Human Immunodeficiency Virus (HIV) Antibody /Antigen

ELISA Test Kit

For in vitro diagnostic and professional use only.

PRODUCT NAME

HIV 1/2 Ab/Ag ELISA Test Kit (Serum/Plasma)

INTENDED USE

This HIV 1/2 Ab/Ag ELISA Test Kit is a qualitative detection of HIV-1 and HIV-2 antibody and P24 antigen in human serum/plasma, which is based on Enzyme Linked Immunosorbent method. The kit is suitable for clinical screening and diagnosis of Human Immunodeficiency Virus infection.

TEST PRINCIPLE

The kit is designed based on enzyme-linked immunosorbent assay with double antigen sandwich method and double antibody sandwich method.

HIV antigen and P24 monoclonal antibody is absorbed in solid phase to the polystyrene reaction microplate, work with biotin antibody, enzyme labeled antigen, enzyme labeled affinity and TMB chromogenic reagent and other reagents to detect HIV-1 and HIV-2 antibody and P24 antigen in human serum/plasma.

COMPONENTS

Materials provided with the kit:

Note: different batches of reagent kit, and different components cannot be exchanged for use. Once open, stable for 3 months at 2-8°C.

SAMPLE REQUIREMENTS

1. Specimen Collection: No special patient’s preparation required. Collect the specimen in accordance with the normal laboratory practice. Either fresh serum/plasma specimens can be used with this assay. Blood collected by venipuncture should be allowed to clot naturally and completely – the serum/plasma must be separated from the clot as early as possible to avoid hemolysis of the RBC.

Care should be taken to ensure that the serum/plasma specimens are clear and not contaminated by microorganisms.

2. Highly lipaemic, icteric, or hemolytic specimens should not be used as they can give false results in the assay. Do not heat inactivate specimens. This can cause deterioration of the target analyte. Samples with visible microbial contamination should never be used.

3. HIV ELISA is intended ONLY for testing of individual serum/plasma samples. Do not use the assay for testing of cadaver samples, saliva, urine or other body fluids, or pooled (mixed) blood.

4. Transportation and Storage: Store specimens at 2-8°C. Specimens not required for assaying within 3 days should be stored frozen (-20°C or lower). Multiple freeze-thaw cycles should be avoided. For shipment, samples should be packaged and labeled in accordance with the existing local and international regulations for transportation of clinical samples and ethological agents.