REF:

C4113 (Multiple Cassette)

INTENDED USE：

HIV Antigen + Type I/Type II Antibody Multiple Test is a rapid chromatographic immunoassay for the qualitative detection of HIV type 1 antibody, type 2 antibody and type 1 P24 antigen in whole blood, serum or plasma specimen to aid in the diagnosis of HIV infection.

SUMMARY：

HIV1/2

HIV Antigen + Type I/Type II Antibody Multiple Test is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from host cell membrane. Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sense genomic RNAs. HIV 1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS. HIV 2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals. Both HIV 1 and HIV 2 elicit immune response. Detection of HIV antibodies in whole blood, serum or plasma is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV. Despite the differences in their biological characteristics, serological activities and genome sequences, HIV 1 and HIV 2 show strong antigenic cross-reactivity. Most HIV 2 positive sera can be identified by using HIV 1 based serological tests. The HIV 1/2 Rapid Test (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV type1 and type 2 in whole blood, serum or plasma specimen.

HIV Antigen + Type I/Type II Antibody Multiple Test is a rapid test to qualitatively detect the presence of antibodies to HIV type1 and type 2 in whole blood, serum or plasma specimen. HIV Antigen + Type I/Type II Antibody Multiple Test is a qualitative, membrane based immunoassay for the detection of antibodies to HIV 1/2 in whole blood, serum or plasma. The membrane is pre-coated with recombinant HIV antigens. During testing, the whole blood, serum or plasma specimen reacts with HIV antigens coated particles in the test Cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigens on the membrane in the test line region. If the specimen contains antibodies to HIV 1 and/or HIV 2, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain HIV 1 and/or HIV 2 antibodies, a colored line will not appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

HIV p24

The HIV p24 antigen is a small piece of protein that is found on the capsule of the HIV virus. When a person is infected with HIV, these bits of protein can be found floating in the blood. The HIV p24 antigen rapid test is the test that detects these bits of protein. This test was first developed as a HIV screening test but rapidly ran out of favor due to the development of more advanced NAT tests. The window period for p24antigen testing is also very small. This test alone is only accurate for between 3 and 6 weeks post exposure. So it is a test with very limited applications unless combined with HIV antibody test. The presence of p24 antigen in the blood indicated a recent HIV infection.

HIV Antigen + Type I/Type II Antibody Multiple Test is a rapid test to qualitatively detect the presence of p24 antigen to HIV 1 in whole blood, serum or plasma specimen. The test utilizes latex conjugate HIV p24 antibody to selectively detect p24 antigen to the HIV type 1 in whole blood, serum or plasma. HIV Antigen + Type I/Type II Antibody Multiple Test is a qualitative, membrane based immunoassay for the detection of p24 antigen to HIV type 1 in whole blood, serum or plasma. The membrane is pre-coated with mouse anti-HIV p24 antibody. During testing, the whole blood, serum or plasma specimen reacts with HIV p24 antibody coated particles in the test Cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with HIV p24 antibody on the membrane in the test line region. If the specimen contains p24 antigen to HIV type 1, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain p24 antigen to HIV type 1, a colored line will not appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.