BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
BIO-RAD LABORATORIES, INC.The BioPlex 2200 ANA Screen with Medical Decision Support Software (MDSS) is a laboratory tool that assists clinicians by analyzing patterns in antibody test results from human serum or plasma samples. Using AI principles (k-nearest neighbor algorithm), it compares patient antibody profiles against a large database to suggest associations with specific systemic autoimmune diseases such as lupus, scleroderma, Sjögren's syndrome, and polymyositis. This software helps improve diagnostic accuracy and guides additional testing decisions.
Intended Use
The BioPlex 2200 ANA Screen is intended for qualitative screening of specific antinuclear antibodies, quantitative detection of antibody to dsDNA, and semi-quantitative detection of 10 separate antibody assays in human serum and/or EDTA or heparinized plasma, as an aid in diagnosis of systemic autoimmune diseases.
Technology
The MDSS is a pattern recognition algorithm based on the k-nearest neighbor (kNN) statistical technique. It analyzes results of 11 individual antibodies from the BioPlex 2200 ANA Screen, comparing unknown patient results to a database of over 1400 known samples to classify the output into Negative, No Association, or Association with specific disease profiles.
Performance
Clinical testing on 908 rheumatology patients and 222 normal blood donors showed concordance of the MDSS with clinical diagnosis for seven targeted systemic autoimmune diseases. Disease agreement percentages ranged from 67.6% sensitivity and 77.7% specificity overall, to detailed concordance per disease and antibody profiles. The MDSS also showed strong positive likelihood ratios and odds ratios for disease classification support.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/3/2004
10 months - 2
FDA Approval
10/27/2005
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