Early Pregnancy Test HCG Human Chorionic Gonadotropin urine rapid test
1. INTEDED USE
This kit is applicable to in vitro qualitative detection of human chorionic gonadotropin (HCG) in serum 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 | Colloidal Gold |
| Sample Type | Urine/Serum |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
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MAIN KIT COMPONENTS * Test device * Sample collection tube * Disposable pipette * Instructions for Use |
PACKING * 25 test /kit * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
4.RESULT EVALUATION AND EXPLANATION
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Positive:
There are two stripes in control area (C) and test area (T). Positive result indicates that: content of HCG in sample is higher than 25mIU/mL. |
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Negative: There is only one red stripe in control area (C). There’s no red stripe in test area (T). Negative result indicates that: content of HCG in sample is lower than 25mIU/mL. |
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Invalid: Failure to show control line C. Invalid result indicates that: it can be caused by incorrect operation process or deteriorated and damaged reagent. Retest shall be conducted in case of invalid result, which shall be operated strictly in accordance with the specification. If the problem still exists, please immediately stop using products of the lot number, and contact local supplier. |
5.CLINICAL PERFORMANCE
Clinical performance of this product’s assessed through collection of 311 cases of clinical samples. Marketed kit of colloidal gold’s used as reference reagent. The BAYSEN reagent test will be compared with the control reagent:
| Baysen Result of RV/AV |
Test result of Reference reagent | Positive coincidence rate: 99.40% (95%C.I. 96.69%~99.89%) Negative coincidence rate: 100.00% (95%C.I.97.40%~100.00%) Total coincidence rate: 99.68% (95%C.I.98.20%~99.94%) |
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| Positive | Negative | Total | ||
| Positive | 166 | 0 | 166 | |
| Negative | 1 | 144 | 145 | |
| Total | 167 | 144 | 311 | |
6. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
