NewScen Coast Bio-Pharmaceutical Co., Ltd

INTENDED USE
The HIV-1/2 Rapid Diagnostic Test (RDT) is a qualitative test for the detection of antibodies to Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) in human serum/plasma. It is considered as an initial screening test for HIV-1/2 antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA.

PRINCIPLE
HIV-1/2 RDT is a chromatographic immunoassay (CIA) for the detection of antibodies to HIV-1/2 in human serum/plasma. HIV-1/2 specific antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HIV-1/2 specific antigens. Antibodies to HIV-1/2, if present, a red colored band will develop on the membrane in proportion to the amount of HIV-1/2 antibodies present in the specimen. Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antibodies to HIV-1/2.

STORAGE
Store the test kits at temperature 4-25°C,in the sealed pouch for the duration of the shelf life (24 months).

ASSAY PROCEDURE
Serum/Plasma
Add 70-100 ul or 2-3 drops of serum or plasma into sample well. Observe the result in 5 –30 minutes
Whole blood
Add 1 drop of whole blood into sample well, after all blood completely absorbed, add 1 drop of whole blood diluent. Observe the result in 5-30 minutes.

INTERPRETATION OF RESULTS

Negative: No apparent band in the test region (1 and 2), only one red band appears in the control region (C). This indicates that no HIV1/2 antibodies have been detected.
Positive: In addition to the band in the control region (C), other one or two red bands will appear in the test region (1 and 2). This indicates that the specimen contains HIV1/2 antibodies.
Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (1 and 2). It indicates a possible error in performing the test. The test should be repeated using a new device.