scholarly journals Original Approach for Automated Quantification of Antinuclear Autoantibodies by Indirect Immunofluorescence

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Daniel Bertin ◽  
Noémie Jourde-Chiche ◽  
Pierre Bongrand ◽  
Nathalie Bardin
Keyword(s):  
Indirect Immunofluorescence ◽  
Clinical Performance ◽  
Attractive Alternative ◽  
Major Step ◽  
Gold Standard Method ◽  
Technical Performance ◽  
Antinuclear Autoantibodies ◽  
Automated Quantification ◽  
Laboratory Standardization ◽  
Original Approach

Introduction. Indirect immunofluorescence (IIF) is the gold standard method for the detection of antinuclear antibodies (ANA) which are essential markers for the diagnosis of systemic autoimmune rheumatic diseases. For the discrimination of positive and negative samples, we propose here an original approach named Immunofluorescence for Computed Antinuclear antibody Rational Evaluation (ICARE) based on the calculation of a fluorescence index (FI).Methods. We made comparison between FI and visual evaluations on 237 consecutive samples and on a cohort of 25 patients with SLE.Results. We obtained very good technical performance of FI (95% sensitivity, 98% specificity, and a kappa of 0.92), even in a subgroup of weakly positive samples. A significant correlation between quantification of FI and IIF ANA titers was found (Spearman'sρ=0.80,P<0.0001). Clinical performance of ICARE was validated on a cohort of patients with SLE corroborating the fact that FI could represent an attractive alternative for the evaluation of antibody titer.Conclusion. Our results represent a major step for automated quantification of IIF ANA, opening attractive perspectives such as rapid sample screening and laboratory standardization.

Current Developments in Diagnostic Assays for Laboratory Confirmation and Investigation of Botulism

2021 ◽  
Author(s):  
Dominick A. Centurioni ◽  
Christina T. Egan ◽  
Michael J. Perry
Keyword(s):  
Gold Standard ◽  
Botulinum Neurotoxin ◽  
Mouse Bioassay ◽  
Environmental Matrices ◽  
Animal Testing ◽  
Gold Standard Method ◽  
Diagnostic Assays ◽  
Technical Performance ◽  
Laboratory Confirmation ◽  
Testing Algorithms

Detection of botulinum neurotoxin or isolation of the toxin producing organism is required for the laboratory confirmation of botulism in clinical specimens. In an effort to reduce animal testing required by the gold standard method of botulinum neurotoxin detection, the mouse bioassay, many technologies have been developed to detect and characterize the causative agent of botulism. Recent advancements in these technologies have led to improvements in technical performance of diagnostic assays; however, many emerging assays have not been validated for the detection of all serotypes in complex clinical and environmental matrices. Improvements to culture protocols, endopeptidase-based assays, and a variety of immunological and molecular methods have provided laboratories with a variety of testing options to evaluate and incorporate into their testing algorithms. While significant advances have been made to improve these assays, additional work is necessary to evaluate these methods in various clinical matrices and to establish standardized criteria for data analysis and interpretation.

Assessment of Clinical Performance during Simulated Crises Using Both Technical and Behavioral Ratings 

1998 ◽  
Vol 89 (1) ◽  
pp. 8-18 ◽  
Author(s):  
David M. Gaba ◽  
Steven K. Howard ◽  
Brendan Flanagan ◽  
Brian E. Smith ◽  
Kevin J. Fish ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Crisis Management ◽  
Clinical Performance ◽  
Assessment Tools ◽  
Rating System ◽  
Ordinal Scale ◽  
Behavioral Ratings ◽  
Technical Performance ◽  
Interrater Variability ◽  
Management Behaviors

