotein are not elevated in the preclinical phase of multiple sclerosis

2010 ◽  
Vol 16 (10) ◽  
pp. 1189-1192 ◽  
Author(s):  
A. Chan ◽  
BF Decard ◽  
C. Franke ◽  
V. Grummel ◽  
D. Zhou ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Flow Cytometry ◽  
Cell Surface ◽  
Disease Onset ◽  
Myelin Oligodendrocyte Glycoprotein ◽  
Clinically Isolated Syndrome ◽  
Detection Methods ◽  
Serum Samples ◽  
Disease Manifestation ◽  
Linear Epitopes

Background: The proposed predictive value of serum anti-myelin antibodies for the development of multiple sclerosis after a first clinically isolated syndrome was recently challenged. Objective: To investigate myelin autoantibodies before first disease manifestation using different detection methods. Methods: Patients with multiple sclerosis who had donated blood at a time prior to development of clinically isolated syndrome were identified via the German National Multiple Sclerosis Society. Control sera were obtained from age- and gender-matched blood donors. IgG-/IgM-antibodies against the extracellular part of native, cell surface-expressed myelin oligodendrocyte glycoprotein were detected by flow cytometry. Antibodies against linear epitopes were identified by immunoblot using recombinant myelin oligodendrocyte glycoprotein (aa1-125) and human myelin basic protein preparations. Results: Fifty eight serum samples from 25 patients covering an interval of 7.3 years—2 months prior to disease onset were available. Longitudinal investigations were performed in 19 patients (2—14 samples per patient, 7 years—2 months prior to disease onset). No significant differences in the prevalence or titres of anti-myelin antibodies were detected between sera of preclinical individuals and healthy donors by either flow cytometry or immunoblot. There was no correlation between interval before clinically isolated syndrome and autoantibody status. Occurrence of antibodies was not associated with symptomatology/severity of clinically isolated syndrome. Conclusion: Neither anti-myelin autoantibodies against cell surface-expressed native myelin oligodendrocyte glycoprotein nor against linear epitopes have a predictive or discriminative role during the preclinical disease phase for developing clinically isolated syndrome or multiple sclerosis later in life.

Comparative yield of HCV RNA testing in blood donors screened by 2.0 versus 3.0 antibody assays

Transfusion ◽  
2002 ◽  
Vol 42 (11) ◽  
pp. 1507-1513 ◽  
Author(s):  
Susan A. Galel ◽  
D. Michael Strong ◽  
Gary E. Tegtmeier ◽  
Paul V. Holland ◽  
Isamu K. Kuramoto ◽  
...  
Keyword(s):  
Blood Donors ◽  
Hcv Rna ◽  
Antibody Assays

scholarly journals Standardization of Aspergillus IgG diagnostic cutoff in Nigerians

2021 ◽  
Vol 8 ◽  
pp. 204993612110501
Author(s):  
Rita O. Oladele ◽  
Akaninyene A. Otu ◽  
Oluwaseyi J. Balogun ◽  
Oladayo M. Babalola ◽  
Augustina O. Nwosu ◽  
...  
Keyword(s):  
Blood Donors ◽  
Age Groups ◽  
Area Under The Curve ◽  
Operating Characteristics ◽  
Igg Antibody ◽  
Accurate Identification ◽  
Test Kit ◽  
Significant Difference ◽  
Antibody Assays ◽  
Chronic Pulmonary Aspergillosis

