Applying the latest IVD technology, Hotgen’s CLIA reagents deliver top-level precision diagnostics to medical institutions of all sizes. The mono-test CLIA cartridges are specifically designed and manufactured to resolve the onboard stability issue of IVD products. The Chemiluminescence Immunoassay products including CLIA analyzers and the Chemiluminescence Immunoassay Kit will enhance laboratory performances in terms of both precision and economy. Boasting strong innovation power and manufacturing capacity, Hotgen is providing over 110 diagnostic parameters, covering over 20 major panels.
| NO. | Panel | Parameter | Registration certificate | Sample type |
| 1 | Cardiac | hs–CTnT | CE lVDR | S/P/WB |
| hs–CTnl | NMPA, CE IVDR | S/P/WB | ||
| CK–MB | NMPA, CE lVDR | S/P/WB | ||
| MYO | NMPA, CE lVDR | S/P/WB | ||
| H–FABP | NMPA, CE | S/P/WB | ||
| Lp–PLA2 | NMPA, CE | S/P/WB | ||
| NT–proBNP | NMPA, CE lVDR | S/P/WB | ||
| BNP | NMPA, CE lVDR | S/P/WB | ||
| ST2 | NMPA | S/P/WB | ||
| CTnl | NMPA | S/P/WB | ||
| D–Dimer | NMPA, CE lVDR | P/WB | ||
| 2 | Inflammation | PCT | NMPA, CE lVDR | S/P/WB |
| PCTm | NMPA | WB | ||
| CRP | NMPA, CE lVDR | S/P/WB | ||
| lL–6 | NMPA, CE lVDR | S/P/WB | ||
| 3 | Tumor | CEA | NMPA, CE lVDR | S/P |
| CA125 | NMPA, CE lVDR | S/P | ||
| HE4 | NMPA, CE lVDR | S/P | ||
| CYFRA21–1 | NMPA, CE lVDR | S/P | ||
| CA15–3 | NMPA, CE lVDR | S/P | ||
| CA242 | NMPA, CE lVDR | S | ||
| CA19–9 | NMPA, CE lVDR | S/P | ||
| CA72–4 | NMPA, CE lVDR | S/P | ||
| CA50 | NMPA | S/P | ||
| NSE | NMPA, CE lVDR | S | ||
| proGRP | NMPA, CE lVDR | S/P | ||
| SCCA | NMPA, CE lVDR | S/P | ||
| tPSA | NMPA, CE lVDR | S/P | ||
| VEGF | NMPA | S | ||
| fPSA | CE | S | ||
| TK1 | NMPA | S/P | ||
| 4 | Liver Disease | AFP | NMPA, CE lVDR | S/P |
| AFP–L3% | NMPA, CE | S/P | ||
| DCP | NMPA, CE | S | ||
| GP73 | NMPA, CE | S/P | ||
| CK18–M30 | NMPA | S | ||
| CK18–M65 | NMPA | S | ||
| 5 | Gastric Function | G–17 | NMPA, CE lVDR | S/P |
| PGl | NMPA, CE lVDR | S/P | ||
| PGll | NMPA, CE lVDR | S/P | ||
| 6 | Renal Function | NGAL | NMPA, CE | S/Urine |
| CYsC | NMPA, CE | S/P/WB | ||
| β2–MG | ||||
| 7 | Brain Injury | S100 | NMPA | S |
| 8 | Anemia | Ferr | NMPA, CE lVDR | S/P |
| VB12 | NMPA, CE lVDR | S/P | ||
| FA | NMPA, CE lVDR | S/P | ||
| 9 | Thyroid | TSH | NMPA, CE lVDR | S/P |
| TT4 | NMPA, CE lVDR | S/P | ||
| TT3 | NMPA, CE lVDR | S/P | ||
| FT4 | NMPA, CE lVDR | S/P | ||
| FT3 | NMPA, CE lVDR | S/P | ||
| Anti–TG | NMPA, CE lVDR | S/P | ||
| Anti–TPO | NMPA, CE lVDR | S/P | ||
| TG | NMPA, CE lVDR | S/P | ||
| 10 | Immunoglobulins | lgE | CE | S/P |
| 11 | Sex Hormone | FSH | NMPA, CE lVDR | S/P |
| E2 | NMPA, CE lVDR | S/P | ||
| T | NMPA, CE lVDR | S/P | ||
