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  • Vibrio Cholerae O1/O139 Antigen Rapid Test

Vibrio Cholerae O1/O139 Antigen Rapid Test

Usage
The Vibrio Cholerae O1/O139 Antigen Rapid Test is a rapid, visual, lateral flow chromatographic immunoassay for the qualitative detection of V. cholerae O1 and/or O139 antigens in human fecal specimens as an aid in the diagnosis of V. cholerae O1 and O139 infection. 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 testing method(s) and clinical findings based on professional judgment of healthcare providers.

 

Background of Clinical Indications

Cholera epidemics, caused by V. cholerae serotype O1 and O139, continue to be a devastating disease of immense global significance in many developing countries. Clinically, cholera may range from asymptomatic colonization to severe diarrhea with massive fluid loss, leading to dehydration, electrolyte disturbances, and death. V. cholerae O1/O139 cause this secretory diarrhea by colonization of the small intestine and production of a potent cholera toxin. Because of the clinical and epidemiological importance of cholera, it is critical to determine as quickly as possible whether or not the organism from a patient with watery diarrhea is positive for V. cholera O1/O139. A fast, simple and reliable method for detecting V. cholerae O1/O139 is a great value for clinicians in managing the disease and for public health officials in instituting control measures. The Vibrio Cholerae O1/O139 Antigen Rapid Test utilizes specific anti-Vibrio cholerae O1 and O139 antibodies to detect V. cholerae O1 and O139 antigens qualitatively and selectively in human fecal specimens. This assay can be performed to get test result at 15-20 minutes by minimally trained personnel and without cumbersome laboratory equipment.

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Packing specification

Principle of Inspection

The Vibrio Cholerae O1/O139 Antigen Rapid Test contains two test strips, the left side for the Vibrio Cholerae O1 Antigen Rapid Test, and the other side for the Vibrio Cholerae O139 Antigen Rapid Test (see illustration of the test procedures on this package insert).

The Vibrio Cholerae O1 Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of V. cholerae O1 antigen in human fecal specimens. The membrane is pre-coated with specific anti-Vibrio cholerae O1 antibodies in the test line region (T). During testing, the extracted specimen reacts with the particle coated with anti-Vibrio cholerae O1 antibodies to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-Vibrio cholerae O1 antibodies immobilized in the membrane and produce a colored line. The presence of this colored line in the test line region (T), indicates a positive result, while its absence indicates a negative result.

The Vibrio Cholerae O139 Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of V. cholerae O1 antigen in human fecal specimens. The membrane is pre-coated with specific anti-Vibrio cholerae O139 antibodies in the test line region (T). During testing, the extracted specimen reacts with the particle coated with anti-Vibrio cholerae O139 antibodies to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-Vibrio cholerae O139 antibodies immobilized in the membrane and produce a colored line. The presence of this colored line in the test line region (T), indicates a positive result, while its absence 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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