Background and objectives: Commercial Aspergillus IgG antibody assays have become pivotal in the current diagnosis of chronic pulmonary aspergillosis (CPA). However, diagnostic cutoffs have been found to vary from manufactures’ recommendations in different settings. This study aimed to establish the Aspergillus IgG reference range among Nigerians and determine a diagnostic cutoff for CPA. Methods: Sera from 519 prospectively recruited healthy blood donors and 39 previously confirmed cases of CPA were analysed for Aspergillus IgG levels using the Bordier test kit (Bordier Affinity Products SA, Crissier, Switzerland). Accuracy versus cutoff profile and receiver operating characteristics (ROC) curve were analysed for both CPA cases and controls using the R-Studio (2020), (Window desktop, version 4.0.2 software with R packages “nnet” and “ROCR”). Results: Among healthy blood donors, 141 (27.2%) were aged 16–25 years with median (interquartile range, IQR) of 22 (20–24) years; 304 (58.6%) were aged 26–40 years with median (IQR) of 32 (29–36) years; while 74 (14.2%) were aged 41–60 years with median (IQR) of 46 (44–49.75). Median IgG level in respective age groups were 0.069 (0.009–0.181), 0.044 (0.014–0.202) and 0.056 (0.01–0.265) with no significant difference found in the three age categories ( p = 0.69). The overall diagnostic cutoff for the diagnosis of CPA was 0.821 with an accuracy of 97.1% and area under the curve (AUC) = 0.986. Conclusion: The optimal diagnostic cutoff for diagnosing CPA in Nigerians using the Bordier kit was 0.821 which is lower than the manufacturer’s recommended cutoff of 1.0. The determination of this cutoff among Nigerians will significantly enhance accurate identification of CPA and assessment of its true burden in Nigeria.

scholarly journals SARS-CoV-2 serological analysis of COVID-19 hospitalized patients, pauci-symptomatic individuals and blood donors

2020 ◽  
Author(s):  
Ludivine Grzelak ◽  
Sarah Temmam ◽  
Cyril Planchais ◽  
Caroline Demeret ◽  
Christèle Huon ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Blood Donors ◽  
Hospitalized Patients ◽  
High Antibody ◽  
Serological Analysis ◽  
Healthy Donors ◽  
Response Profile ◽  
Antibody Titers ◽  
Antibody Profiling ◽  
Nucleoprotein N

AbstractIt is of paramount importance to evaluate the prevalence of both asymptomatic and symptomatic cases of SARS-CoV-2 infection and their antibody response profile. Here, we performed a pilot study to assess the levels of anti-SARS-CoV-2 antibodies in samples taken from 491 pre-epidemic individuals, 51 patients from Hôpital Bichat (Paris), 209 pauci-symptomatic individuals in the French Oise region and 200 contemporary Oise blood donors. Two in-house ELISA assays, that recognize the full-length nucleoprotein (N) or trimeric Spike (S) ectodomain were implemented. We also developed two novel assays: the S-Flow assay, which is based on the recognition of S at the cell surface by flow-cytometry, and the LIPS assay that recognizes diverse antigens (including S1 or N C-terminal domain) by immunoprecipitation. Overall, the results obtained with the four assays were similar, with differences in sensitivity that can be attributed to the technique and the antigen in use. High antibody titers were associated with neutralisation activity, assessed using infectious SARS-CoV-2 or lentiviral-S pseudotypes. In hospitalized patients, seroconversion and neutralisation occurred on 5-14 days post symptom onset, confirming previous studies. Seropositivity was detected in 29% of pauci-symptomatic individuals within 15 days post-symptoms and 3 % of blood of healthy donors collected in the area of a cluster of COVID cases. Altogether, our assays allow for a broad evaluation of SARS-CoV2 seroprevalence and antibody profiling in different population subsets.

scholarly journals Performance Assessment of First-Generation AntiSARS-CoV-2 Serological Assays

2020 ◽  
Author(s):  
Tahir S Shamsi ◽  
Mehjabeen Imam ◽  
Shabnum Khawaja ◽  
Arshi Naz ◽  
Ahson Q Siddiqi ◽  
...  
Keyword(s):  
Health Care Professionals ◽  
First Generation ◽  
Blood Donors ◽  
High Sensitivity ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Antibody Assays ◽  
Post Onset ◽  
Higher Sensitivity

