Diagnostic Kit for Antibody to Helicobacter Pylori
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 | 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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MAIN KIT COMPONENTS * Test device * Sample collection tube * Disposable pipette * Instructions for Use |
PACKING * 25 test /kit * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
4.RESULT EVALUATION AND EXPLANATION
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Positive: There are two stripes in control area (C) and test area (T). Positive result indicates that: the sample contains anti helicobacter pylori antibody. |
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Negative: There is only one red stripe in control area (C). There’s no red stripe in test area (T). Negative result indicates that: anti-helicobacter pylori antibody cannot be detected in sample, or content of anti-helicobacter pylori antibody in sample is lower than limit of detection of the kit. |
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Invalid: Failure to show control line C. Invalid result indicates that: it can be caused by incorrect operation process or deteriorated and damaged reagent. Retest shall be conducted in case of invalid result, which shall be operated strictly in accordance with the specification. If the problem still exists, please immediately stop using products of the lot number, and contact local supplier. |
5.CLINICAL PERFORMANCE
Clinical performance of this product’s assessed through collection of 331 cases of clinical samples. Sample providers include patients infected with helicobacter pylori and normal subjects. Marketed kit of colloidal gold methods used as reference reagent, in comparison of Baysen reagent detection with reference reagent:
| Baysen Result of RV/AV |
Test result of Reference reagent | Positive coincidence rate: 98.92% (95%C.I. 96.16%~99.70%) Negative coincidence rate: 100.00% (95%C.I. 97.42%~100.00%) Total coincidence rate: 99.40% (95%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
