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| Customization: | Available |
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| Type: | IVD Reagent |
| Sensitivity: | 10mlu/Ml |
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Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit(Colloidal Gold)
IVD for Self-testing, for Professional laboratory use, for near-patient testing
[INTENDED USE]
The human chorionic gonadotropin(HCG) pregnancy test kit is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in the detection of pregnancy. This test is for women who are planning pregnancy or suspected pregnant to aid in the early detection of pregnancy. This test is suitable for self-testing, professional laboratory use and near-patient testing.
1. Accuracy
The comparison studies were conducted using Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit (Coloidal Gold)and commercially available tests. The study included 250 urine specimens, and both assays identified 150 negative and 100 positive results. The results were >99% in agreement.
2. Limit of Detection
The limit of Detection was determined by tested controls which has been standardized to the WHO International Standard.
The Limit of Detection is 10mlU/mL. This test kit detects HCG at a concentration of 10mlU/mL or greater.
3. Precision
The results of HCG standard at the same concentration were consistent, and the chromaticity was uniform
4. Analytical Specificity
The addition of LH (500mlU/mL), FSH (1,000mlU/mL), and TSH (1,000ulU/mL) to negative and positive specimens showed no cross-reactivity.
Interfering Substances
| Product Name | Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit(Colloidal Gold) |
| Sensitivity | 10mlU/mL |
| Brand | Singclean |
| Specimens | Urine |
| MATERIALS PROVIDED | Test strip/Test cassette/Test midstream Instructions for use Dropper (for test cassette only)Desiccant |
| MATERIALS REQUIRED BUT NOT PROVIDED | Disposable specimen container Timer |
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