The clinical and epidemiological use of SARS-CoV-2 antibody assays is under debate with urgent need to validate and verify the performance of SARS-CoV-2 serologic assays. We aim to assess the clinical and analytical performance of three commercial serological assays of SARS-CoV-2, comparing three anti-SARS-CoV-2-IgG ELISA and identifying the seroconversion and seroprevalence in our population. A cross sectional study conducted from April 2020 to July 2020 at National Institute of Blood disease and Bone Marrow Transplantation Karachi, Pakistan with sample size of 404, enrolled consecutively. Participants were categorized into four groups namely convalescent plasmadonors (CPDs n=239), health care professionals (HCPs n=44), healthy blood donors (HBDs n=70) and from community (n=51). We evaluated the performance of Elecsys anti-SARS-CoV-2 electrochemiluminescence (ECLIA) assay on Cobas-e411 by Roche, three qualitative anti-SARS-CoV-2-IgG enzyme linked imunosorbant assay (ELISA) by (Generic assays, Euroimmun & Omega diagnostics) ,one quantitative ELISA assay by AESKU Diagnostics and two immune chromatography(ICT) kits namely InstaTestTM by CORTEZ and TEST IT by TURKLAB. From total 404 subjects, 322 (83.5%) were males. Mean age was 36.79 plus minus 11.95 years. Among 239 in CPDs group, 202(84.5%) showed positive antibodies by ECLIA. The qualitative anti-SARS-CoV-2 IgG ELISA was positive in 174 (72.8%) and quantitative IgG in 180(75.3%) with mean titer of 56.7 plus minus 39.7 U/ml. Sensitivity and specificity of ECLIA were 97.44& 99%, ELISA by Generic assays were 67.85% and 89.9%; Euroimmun had 90.38% and 94.9%; Omega Diagnostics 96.4% and 95% and the AESKULISA 93.75% and 100% respectively. Seroconversion was found to be 53.8% and 77.77% within 7 -8 days and 12 to 14 days post onset of symptoms respectively. ICT had more specificity but less sensitivity. Seroprevalence was found to be 84.5%, 40.9% and 21.4% in CPDs, HCPs and HBDs respectively. The Roche ECLIA, qualitative ELISA by Omega Diagnostics & Euroimmun showed higher sensitivity as well as higher specificity. Quantitative ELISA has higher specificity and relatively high sensitivity. Significant numbers of COVID patients do not have detectable antibodies by all assays.

HNA−1a, −1b, −2a, −3a and −4a Frequencies in Brazilian Persons.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3837-3837 ◽  
Author(s):  
Angela M. Norcia ◽  
Elisa Y. Kimura ◽  
Akemi K. Chiba ◽  
Elyse Moritz ◽  
Mihoko Yamamoto ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
African Americans ◽  
Blood Donors ◽  
Mononuclear Cells ◽  
Flow Cytometric Analysis ◽  
Fluorescein Isothiocyanate ◽  
Blue Staining ◽  
Drug Induced ◽  
Flow Cytometric ◽  
The Gift

