Accu Test HIV 1/2 Ab Test Kit

Accu Test HIV 1/2 Ab Test Kit is a visual, solid phase immunochromatographic assay for qualitative in-vitro diagnostic detection of antibodies against HIV-1 and HIV-2 in human serum/plasma. The product may be used as an aid in the diagnosis of HIV infection. A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm. The Human Immunodeficiency Virus (HIV) is a retrovirus that infects immune system cells, 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.

Uses:

• It is used to detect antibodies against HIV-1 and HIV-2 in human serum/plasma.

Product Specifications and Features:

• AccuTest HIV – 1/2 Ab employs a chromatographic lateral flow device in a cassette format

• Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HIV-1 (gp120 + gp41), and HIV-2 (GP-36) are dry-immobilised at the end of nitrocellulose membrane strip

• HIV-1, and HIV-2 antigens are bound at the Test Zone (1 & 2) respectively

• Goat Anti-Mouse IgG antibodies are bound at the Control Zone(C). When added, the sample migrates by capillary diffusion, rehydrating the gold conjugate

• If there are HIV-1 or HIV-2 antibodies in the sample, they will bind with the gold-conjugated antigens forming particles

• These particles will continue to migrate along the strip until the Test Zone (1 or 2), where they are captured by the HIV-1 or HIV-2 antigens generating a visible purple line

• If the specimen contains antibodies to HIV-1, the specimen will bind to the 1 test line and product line

• If the specimen contains antibodies to HIV2, the specimen will bind to the 2 test line

• If there are no HIV-1 or HIV-2 antibodies in the sample, no purple line is formed in the Test Zone

• The gold conjugate will continue to migrate alone until it is captured in the Control Zone (C) by the Goat Anti Mouse IgG antibodies aggregating in a purple line, which indicates that the migration of liquid has been successful

• The control line must be present for the test to be valid

Indications:

• Specimen with extremely high concentrations of red blood cells, fibrin should be recentrifuged before use

• AccuTest HIV – 1/2 Ab Test Device (Serum/Plasma) is for in vitro diagnostic use only

• AccuTest HIV – 1/2 Ab Test Device (Serum/Plasma) will only indicate the presence of antibodies to HIV-1/2 in the specimen and should not be used as the sole criteria for diagnosing HIV-1, HIV-2, and/or HIV-1 subtype O infection

• For confirmation of reactive test results, specimens should undergo further testing using different assays, such as rapid diagnostic tests, EIA and/or Western blotting in accordance with a validated HIV testing algorithm

• As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician

• Results should not be used to determine the serotype of HIV infections

• Do not mix components from different lot numbers

Directions For Use:

• Allow the test device, buffer and specimen to reach room temperature (15-30 °C) 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 (10µl) of sample into the sample well, then add 2 drops of assay diluent (about 75 µl) and start the timer

• As the test begins to work, you will see purple colour moving across the resulting window in the centre of the test disk

• Wait for the coloured lines to appear

• Interpret test results at 15 to 20 minutes

• Do not interpret test result after 20 minutes

Safety Information:

• Store as packaged in the sealed pouch at 4-30 °C (storage in the refrigerator is permitted). Do not store in the freezer. Protect the test kit from humidity

• The test device is stable until the expiration date is printed on the test kit and/or sealed test device pouch

• Do not use it beyond the expiration date

• The test device must remain in the sealed pouch until use

• For best results, adhere to the instructions provided

• All specimens should be handled as potentially infectious

• The test device is sensitive to humidity as well as heat

• Do not use test kit if pouch is damaged or seal is broken

• Use test device immediately after removing from the pouch

• The components (test device and assay diluents) in this kit have been quality control tested as a standard batch unit

• Read the label carefully before use

• Keep out of reach of children

• For external use only