Background Techniques are needed to assess anesthesiologists' performance when responding to critical events. Patient simulators allow presentation of similar crisis situations to different clinicians. This study evaluated ratings of performance, and the interrater variability of the ratings, made by multiple independent observers viewing videotapes of simulated crises. Methods Raters scored the videotapes of 14 different teams that were managing two scenarios: malignant hyperthermia (MH) and cardiac arrest. Technical performance and crisis management behaviors were rated. Technical ratings could range from 0.0 to 1.0 based on scenario-specific checklists of appropriate actions. Ratings of 12 crisis management behaviors were made using a five-point ordinal scale. Several statistical assessments of interrater variability were applied. Results Technical ratings were high for most teams in both scenarios (0.78 +/- 0.08 for MH, 0.83 +/- 0.06 for cardiac arrest). Ratings of crisis management behavior varied, with some teams rated as minimally acceptable or poor (28% for MH, 14% for cardiac arrest). The agreement between raters was fair to excellent, depending on the item rated and the statistical test used. Conclusions Both technical and behavioral performance can be assessed from videotapes of simulations. The behavioral rating system can be improved; one particular difficulty was aggregating a single rating for a behavior that fluctuated over time. These performance assessment tools might be useful for educational research or for tracking a resident's progress. The rating system needs more refinement before it can be used to assess clinical competence for residency graduation or board certification.

scholarly journals Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Rebeca Santano ◽  
Diana Barrios ◽  
Fàtima Crispi ◽  
Francesca Crovetto ◽  
Marta Vidal ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Predictive Value ◽  
Diagnostic Tests ◽  
Distress Syndrome ◽  
Clinical Performance ◽  
External Validation ◽  
Severe Respiratory Distress ◽  
Technical Performance ◽  
Severe Respiratory Distress Syndrome

AbstractSerological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and the COVID-19 ELISA IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.

scholarly journals Prevalence of antinuclear autoantibodies in the serum of normal blood dornors

2003 ◽  
Vol 58 (6) ◽  
pp. 315-319 ◽  
Author(s):  
Solange Assuncion Villagra Fernandez ◽  
Alice Zoghbi Coelho Lobo ◽  
Zilda Najjar Prado de Oliveira ◽  
Ligia Maria Ichimura Fukumori ◽  
Alexandre Marques Périgo ◽  
...  
Keyword(s):  
Indirect Immunofluorescence ◽  
Clinical Condition ◽  
Blood Donors ◽  
Antinuclear Antibodies ◽  
Normal Blood ◽  
Healthy Population ◽  
Age Group ◽  
Immunofluorescence Technique ◽  
Antinuclear Autoantibodies ◽  
Indirect Immunofluorescence Technique

OBJECTIVE:To examine the presence of serum antinuclear autoantibodies in a healthy population. METHODS: Serum of 500 normal blood donors between 18 and 60 years of age were tested for the presence of autoantibodies. Antinuclear antibodies were detected by indirect immunofluorescence technique using HEp-2 epithelial cells as the substrate. The presence of dnaN was detected by indirect immunofluorescence technique using Critidia lucillae as the substrate. Anti-SSA (RO), anti-SSB (LA), anti-Sm, and anti-RNP were determined by double radial immunodiffusion. RESULTS: In the evaluation of the presence of serum antibodies, antinuclear antibodies were detected in 22.6% of the sera. The presence of other antibodies was not significant. The majority of the titers were 1:40. CONCLUSION: The presence of autoantibodies is not necessarily pathologic and has to be related to the age group, gender, and clinical condition of the patient.

scholarly journals Antinuclear antibody patterns by indirect immunofluorescence test: An experience from a rural tertiary health centre of Puducherry, South India

2021 ◽  
Vol 8 (3) ◽  
pp. 260-262
Author(s):  
Udhayasankar Ranganathan ◽  
Gopal Rangasamy ◽  
Mangaiyarkarasi Thiyagarajan ◽  
Sunil Shivekar
Keyword(s):  
Autoimmune Diseases ◽  
Indirect Immunofluorescence ◽  
South India ◽  
Health Centre ◽  
Connective Tissue Diseases ◽  
Care Hospital ◽  
Gold Standard Method ◽  
Geographical Regions ◽  
The Common ◽  
The Mean