Abstract Granulocyte reactive antibodies have been found to cause clinical disorders such as transfusion related acute lung injury (TRALI), febrile transfusion reactions, alloimmune neonatal neutropenia, immune neutropenia after bone marrow transplantation, refractoriness to granulocyte transfusion, drug-induced neutropenia and autoimmune neutropenia. Using the granulocyte immunofluorescence test (GIFT) by microscopic and flow cytometric analysis, the frequencies of the neutrophil antigens HNA−1a, −1b, −2a, −3a and −4a were determined among 100 random Brazilian blood donors from the Blood Center of Universidade Federal de Sao Paulo, SP, Brazil. Granulocytes were separated from mononuclear cells and red cells by sedimentation with 5% dextran, followed by centrifugation on Ficoll-paque (d = 1.077), and then incubated with anti-sera (anti-HNA−1a, −1b, −2a, −3a, and −4a obtained from American Red Cross, North Central Blood Services, St. Paul, MN) conjugated with fluorescein isothiocyanate (FITC) labeled F(ab’)2 fragments of anti-human IgG. Only cell suspensions containing ≥95% neutrophils with viability ≥90% according to the trypan-blue staining were analyzed. The frequencies of HNA−1a, −1b and −2a were 65%, 83% and 94%, respectively, and for such alloantigens exact same results were observed using either the GIFT performed by microscopy or by flow cytometry. The frequency of HNA-3a was 86% by the microscopic GIFT, and 95% by the flow cytometry analysis; while the frequency of HNA−4a was 93% by the microscopic GIFT, and 94% by the flow cytometric technique. These results indicate that: GIFT by flow cytometry is more sensitive than the GIFT by microscopy to detect HNA−3a; the phenotypic frequencies found for neutrophil antigens HNA−1a and −1b among Brazilian blood donors are quite similar to those reported among African Americans, but different from those reported for Japanese and Chinese individuals; the phenotype frequencies of the neutrophil antigens HNA−2a, −3a, and −4a in Brazilians are quite similar to those found among Caucasians (Table). (These studies were funded by FAPESP, SP, Brazil - 05/55237–9). Asians Brazilians Antigen African Americans Chineses Hindus Japaneses Caucasians M FC M, microscopy; FC, flow cytometry; nd, not done HNA-1a 46 – 68 90 44 88 52 – 54 65 65 HNA-1b 78 – 84 52 83 51 – 64 87 – 89 83 83 HNA-2a nd 99 nd 89 87 – 97 94 94 HNA-3a nd nd nd nd 99 86 95 HNA-4a nd nd nd nd 96 93 94

scholarly journals Clinical Comparison of QUANTA Flash dsDNA Chemiluminescent Immunoassay with Four Current Assays for the Detection of Anti-dsDNA Autoantibodies

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Maria Infantino ◽  
Francesca Meacci ◽  
Chelsea Bentow ◽  
Peter Martis ◽  
Maurizio Benucci ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Control Group ◽  
Immunofluorescence Test ◽  
Indirect Immunofluorescence Test ◽  
Crithidia Luciliae ◽  
Dsdna Antibody ◽  
Antibody Assays ◽  
Chemiluminescent Immunoassay ◽  
Antibody Tests ◽  
Good Agreement

Introduction. The objective of the present study was to compare QUANTA Flash dsDNA, a chemiluminescent immunoassay (CIA) on the BIO-FLASH, a rapid-response chemiluminescent analyzer, to three other anti-dsDNA antibody assays and to Crithidia luciliae indirect immunofluorescence test (CLIFT). Methods. In the first part of the study, 161 samples, 61 from patients suffering from systemic lupus erythematosus (SLE) and 100 from a disease control group, were tested by QUANTA Flash dsDNA CIA, QUANTA Lite dsDNA SC ELISA, BioPlex 2200 multiplex flow immunoassay (MFI), ImmuLisa dsDNA ELISA, and NOVA Lite CLIFT. A second cohort of 69 SLE patients was then tested by QUANTA Flash dsDNA and CLIFT to expand the study. Results. The overall qualitative agreements varied between 77.0% (NOVA Lite CLIFT versus QUANTA Lite) and 89.4% (ImmuLisa versus NOVA Lite CLIFT). The clinical sensitivities for the anti-dsDNA antibody tests varied from 8.2% (NOVA Lite CLIFT) to 54.1% (QUANTA Lite), while the clinical specificities varied from 88.0% (BioPlex 2200) to 100.0% (NOVA Lite CLIFT). Good correlation was found between QUANTA Flash dsDNA and NOVA Lite CLIFT. Conclusion. Significant variations among dsDNA methods were observed. QUANTA Flash dsDNA provides a good combination of sensitivity and specificity for the diagnosis of SLE and good agreement to CLIFT.

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