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  • Typhoid IgG/IgM Rapid Test
  • Typhoid IgG/IgM Rapid Test

Typhoid IgG/IgM Rapid Test

Usage
The Typhoid IgG/IgM Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human whole blood, serum or plasma specimens. It is intended to be used healthcare professionals as a screening test and as an aid in the diagnosis of infection with S. typhi. The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative method(s) and clinical findings based on professional judgment of healthcare providers.

 

Background of Clinical Indications

Typhoid fever is caused by S. typhi, a Gram-negative bacterium. World-wide an estimated 17 million cases and 600,000 associated deaths occur annually1 . Patients who are infected with HIV are at significantly increased risk of clinical infection with S. typhi2 . Evidence of h. pylori infection also presents an increase risk of acquiring typhoid fever. 1-5% of patients become chronic carrier harboring S. typhi in the gallbladder. The clinical diagnosis of typhoid fever depends on the isolation of S. typhi from blood, bone marrow or a specific anatomic lesion in the facilities that cannot afford to perform this complicated and time consuming procedure, Widal test (also referred as Weil-Felix Test) is used to facilitate the diagnosis. However, many limitations lead to difficulties in the interpretation of the Widal test3, 4 . The Typhoid IgG/IgM Rapid Test is a rapid test which utilizes a combination of monoclonal anti-human IgM and anti-human IgG coated colored particles for the qualitative detection of anti-Salmonella typhi (S. typhi) IgG and IgM in human whole blood, serum or plasma specimens at 15-20 minutes.

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Packing specification

Principle of Inspection

The Typhoid IgG/IgM Rapid Test is a qualitative membrane-based immunoassay for the detection of anti-Salmonella typhi (S. typhi) IgG and IgM in human whole blood, serum or plasma specimens. This test device consists of two components: an IgG component and an IgM component. The IgG line region (“G) is pre-coated with reagents for the detection of anti-S. typhi (IgG). The IgM line region (“M”) is pre-coated with monoclonal anti-human IgM for detection of anti-S. typhi (IgM). During testing, specimen dispensed into the sample well of the test device binds with Typhoid conjugates impregnated in the reagent area, if the specimen contains sufficient anti-Typhoid antibodies. The immunocomplex thus formed migrates by capillary action. If the present antibodies in specimen are of IgG types, the immunocomplex is then captured by the pre-coated reagents on the membrane, forming a colored IgG line (“G), indicating a S. typhi IgG positive test result. If the present antibodies in the specimen are of IgM type, the immunocomplex would be captured on the membrane by the pre-coated anti-human IgM antibody, forming a colored IgM line (“M”), indicating a S. typhi IgM positive test result. Absence of any test lines (IgM and IgG) indicates 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 line, 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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