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

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

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ISO 13485, CE

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Product Details
Product Name:
PGI Rapid Test Kit
Sample Buffer:
20 Vials
Linearity Range:
Within The Specified Linearity Range (4.0%,14.0%)
Room Temperature
12 Months
Applicable Instrument:
NIR-1000 Dry Fluoroimmunoassay Analyser
WWHS Biotech INC
Annual Capacity:
5 Million A Year
Payment & Shipping Terms
Minimum Order Quantity
Packaging Details
Colorful Paper Box
Delivery Time
7 Days
Payment Terms
L/C, T/T
Supply Ability
30000 Kits per Week
Product Description

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 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.





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


Other WWHS Assay Items


 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


PGI Tumor Marker High Precision Rapid Test Kit WWHS FIA POCT Assay 0PGI Tumor Marker High Precision Rapid Test Kit WWHS FIA POCT Assay 1



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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