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ISO 13485, CE
PGI Rapid Quantitative Fluorescence Immunoassay Test Kit WWHS FIA POCT IVD
Human pepsinogens I (PGI) and II (PGII) are proenzymes of pepsin—an endoproteinase of gastric juice.
PGI is secreted mainly by chief cells in the fundic mucosa, whereas PGII is also secreted by the pyloric glands and the proximal duodenal mucosa.
Phosphoglucose isomerase (glucose-6-phosphate isomerase or PGI, EC 18.104.22.168) 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.
1. Accurate: Double antibody sandwich method, high sensitivity.
2. Rapid: Get results in 15 minutes.
3. Convenient: No need professional training, test could be performed at any time, any place.
1. Plasma, serum and whole blood can be used as samples. The whole blood should be collected in a tube containing heparin, citrate or EDTA as the anticoagulant. If the serum procedure is used, collect blood in a tube without anticoagulant and allow clotting. Hemolyzed samples should not be used.
2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
3. It is highly recommended to use fresh samples instead of keeping the samples at room temperature for a long time. After samples were collected, the detection should be completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored at 2℃~8℃ for 24 hours. Plasma and serum samples can be stored at 2℃~ 8℃ for 7 days, -20℃for 30 days.
4. Before testing, the sample should return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use. Repeated freeze-thaw cycles should be avoided.
|Test Cards||20 Strip||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 Buffer||20(300μL/tube)||Phosphate buffer|
|Information Card||1 Individual||With AFP specific stand curve file|
|cat#.||Product Item||Specimen||Reaction Time||Measure Range||Clinical Range||Itended Use|
|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|
|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|
Interpretation of results
1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2. For samples with AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /ml", respectively.
Limitations of methods
1. This kit is only used to detect human plasma/whole blood samples
2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
3. The content of triglyceride in the sample shall not exceed 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.
4. When the concentration of AFP in the sample is less than 20000ng/ml, there is no hook effect.
5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. When RF concentration in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.
WWHS NIR-1000 dry fluoroimmunoassay analyser
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