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  • Anti-HIV (1&2) Rapid Test
  • Anti-HIV (1&2) Rapid Test

Anti-HIV (1&2) Rapid Test

Usage
The Anti-HIV (1&2) Rapid Test is a serological, lateral flow chromatographic immunoassay for the qualitative detection of human immunodeficiency virus (HIV) type 1 antibody, 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 Anti-HIV (1&2) 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

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.

The Anti-HIV (1&2) Rapid Test utilizes recombinant HIV antigen coated particle and recombinant HIV antigen immobilized on a membrane to detect HIV type 1 and/or HIV type 2 antibody qualitatively in human whole blood, serum or plasma specimens.

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Packing specification

Principle of Inspection

The Anti-HIV (1&2) Rapid Test is a qualitative membrane-based immunoassay for the detection of HIV type 1 and/or 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 2) a nitrocellulose membrane strip containing a test line (T) and a control line (C). The test line (T) 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.

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 sufficient HIV type 1 and/or HIV type 2 antibodies, a colored line will appear in the test line region (T), indicating a HIV positive result. Absence of the test line (T) 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, 40 Tests/Kit, 50 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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