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.
