Procalcitonin Test kit for detection of Bacterial infection and Spesis
1. INTEDED USE
This kit is applicable to the in vitro quantitative detection on the content of procalcitonin (PCT) in human serum/plasma/whole blood samples and is mainly used for implementing auxiliary diagnosis of clinical systemic bacterial infection and sepsis. This kit only provides the test result of Procalcitonin, and the obtained result shall be analyzed in combination with other clinical information. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | PCT |
| 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 165 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 linearity regression. The correlation coefficients of the two tests are Y=0.997X+0.041 and R=0.9896, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
7.GLOBAL PARTNER
