POCT Reagent Blood PRL Prolactin Diagnostic Kit
1. INTEDED USE
This kit is applicable to the in vitro quantitative detection on the content of prolactin (PRL) in human serum/plasma/blood sample and is mainly used for evaluating the endocrine function of pituitary gland. This kit only provides the test result of prolactin (PRL). The obtained result should be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | PRL |
| 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 * Disposable pipette * 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 150 clinical samples. The corresponding kit of listed electrochemiluminescence method is used as the control reagent. The test results are compared and their comparability is studied with linear regression. The correlation coefficients of the two tests are Y=1.063X+0.009and R=0.9742, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
