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  • HAV IgM Rapid Test
  • HAV IgM Rapid Test

HAV IgM Rapid Test

Usage
The HAV IgM Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis A Virus (HAV) in human whole blood, serum, or plasma specimens to aid in the diagnosis of HAV. The test only provides preliminary analysis results but not critical diagnosis criteria. Any reactive specimen with the HAV IgM Rapid Test must be analyzed confirmed with alternative testing method(s) and clinical findings. The test is intended for healthcare professional use.

 

Background of Clinical Indications

HAV is a positive RNA virus, a unique member of picornavirdae1 .Its transmission depends primarily on serial transmission from person to person by the fecal-oral route. Although hepatitis A is not ordinarily a sexually transmitted disease, the infection rate is high among male homosexuals, as result of oral-anal contact2,3. The presence of specific anti-HAV IgM in blood samples suggests acute or recent HAV infection4-6 . The IgM antibody rapidly increases in titer over a period of 4-6 weeks post infection, and then declines to non-detectable levels within 3 to 6 months in most patients7 . The HAV IgM Rapid Test utilizes specific anti-human IgM monoclonal antibodies immobilized on membrane to detect anti-HAV IgM qualitatively in human whole blood, serum or plasma specimens. The test can be performed without cumbersome laboratory equipment, and the results are available within 20 minutes.

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Packing specification

Principle of Inspection

The HAV IgM Rapid Test is a qualitative membrane-based immunoassay for the detection of anti-HAV IgM in human whole blood, serum, or plasma specimens. The test device consists of: 1) a burgundy-colored conjugate pad containing HAV antigen conjugated with colloidal gold (HAV Ag conjugates) and a control antibody conjugated with colloidal gold, and 2) a nitrocellulose membrane strip containing a test line (T) and a control line (C). The test line is precoated with mouse anti-human IgM, and the control line is pre-coated with a control line antibody. When an adequate volume of diluent specimen is added to the specimen well(S) of the device, the specimen migrates by capillary action across the device. If the specimen contains anti-HAV IgM antibodies, a colored line will appear in the test line region (T). Absence of test line 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.

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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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