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Address: B318 Building B, Western Silicon Valley, Bao'an District, Shenzhen, China
Contact name:Sherry Cai
Dewei Medical Equipment Co., Ltd |
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INTENDED USE
The HBsAg, HCV, HIV & Syphilis Rapid Test Combo is a rapid visual immunoassay for the qualitative, presumptive detection of HBsAg, antibodies to HCV, antibodies to HIV1/HIV-2 and antibodies to Treponema Pallidum (TP) in human whole Blood, serum or plasma specimens.
For in vitro diagnostic use only.
PRINCIPLE
The HBsAg Rapid Test detects HBsAg through visual interpretation of color development on the internal strip. Anti-HBsAg antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-HBsAg antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is enough HBsAg in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The HCV Rapid Test detects antibodies to HCV through visual interpretation of color development in the internal strip. Protein A is immobilized on the test region of the membrane. During testing, the specimen reacts with recombinant HCV antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient HCV antibodies in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The HIV 1/2 Rapid Test detects antibodies to HIV-1/HIV-2 through visual interpretation of color development on the internal strip. Recombinant HIV antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with HIV antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient HIV-1/HIV-2 antibodies in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The Syphilis Rapid Test detects antibodies to Treponema Pallidum (TP) through visual interpretation of color development on the internal strip. Specific recombinant TP antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with recombinant TP-specific antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient antibodies to Treponema Pallidum (TP) in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
MAIN CONTENTS
Rapid Test Cassette in Pouch
Buffer
Disposable dropper
Package insert
SRORAGE
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).
The test is stable through the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use beyond the expiration date.
OPERATION
Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use.
1.Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the test with patient or control
identification. For best results, the assay should be performed
within one hour.
2.Using the provided disposable dropper, transfer 2 drops of
serum/plasma to specimen well (S) of the cassette, then start the
timer.
OR
Transfer 1 drop of whole blood specimen to each specimen well (S)
of the cassette with the provided disposable dropper, then add 1
drop of buffer and start the timer.
OR
Allow 2 hanging drops of fingerstick whole blood specimen to fall
into the center of each specimen well (S) on the cassette, then add
1 drop of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result area.
As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be
read at 10 minutes. Do not interpret the result after 20 minutes.
