Human Immunodeficiency Virus HIV 1/2 Aids Rapid Blood Test Kit
Single Package
INTENDED USE
The HIV 1/2 Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual
immunoassay for the qualitative, presumptive detection of
antibodies to HIV-1/HIV-2 in human serum or plasma specimens. This
kit is intended for use as an aid in the diagnosis of HIV
infection.
PRINCIPLE
The HIV 1/2 Rapid Test detects antibodies to HIV-1/HIV-2 through
visual interpretation of color development on the internal strip.
Recombinant HIV antigens are immobilized on the test region of the
membrane. During testing, the specimen reacts with HIV antigen
conjugated to colored particles and precoated onto the sample pad
of the test. The mixture then migrates through the membrane by
capillary action and interacts with reagents on the membrane. If
there are sufficient HIV-1/HIV-2 antibodies in the specimen, a
colored band will form at the test region of the membrane. The
presence of this colored band indicates a positive result, while
its absence indicates a negative result. The appearance of a
colored band at the control region serves as a procedural control,
indicating that the proper volume of specimen has been added and
membrane wicking has occurred.
WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test should be discarded according to local regulations.
STORAGE AND STABILITY
The kit should be stored at 2-30°C until the expiry date printed on
the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Care should be taken to protect the components of the kit from
contamination. Do not use if there is evidence of microbial
contamination or precipitation. Biological contamination of
dispensing equipment, containers or reagents can lead to false
results.
OPERATION
Allow the test device, specimen, buffer, and/or controls to
equilibrate to room temperature (15-30°C) prior to testing.
