Immunoassay H. Pylori Antibody Stomach Ulcer Blood Test Kit
1. INTEDED USE
This kit is applicable to in vitro qualitative detection of antibody to H.pylori (HP) in human whole blood, serum or plasma sample, which’s suitable for auxiliary diagnosis of HP infection. This kit only provides test results of antibody to H.pylori (HP), and results obtained shall be used in combination with other clinical information for analysis.
2. PRODUCT SPECIFICATION
| Model No. | HP-Ab |
| 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 * Disposable pipette * Instructions for Use |
PACKING
* 25 test /kit * Aluminum foil bag labeling * shrink wrap |
3.TEST METHOD
4.CLINICAL PERFORMANCE
Clinical performance of this product’s assessed through collection of 332 cases of clinical samples. Sample providers include patients infected with helicobacter pylori and normal subjects. Marketed kit of turbidimetric inhibition immunoassay’s used as reference reagent, and Baysen reagent detection’s compared with reference reagent.
| Baysen Results of HP-Ab | Test result of Reference reagent | Positive coincidence rate: 98.76% (95%C.I. 95.58%~99.66%) Negative coincidence rate: 100.00% (95%C.I. 97.80%~100.00%) Total coincidence rate: 99.40% (95%C.I. 97.83%~99.83% |
||
| Positive | Negative | Total | ||
| Positive | 159 | 0 | 159 | |
| Negative | 2 | 171 | 173 | |
| Total | 161 | 171 | 332 | |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
