The HIV (1+2) Ag/Ab combo rapid test kit is a rapid, qualitative test for the detection of HIV p24 antigen and antibodies to all isotypes (IgG, IgM and IgA) specific to HIV-1 including subtype-O and/or HIV-2 simultaneously in human serum, plasma or whole blood. Theantigens are prepared with proteins to have HIV-1, gp41, gp120 and gp36. For HIV 2, p24 ab & gp36. The HIV (1+2) Ag/Ab Combo Test kit (3lines) is intended for professional use, only for aninitial screening test and reactive samples
should be confirmedby a supplemental assay such as ELISA or Western Blot test.
1. For in vitro diagnostic uses only.
2. Clean up spills thoroughly using an appropriate disinfectant.
3. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they wereinfectious
waste, in a biohazard container.
4. Do not mix and interchange different specimen.
5. Anticoagulants such as heparin, EDTA and sodium citrate do not affect the test result.
6. Lcteric, lipemic, hemolysed, heat treated and contaminated specimens may give erroneous results.
7. Do not use test kit beyond expiration date.
SUMMARY AND EXPLANATION OF THE TEST
HIV (Human Immunodeficiency Virus) is recognized as the etiologic agent of Acquired immune Deficiency Syndrome (AIDS). The virus is transmitted by sexual contact, exposure to infected blood, certain body fluids or tissues, and from mother to fetus orchild during the perinatal period. HIV-1 has been isolated from patients with high potential risk of developing AIDS.
HIV-1 appears to be the most common one while HIV-2 is mostly found in patient samples from West African region. Its course is marked by increasing levels of viral replication and the emergence of more virulent viral strains. This process causes the destruction of the immune system. HIV infection is staged by CD4 cell counts and clinical symptoms. Not all people progress through all “stages” and the time frames may also very greatly from person to person.
The 4th generation HIV(1+2) Ag/Ab Combo Test kit (3lines) containsa membrane strip, which is pre-coated with mouse
monoclonal Anti-HIV p24 antibody on test line “2” region with gp36 and test line “1” region with recombinant HIV-1/HIV-2 antigens respectively. The mixture of mouse monoclonal anti-HIV p24 antibody and recombinant HIV-1/HIV-2 antigen-colloid gold conjugate form a visible lines (1&2) as the antigen-antibody-antigen or antibody-antigen-antibody gold particle complex with high degree of sensitivity and specificity.
The test lines and control line in the result window have been clearly labeled. For line “2” is for HIV p24 antigen and/or
antibodies to HIV-2 and line “2” is for antibodies to HIV-1/HIV-2, and “C” for Control line. All the test lines and control line in the result window are not visible before applying any sample. The control line is used for procedural control and should always appear if the test procedure is performed correctly.
SPECIMENS COLLECTION AND STORAGE
Fingerstick Specimens(Whole Blood)
1. Clean the area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce it with a sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Use micropipet to obtain about 100ul fresh blood .
1. Have a certified phlebotomist collect whole blood into a purple,blue or green top collection tube (containing EDTA, citrate or
heparin, respectively) by veinpuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma for testing, or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.
1. Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.