HIV 1&2 Antibody Rapid Diagnostic Test Kit

Instruction for Use

A lateral flow immunochromatographic assay for the qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) type 1 and type 2 in serum or plasma.

Assay Procedure

Allow the test device, buffer, specimen to equilibrate to room temperature (15-30°C) prior to testing.

• Remove the test device from its protective pouch, lay it on a dry and clean flat surface, and label the device with patient or control number.
• Use the dropper or pipette to withdraw specimen from the specimen collection container and dispense 2 drops (approximately 60μL) of serum or plasma into the sample well, then add 1 drops of buffer (approximately 40μL), and start the timer. See illustration below and start the timer. Avoid trapping air bubbles in the specimen well (S). Please see the illustration below.
• Wait for the red line(s) to appear. The result should be read in 10 minutes. Do not interpreter result after 20 minutes.

Interpretation of assay result

(Please refer to the above illustration)

Negative Result: If only the C band is developed, the test indicates that no detectable HIV antibodies present in the specimen. The result is negative.

Positive Result: If both C and T bands are developed, the test indicates that the presence of antibodies to HIV 1, or HIV2 or both in the specimen. The result is HIV positive.

The intensity of the color in the test line region (T) may vary depending on the concentration of HIV antibodies present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.

Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.

Invalid: If no C band is developed, the assay is invalid regardless of color development on the T band as indicated below. Repeat the assay with a new device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.