Anti-nuclear antibodies (ANA) are known to be associated with autoimmune diseases and most commonly with connective tissue diseases (CTD). Screening for ANA is the first investigation of choice in the diagnosis of autoimmune diseases and indirect immunofluorescence (IIF) test using Hep-2 cells has been considered the gold standard method. The prevalence of autoimmune diseases and hence the ANA positivity and ANA IIF patterns differ in various geographical regions. This study was aimed to estimate the ANA positivity rates among patients with suspected or confirmed auto immune diseases and to determine the common ANA IIF patterns in the positive samples.: This is a retrospective study including 235 patients with either clinical suspicion of, or suffering from autoimmune diseases attending a tertiary health care hospital in Puducherry, South India, between November 2018 and April 2020. ANA IIF test (Hep 20-10/ primate liver, Euroimmun, Germany) was performed with 1:100 dilutions of patient serum.The ANA positivity rate was 14.5% (34 out of 235 samples were positive). ANA was positive in 10 (13.3%) males and 24 (15%) females. The mean age of ANA positive patients were 43.4 years.The most common pattern was nucleus fine granular (n=8) followed by cytoplasm fine granular (n=7) and centromere (n=4).A significant ANA positivity rate was found in our study and a detailed clinical study has to be conducted to draw further conclusions.

scholarly journals Electronic clinical quality measure reporting challenges: findings from the Medicare EHR Incentive Program’s Controlling High Blood Pressure Measure

2017 ◽  
Vol 25 (2) ◽  
pp. 127-134 ◽  
Author(s):  
Dawn M Heisey-Grove ◽  
Hilary K Wall ◽  
Janet S Wright
Keyword(s):  
Blood Pressure ◽  
Quality Improvement ◽  
Health Care Professionals ◽  
Clinical Performance ◽  
Care Delivery ◽  
Quality Measure ◽  
Fee For Service ◽  
Clinical Quality ◽  
Practice Level ◽  
Technical Performance

Abstract Objective To identify physician and practice characteristics associated with high clinical and technical performance on the electronic clinical quality measure (eCQM) that calculates the proportion of patients with hypertension who have controlled blood pressure. Materials and Methods The study included 268 602 physicians participating in the Medicare Electronic Health Record Incentive Program between 2011 and 2014. Independent variables included delivery reform participation and physician, practice level, and area characteristics. Successful technical performance was a reported eCQM with non-zero values in both the numerator and denominator. Successful clinical performance was a reported eCQM value of ≥70% hypertension control. Results Physicians with longer experience using certified health information technology, participants in delivery reform programs, and specialists that traditionally manage hypertension were 5%–15% more likely to achieve 70% control. Physicians in smaller and rural practices and a subset of physicians unlikely to primarily manage hypertension were more likely to submit measures with a zero value in either the numerator or denominator. Discussion More physicians are using eCQMs to track and report their quality improvement efforts. This research presents the first examination of national eCQM data to identify physician and practice-level characteristics associated with performance. Conclusion With careful selection of measures relevant to the clinician’s specialty, complete data entry, and support for continuous quality improvement, health care professionals can excel technically and clinically. As care delivery transitions from fee-for-service to quality- and value-based models, high performers may realize financial gains and better patient outcomes. These analyses suggest patterns that may inform steps to improve performance.

scholarly journals Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays

2021 ◽  
Author(s):  
Rebeca Santano ◽  
Diana Barrios ◽  
Fàtima Crispi ◽  
Francesca Crovetto ◽  
Marta Vidal ◽  
...  
Keyword(s):  
Positive Predictive Value ◽  
Predictive Value ◽  
Diagnostic Tests ◽  
Distress Syndrome ◽  
Clinical Performance ◽  
External Validation ◽  
Severe Respiratory Distress ◽  
Technical Performance ◽  
Severe Respiratory Distress Syndrome

