Multi Infectious Disease Combo Rapid Test

Background of Clinical Indications

Human Immunodeficiency Virus type-1 (HIV-1) and type-2 (HIV-2) are enveloped single strand RNA virus that cause acquired immunodeficiency syndrome (AIDS). Current data indicate that the HIV is transmitted through sexual contact, exposure to blood (including sharing contaminated needle and syringe) or certain blood products or from an infected mother to her child during the prenatal period. People with increased risk of HIV infection include intravenous drug users, homosexuals, and hemophiliacs. The presence of antibodies to HIV- 1/HIV-2 indicates previous exposures to HIV-1/HIV-2 virus. Hepatitis B virus (HBV) is the most common cause of persistent viremia and the most important cause of chronic liver disease and hepatocellular carcinoma. Clinically apparent HBV infections may have been in existence for several millennia. It is estimated that there are 300 million chronic carriers of HBV in the world. The carrier rates vary from as little as 0.3% (Western countries) to 20% (Asia, Africa). HBV is a hepatotropic DNA virus. The core of the virus contains a DNA polymerase, the core antigen (HBcAg) and the e antigen (HBeAg). The core of HBV is enclosed in a coat that contains lipid, carbohydrate and protein including an antigen termed hepatitis B surface antigen (HBsAg). HBsAg is the first marker to appear in the blood in acute hepatitis B, detectable 1 week to 2 months after exposure and 2 weeks to 2 months before the onset of symptoms. Three weeks after the onset of acute hepatitis almost half of the patients will still be positive for HBsAg. In the chronic carrier state, HBsAg persists for long periods (6-12 months) with no seroconversion to the corresponding antibodies. Therefore, screening for HBsAg is highly desirable for all donors, pregnant women and people in high-risk groups. Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA Virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV is found in over 80% of patients with well-documented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to the first-generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity and to increase the sensitivity of the HCV antibody tests. Dual infection with HBV and HCV is not uncommon in geographic areas where a high endemic level of both infections is reported such as Southeast-Asia and the Mediterranean. In general, the prevalence is around 10-20% in patients with chronic HBV infection, and 2-10% of anti-HCV-positive patients have markers of HBV infection. Co-infection of HBV and HCV was found to be high in HIV-infected people (66%), particularly in HIV infected drug users (84%). Syphilis is a systemic disease caused by Treponema Pallidum. The signs and symptoms of syphilis vary depending in which of the four stages it presents (primary, secondary, latent, and tertiary). Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane. One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis. Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment. The Multi Infectious Disease Combo Rapid Test utilizes specific recombinant antigens and antibodies to detect human immunodeficiency virus (HIV) type 1 antibody, type 2 antibody, hepatitis B virus (HBV) surface antigen, anti-HCV antibodies, and antibodies (IgG and IgM) to Treponema Pallidum qualitatively and selectively in human oral mucosal transudate swab specimens. This assay can be performed to get test result at 15-30 minutes by minimally trained personnel and without cumbersome laboratory equipment.