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PGI Tumor Marker High Precision Rapid Test Kit WWHS FIA POCT Assay

WWHS Biotech.Inc(exclusive marketed by Dawin)

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PGI Tumor Marker High Precision Rapid Test Kit WWHS FIA POCT Assay

Country/Region china
City & Province shenzhen
Categories Incontinence Care
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Product Details

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

 

 

NameQuantityComponent
Test cards25It 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 diluent25Phosphate buffer
ID card1With 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 ItemSpecimenReaction TimeMeasure RangeClinical RangeItended Use
PG ISerum / Plasma15min.2.5-200ug/L>70ng/mlgastric abnormalities

 

NameLoading CapacityComponent
Test Card20 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 Buffer20 vials (0.3mL/vial) Phosphate buffer
Information Card1 Piece Record standard curve information of this batch of reagents

 

Other WWHS Assay Items

 

 Tumor Marker     
cat#.Product itemSpecimenReaction TimeMeasure RangeClinical RangeItended Use
20AFPSerum/Plasma15min.2.5-200ng/ml<20ng/mlpregnancy cancer
21CEASerum/Plasma15min.1-200ng/ml<5ng/mlcolon cancer, colorectal cancer,etc.
22NSESerum/Plasma15min.1-400ng/ml<16ng/mlnon-small cell lung cancer
23FOBfecal specimens10min.50-1000ng/ml<100ng/mlAbnormal recessive gastrointestinal bleeding
24PG IISerum/Plasma15min.1-100ug/LPGI/PGII>3.0gastric abnormalities
25PG ISerum/Plasma15min.2.5-200ug/L>70ng/mlgastric abnormalities
26TPSASerum/Plasma15min.0.5-40ng/ml<4ng/mlprostate cancer
27FPSASerum/Plasma15min.0.1-10ng/ml<1ng/mlprostate cancer
28CA12-5Serum/Plasma15min.20-500U/ml<35U/mlovarian cancer
29CA15-3Serum/Plasma15min.10-400U/ml< 25 U/mLbreast cancer
30HE4Serum/Plasma15min.50-2000pmol/L<140 pmol/Lovarian cancer
31CA19-9Serum/Plasma15min.10-400U/ml< 27 U/mLpancreatic cancer
32β-HCGSerum/Plasma15min.5-400mIU/ml<10 mIU/mLEarly pregrancy, ectopic HCG cancer,incomplete abortion
33CK19(Cyfra21-1)Serum/Plasma15min.0.5-50ng/ml<2.5ng/mlnon-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.

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