Accu Test HIV 1/2 Ab Test Kit

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 detection of antibodies against HIV-1 and HIV-2 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