Syphilis and HIV 1.2.O Combo Rapid Test

Intended Use

Syphilis and HIV 1.2.O Combo Rapid Test (Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of antibodies to HIV 1/HIV-2 and Treponema Pallidum (TP) in human serum or plasma specimens. Syphilis and HIV 1.2.O Combo Rapid Test is intended for use as an aid in the HIV and/or syphilis infection

Principle

The Syphilis and HIV 1.2.O Combo Rapid Test Device utilizes the principle of immunochromatography, each strip detects antigen or antibody through visual interpretation of color development on the internal strip.

Recombinant HIV antigens and specific recombinant TP antigens are immobilized on the test region of each membrane. During testing, the specimen reacts with antibodies or antigens 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 antigen or antibody in the specimen, a colored band will form at the test region of each 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.

Materials

● Combo test devices

● Package insert

● Disposable pipettes

Advantages

● Diagnosis of HIV infection

● Convenient, easy to operate

● Storage at 2-30°C

● Results in 15 min

● 99% Accuracy

Procedure

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 device with patient or control identification. For best results, the assay should be performed within one hour.

2. Using the provided disposable pipette, transfer 3 drops of specimen (approximately 75 µL) into each specimen well (S) of the device, then 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 15 minutes. Do not interpret the result after 30 minutes.

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