FIA Analyzer
| Product Class | Test Item | Specimen Type | Reaction Time | Linear Range | Qualification |
|---|---|---|---|---|---|
| Cardiac Markers | cTnI | WB/Plasma | 15 min | 0.05-50ng/mL | NMPA CH ISO13485 |
| Myo | Serum/Plasma | 15 min | 2.5-400ng/mL | NMPA CH ISO13485 | |
| CK-MB | Serum/Plasma | 15 min | 1-80ng/mLL | NMPA CH ISO13485 | |
| D-Dimer | WB/Plasma | 3 min | 0.1-10mg/mL | NMPA CH ISO13485 | |
| NT-proBNP | WB/ Serum/Plasma | 15 min | 15-35000pg/mL | NMPA CH ISO13485 | |
| 3 in 1(cTnI/CK-MB/Myo) | WB/Plasma | 15 min | Same as individual item | NMPA CH ISO13485 | |
| 5 in 1 (cTnI/ CK-MB/Myo/D-Dimer/NT-proBNP) | WB | 15 min | Same as individual item | NMPA CH ISO13485 | hFABP | Serum/Plasma | 15 min | 2-120ng/mL | NMPA CH ISO13485 | HCY | Plasma | 15 min | 3-50μmol/L | NMPA ISO13485 |
| BNP | WB/Plasma | 10 min | 10-5000pg/mL | NMPA ISO13485 | |
| ST2 | Serum | 15 min | 2-200.0ng/mL | ISO13485 | |
| Lp-PLA2 | WB/ Serum/Plasma | 10 min | 5-800.0ng/mL | ISO13485 | |
| Hormones Markers | β-HCG | Serum/Plasma | 10 min | 5-200000mIU/mL | NMPA CH ISO13485 |
| PROG | Serum | 10 min | 0.3-80ng/mL | NMPA CH ISO13485 | |
| TES | Serum | 10 min | 0.2-20ng/mL | NMPA CH ISO13485 | |
| FSH | Serum | 10 min | 1-200mIU/mL | NMPA CH ISO13485 | |
| LH | Serum | 10 min | 1-200mIU/mL | NMPA CH ISO13485 | |
| PRL | Serum | 10 min | 1-4000μIU/mL | NMPA CH ISO13485 | |
| PRL | Serum | 10 min | 1-4000μIU/mL | NMPA CH ISO13485 | |
| E2 | Serum | 10 min | 10-3000pg/mL | NMPA CH ISO13485 | |
| 3 in 1(FSH/LH/PRL) | Serum | 10 min | Same as individual item | NMPA CH ISO13485 | |
| AMH | Serum/Plasma | 10 min | 0.1-25ng/mL | CH ISO13485 | |
| Inflammation Markers | PCT | WB/Serum/Plasma | 15 min | 0.1-100ng/mL | NMPA CH ISO13485 |
| CRP | WB/Serum/Plasma | 3 min | 0.5-200mg/L | NMPA CH ISO13485 | |
| SAA | WB/Serum/Plasma | 3 min | 1-200mg/L | NMPA CH ISO13485 | |
| CRP/SAA | WB/Serum/Plasma | 3 min | CRP:5.0-200mg/L SAA:1.0-200mg/L | NMPA CH ISO13485 | |
| Total IgE | WB/Serum/Plasma | 12 min | 1-1000IU/mL | CH ISO13485 | |
| IL-6 | Plasma/Serum | 15 min | 5-1000pg/mL | ISO13485 | |
| Thyroid | TSH | Plasma/Serum | 20 min | 0.4-100μIU/mL | NMPA CH ISO13485 |
| TT3 | Serum | 15 min | 0.5-10nmol/L | NMPA CH ISO13485 | |
| TT4 | Plasma/Serum | 15 min | 10-320nmol/L | NMPA CH ISO13485 | |
| Diabetes and Renal Injury Markers | HbA1c | WB | 5 min | 4-15% | NMPA CH ISO13485 NGSP |
| MAU | Urine | 10 min | 2-300mg/L | NMPA CH ISO13485 | |
| NGAL | Urine | 10 min | 10-5000ng/mL | NMPA CH ISO13485 | |
| CysC | WB /Plasma | 5 min | 0.2-8mg/L | NMPA CH ISO13485 | |
| Health Check | Ferr | Serum | 15 min | 1-1000ng/mL | NMPA CH ISO13485 |
| 25(OH)-D | WB | 10 min | 5-120ng/mL | NMPA CH ISO13485 | |
| Tumor Markers | CEA | Serum/Plasma | 10 min | 0.5-500ng/mL | CH ISO13485 |
| AFP | Serum/Plasma | 10 min | 3-2000ng/mL | CH ISO13485 | |
| CEA/AFP | Serum/Plasma | 10 min | Same as individual item | CH ISO13485 | |
| tPSA | Serum | 15 min | 0.5-200ng/mL | CH ISO13485 | |
| fPSA | Serum | 15 min | 0.2-30ng/mL | CH ISO13485 | |
| PGI | Serum | 15 min | 1-200ng/mL | CH ISO13485 | |
| PGII | Serum | 15 min | 0.5-200ng/mL | CH ISO13485 | |
| PGI/PGII | Serum | 15 min | Same as individual item | CH ISO13485 | |
| Infectious Disease | HBsAg | Serum/Plasma | 10 min | 0.5-250IU/mL | ISO13485 |
| HCV | Serum/Plasma | 10 min |
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