FIA Test C-peptide diagnostic kit
1. INTEDED USE
This kit is intended for in vitro quantitative detection on the content of C-peptide in human serum/plasma/whole blood sample and is intended for auxiliary classify diabetes and pancreatic β-cells function detection. This kit only provides C-peptide test result, and the obtained result shall be analyzed in combination with other clinical information. This kit is for healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | C-P |
| 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: take out sample diluents, add 80µL of serum/plasma/whole bloodsample, and sufficiently mix. Step 2: Add 80µL of above mixed solution into the sample hole of test device. |
| 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 evaluation performance of the product is assessed through collecting 117 clinical samples. The results are compared by using the corresponding kit of marketed chemiluminescence method as the reference reagent. Their comparability is studied by regression analysis, expected bias at the medical decision level and its confidence intervals index evaluation. Clinical evaluation test results show that this product is equivalent to the application testing performance of similar products already on the market.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
