A rapid test for the diagnosis of Human Immunodeficiency Virus (HIV) type 1 antibody, type 2 antibody, Subtype O antibody and type 1 p24 antigen qualitatively in human whole blood, serum or plasma specimen. For professional in vitro diagnostic use only.
The HIV 1.2.O and p24 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HIV type 1 antibody, type 2 antibody, Subtype O antibody and type 1 p24 antigen in human whole blood, serum or plasma specimen to aid in the diagnosis of HIV infection.
【MATERIALS】
Materials provided
• Test cassettes • Droppers • Buffer • Package insert
Materials required but not provided
• Specimen collection containers • Timer • Centrifuge
• Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
• Lancets (for fingerstick whole blood only)
【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 L) to the specimen well of test cassette, then add 1 drop of buffer (approximately 40 L), and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 L) to the specimen well of test cassette, then add 2 drops of buffer (approximately 80 L), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50 L of fingerstick whole blood specimen to the specimen well of test cassette, then add 2 drops of buffer (approximately 80 L), and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the results after 20 minutes.
Note: It is suggested not to use the buffer beyond 6 months after opening the vial.
