Product Description

AccuTest HIV - 1-2 Ab test is a visual, solid phase immunochromatographic assay for qualitative in-vitro diagnostic detection of antibodies against HIV-1 and HIV-2 in human serum Or plasma. The product may be used as an aid in diagnosis of HIV infection. A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm.

Introduction:

The Human Immunodeficiency Virus (HIV) is a retrovirus that infects cells of the immune system, destroying or impairing their function. The most advanced stage of HIV infection is Acquired Immunodeficiency Syndrome (AIDS). The general method of detecting infection with HIV is to observe the presence of antibodies to the virus by an EIA method followed by confirmation with any confirmation method. AccuTest HIV -1-2 Ab is a simple, visual qualitative test that detects antibodies in human serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes.

Storage & Stability:

Store as packaged in the sealed pouch at 4-30 C (storage in refrigerator is permitted). Do not store in the freezer. Protect the test kit from humidly. The test device is stable until the expiration date printed on the test kit and/or sealed test device pouch. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use. 

Specimen Collection & Storage:

The test must be performed using human serum/plasma.

To collect serum/plasma: a. Collect according to safe phlebotomy procedures, using vacuum technique into tubes for serum or plasma preparation b. Prepare serum or plasma from whole blood as soon as possible to avoid hemolysis. Dont use turbid or haemolysed specimens.

Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature (15-30C) for not more than 8 hours. If specimens are not immediately tested they should be refrigerated at 4-8C for up to 3 days. For storage periods greater than three days, freezing at -20 C is recommended. The specimens should be brought to room temperature prior to use. Frozen specimens must be completely thawed and mixed well prior to testing.

Procedure:

• Allow the test device, buffer and specimen to reach room temperature (15-30C) prior to testing.
• Remove the test device from the foil pouch and use the test device as soon as possible (within one hour).
• Place the device on a flat, dry surface. Label with specimen ID.
• Holding the sample dropper vertically above the test disk, slowly transfer 1 drop (10Ul) of sample in to the sample well, then add 2 drops of assay diluent (about 75 Ul) and start the timer.
• As the test begins to work, you will see purple color moving across the result Window in the center of the Test Disk.
• Wait for the colored lines to appear. Interpret test results at 15 to 20 minutes. Do not interpret test result after 20 minutes.