Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO 13485, CE
Model Number:
β-HCG
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【Product name】bHCG.pdf
β- Human Chorionic Gonadotropin(β-HCG)Rapid Quantitative Test(Fluorescence immunoassay)
【Intended use】
This kit is used for quantitative determination of β-HCG in human whole blood, plasma and serum.
Human chorionic gonadotropin (HCG) is a glycoprotein secreted by trophoblast cells of the placenta, which is produced by α and β The glycoprotein composition of dimer. The molecular weight of glycoprotein hormone is 36700, The α subunits are similar to FSH, LH and β-HCG secreted by pituitary gland, so they can cross react with each other, but not with β subunits. After the fertilized eggs move to the uterine cavity for implantation, mature women form embryos. In the process of growing into fetus, placental syncytiotrophoblast cells produce a large amount of HCG, which can be excreted into the urine through the blood circulation of pregnant women. The HCG levels in serum and urine increased rapidly at 1-2.5 weeks of gestation, peaked at the 8th week of gestation, and then decreased to the medium level at the 4th month of gestation, and maintained until the end of pregnancy.
【Components】
| Name | Quantity | Component |
| Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled β-HCG monoclonal mouse antibody), nitrocellulose membrane (coated with β-HCG monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing |
| Sample diluent | 25(300μL/tube) | Phosphate buffer |
| ID card | 1 | With specific stand curve file |
The components in different batches of kits cannot be used interchangeably.
【Applicable instruments】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
| Assay list | ||||||
| Cardiac | ||||||
| cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended Use |
| 1 | cTnI | WB/Serum/Plasma | 12min. | 0.1-40ng/ml | <0.3ng/ml | several heart diseases including myocardial infarction and heart failure. |
| 2 | Myo | WB/Serum/Plasma | 12min. | 5-400ng/ml | <58ng/ml | acute myocardial infarction (AMI) in early stage. |
| 3 | CK-MB | WB/Serum/Plasma | 12min. | 1-200ng/ml | <5ng/ml | acute myocardial infarction (AMI) in early stage. |
| 4 | NT-proBNP | WB/Serum/Plasma | 10min. | 20-35000pg/ml | Under 75:0~347pg/mL, Over 75:0~449pg/mL |
heart failure . |
| 5 | D-Dimer | WB/Plasma | 10min. | 40-10000ng/ml | <500ng/ml | disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc. |
| 6 | cTnI+Myo+CKMB | WB/Serum/Plasma | 12min. | same with single item | same with single item | Triple marker of myocardial infarction. |
| 7 | ST2 | WB/Serum/Plasma | 10min. | 10-400ng/ml | <35ng/ml | heart failure . |
| 8 | Lp-PLA2 | WB/Serum/Plasma | 10min. | 10-900ng/ml | <175ng/ml | Risk evaluation of ACS and atherosclerotic ischemic stroke patients. |
| 9 | S100-β | WB/Serum/Plasma | 10min. | 0.05-10ng/ml | <0.2ng/ml | Cerebral infarction, cerebral injury. |
| Inflammation | ||||||
| 10 | CRP / hs-CRP | WB/Serum/Plasma | 3min. | 0.5-200mg/L | CRP<10mg/L,hs-CRP<1mg/L | nonspecficity inflammatory marker. |
| 11 | SAA | Serum | 5min. | 1-200mg/L | <10mg/L | inflammation&infection. |
| 12 | PCT | WB/Serum/Plasma | 10min. | 0.2-100ng/ml | <0.5ng/ml | Sepsis |
| 13 | CRP+SAA | WB/Serum/Plasma | 5min. | same with single item | same with single item | inflammation&infection. |
| 14 | IL-6 | WB/Serum/Plasma | 10min. | 5-4000pg/ml | 10pg/ml | diabetes,rheumatoid arthritis,etc |
