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Automated Reading of Anti-neutrophil Cytoplasmic Autoantibodies, Indispensable Markers of Vasculitis

Automated Reading of Anti-neutrophil Cytoplasmic Autoantibodies (ANCA), Indispensable Markers of Vasculitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03640078
Acronym
ANCA
Enrollment
2000
Registered
2018-08-21
Start date
2018-10-31
Completion date
2021-04-30
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Diseases

Brief summary

Neutrophil cytoplasmic autoantibodies (ANCA) are essential serum markers in the diagnosis of vasculitis. Indirect immunofluorescence with microscope reading by two readers is the reference technique for their detection. In the AP-HM immunology laboratory we are looking for ANCAs in more than 7000 sera per year. The reading of the slides is time-consuming, dependent operator, and lacks standardization. In order to optimize these parameters, we propose the automation of ANCA reading by using a robotic platform developed in our laboratory and called ICARE (Immunofluorescence for Computed Antibodies Rational Evaluation). This microscopic imaging platform with automated reading is currently used in daily routine for the detection of anti-nuclear autoantibodies. The objective of the project is to establish an algorithm allowing i) to automatically and reproducibly discriminate the positive ANCAs from the negative ANCAs and ii) to propose to the biologist a fluorescence aspect. The investigators will then validate this algorithm on 2000 consecutive routine samples sent to the laboratory for ANCA research. The usual care will not be changed, only a phase of acquisition of the images will be added to the analysis. The investigators expect to use this algorithm ICARE / ANCA in daily hospital routine and thus optimize the results with a real economic impact is 50% less reading time.

Detailed description

Neutrophil cytoplasmic autoantibodies (ANCA) are essential serum markers in the diagnosis of vasculitis. Indirect immunofluorescence with microscope reading by two readers is the reference technique for their detection. In the AP-HM immunology laboratory we are looking for ANCAs in more than 7000 sera per year. The reading of the slides is time-consuming, dependent operator, and lacks standardization. In order to optimize these parameters, we propose the automation of ANCA reading by using a robotic platform developed in our laboratory and called ICARE (Immunofluorescence for Computed Antibodies Rational Evaluation). This microscopic imaging platform with automated reading is currently used in daily routine for the detection of anti-nuclear autoantibodies. The objective of the project is to establish an algorithm allowing i) to automatically and reproducibly discriminate the positive ANCAs from the negative ANCAs and ii) to propose to the biologist a fluorescence aspect. The investigators will then validate this algorithm on 2000 consecutive routine samples sent to the laboratory for ANCA research. The usual care will not be changed, only a phase of acquisition of the images will be added to the analysis. The investigators expect to use this algorithm ICARE / ANCA in daily hospital routine and thus optimize the results with a real economic impact is 50% less reading time. . From a valorisation point of view, this project could be the subject of a publication in an international scientific journal, a patent filing and an exploitation with an industrial partner.

Interventions

OTHERacquisition imaging

The usual care of the sera will not be modified, only a phase of acquisition of the images will be added to the analysis

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Vasculitis patients having signed a consent

Exclusion criteria

* patients refusing to sign a consent

Design outcomes

Primary

MeasureTime frameDescription
The number of positive ANCAs1 dayThe number of positive ANCAs detected in order to automatically and reliably discriminate against positive ANCAs from negative ANCAs

Countries

France

Contacts

Primary ContactDANIEL BERTIN, MD
Daniel.BERTIN@ap-hm.fr+33 049386049

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026