Iron Deficiency Anemia Ferritin Test kit
1. INTEDED USE
This kit is intended for in vitro quantitative detection of ferritin (FER) content in human serum/plasma/whole blood samples and is for auxiliary diagnosis for iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia, as well as monitoring the recurrence and metastasis of malignant tumor. This kit only provides the test result of ferritin, and the obtained result shall be analyzed in combination with other clinical information. This kit is for healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | FER |
| 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 *solution *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 | Add 80µL urine sample into well of test device in case of consistent information; |
| 9 | After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 10 | Immune analyzer will automatically complete test and analysis when test time is reached. |
| 11 | 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 165 clinical samples. The results are compared by using the corresponding kit of marketed chemiluminescence method as the reference reagent. Their comparability is studied by linear regression. The correlation coefficients of the two tests are Y=1.010X-0.108 and R=0.9839, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
