Quantitative Serum Human Chorionic Gonadotropin Rapid Test
1. INTEDED USE
This kit is applicable to in vitro quantitative detection of human chorionic gonadotropin (HCG) in human serum/plasma/whole blood sample, which’s suitable for auxiliary diagnosis of early trimester of pregnancy. This kit only provides human chorionic gonadotropin test results, and results obtained shall be used in combination with other clinical information for analysis.
2. PRODUCT SPECIFICATION
| Model No. | HCG |
| 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 this product was evaluated by collecting 202 clinical samples. The test results were compared using the corresponding kits for chemiluminescence on the market as reference reagents, and their comparability was studied by linear regression. The correlation coefficients of the two tests were Y=1.007X+ 82.828 and R=0.9882, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
