Abstract
Objective: Pepsinogen I and II (PG I and PG II) levels in the blood are good indicators of gastric activity, and can be used independently or in combination to monitor for peptic ulcer and atrophic gastritis in the screening of patients at high risk of stomach cancer. In particular, PG I/II ratio is being increasingly used in routine health screening and other medical check-ups. In the present study, CIAS LATEX™ PG I and PG II latex immunoassays were evaluated with regard to fundamental performance and screening in medical check-ups.
Materials and Methods: Assays were performed using a TBA™-c8000 automated analyzer. A total of 678 samples obtained during medical checkups were analyzed.
Results: The fundamental performance of the assay was good. In a clinical assessment, positive rates for the latex immunoassay and chemiluminescent assay were 8.0% and 12.6%, respectively. The coincidence rates were 95.1%, and 96.9% of disagreements were positive for the chemiluminescent assay but negative for the latex immunoassay. In addition, upper esophagogastroduodenoscopy and endoscopic diagnosis findings for 51 subjects in whom there was disagreement for both assays produced concordance rates of 68.6% for the latex immunoassay and 56.9% for the chemiluminescent assay. The positive rate increased with age. It was <3% in the <49 years group and >11% in the >50 years group.
Conclusions: The results reported here indicate that the accuracy and precision of the latex immunoassay were very high. Also, as this assay can be adapted for use with a universal automated analyzer, it would be useful in pepsinogen level testing in health screening and other medical check-ups.
