Biochip Langdao (Tianjin)Medical Technology Limited

1.Product Overview

 [product name] : Pepsinogen I(PGI)

 [Package Specification] :30 tests/kit;60 tests/kit

 [Applicable Device] : CLite-160i

 [Specimen Type] : serum

 [Storage] : 2-8℃

 [Product validity] : 12 months

 [Detection method] : magnetic particle chemiluminescence method

2.technique principle

  Double antibody sandwich method was used in the kit. The detection principle is: the sample to be tested, R1 reagent, R2 reagent and M reagent are mixed for incubation, and the fluorescein (FITC) labeled PGI antibody 1 in R1 reagent and the alkaline phosphatase (ALP) labeled PGI antibody 2 in R2 reagent are combined with the PGI antigen molecules in the sample to form an immune complex. The immune complex is further captured by anti-FITC antibodies coupled to the surface of the magnetic particle and adsorbed to the surface of the magnetic particle. After washing, the unbound material was removed and the luminescent substrate was added, ALP catalyzed the luminescence of the substrate, and the relative luminescence intensity (RLU) was determined

3.The clinical significance

  Pepsinogen I(PGI)is a precursor of pepsin mainly secreted by the chief cells in the gastric fundus. Upon exposure to hydrochloric acid (HCl), it is converted into pepsin, which participates in protein digestion. The clinical significance of Pepsinogen I includes:

1）. Assessment of Gastric Mucosal Function: Levels of Pepsinogen I can reflect the number and functional status of the chief cells in the gastric mucosa. A decrease in its concentration may indicate atrophy of the gastric mucosa or reduced gastric acid secretion, possibly associated with chronic atrophic gastritis, gastric cancer, etc.

2）. Screening for Gastric Cancer: Testing for Pepsinogen I levels has been considered as a useful tool for screening early gastric cancer. In some countries and regions, particularly areas with high incidence of gastric cancer, serological detection of Pepsinogen I level is used to identify early gastric cancer.

3）. Differential Diagnosis: Measuring Pepsinogen I helps differentiate between various gastric diseases such as peptic ulcers and gastric cancer. In certain cases, an elevated level of Pepsinogen I might suggest Helicobacter pylori infection or Zollinger-Ellison syndrome.

4）. Evaluating Treatment Effectiveness: Monitoring Pepsinogen I during treatment for abnormalities in gastric acid secretion or gastric mucosa-related disorders allows health professionals to assess the effectiveness of treatments and adjust their strategies accordingly.

5）. Long-term Health Monitoring: For individuals with existing gastric conditions or a family history of gastric cancer, periodically monitoring Pepsinogen I levels serves as a long-term health surveillance method.

6）. Use Alongside Other Biomarkers: Pepsinogen I is often tested alongside Pepsinogen II (Pepsinogen II, PGII), and their ratio (PGI/PGII) plays a crucial role in evaluating the condition of the gastric mucosa.

  While testing for Pepsinogen I is important for evaluating gastric health, it cannot be used alone for diagnostic purposes. It typically requires integration with patients' clinical symptoms, endoscopic findings, imaging results, and other laboratory indices for comprehensive evaluation. Regardless of circumstances, interpretation of Pepsinogen I test results should always involve medical professionals who provide guidance on subsequent management.

4.Product features and indicators

High sensitivity: the detection limit is not higher than2.5ng/mL;

Wide linear range: samples in the range of 2.5~200.0 (ng/mL) do not need to be diluted;

Good correlation: c correlation R > 0.95 with Biohit reagent;

Good stability: the calibration cycle can be up to 14 days, and the reagent can be stored at 4℃ for 1 year;

Fast results: only 16-18 minutes to get results.