Diagnostic Kit for Cortisol
1. INTEDED USE
This kit is applicable to in vitro quantitative detection of cortisol (COR) in human serum/plasma sample, which’s mainly used for assessment of adrenal, pituitary, and hypothalamic function. This kit only provides cortisol (COR) test results, and results obtained shall be used in combination with other clinical information for analysis.
2. PRODUCT SPECIFICATION
| Model No. | Cor |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | Serum/Plasma |
| 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 sample, andmix well 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 performance of this product’s assessed through collection of 164 cases of clinical samples. Marketed kit of electrochemiluminescence’s used as reference reagent. Detection results have been compared and their comparability has been studied through linear regression, and correlation coefficients of the two assays arY=0.967X+0.269 and R=0.9855 respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
