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  • FOB Rapid Test
  • FOB Rapid Test

FOB Rapid Test

Usage
The FOB Rapid Test is a rapid, lateral flow chromatographic immunoassay for the qualitative detection of fecal occult blood in human fecal specimens. It is intended to be used by healthcare professionals as a screening test to aid in the detection of bleeding caused by a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer. 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

Many diseases can cause hidden blood in the feces. This is also known as fecal occult blood (FOB), human occult blood, or human hemoglobin (hHb). In the early stages, gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms, only occult blood. Traditional guaiac-based methods lack sensitivity and specificity, and also have diet restrictions prior to testing.1,2 The FOB Rapid Test is a rapid test to qualitatively detect low levels of fecal occult blood. The test utilizes a double antibody sandwich assay to selectively detect hHb at the cut-off of 50 ng/mL in buffer or 6.0 μg/g in feces. In addition, compared to guaiac assays, the accuracy of the test is not affected by the diet of the patients.

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Packing specification

Principle of Inspection

The FOB Rapid Test is a qualitative membrane-based immunoassay for the detection of fecal occult blood in human feces specimens. The membrane is pre-coated with anti-hemoglobin antibody in the test line region (T) of the test. During testing, the specimen reacts with the particle coated with anti-hemoglobin antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-hemoglobin antibody on 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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