INTENDED USE

The HIV1/2 and Syphilis antibody Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to HIV 1/2、Syphilis in Whole blood/Serum/Plasma It provides an aid in the diagnosis of infection with HIV1/2、Syphilis.

SUMMARY

Discovered in 1983, the Human Immunodeficiency Virus is a retrovirus and identified as the etiologic agent for the Acquired Immunodeficiency Syndrome (AIDS), and AIDS related complex. AIDS is characterized by changes in the population of T-cell lymphocytes that play a key role in the immune defense system. In the infected individual the virus causes a depletion of a subpopulation of T-cells, called T-helper cells, which leaves these patients susceptible to opportunistic infections and certain malignancies. The major routes of transmission are sexual contact, exposure to contaminated blood or blood products (including sharing of contaminated syringes and needles) and mother-to-newborn transmission. Human immunodeficiency virus type I and type II (HIV-1 and HIV- 2) are enveloped single strain RNA positive virus. The causative relationship between HIV-1 and HIV-2 virus and AIDS has been established over decades. HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy individuals with a high risk for developing AIDS . HIV-2 has been isolated from West African AIDS patients and from sero-positive asymptomatic individuals. Both HIV-1 and HIV-2 virus can elicit strong immune responses, including the production of anti-virus antibodies. Presence of specific anti HIV-1 and/or HIV-2 virus antibody in blood, Whole blood/Serum/Plasma indicates the exposure of an individual to the HIV-1 and/or HIV-2 virus, being of great value for clinical diagnosis.
Enzyme Immunoassays (EIAs), Western Blots (WB), Nucleic Acid Amplification Test (NAT) assays and various other test systems are currently available for detection of HIV-1 and HIV-2 infection. The HIV 1/2 Rapid Test utilizes immobilized antigens for the detection of antibodies to HIV-1 and HIV-2, and is a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2.
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. Relatively little is known about the organism in comparison with other bacterial pathogens. According to the Center for Disease Control ( CDC), the number of cases of Syphilis infection has markedly increased since 1985. Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users 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 Syphilis Rapid Test Device ( Whole blood/Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies ( IgG and IgM) qualitatively and selectively in whole blood,serum or plasma.

PRINCIPLE

The HIV 1/2 and Syphilis Rapid Test is an immunoassay based on the principle of the double antigen-sandwich technique. During testing, a Whole blood/Serum/Plasma specimen migrates upward by capillary action. The antibodies to HIV-1 or HIV-2 or TP antibodies ( IgG and IgM )if present in the specimen will bind to the HIV(T2 regions) and SYP(T1 regions) conjugates. The immune complex is then captured on the membrane by the pre-coated recombinant HIV and TP antigens, and a visible colored line will show up in the test line region indicating a positive result. In the absence of antibodies to HIV-1 or HIV-2 or TP, a colored line will not form in the test line region indicating a negative result.
To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.