Intended Use

The HIV 1/2 Rapid Test Device (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to HIV 1 and/or HIV 2 in whole blood, serum or plasma.

adv_img

DIRECTIONS FOR USE

Allow the test device, specimen, buffer, and/or controls to

equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Place the test device on a clean and level surface. For Serum, Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum, plasma (approximately 40 µL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 40 µL) and start the timer. See illustration below. For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of venipuncture whole blood (approximately 80 µL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 40 µL) and start the timer. See illustration below. For Fingerstick Whole Blood specimen: Allow 3 hanging drop of fingerstick whole blood specimen (approximately 80 µL) to fall into the center of the specimen well (S) on the test device, then add

2 drops of buffer (approximately 40 μL) and start the timer. See illustration below.

3. Wait for the red line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 minutes.

fgh

(Please refer to the illustration above)

POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the test region (T).

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

NEGATIVE: One red line appears in the control region (C). No apparent red or pink line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.