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 CLIA products will enhance laboratory performances in terms of both precision and economy. Boasting strong innovation power and manufacturing capacity, Hotgen is providing over 100 diagnostic parameters, covering 20 major panels.
NO. | Panel | Parameter | Registration certificate | Sample type |
1 | Cardiac | hs-cTnT | T-FDA | S/P/WB |
hs-cTnI | NMPA, CE, ANVISA | S/P/WB | ||
CK-MB | NMPA, CE, ANVISA | S/P/WB | ||
MYO | NMPA, CE, ANVISA | S/P/WB | ||
H-FABP | NMPA, CE | S/P/WB | ||
Lp-PLA2 | NMPA, CE | S/P/WB | ||
NT-proBNP | NMPA, CE, ANVISA | S/P/WB | ||
BNP | NMPA | S/P/WB | ||
ST2 | NMPA, ANVISA | S/P/WB | ||
cTnI | NMPA | S/P/WB | ||
D-Dimer | NMPA,CE | P/WB | ||
2 | Inflammation | PCT | NMPA, CE, ANVISA | S/P/WB |
PCTm | NMPA | WB | ||
CRP | NMPA, CE | S/P/WB | ||
IL-6 | NMPA, CE, ANVISA | S/P/WB | ||
3 | Tumor Marker | CEA | NMPA, CE | S/P |
CA125 | NMPA, CE | S/P | ||
HE4 | NMPA, CE | S/P | ||
CYFRA21-1 | NMPA, CE | S/P | ||
CA15-3 | NMPA, CE | S/P | ||
CA242 | NMPA, CE | S | ||
CA19-9 | NMPA, CE | S/P | ||
CA72-4 | NMPA, CE | S/P | ||
CA50 | NMPA | S/P | ||
NSE | NMPA, CE | S | ||
proGRP | NMPA | S/P | ||
SCCA | NMPA | S/P | ||
tPSA | NMPA, CE | S/P | ||
VEGF | NMPA | S | ||
fPSA | S | |||
TK1 | NMPA | S/P | ||
4 | Liver disease | AFP | NMPA, CE | 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 | S/P |
PGI | NMPA, CE | S/P | ||
PGII | NMPA, CE | S/P | ||
6 | Renal function | NGAL | NMPA, CE | S |
CysC | CE | S/P/WB | ||
β2-MG | ||||
7 | Brain injury | S100 | NMPA | S |
8 | Anemia | Ferr | NMPA, CE | S/P |
VB12 | NMPA, CE | S/P | ||
FA | NMPA | S | ||
9 | Thyroid | TSH | NMPA, CE, ANVISA | S/P |
TT4 | NMPA, CE | S/P | ||
TT3 | NMPA, CE, ANVISA | S/P | ||
FT4 | NMPA, CE, ANVISA | S/P | ||
FT3 | NMPA, CE, ANVISA | S/P | ||
Anti-TG | NMPA, CE | S/P | ||
Anti-TPO | NMPA, CE | S/P | ||
TG | NMPA | S/P | ||
Anti-TSHR | ||||
10 | Sex hormone | FSH | NMPA, CE | S/P |
E2 | NMPA, CE | S/P | ||
T | NMPA, CE | S/P | ||
P | NMPA, CE | S/P | ||
LH | NMPA, CE | S/P | ||
PRL | NMPA, CE | S/P | ||
AMH | NMPA, CE | S | ||
β-HCG | NMPA, CE | S/P | ||
Inhibin B | CE | S | ||
11 | Growth hormone | GH | NMPA | S/P |
IGFBP-3 | NMPA | S/P | ||
IGF-1 | ||||
12 | Diabetes | HbA1c | NMPA, CE | WB |
C-P | NMPA, CE | S/P | ||
INS | NMPA, CE | S/P | ||
ADP | NMPA | S/P | ||
GADA | NMPA, CE | S/P | ||
IA-2A | NMPA, CE | S/P | ||
IAA | NMPA, CE | S/P | ||
ICA | NMPA, CE | S/P | ||
13 | Hypertension | Cortisol | NMPA, CE | S/P/Urine |
ALD | NMPA, CE | S/P | ||
Renin | NMPA, CE | P | ||
ACTH | NMPA | P | ||
14 | Bone Metabolism | 25-OH-VD | NMPA, CE | S/P |
PTH | NMPA, CE | S/P | ||
BGP | NMPA, CE | S/P | ||
Total P1NP | NMPA | S/P | ||
β-CTx | NMPA | S/P | ||
15 | Rheumatoid Arthritis | Anti-CCP | NMPA | S/P |
RF-IgA | NMPA | S/P | ||
RF-IgM | NMPA | S/P | ||
RF-IgG | NMPA | S/P | ||
16 | Cytokine | IL-2 | NMPA, CE | S |
IL-4 | NMPA | S/P | ||
IL-5 | NMPA | S | ||
IL-8 | NMPA, CE | S | ||
IL-10 | NMPA, CE | S | ||
IL-1β | NMPA, CE | S | ||
TNFα | NMPA, CE | S | ||
IL-2R | NMPA | S/P | ||
IL-17A | NMPA | S/P | ||
IFN-γ | NMPA | S/P | ||
IL-12p70 | NMPA | S | ||
IL-22 | NMPA | S | ||
17 | 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 | ||
IL-6-STAT | NMPA | S/P/WB | ||
D-Dimer STAT | NMPA | P/WB | ||
NT-proBNP STAT | NMPA | S/P/WB | ||
hs-cTnI STAT | NMPA | S/P/WB | ||
CK-MB STAT | NMPA | S/P/WB |
Using together with MQ60 CLIA analyzers, Hotgen’s CLIA reagents are 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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