Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO 13485, CE
Model Number:
PG I
Contact Us
PGI Tumor Marker High Precision Rapid Test Kit WWHS FIA POCT Assay
Intended use
This kit is used for quantitative determination of PG I in human whole blood, plasma and serum.
Pepsinogen (PG) is an endoprotease with digestive function. It is a single chain polypeptide composed of 375 amino acids. In vivo, the cell source and tissue distribution of PG I and PG II are different. Studies have shown that the decrease of PG I level is a reliable marker for the occurrence and development of gastric diseases.
Phosphoglucose isomerase (glucose-6-phosphate isomerase or PGI, EC 5.3.1.9) is an important housekeeping enzyme. PGI catalyzes the interconversion of glucose-6- phosphate to fructose-6-phosphate. PGI performs multiple functions & intracellularly plays key role in both glycolysis and gluconeogenesis. Extracellularly, PGI [also called Autocrine Motility Factor (AMF)] functions as a cytokine, which stimulates cell motility and is associated with tumor development and metastasis. In humans, PGI deficiency causes hemolytic anemia, whereas increased PGI activity is observed in many cancers such as gastrointestinal, kidney and breast cancer. Early detection of abnormal phosphoglucose isomerase activity is crucial for diagnosis, prediction and therapeutic strategy.
Test principle
The PG I Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of PG I. The PG I antigen in the sample was first bound with the conjugated compound of fluorescent labeled PG I monoclonal antibody, then moved and combined with another PG I monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyzer.
Components
| Name | Quantity | Component |
| Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled PG I monoclonal mouse antibody), nitrocellulose membrane (coated with PG I monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing |
| Sample diluent | 25 | Phosphate buffer |
| ID card | 1 | With specific stand curve file |
Importance of IVD
The importance of in vitro diagnosis in life and health is mainly reflected in that no matter healthy people, asymptomatic and symptomatic people and people with chronic diseases are inseparable from diagnostics, and diagnosis runs through the whole medical cycle. In particular, modern medicine has entered the era of precision medicine, and the core of precision medicine is accurate diagnosis.
| Tumor Marker | |||||
| Product Item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended Use |
| PG I | Serum / Plasma | 15min. | 2.5-200ug/L | >70ng/ml | gastric abnormalities |
| Name | Loading Capacity | Component |
| Test Card | 20 Persons | The product consists of fluorescent mat (coated with fluorescently-labeled PG I antibody), nitrocellulose membrane (coated with PG I antibody), absorbent paper and PVC soleplate, and so on. |
| Sample Buffer | 20 vials (0.3mL/vial) | Phosphate buffer |
| Information Card | 1 Piece | Record standard curve information of this batch of reagents |
| Tumor Marker | ||||||
| cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended Use |
| 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 |
Test Method
1. Please thoroughly read the specification before test. Frozen test card and sample should be placed at room temperature (15-30) ℃ for at least 30min before use.
2. Start NIR-1000 dry fluoroimmunoassay analyser and verify quality control according to the specification.
3. The quality of reagent is controlled using internal quality control product (not provided) of the company and result should be controllable.
4. Take out the test card from the aluminum foil bag and use it within 15min
5. Place the test card on a clean horizontal table top and label it.
6. Take 10μL of sample and add it into HbA1c sample buffer (1.00mL). Then, mix the solution evenly, take 100μL of the solution and add it into the well.
7. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, keep time for 10min and press 【Instant test】. The analyser will judge and read the test result automatically. Or press 【Fixed time test】 to keep time for 10min automatically. The analyser will judge and read the test result automatically and display it in the screen.
Applicable Instrument
WWHS NIR-1000 dry fluoroimmunoassay analyser
cells; bound antibodies are visualized by incubation with fluorescently labeled antihuman antibody.
Send your inquiry directly to us
