HIV(1+2) Antibody Rapid Test Kit

For qualitative detection of HIV(1+2) Antibodies in serum/plasma and whole Blood

Main Features

► Sensitivity: 100%
► Specificity: Higher than 99%
► Simple: No Instrument Required
► Ambient Storage
► Reliable: able to differentiate HIV Type I and Type II
► Certified by Authoritative Certification
► Unique 3-line Patented Design
► Winner of "the 2008 National HIV Antigen Diagnostic Kit for Clinical Performance Assessment"

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.

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.



Storage

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

Reagents and Materials Provided

Each kit contains:
1. 40 test cassettes(individually pouched)
2. Each pouch contains one cassette with one desiccant bag
3. One bottle of diluent buffer(5ml)
4. 40 disposable plastic droppers
5. Instruction for use

Materials Required But Not Provided

1. Timer or stopwatch
2. Blood collection devices, for the testing of venous whole blood, serum or plasma
3. Biohazard disposal container
4. Disposable gloves

For finger stick samples, the following materials are required:
Alcohol pad
Sterile lancet
Sterile gauze or cotton

Warning

For Invitro Diagnostic Use ONLY
Read the package insert completely before use. It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false negative result (i.e.a missed positive) .