Autoimmune disease
Conditions
Interventions
ANA pattern negative:None
ANA single pattern positive:None
ANA compound pattern positive:None
Titer system validation sample:None
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ANA fluorescence image: From January 2023 to September 2025, the ANA screening project was conducted at Renji Hospital. The HEp-2 IFA fluorescence images were obtained through testing and the reports were issued normally: Positive samples: 1) Fluorescence titer = 1:80, meeting the fluorescence pattern interpretation standards of ICAP AC-1 to AC-29; 2) Single pattern positive or more than two compound pattern positive; 3) With clear clinical diagnostic information. Negative samples: 1) Fluorescence titer < 1:80; 2) Meeting the pattern interpretation standard of ICAP AC-0 as negative. 2. The fluorescence image of the HEp-2 cell matrix is clear, the staining is uniform, and there is no overexposure or blurring; 3. The image resolution is = 1920×1080 pixels, and the file format is lossless compression (such as TIFF or PNG); 4. The basic information of the patients corresponding to the samples and the preliminary clinical diagnosis (image acquisition equipment, pattern classification, titer) are recorded completely; 5. The manual interpretation results (pattern classification, titer value) have been independently reviewed and agreed upon by at least two senior laboratory physicians.
Exclusion criteria
Exclusion criteria: 1. The fluorescence images suffer from focusing blurring, uneven staining, cell rupture or background noise interference; 2. The image files are damaged or cannot be fully read; 3. Samples that do not conform to the ICAP AC-0 to AC-29 fluorescence pattern characteristics, unclear clinical diagnoses or controversial manual interpretation results; 4. Key variables (such as titer, karyotype category) are missing; 5. The patient identity information associated with the samples has not been fully anonymized; 6. The source of the samples does not comply with the approval requirements of the hospital's ethics committee regarding the secondary utilization of biological samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Karyotype classification accuracy;Precision;Recall;F1 score;ROC curve and AUC value; | — |
Countries
China
Contacts
Public ContactZheng Bing
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed