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  • HIV Ag/Ab Tri-line Rapid Test
  • HIV Ag/Ab Tri-line Rapid Test

HIV Ag/Ab Tri-line Rapid Test

Usage
The HIV Ag/Ab Tri-line Rapid Test is a tri-line, serological, lateral flow chromatographic immunoassay for the simultaneous and qualitative detection of human immunodeficiency virus type 1 (HIV-1) p24 antigen, human immunodeficiency virus type 1 antibody and type 2 antibody in human whole blood, serum, or plasma specimens to aid in the diagnosis of infection with HIV. The test only provides preliminary analysis results but not critical diagnosis criteria. Any reactive specimen with the HIV Ag/Ab Tri-line Rapid Test must be analyzed and confirmed with alternative testing method(s) and clinical findings. The test is intended for healthcare professional use. Applications of the test including, screening test for sex transmitted diseases (STD’s) among high-risk group of people, regular health examinations, and field screen test for blood bank.

 

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 HIV-1 p24 antigen indicates fresh infection with HIV-1 virus, and presence of antibodies to HIV- 1/HIV-2 indicates previous exposures to HIV-1/HIV-2 virus. The HIV Ag/Ab Tri-line Rapid Test utilizes anti-HIV-1 p24 antibody and recombinant HIV antigen immobilized on a membrane to detect HIV-1 p24 antigen, HIV type 1 and HIV type 2 antibodies qualitatively and selectively in human whole blood, serum, or plasma specimens.

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Packing specification

Principle of Inspection

The HIV Ag/Ab Tri-line Rapid Test is a qualitative membrane-based immunoassay for the detection of HIV-1 p24 antigen, HIV type 1 and HIV type 2 antibody in human whole blood, serum, or plasma specimens. The test device consists of: 1) a burgundy-colored pad containing colloidal gold particles coated with recombinant HIV-1 antigen gp41/120, recombinant HIV-2 antigen gp36, and colloidal gold particles coated with monoclonal anti-HIV-1 p24 antibody and 2) a nitrocellulose membrane strip containing two test lines (Ab line and Ag line) and a control line (C). The Ab line is coated with recombinant HIV-1 antigen gp41/120 and recombinant HIV-2 antigen gp36 for the detection of HIV type 1 and HIV type 2 antibodies, and the Ag line is coated with monoclonal anti-HIV-1 p24 antibody for the detection of HIV-1 p24 antigen. When an adequate volume of specimen is added to the specimen well(S) of the device, the specimen migrates by capillary action across the device and interacts with the immobilized antigens respectively. If the specimen contains HIV type 1 and/or HIV type 2 antibodies, a colored line will appear in the Ab line region. If the specimen contains HIV-1 p24 antigen, a colored line will appear in the Ag line region. Absence of any test lines (Ab and Ag) suggests a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control lines, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.

Specification packaging

25 Tests/Kit.

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About Kangte

Zhejiang Kangte Biotechnology Co., Ltd

Zhejiang Kangte Biotechnology Co., Ltd. was established in 2001 and is located in Zhejiang Xinchang Provincial High-tech Industrial Park. It is a national high-tech enterprise integrating R&D, production and sales of in vitro diagnostic reagents. Relying on the pioneering team spirit and scientific management, the company has repeatedly won the national advanced production unit in the in vitro diagnostic industry. 

The company has GMP standard workshops, clean workshops, R&D laboratories, equipped with high-precision testing equipment and fully automatic production equipment. In order to enhance the company's overall R&D strength, it has established a good "production-study-research" cooperative relationship with many colleges and universities. The company has obtained a number of invention patents and utility model patents and has passed ISO9001, ISO14001, ISO13485, and other system certifications. The company currently has more than 100 registered products, covering biochemical, immunological, and other fields, and many of the products have reached the leading domestic level in technology. 

The company adheres to the concept of "integrity, professionalism, efficiency and innovation" to serve customers, and constantly introduces products with higher technological content to provide customers. The company will, as always, position itself in "service technology, professionalism and efficiency, and achieve customers", and work hard to jointly shape the IVD industry and continuously improve the level of human health.

 

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