Blood Pepsinogen I / Ⅱ Combo Test kit For Stomach Cancer
1. INTEDED USE
This kit is intended for the in vitro quantitative detection the content of Pepsinogen I/ Pepsinogen II (PG I/PG II) in human serum/plasma/whole blood samples to evaluate the function of gastric oxyntic gland cells and the lesion of gastric fundic mucosa. This kit only provides test result of Pepsinogen I / Pepsinogen II (PG I/PG II). The obtained result shall be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | PGI/II |
| 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. The results are compared by using the corresponding kit of marketed enzymelike immunosorbent method as the reference reagent. Use linear regression to investigate their comparability. Correlation coefficients of two tests of PG I are Y=0.985X+1.715 and R=0.9838 respectively. Correlation coefficients of two tests of PG II are Y=1.002X+0.018 and R=0.9850 respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
