Evaluation of Anti-neutrophil Cytoplasm Antibodies Test
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Anti-proteinase 3 antibody (PR3), anti-myeloperoxidase (MPO) antibody presence in patients with small-vessel vasculitis versus patients without vasculitis [within two weeks of immunosuppressive treatment not after that]
Antibodies are detected using chemiluminescent enzyme immunoassay (CLEIA).Values above 3.5 u/ml are considered positive
Eligibility Criteria
Criteria
Inclusion Criteria:
.All patients included must be older than 18 years and able to give informed consent.
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Classification criteria and nomenclature for AAV are from the American College of Rheumatology
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kagawa univeristy | Miki | Kagawa | Japan | 761-0793 |
Sponsors and Collaborators
- Sohag University
Investigators
- Principal Investigator: Mai Mansour, Sohag University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANCA testing evaluation