Evaluation of Anti-neutrophil Cytoplasm Antibodies Test

Evaluation of ANCA Testing by Antigen Specific Assays in Small Vessel Vasculitis

Anti-neutrophil cytoplasm antibodies (ANCA) are defined as important serological markers for the diagnosis of some forms of small vessel vasculitis, including granulomatosis with polyangiitis (GPA) , microscopic polyangiitis(MPA) and to a lesser extent Churg -Strauss syndrome or Eosinophilic granulomatosis with polyangiitis (EGPA).So they are called ANCA-associated vasculitis(AAV).

An international consensus statement for ANCA testing statement was issued in 2017 and states that the antigen specific immunoassays can be used for the accurate diagnosis of ANCA-associated vasculitis without the need for indirect immunofluorescence(IIF). In the present study we will test whether the antigen specific assays screening is a valuable alternative to IIF confirming with immunoassay for the diagnosis of AAV on a number of patients and controls.

Aim To evaluate the performance of the recommended strategy for the detection of ANCA based on screening with antigen specific immunoassays on a number of AAV patients and relevant disease controls In Kagawa university hospital (rheumatology department).

Patients and methods This is a prospective study will be conducted at the department of rheumatology in Kagawa university hospital in which consecutive samples will be included from patients suspected to have AAV; patients subsequently identified as having AAV will be included as AAV patients, while patients in which the diagnosis AAV is rejected, will be included as disease controls. PR3-and MPO-ANCA will be performed using assays from Medical & Biological Laboratories Co (Anchor CLEIA) isayama.takuya@mbl.co.jp

Study Overview

• Status: Unknown
• Conditions: Immunological Testing in Small-vessel Vasculitis
• Intervention / Treatment: Diagnostic test: Indirect immunofluorescence (IIF) , myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays

Detailed Description

To evaluate the performance of the recommended strategy for the detection of ANCA based on screening with antigen specific immunoassays on a number of AAV patients and relevant disease controls (i. e., patients for whom ANCA would be requested in the context of small-vessel vasculitis such as patients with infections, drug-induced diseases, connective tissue disease, etc.).

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Japan
  • Kagawa
    • Miki, Kagawa, Japan, 761-0793
      • Kagawa univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

.All patients included must be older than 18 years and able to give informed consent.

• Classification criteria and nomenclature for AAV are from the American College of Rheumatology
• Serum sampling should be done before initiation of immunosuppressive treatment or no later than 2 weeks after onset of low-medium dose of immunosuppressive treatment (but this should be documented)

Exclusion Criteria:

.Patients younger than 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases with ANCA vasculitis; Indirect immunofluorescence (IIF) will be performed as well as myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays and evaluated	Diagnostic test: Indirect immunofluorescence (IIF) , myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays; Measurement and evaluation of the ANCA testing
Controls with autoimmune diseases other than ANCA vasculitis; Indirect immunofluorescence (IIF) will be performed as well as myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays and evaluated	Diagnostic test: Indirect immunofluorescence (IIF) , myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays; Measurement and evaluation of the ANCA testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-proteinase 3 antibody (PR3), anti-myeloperoxidase (MPO) antibody presence in patients with small-vessel vasculitis versus patients without vasculitis	Antibodies are detected using chemiluminescent enzyme immunoassay (CLEIA).Values above 3.5 u/ml are considered positive	within two weeks of immunosuppressive treatment not after that

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Mai Mansour, Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: ANCA vasculitis, ANCA testing, antigen specific essays, IIF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Vasculitis; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: ANCA testing evaluation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No