BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Overview
The BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM is a fully automated, random access multiplex immunoassay system designed for clinical laboratories. It is not an AI tool for a physician directory, but rather a sophisticated in vitro diagnostic (IVD) system with integrated software to aid in the diagnosis of systemic autoimmune diseases and other conditions.
The system utilizes multiplex bead technology to simultaneously detect and differentiate multiple autoantibodies and other analytes from a single patient sample, improving workflow efficiency and turnaround time compared to traditional single-analyte methods. The Medical Decision Support Software (MDSS) is an optional feature that employs an interpretive software algorithm, specifically a k-Nearest Neighbor (kNN) algorithm, to associate patient antibody results with predefined profiles correlated with specific connective tissue diseases such as Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Sjögren’s Syndrome (SS), Scleroderma (Systemic Sclerosis), and Polymyositis. This provides clinicians with valuable, actionable information to support faster diagnoses and improved patient outcomes.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Fully automated random access system
- Multiplex immunoassay technology (up to 25 analytes per tube)
- Medical Decision Support Software (MDSS) with interpretive algorithm (kNN)
- High throughput (up to 1200-1400 patient results per hour)
- Simultaneous detection of multiple autoantibodies and analytes
- Reduced hands-on time and labor costs
- Internal quality control beads for reliable results
- Consolidation of autoimmune, infectious disease, and vitamin D testing
- Interfaces with Laboratory Information Systems (LIS)
- Aids in diagnosis of systemic autoimmune diseases
Use Cases
- Screening and diagnosis of systemic lupus erythematosus (SLE)
- Diagnosis of mixed connective tissue disease (MCTD)
- Diagnosis of Sju00f6gren's syndrome (SS) and scleroderma
- Detection of autoantibodies for vasculitis, rheumatoid arthritis, and celiac disease
- Testing for infectious diseases (e.g., HIV, Syphilis, EBV, ToRC)
- Vitamin D testing
What Physicians Need to Know
The BioPlex 2200 ANA Screen with MDSS serves as a valuable aid in the diagnosis of systemic autoimmune diseases. Physicians should interpret MDSS associations in conjunction with clinical findings and other laboratory tests, as the software provides potential disease classifications based on autoantibody profiles. The ability to detect multiple clinically relevant autoantibodies simultaneously and receive interpretive guidance can help streamline the diagnostic process for conditions like SLE, MCTD, Sju00f6gren's Syndrome, Scleroderma, and Polymyositis, potentially leading to faster diagnoses and improved patient outcomes.
The BioPlex 2200 System is a fully automated, multiplex platform that integrates ANA screening and follow-up testing into a single step. This integration significantly enhances laboratory efficiency by reducing hands-on time, improving throughput, and optimizing the management of ANA workloads. Its design allows for seamless incorporation into existing laboratory workflows, minimizing the need for multiple test methods and manual processes, thereby reducing operational costs and improving overall turnaround time for results.
Details
| Category | Clinical Decision Support & Reference, Lab & Diagnostics |
| Pricing | Contact for pricing |
| Deployment | On-premise (clinical laboratories, hospitals, national reference laboratories, public health laboratories) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The device, including the Medical Decision Support Software (MDSS), received FDA marketing clearance (K043341) on October 27, 2005. It is cleared for correlating patient antibody results with specific autoimmune diseases, making it the first product of its kind to be FDA-cleared for this purpose. |
| Integrations | |
| EHR | Not specified |
| Specialties | Infectious Disease, Laboratory Medicine, Rheumatology |
What the Web Says
The BioPlex 2200 ANA Screen with Medical Decision Support Software (MDSS) is a fully automated, multiplexed system designed to detect and differentiate clinically relevant antinuclear antibodies (ANA) to aid in the diagnosis of systemic autoimmune diseases. It offers faster turnaround times and can provide up to 14 individual results per test, including a composite ANA screen and up to 13 specific ANA analytes. The MDSS is an optional feature that uses an interpretive algorithm to associate patient antibody results with specific autoimmune diseases, providing valuable diagnostic information to physicians.
Overall: PositiveStrengths
- Faster result turnaround time due to multiplex technology, potentially leading to quicker diagnoses and improved patient outcomes.
- Provides multiple results per test (up to 14 individual results), streamlining ANA screening and follow-up testing in one step.
- Medical Decision Support Software (MDSS) offers interpretive algorithms to associate antibody profiles with specific autoimmune diseases, a feature not previously available in clinical diagnostic systems.
- High throughput capability, processing up to 1200-1400 results per hour, which can reduce hands-on time and labor costs.
- Improved sensitivity compared to traditional IIF on HEp-2 cells for detecting clinically relevant autoantibodies.
- Reduces operational costs by minimizing the need for separate follow-up tests and expanding in-house testing menus.
Limitations
- Some studies show discrepancies between BioPlex 2200 ANA screening and IIF ANA screening results, although concordance is good for specific anti-dsDNA and anti-ENA antibodies.
- A particular concern for some users was that the system does not provide an IIF pattern and titer, which is a traditional method for ANA detection.
- The BioPlex 2200 has a lower positive rate than IIF for autoantibody screening in healthy subjects.
Based on reviews from: Bio-Rad, PubMed, ResearchGate, BioSpace, myadlm.org, accessdata.fda.gov, Clinical Pathology Laboratories
Last updated: 2026-07-17
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