Helicobacter Pylori antibdy Hp-Ab uncut sheet
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 Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Serum,plasma,whole blood |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
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Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 |
Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in sample marking.
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| 2 |
In case of serum and plasma sample, add 2 drops to the well, and then add 2 drops of sample diluent dropwise. In case of whole blood sample, add 3 drops to the well, and then add 2 drops of sample diluent dropwise.
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| 3 |
Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation).
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4.RESULT EVALUATION AND EXPLANATION
5.CLINICAL PERFORMANCE
Clinical performance of this product’s assessed through collection of 331 cases of clinical samples. Sample providers include patients with abnormal hp-ab index, patients with fecal occult blood and normal people. Marketed kit of colloidal gold methods used as reference reagent. The WIZ BIOTECH reagent test will be compared with the control reagent:
| Baysen Result of hp--ab |
Test result of Reference reagent | Positive coincidence rate: 98.92(95%C.I.96.16%~99.7%) Negative coincidence rate: 100.00(95%C.I.97.42%~100.00%) Total coincidence rate:99.65% (99.4%C.I. 97.82%~99.83%) |
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| Positive | Negative | Total | ||
| Positive | 184 | 0 | 184 | |
| Negative | 2 | 145 | 147 | |
| Total | 186 | 145 | 331 | |
6. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
