Thyroid Function Thyroid Stimulating Hormone Test Blood Test
1. INTEDED USE
This kit is intended for in vitro quantitative detection on the thyroid-stimulating hormone (TSH) existing in the human serum/plasma/whole blood samples and is used for evaluating the pituitary-thyroid function. This kit only provides the test result of thyroid-stimulating hormone (TSH), and the obtained result shall be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | TSH |
| 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
4.CLINICAL PERFORMANCE
Clinical evaluation performance of the product is assessed through collecting 168 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 = 0.998x-0.331 and R = 0.9821, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
