Diagnostic Kit for Glycosylated Hemoglobin A1c
1. INTEDED USE
This kit is applicable to the in vitro quantitative detection on the content of glycated hemoglobin (HbA1c) in human whole blood samples and is mainly used for implementing auxiliary diagnosis of diabetes and monitor blood glucose level. This kit only provides the test result of glycosylated hemoglobin. The obtained result should be analyzed in combination with other clinical information. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | HbA1c |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | 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 | Read the instruction for use and test operation manual completely before the test and restore the reagent to room temperature before the test. Do not perform the test without restoring the reagent to room temperature to avoid affecting the accuracy of the test results. |
| 2 | Select standard test mode of WIZ-A101 portable immune analyzer |
| 3 | Open the aluminum foil bag package of reagent, and take out the test device; |
| 4 | Horizontally insert the test device into the slot of immune analyzer; |
| 5 | On home page of operation interface of immune analyzer, click “Standard” to enter test interface; |
| 6 | Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument, and select sample type; Note: Each batch number of the kit shall be scanned for one time. If the batch number has been scanned, then skip this step; |
| 7 | Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit label; |
| 8 | After information is consistent, take sample buffer, add 10μL of whole blood sample and sufficiently mix for 1 minute; |
| 9 | Add 80µL of above mixed-well solution into the sample hole of test device; |
| 10 | After sample addition is completed, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 11 | Immune analyzer will automatically complete test and analysis when test time is reached. |
| 12 | 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 evaluation performance of the product is assessed through collecting 155 clinical samples. The corresponding kit of the listed HPLC method is used as the reference reagent. The test results are compared, and their comparability is studied with linearity regression. The correlation coefficients of the two tests are Y=0.960X+0.277 and R=0.9849, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