| Thyroid Hormone | ||||||
| 15 | TSH | Serum/Plasma | 15min. | 0.3-100mU/L | 0.35-5mU/L | hyperthyroidism and hypothyroidism |
| 16 | TT3 | Serum/Plasma | 15min. | 0.5-10nmol/L | 1.3-3.1nmol/L | thyroid dysfunction |
| 17 | TT4 | Serum/Plasma | 15min. | 5-300nmol/L | 66-181nmol/L | thyroid dysfunction |
| 18 | FT3 | Serum/Plasma | 15min. | 1-100pmol/L | 4-10pmol/L | thyroid dysfunction |
| 19 | FT4 | Serum/Plasma | 15min. | 5-300pmol/L | 19-39pmol/L | thyroid dysfunction |
| Tumor Marker | ||||||
| 20 | AFP | Serum/Plasma | 15min. | 2.5-200ng/ml | <20ng/ml | pregnancy cancer |
| 21 | CEA | Serum/Plasma | 15min. | 1-200ng/ml | <5ng/ml | colon cancer, colorectal cancer,etc. |
| 22 | NSE | Serum/Plasma | 15min. | 1-400ng/ml | <16ng/ml | non-small cell lung cancer |
| 23 | FOB | fecal specimens | 10min. | 50-1000ng/ml | <100ng/ml | Abnormal recessive gastrointestinal bleeding |
| 24 | PG II | Serum/Plasma | 15min. | 1-100ug/L | PGI/PGII>3.0 | gastric abnormalities |
| 25 | PG I | Serum/Plasma | 15min. | 2.5-200ug/L | >70ng/ml | gastric abnormalities |
| 26 | TPSA | Serum/Plasma | 15min. | 0.5-40ng/ml | <4ng/ml | prostate cancer |
| 27 | FPSA | Serum/Plasma | 15min. | 0.1-10ng/ml | <1ng/ml | prostate cancer |
| 28 | CA12-5 | Serum/Plasma | 15min. | 20-500U/ml | <35U/ml | ovarian cancer |
| 29 | CA15-3 | Serum/Plasma | 15min. | 10-400U/ml | < 25 U/mL | breast cancer |
| 30 | HE4 | Serum/Plasma | 15min. | 50-2000pmol/L | <140 pmol/L | ovarian cancer |
| 31 | CA19-9 | Serum/Plasma | 15min. | 10-400U/ml | < 27 U/mL | pancreatic cancer |
| 32 | β-HCG | Serum/Plasma | 15min. | 5-400mIU/ml | <10 mIU/mL | Early pregrancy, ectopic HCG cancer,incomplete abortion |
| 33 | CK19(Cyfra21-1) | Serum/Plasma | 15min. | 0.5-50ng/ml | <2.5ng/ml | non-small cell lung cancer |
| Fertility | ||||||
| 34 | HCG / β-HCG | Serum/Plasma | 10min. | 5-20000mIU/ml | <5 mIU/mL | early pregrancy. |
| 35 | AMH | Serum/Plasma | 10min. | 0.1-16ng/ml | Male: 20-60 years old, 0.92-13.89 ng/mL Female: 20-29 years old, 0.88-10.35 ng/mL 30-39 years old, 0.31-7.86 ng/mL 40 -50 years old, <5. 07 ng/mL |
ovarian reserve level |
| Gastrointestinal | ||||||
| 36 | FOB | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
| 37 | TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
| 38 | FOB+TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
| Infection | ||||||
| 39 | C.Pneumonia | WB/Serum/Plasma | 15min. | qualitative | qualitative | CP infection |
| 40 | M.Pneumonia | WB/Serum/Plasma | 15min. | qualitative | qualitative | MP infection |
| 41 | Covid-19 Antigen | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
| 42 | Covid-19 Ab IgG/IgM | WB/Serum/Plasma | 15min. | qualitative | qualitative | respiratory tract |
| 43 | FluA | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
| 44 | FluB | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
| Renal Injury | ||||||
| 45 | CysC | WB/Serum/Plasma | 5min. | 0.4-9mg/L | 0.5-1.1mg/L | renal function |
| 46 | NGAL | Urine | 10min. | 10-1500ng/mL | <132ng/mL | acute kidney injury. |
| Other | ||||||
| 47 | FERR | Serum | 5min. | 10-500ng/ml | Male:24ng/mL~335ng/mL, Female:11ng/mL~307ng/mL |
iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia |
| 48 | HbA1c | WB | 10min. | 4%-14% | 4%-6% | diabetes |
| 49 | VD | Serum/Plasma | 15min. | 8-70ng/mL | 19-57ng/mL | fetation |
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