Machine Use Antigen to Helicobacter Pylori Detection Kit
1. INTEDED USE
This kit is intended for in vitro qualitative detection of helicobacter pylori antigen in human stool sample, which is for evaluation of helicobacter pylori infection. This kit only provides detection result of helicobacter pylori antigen, and results obtained shall be used in combine with other clinical information for analysis. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | HP-AG |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | faeces |
| 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
| 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: Remove the cap of sampling tube, discard the first two drops of diluted sample, add 3 drops (approx. 100μL) of bubble-free diluted sample dropwise to well of test device vertically and slowly; |
| 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 296 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 Resultsof HP-AG | Test result of Reference reagent | Positive coincidence rate: 98.82% (95%C.I. 95.81%~99.68%) Negative coincidence rate: 100.00% (95%C.I. 97.04%~100.00%) Total coincidence rate: 99.32% (95%C.I. 97.57%~99.81%) |
||
| Positive | Negative | Total | ||
| Positive | 168 | 0 | 168 | |
| Negative | 2 | 126 | 128 | |
| Total | 170 | 126 | 296 | |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
