The HIV 1/2 Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HIV-1/HIV-2 in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HIV infection.
1) Fingerstick Specimens (Whole Blood)
Clean the area to be lanced with Alcohol prep pad. Squeeze the end of the fingertip and pierce it with the sterile lancet.
Wipe away the first drop of blood with sterile gauze or cotton. Using Disposable pipette, collect blood from the puncture site.
2) [Serum or plasma] Centrifuge whole blood to get plasma or serum specimen.
3) If serum is not tested immediately, it should be refrigerated at 2-8 degrees Centigrade. For storage periods greater than three days, freezing is recommended. They should be brought to room temperature prior to use.
4) Serum containing precipitate may yield inconsistent test results. Such specimens must be clarified prior to assaying.
5) The whole blood may be used for testing immediately or may be stored at 2-8 degrees Centigrade up to three days.
Procedure For Testing
1) Let the pouched test come to room temperature(15-30°C). Remove the test device from the foil pouch, and place it on a flat, dry surface.
2) Transfer the specimen by Disposable pipette:
Draw and transfer 1 drop (approximately 30μl) of whole blood (or 20μl serum or plasma)to the sample well of the test device, then add 2 drops of Assay diluent (approximately 60μl) and start the timer.
3) As the test begins to work, you will see purple color move across the result window in the center of the test device.
4) Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
Caution: The above interpreting time is based on reading the test results at room temperature range of 15 to 30 °C. If your room temperature is significantly lower than 15 °C, then the interpreting time should be properly increased to 30 minutes.