AbstractSerological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.

scholarly journals An Automatic Indirect Immunofluorescence Cell Segmentation System

2014 ◽  
Vol 2014 ◽  
pp. 1-13 ◽  
Author(s):  
Yung-Kuan Chan ◽  
Der-Chen Huang ◽  
Kuo-Ching Liu ◽  
Rong-Tai Chen ◽  
Xiaoyi Jiang
Keyword(s):  
Indirect Immunofluorescence ◽  
Correct Diagnosis ◽  
Control Cell ◽  
Cell Counting ◽  
Cell Segmentation ◽  
Population Doubling ◽  
Inspection System ◽  
Cell Detection ◽  
Automatic Inspection ◽  
Antinuclear Autoantibodies

Indirect immunofluorescence (IIF) with HEp-2 cells has been used for the detection of antinuclear autoantibodies (ANA) in systemic autoimmune diseases. The ANA testing allows us to scan a broad range of autoantibody entities and to describe them by distinct fluorescence patterns. Automatic inspection for fluorescence patterns in an IIF image can assist physicians, without relevant experience, in making correct diagnosis. How to segment the cells from an IIF image is essential in developing an automatic inspection system for ANA testing. This paper focuses on the cell detection and segmentation; an efficient method is proposed for automatically detecting the cells with fluorescence pattern in an IIF image. Cell culture is a process in which cells grow under control. Cell counting technology plays an important role in measuring the cell density in a culture tank. Moreover, assessing medium suitability, determining population doubling times, and monitoring cell growth in cultures all require a means of quantifying cell population. The proposed method also can be used to count the cells from an image taken under a fluorescence microscope.

Clinical and technical evaluation of the ACS:OV serum assay and comparison with three other CA125-detecting assays

2003 ◽  
Vol 40 (6) ◽  
pp. 663-673 ◽  
Author(s):  
Elvira M Davelaar ◽  
Eltjo MJ Schutter ◽  
Silvia von Mensdorff-Pouilly ◽  
Gerard J van Kamp ◽  
Rob A Verstraeten ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Clinical Performance ◽  
Uterine Disease ◽  
Serum Samples ◽  
Ovarian Disease ◽  
Technical Performance ◽  
Serum Assay ◽  
Benign Ovarian Tumours ◽  
Patient Groups

Background: In this study the clinical and technical performance of the CA125- detecting Bayer ACS:OV immunoluminometric serum assay was compared with three other well-established CA125-detecting assays. Methods: A total of 1112 serum samples was included in this evaluation: 462 from apparently healthy women, 153 from patients with benign ovarian disease, 163 from patients with malignant ovarian disease, 10 from patients with borderline ovarian malignancies and 78 samples from 12 ovarian cancer patients during monitoring of disease. Serum samples from women with malignant endometrial ( n = 68) and colon ( n = 32) diseases were also included. Moreover, serum samples from women with benign uterine disease and endometriosis ( n = 136) plus 10 serum samples from men ( n = 7) and women ( n = 3) with human anti-mouse antibodies (HAMA) after immunoscintigraphy were included. All samples were tested in duplicate with the Bayer ACS:OV, the Centocor CA125 II, the Abbott IMx CA125 and the Roche (formerly Boehringer Mannheim) Enzymun-Test® CA125 II assays. Results: The clinical performance of the Bayer ACS:OV assay, assessed in various patient groups, was similar to that of the two other automated assays. In serum from patients with benign diseases the highest values were found in patients with benign ovarian tumours. In the ovarian cancer patients followed during the course of disease we found similar marker patterns with all four assays. In contrast to the Roche Enzymun-CA125 II assay and to a lesser extent the Centocor CA125 II assay, the Bayer ACS:OV assay was less sensitive to interference from HAMA. Conclusion: The Bayer ACS:OV assay is a precise and reliable test for the quantification of CA125 in serum.

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