Helicobacter Pylori antigen Hp-Ag uncut sheet
1. INTEDED USE
The H. pylori Antigen Rapid Test Device (the “uncut sheet” format for manufacturing use) is intended for the qualitative detection of Helicobacter pylori (H. pylori) antigen in human stool specimens.
This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis of H. pylori infection and for monitoring the effectiveness of eradication therapy in patients presenting with clinical signs and symptoms suggestive of gastroduodenal disorders such as active chronic gastritis, gastric ulcer, or duodenal ulcer.
The device provides presumptive (preliminary) screening test results. The test result should be interpreted in conjunction with patient history, clinical presentation, and other laboratory findings.
This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | HP-AG Uncut sheet |
| Methodology | Latex |
| Sample Type | Faces |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
|
3.TEST METHOD
| 1 | Use sample collection tube to collect, mix well and dilute the sample. Use sampling stick to take about 30mg of stool. Then, transfer the stool to a sample collection tube containing sample diluent, tighten by rotating, and shake sufficiently. |
| 2 | If stool of patient with diarrhea is loose, use disposable pipette to draw the sample, add 3 drops (about 100μL) of sample-to-sample collection tube, and shake the sample and sample diluent sufficiently. |
| 3 | Take the test device out of the aluminum foil bag, place it on a horizontal worktable flat, and make a proper mark. |
| 4 | Discard the first two drops of diluted sample. Then, vertically, and slowly add 3 drops (about 100μL) of bubble-Free diluted sample to the center of sample hole of the test device and start timing. |
| 5 | The result shall be read within 10-15 minutes. Test result obtained after 15 minutes is invalid (for detail about result see Interpretation of Test Results). |
4.RESULT EVALUATION AND EXPLANATION
5.CLINICAL PERFORMANCE
Clinical performance of this product’s assessed through collection of 315 cases of clinical samples. Sample providers include patients infected with helicobacter pylori and normal subjects. Use marketed kit of turbidimetric inhibition immunoassays as reference reagent to compare with WIZ BIOTECH reagent.
| Baysen Result of hp--ag |
Test result of Reference reagent | Positive coincidence rate: 98.91%(95%C.I.96.12%~99.70%) Negative coincidence rate: 100.00(95%C.I.97.15%~100.00%) Total coincidence rate:99.37% (95%C.I. 97.71%~99.83%) |
||
| Positive | Negative | Total | ||
| Positive | 182 | 0 | 182 | |
| Negative | 2 | 131 | 133 | |
| Total | 184 | 131 | 315 | |
6. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
7.EXHIBITION
