Active Member
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[China]
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
Contact name:Edward YU
Hangzhou Aichek Medical Technology Co.,Ltd |
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| Product Name | Hepatitis B HbsAg Rapid Test uncut sheet |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only
INTENDED USE
The HBsAg Rapid Test Strip (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of HBsAg in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.
PERFORMANCE CHARACTERISTICS
Table: HBsAg Rapid Test vs. EIA
Relative Sensitivity: 99.9% (99.3%-100.0%)* Relative Specificity: >99.9% (99.7%-100.0%)* Overall Agreement: 99.9% (99.8%-99.9%)* *95% Confidence Interval | HBsAg Rapid Test | ||||
| + | - | Total | |||
| EIA | + | 820 | 1 | 821 | |
| - | 1 | 2134 | 2135 | ||
| 821 | 2135 | 2956 | |||
PRINCIPLE
The HBsAg Rapid Test Strip (Serum/Plasma) has been designed to detect the HBsAg through visual interpretation of color development in the strip. The membrane was immobilized with anti-HBsAg antibodies on the test region. During the test, the specimen is allowed to react with colored anti-HBsAg antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough HBsAg in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
