Dataset Information

Immediate determination of ACPA and rheumatoid factor--a novel point of care test for detection of anti-MCV antibodies and rheumatoid factor using a lateral-flow immunoassay.

ABSTRACT:

Introduction

Autoantibodies against mutated and citrullinated vimentin (MCV) represent a novel diagnostic marker for rheumatoid arthritis (RA). Recently, an increased sensitivity for anti-MCV compared to autoantibodies against cyclic citrullinated peptides (anti-CCP2) was shown in cohorts of patients with early RA and established disease.The aim of this study was to develop and evaluate a point of care test (POCT) for detection of anti-MCV antibodies immediately at the first visit or at the bed side.

Methods

A lateral-flow immunoassay was developed for simultaneous detection of anti-MCV antibodies and rheumatoid factor (RF-IgG) and evaluated in a prospective setting. Analyses were performed from whole blood samples of patients with seropositive RA (n=108), seronegative RA as well as other rheumatic disorders (n=122), and healthy blood donors (n=200) and compared to detection via ELISA.

Results

Using the POCT, anti-MCV antibodies were detected in 54.6% and RF-IgG in 56.5% of patients with RA. Specificity was 99.1% for anti-MCV antibodies and 91.2% for RF-IgG. Compared to ELISA's results, POCT sensitivity was 69.3% for anti-MCV and 55.6% for RF-IgG, specificity was 99.7% and 97.2%, respectively.

Conclusions

This POCT for detection of anti-MCV antibodies and RF-IgG provides high specificity for the diagnosis of RA and is useful in clinical practice due to its simplicity and its reliable performance. This test can greatly improve a timely management of RA and may help in screening patients with suspected RA in non-specialized settings prompting early referrals.

SUBMITTER: Renger F

PROVIDER: S-EPMC2911914 | biostudies-literature | 2010

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Immediate determination of ACPA and rheumatoid factor--a novel point of care test for detection of anti-MCV antibodies and rheumatoid factor using a lateral-flow immunoassay.

Renger Franziska F Bang Holger H Feist Eugen E Fredenhagen Gert G Natusch Alexander A Backhaus Marina M Burmester Gerd-R GR Egerer Karl K

Arthritis research & therapy 20100622 3

<h4>Introduction</h4>Autoantibodies against mutated and citrullinated vimentin (MCV) represent a novel diagnostic marker for rheumatoid arthritis (RA). Recently, an increased sensitivity for anti-MCV compared to autoantibodies against cyclic citrullinated peptides (anti-CCP2) was shown in cohorts of patients with early RA and established disease.The aim of this study was to develop and evaluate a point of care test (POCT) for detection of anti-MCV antibodies immediately at the first visit or at ...[more]

PMID: 20569500

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Project description:The urgent need to scale up testing capacity during the COVID-19 pandemic has prompted the rapid development of point-of-care diagnostic tools such as lateral flow immunoassays (LFIA) for large-scale community-based rapid testing. However, studies of how the general public perform when using LFIA tests in different environmental settings are scarce. This user experience (UX) study of 264 participants in Northern Ireland aimed to gather a better understanding of how self-administered LFIA tests were performed by the general public at home. The UX performance was assessed via analysis of a post-test questionnaire including 30 polar questions and 11 7-point Likert scale questions, which covers the multidimensional aspects of UX in terms of ease of use, effectiveness, efficiency, accuracy and satisfaction. Results show that 96.6% of participants completed the test with an overall average UX score of 95.27% [95% confidence interval (CI) 92.71-97.83%], which suggests a good degree of user experience and effectiveness. Efficiency was assessed based on the use of physical resources and human support received, together with the mental effort of self-administering the test measured via NASA Task Load Index (TLX). The results for six TLX subscales show that the participants scored the test highest for mental demand and lowest for physical demand, but the average TLX score suggests that the general public have a relatively low level of mental workload when using LFIA self-testing at home. Five printed LFIA testing results (i.e. the 'simulated' results) were used as the ground truth to assess the participant's performance in interpreting the test results. The overall agreement (accuracy) was 80.63% [95% CI 75.21-86.05%] with a Kappa score 0.67 [95% CI 0.58-0.75] indicating substantial agreement. The users scored lower in confidence when interpreting test results that were weak positive cases (due to the relatively low signal intensity in the test-line) compared to strong positive cases. The end-users also found that the kit was easier to use than they expected (p < 0.001) and 231 of 264 (87.5%) reported that the test kit would meet their requirements if they needed an antibody testing kit. The overall findings provide an insight into the opportunities for improving the design of self-administered SARS-CoV-2 antibody testing kits for the general public and to inform protocols for future UX studies of LFIA rapid test kits.

Dataset Information

Immediate determination of ACPA and rheumatoid factor--a novel point of care test for detection of anti-MCV antibodies and rheumatoid factor using a lateral-flow immunoassay.

Introduction

Methods

Results

Conclusions

Publications

Immediate determination of ACPA and rheumatoid factor--a novel point of care test for detection of anti-MCV antibodies and rheumatoid factor using a lateral-flow immunoassay.

Similar Datasets

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