HIV Ag&Ab CARD (4TH Generation)

Intended Use

HIV Ag & Ab Card (4th Generation) is a visual, rapid qualitative and sensitive solid phase
immunochromatographic assay for the differential detection of HIV-1 p24 Antigen and Antibodies (IgM, IgG &
IgA) to HIV-1& HIV-2 in Human Serum/ Plasma/ Whole blood (collected by venipuncture or Fingerprick). The
test is a screening test for p24 antigen (HIV-1) and HIV antibodies (anti-HIV-1 & anti-HIV-2) and is for in vitro
diagnostic use only. It is intended for screening of blood donors or other individuals at risk for HIV-1 & HIV-2
infection and for clinical diagnostic testing. It is a screening test for p24 antigen (HIV-1) and HIV antibodies
(anti-HIV-1 & anti-HIV-2). The test is for in vitro diagnostic use only and is intended for screening of blood
donors or others individuals at risk for HIV-1 and/or HIV-2 infection and for clinical diagnostic testing.

Salient Features

• Finger prick, rapid, visual and qualitative Immunoassay.
• 4TH Generation Rapid test for differential detection of p24 Antigen & antibodies for HIV in serum/plasma /whole blood.
• Ideal for Blood screening, detects sero-negative HIV Cases.
• Use of gp-41, C terminus of gp120 for HIV-1 , gp-36 for HIV -2 antibodies and Anti-p24 for HIV p24 Ag detection.
• Detection of Group ‘0’ & subtype ‘C’ of HIV-1, which is most prevalent in India.
• Based on Immunochromatography Technique.
• See through device for easy interpretation of results.
• Sensitivity : 100 % & Specificity: 100%
• Analytical Sensitivity of HIV p24 Ag : 100 IU/ml (traceable to p24 Antigen NIBSC Standard, U.K. Code No. 90/636)
• Long Shelf life 30 months at 2-30°C
• Convenient pack size: 25 T.

Principle

HIV Ag & Ab (4th Generation) Test kit consists two devices; one device for detection of HIV-1 p24 antigen and
second device for the detection of HIV-1 & HIV-2 antibodies in human serum/ plasma/whole blood.
HIV Antigen device contains two lines; “C” (Control Line) & “Ag” (HIV-1 p24 Antigen detection Test Line). Test
line is coated with anti-p24 antibodies. When a sample is added to the HIV Antigen device followed by the
addition of assay buffer, HIV-1 p24 antigen if present in the sample will bind to the anti-p24 gold colloid
conjugate making antigen antibodies complex. This complex migrates along the membrane to the test region
and forms the visible purple line at “Ag” region as antibody-antigen-antibody gold conjugate complex.
HIV Antibody test device contains two lines; “C” (Control line), & “Ab” (HIV-1 & HIV-2 Antibody detection Test
Line). The test line is coated with HIV-1 & HIV-2 Antigens for the detection of HIV Antibodies. When a sample is
added to the HIV Antibody device followed by the addition of assay buffer, anti-HIV-1 and/or anti-HIV-2
antibodies if present in the sample, bind to the respective HIV-1 and/or HIV-2 antigen gold colloid conjugate
making antigen-antibodies complexes. These complexes migrate along the membrane to the test region and
form the visible purple line at “Ab” region as antigen-antibody-antigen gold colloid conjugate complex.
The intensity of the test bands in the respective device will vary depending upon the amount of antigen/antibody present in the sample.
The appearance of any pink/purple color line in a specific test region should be considered as reactive for that particular antigen and/or antibody. A red procedural control line
should always develop in the test device window to indicate that the test has been performed properly.

Ordering Information