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  • Rota/Adeno Antigen Rapid Test
  • Rota/Adeno Antigen Rapid Test

Rota/Adeno Antigen Rapid Test

Usage
The Rota/Adeno Antigen Rapid Test is a rapid, lateral flow chromatographic immunoassay for the qualitative detection and differentiation of rotavirus and adenovirus antigens in fecal specimens. It is intended to be used by healthcare professionals as a screening test to aid diagnosis of infection with rotavirus and adenovirus. 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

Rotaviruses are the main cause of acute gastroenteritis, particularly in children under two years of age. Its discovery in 1973 and its association with child gastroenteritis represented a breakthrough in the study of gastroenteritis not due to acute bacterial infection. Transmission occurs through the fecal-oral route; the incubation period is between 1 and 3 days. Adenoviruses are the second leading cause of viral gastroenteritis in children (10-15%). They can also cause respiratory diseases and depending on the serotype, diarrhea, conjunctivitis, cystitis, and others. At least 47 adenovirus serotypes have been identified and in all of them the hexon antigen is present. Serotypes 40 and 41 are associated with gastroenteritis. The main clinical symptom of gastroenteritis caused by adenovirus is diarrhea, for 9 to 12 days, also occurring with fever and vomiting. The Rota/Adeno Antigen Rapid Test utilizes pairs of specific antibodies to qualitatively detect and differentiate rotavirus and adenovirus antigens in fecal specimens. The test can be performed without cumbersome laboratory equipment, and the results are available within 15 minutes.

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Packing specification

Principle of Inspection

The Rota/Adeno Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of rotavirus and adenovirus antigens in fecal specimens. The membrane is pre-coated with specific monoclonal antibodies in the test line region. During testing, the specimen reacts with the particle coated with anti-rotavirus and anti-adenovirus antibodies to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-rotavirus and/or anti-adenovirus antibodies immobilized in the membrane and produce a colored line(s). The presence of this colored line(s) in the test line region (R and/or A), 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

1 Test/Kit, 2 Tests/Kit, 5 Tests/Kit, 7 Tests/Kit, 10 Tests/Kit, 20 Tests/Kit, 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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