FIA Test Antibody to Helicobacter Pylori Detection 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. It must only be used by healthcare professionals.
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 * Instructions for Use |
PACKING
* 25 test /kit * Aluminum foil bag labeling * shrink wrap |
3.TEST METHOD
| 1 | Please read the instructions carefully before use, and operate in strict accordance with the requirements of the instructions to ensure the accuracy of the results. Make sure balance the test device and specimen to room temperature (15°C~30°C) prior to test. |
| 2 | Ⅰ Select standard detection mode of Portable Immune Analyzer (WIZ-A101) |
| 3 | I-1: Use of portable immune analyzer |
| 4 | Open the reagent aluminum foil bag and take out the test card; |
| 5 | Insert the test card into the slot of Analyzer horizontally; |
| 6 | On the homepage of the operation interface on Analyzer, click "Standard" to enter the detection interface; |
| 7 | On the homepage of the operation interface on Analyzer, click "Standard" to enter the detection interface; |
| 8 | Click "QC scan" to scan the QR code inside the kit box and input the relevant parameters of the kit into the instrument; Note: each production batch number reagent should be scanned once. If this batch number has been scanned, this step can be omitted. |
| 9 | Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit marker. |
| 10 | Start to add sample in case of consistent information:
Step 1: slowly pipette 20μL serum/plasma/whole blood sample at once, and pay attention not to pipette bubbles; Step 2: pipette sample to sample diluent, and thoroughly mix sample with sample diluent; Step 3: pipette 80µL thoroughly mixed solution into well of test device and pay attention no to pipette bubbles during sampling. |
| 11 | After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 12 | Immune analyzer will automatically complete test and analysis when test time is reached. |
| 13 | Ⅰ-2: Result calculation and display After test by immune analyzer is completed, test result will be displayed on test interface or can be viewed through “History” on home page of operation interface. |
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 WIZ BIOTECH reagent detection’s compared with reference reagent.
| Baysen Resultsof HP-AG | 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
