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 |
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 |
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.
