Pepsinogen I Pepsinogen Ⅱ And Gastrin 17 Blood Combo Test
1. INTEDED 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.
2. PRODUCT SPECIFICATION
| Model No. | PGI/II/G-17 |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | Serum/Plasma/Whole blood |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485,CE,MHRA |
| MAIN KIT COMPONENTS
* Test device * Sample diluents * Instructions for Use |
PACKING* 25 test /kit
* Aluminum foil bag labeling * shrink wrap |
3.TEST METHOD
4.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.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
