• High-Throughput Dual-Mode Testing
Supports both CLIA and DLCM, delivering up to 300-400 tests/hour in CLIA mode and up to 2000 tests/hour in DLCM mode for maximum laboratory efficiency.
• Fast and Reliable Results
Provides rapid turnaround with a first report time of 21 (CLIA)/37 (DLCM) minutes, one stop complete solution for auto-antibody detection.
• Scalable Modular Connectivity
Modular connection of up to 4 units, and build the World's 1st Autoimmune Dx Streamline -seamless integration with PATHVIZON F7 or TLA-ready laboratory setup.
| Panel | Test Item | |
| CLIA (Autoimmune Diagnostics) | CTD | dsDNA, Nucleosome, Histone, CENP-B, Sm, P0, SS-A/Ro52kD, SS-A/Ro60kD, SS-B/La, PCNA, AMA M2, Scl-70, U1-snRNP, Jo-1, PM-Scl, *Mi-2, *Ku, Clq |
| RA | CCP, MCV, *RA33 | |
| APS | β2GP1 (IgG, IgM, IgA, Screen), Cardiolipin (IgG, IgM, IgA, Screen), β2GP1-D1-IgG, aPS/PT (IgG, IgM) | |
| Vasculitis | MPO, PR3, GBM | |
| Myositis | MDA5 | |
| Diabetes | GAD, IA2, ICA, IAA, *Zn8 | |
| CLIA (Specialized Assay Menu) | Tuberculosis | TB-IGRA |
| Alzheimer's Disease | pTau-181, Aβ 1-40, Aβ1-42, *pTau-217, *GFAP, *Nfl | |
| Metabolism | T1DM: Anti-GAD, Anti-IA2, Anti-ICA, Anti-IAA; *Vit-D | |
| Respiratory & Lung Diseases | M. Pneumonia IgM/IgG, C. Pneumonia IgM/IgG, *KL-6 | |
| Liver Diseases | *AFP, *AFP-L3, *PIVKA/DCP, *HBCrAg, *GPC-3, *ELF | |
| Cytokines | IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IFN-α, IFN-γ, TNFα, *IL-2R, *IL-18 | |
| DLCM | ANA, Antinuclear Antibody | dsDNA, Nucleosome, Histone, CENP-B, Sm, P0, SS-A/Ro52kD, SS-A/Ro60kD, SS-B/La, PCNA, AMA M2, Scl-70, U1-snRNP, Jo-1, PM-Scl, *Mi-2, *Ku |
| RA, Rheumatoid arthritis | CCP, MCV, *RA33 | |
| ANCA, Vasculitis | MPO, PR3, GBM | |
| ALD, Autoimmune Liver Disease | AMA M2, sp100, gp210, LKM-1, LC-1, SLA/LP, SS-A/Ro52kD | |
| MYO, Myositis | TIF1γ, MDA5, NXP2, SAE1, PM-Scl100, PM-Scl75, Jo-1, SRP, PL-7, PL-12, EJ, OJ, SS-A/Ro52kD, HMGCR, *Ku |
*ongoing
Specification | Details |
Testing Speed (CLIA) | Single module: 400 tests/hr; Cascaded: Up to 1600 tests/hr |
Testing Speed (DLCM) | Single module: 100 tests/hr; Cascaded: Up to 400 tests/hr |
Sample Capacity | 600 samples (dual-layer, 30 sample racks per layer) |
Reagent Capacity | 36 CLIA positions, 18 multi-plex positions |
Reagent Refrigeration | Set at 5°C (deviation within ±3°C) |
Incubation Temp | Set at 37°C (deviation within ±0.5°C) |
Reaction Cup Capacity | 3000 cups per analysis host module |
Dimensions (L x W x H) | 1880 mm x 1140 mm x 1280 mm |
Weight | Host Module: 450 kg; Sample Management Module: 120 kg |
Cat. No. | Product Name | Spec. | Certificate |
C2011 | PATHVIZON X50 | 1 set | NMPA |