Poct Reagent Prog Progesterone Ovulation Blood Test kit
1. INTEDED USE
This kit is applicable to the in vitro quantitative detection of the content of progesterone (PROG) in human serum/plasma/whole blood sample, and mainly used for auxiliary diagnosis of disease associated with abnormal progesterone. The kit only provides the test result of progesterone. The obtained result shall be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | Prog |
| 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 180 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=0.905X+0.873 and R=0.9863, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
