1.Product Description

(1)The HIV 1/2 Rapid Test Device (Whole Blood/Serum/ Plasma) is a rapid test to qualitatively detect the presence of antibody to HIV 1 and/or HIV 2 in whole blood, serum or plasma specimen.The test utilizes latex conjugate and multiple recombinant HIV proteins to selectively detect antibodies to the HIV 1/2 in whole blood, serum or plasma. 

2.Storage and Stability

(1)The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

3.Materials Provided

(1)Test devices

(2)Disposable specimen droppers

(3)Buffer

(4)Package insert

4.Materials Required But Not Provided

(1)Specimen collection containers

(2)Lancets (for fingerstick whole blood only)

(3)Disposable heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)

(4)Centrifuge (for plasma only)

(5)Timer

5.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.

(3)For Serum, Plasma or Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 1 drop of serum, plasma or venipuncture whole blood (approximately 25 mL) to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.

(4)For Fingerstick Whole Blood specimen:

(5)To use a capillary tube: Fill the capillary tube and transfer approximately 25 mL of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.

(6)To use hanging drop: Allow 1 hanging drop of fingerstick whole blood specimen (approximately 25 mL) to fall into the center of the specimen well (S) on the test device, then add 1 drop of buffer (approximately 40 mL) and start the timer. See illustration below.

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