| P | NMPA, CE lVDR | S/P | ||
| LH | NMPA, CE lVDR | S/P | ||
| PRL | NMPA, CE lVDR | S/P | ||
| AMH | NMPA, CE lVDR | S | ||
| β–HCG | NMPA, CE lVDR | S/P | ||
| lnhibin B | CE | |||
| 12 | Growth Hormone | GH | NMPA, CE lVDR | S/P |
| lGFBP–3 | NMPA, CE lVDR | S/P | ||
| lGF–1 | ||||
| 13 | Diabetes | HbA1c | NMPA, CE lVDR | WB |
| C–P | NMPA, CE | S/P | ||
| lNS | NMPA, CE | S/P | ||
| ADP | NMPA | S/P | ||
| GADA | NMPA, CE lVDR | S/P | ||
| lA–2A | NMPA, CE lVDR | S/P | ||
| lAA | NMPA, CE lVDR | S/P | ||
| lCA | NMPA, CE lVDR | S/P | ||
| 14 | Hypertension | Cortisol | NMPA, CE | S/P/Urine |
| ALD | NMPA, CE | S/P | ||
| Renin | NMPA, CE | P | ||
| ACTH | NMPA | P | ||
| 15 | Bone Metabolism | 25–OH–VD | NMPA, CE lVDR | S/P |
| PTH | NMPA, CE | S/P | ||
| BGP | NMPA, CE | S/P | ||
| Total P1NP | NMPA | S/P | ||
| β–CTx | NMPA | S/P | ||
| 16 | Rheumatoid Arthritis | Anti–CCP | NMPA, CE lVDR | S/P |
| RF–lgA | NMPA | S/P | ||
| RF–lgM | NMPA | S/P | ||
| RF–lgG | NMPA | S/P | ||
| 17 | Cytokine | lL–2 | NMPA, CE | S |
| lL–4 | NMPA | S/P | ||
| lL–5 | NMPA | S | ||
| lL–8 | NMPA, CE | S | ||
| lL–10 | NMPA, CE | S | ||
| lL–1β | NMPA, CE | S | ||
| TNFα | NMPA, CE | S | ||
| lL–2R | NMPA,CE lVDR | S/P | ||
| lL–17A | NMPA | S/P | ||
| lFN–γ | NMPA, CE | S/P | ||
| lL–12p70 | NMPA | S | ||
| lL–22 | NMPA | S | ||
| 18 | TORCH | Toxo lgG | ||
| Toxo lgM | ||||
| RUB lgG | ||||
| RUB lgM | ||||
| CMV lgG | ||||
| CMV lgM | ||||
| HSV–1/2 lgG | ||||
| HSV–1/2 lgM | ||||
| HSV–1 lgG | ||||
| HSV–1 lgM | ||||
| HSV–2 lgG | ||||
| HSV–2 lgM | ||||
| 19 | STAT | PCT STAT | NMPA | S/P/WB |
| H–FABP STAT | NMPA | S/P/WB | ||
| NGAL STAT | NMPA | S | ||
| MYO STAT | NMPA | S/P/WB | ||
| BNP STAT | NMPA | P/WB | ||
| lL–6 STAT | NMPA | S/P/WB | ||
| D–Dimer STAT | NMPA | P/WB | ||
| NT–proBNP STAT | NMPA | S/P/WB | ||
| hs–CTnl STAT | NMPA | S/P/WB | ||
| CK–MB STAT | NMPA | S/P/WB | ||
| 20 | Infectious Disease | HBsAg | ||
| HCV–Ab | ||||
| HlV–Ab/Ag | ||||
| TP–Ab | ||||
| 21 | Tuberculosis (TB-IGRA) | Protein extraction reagent | NMPA, CE lVDR | WB |
| lFN–γ | NMPA, CE | S/P | ||
Using together with the MQ60 CLIA analyzer, the reagent in Hotgen CLIA test kit is capable to convey high-precision diagnostics, including cardiovascular diseases, inflammation, cancers, hormone diseases, diabetes, rheumatoid arthritis, brain injury, and etc. The number of testing parameters is ever increasing, currently at over 100.
Storage conditions: 2-8℃ cold chain storage and shipment
Shelf life: 12 months
Discover the precision and reliability of Hotgen IVD products. Contact us today to enrich your product portfolio & enhance your diagnostic capabilities and patient care.
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