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  • HBsAg Rapid Test
  • HBsAg Rapid Test

HBsAg Rapid Test

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

 

Background of Clinical Indications

HBV is a hepatotropic DNA virus. The core of the virus contains a DNA polymerase, the core antigen (HBcAg) and the e antigen (HBeAg). The core of HBV is enclosed in a coat that contains lipid, carbohydrate and protein including an antigen termed hepatitis B surface antigen (HBsAg). HBsAg is the first marker to appear in the blood in acute hepatitis B, detectable 1 week to 2 months after exposure and 2 weeks to 2 months before the onset of symptoms. Three weeks after the onset of acute hepatitis almost half of the patients will still be positive for HBsAg. In the chronic carrier state, HBsAg persists for long periods (6-12 months) with no seroconversion to the corresponding antibodies. Therefore, screening for HBsAg is highly desirable for all donors, pregnant women, and people in high-risk groups. The HBsAg Rapid Test utilizes anti-HBsAg antibodies to detect elevated levels of HBsAg qualitatively in human whole blood, serum, or plasma 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 HBsAg Rapid Test is a qualitative membrane-based immunoassay for the detection of HBsAg in human whole blood, serum, or plasma specimens. The test device consists of: 1) a burgundy-colored pad containing colloidal gold particles coated with anti-HBsAg antibody (anti-HBsAg conjugates), 2) a nitrocellulose membrane strip containing a test line (T) pre-coated with anti-HBsAg antibodies for the detection of hepatitis B virus surface antigen. When an adequate volume of specimen is added to the specimen well(S) of the device, the specimen migrates by capillary action across the device and interacts with the immobilized anti-HBsAg antibodies. If the specimen contains hepatitis B virus surface antigen, a colored line will appear in the test line region (T), indicating a HBsAg positive result. Absence of this 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, 50 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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