Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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| Product Name | Infection Disease AIDS HIV1/2 Rapid 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 HIV 1/2 Rapid Test Strip (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HIV-1/HIV-2 in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HIV infection.
PERFORMANCE CHARACTERISTICS
Table: HIV 1/2 Rapid Test vs. EIA
|
Relative Sensitivity: >99.9% (99.0%-100.0%)* Relative Specificity: >99.9% (99.3%-100.0%)* Overall Agreement: >99.9% (99.5%-100.0%)* *95% Confidence Interval |
HIV 1/2 Rapid Test | ||||
| + | - | Total | |||
| EIA | + | 365 | 1 | 366 | |
| - | 0 | 760 | 760 | ||
| 365 | 761 | 1126 | |||
PRINCIPLE
The HIV 1/2 Rapid Test Strip (Whole Blood/Serum/Plasma) has been designed to detect antibodies to HIV-1/HIV-2 through visual interpretation of color development in the internal strip. The membrane was immobilized with recombinant HIV antigens on the test region. During the test, the specimen is allowed to react with colored HIV antigens 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 HIV-1/HIV-2 antibodies 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.