Immunoassay Blood TT4 Total Thyroxine detection kit
1. INTEDED USE
his kit is applicable to the in vitro quantitative detection on the content of total thyroxine (TT4) in human serum/plasma samples and is mainly used for evaluating thyroid function. This kit only provides test result of total thyroxine (TT4). The obtained result should be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | TT4 |
| 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
4.CLINICAL PERFORMANCE
Clinical evaluation performance of the product is assessed by collecting 205 clinical samples. Use a corresponding marketed chemiluminescence kit as the control reagent and compare the test results. Their comparability is studied by linear regression. The correlation coefficients of the two tests are Y=0.939X-1.569 and R=0.9854, respectively
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
