Diagnostic Kit for Pepsinogen I/Pepsinogen II /Gastrin-17

Methodology:fluorescence immunochromatographic assay

Production information

INTENDED USE

This kit is applicable to the in vitro quantitative detection of concentration of Pepsinogen I (PGI), Pepsinogen II
(PGII) and Gastrin 17 in human serum/plasma/whole blood samples, to evaluate gastric oxyntic gland cell
function, gastric fundus mucosa lesion and atrophic gastritis. The kit only provides test result of Pepsinogen I
(PGI), Pepsinogen II (PGII) and Gastrin 17. The obtained result shall be analyzed in combination with other clinical
information. It must only be used by healthcare professionals.

Test procedure

	Superiority The kit is high accurate,fast and can be transported at room temperature.It’s easy to operate,the mobile phone app can assist in the interpretation of results and save them for easy follow-up. Specimen type : serum/plasma/whole blood samples Testing time:10-15mins Storage:2-30℃/36-86℉ Methodology:Solid Phase
Feature: •  High sensitive •  result reading in 15 minutes •  Easy operation • 2 tests in one time

The Clinical Performance

Clinical evaluation performance of the product is assessed by collecting 200 clinical samples. Use the marketed kit of enzyme linked immunosorbent assay as the control reagent. Compare the PGI test results. Use linearity regression to investigate their comparability. Correlation coefficients of two tests are y = 0.964X + 10.382 and R=0.9763 respectively. Compare the PGII test results. Use linearity regression to investigate their comparability. Correlation coefficients of two tests are y = 1.002X + 0.025 and R=0.9848 respectively. Compare the G-17 test results. Use linearity regression to investigate their comparability. Correlation coefficients of two tests are y =0.983X + 0.079 and R=0.9864 respectively.