A CLIA test kit for the quantitative determination of PepsinogenⅠ(PGⅠ) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The PepsinogenⅠ(PGⅠ) Test Kit (CLIA) is intended for quantitative determination of PepsinogenⅠ(PGⅠ) in human serum and plasma, as an aid in diagnosis of stomach disease in clinical practice.
For professional in vitro diagnostic use only.
【SUMMARY】
Pepsinogen (PG) is the precursor of pepsin, which is a digestive enzyme specifically produced in the gastric mucosa. The human stomach expresses two isoenzymes, PG Ⅰ and PG Ⅱ , which have different biochemical and immune properties. Histological studies based on immunohistochemistry using specific antibodies or in situ hybridization clearly identified PGI and PGII producing cells. PGⅠis mainly secreted by the principal cells of the fundus glands and mucous neck cells, but PGⅡ is
produced not only in these cells, but also in the Brunner gland cells of the heart, pylorus and duodenum1 .
Pepsinogen is mainly excreted into the gastric cavity, but about 1% of it enters the bloodstream. Studies have clarified that the serum PG level reflects the morphology and function of the gastric mucosa and various pathological conditions, such as inflammation. It is worth noting that in the process of chronic atrophic gastritis, mucosal atrophy progresses from the pyloric gland side to the oral side, and the level of PGⅠ and the ratio of PGⅠ/PGⅡ decrease with the progress of mucosal atrophy.
These clinically important changes in serum PG levels are due to the unique distribution of the above-mentioned PG-producing cells in the epithelial cells of the gastric mucosa. In addition, the results of past pathological and epidemiological studies have shown that there is a strong correlation between chronic atrophic gastritis and differentiated gastric cancer.
Therefore, chronic atrophic gastritis is considered to be a precancerous lesion. The pepsinogen test is based on the correlation between chronic atrophic gastritis and the development of gastric cancer on the one hand, and on the other hand is more based on the correlation between chronic atrophic gastritis and low PG levels. By introducing a PG test that can identify subjects at high risk for gastric cancer, and by introducing an endoscopy for screening subjects with a positive PG test, the efficiency of gastric cancer detection can be significantly improved.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the PGⅠ antibody labeled with alkaline phosphatase, and the magnetic particles coated with the PG Ⅰ antibody are mixed. After incubation, the PGⅠ in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies. The third step is to add the chemiluminescent substrate solution to the immune complex.
Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of PGⅠ in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of PGⅠ in the sample.
【REAGENTS】
The reagent strip includes PGⅠ antibody coated with magnetic particles, alkaline phosphatase labeled PGⅠantibody, wash buffer and substrate solution.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Read the entire package insert carefully prior to testing.
3. Do not use after the expiration date indicated on the package.
4. The single reagent strip has been assembled into a ready-to-use unit that cannot be separated.
5. Do not interchange or mix reagents from different batches.
6. Used test materials should be disposed of in accordance with local regulations.
7. Test kits and samples need to be equilibrated to room temperature before testing.
8. It is recommended to use fresh blood. Samples with high-fat chylo, jaundice, and high rheumatoid factor are not recommended and hemolyzed samples are also not recommended.
9. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
10. The test results of this kit are for clinical reference only, clinical diagnosis and treatment of patients should be comprehensively considered in conjunction with their symptoms/signs, medical history, other laboratory tests and treatment responses.
11. Due to methodological or antibody specificity and other reasons, test the same sample with reagent strips from different manufacturers may result in different test results. The results obtained from testing with different reagent strips should not be directly compared with each other, which may cause erroneous medical interpretations.
12. Store and test reasonably in strict accordance with the instructions of the package insert. Keep the reagents away from light, do not turn it over.
13. The PepsinogenⅠ(PGⅠ) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals
