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  • HPV Antigen Rapid Test
  • HPV Antigen Rapid Test

HPV Antigen Rapid Test

Usage
The HPV Antigen Rapid Test is a serological, lateral flow chromatographic immunoassay for the qualitative detection of HPV L1 Capsid protein in female cervical swab specimens. It is intended to be used as an aid in the diagnosis of cervical pre-cancer and cancer including types 6, 11, 16, 18, 31, 33, 45, 52 and 58. The test only provides preliminary screening results but not critical diagnosis criteria. Any reactive specimen with the HPV Antigen 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

Infection with human papillomavirus (HPV) is a leading cause of cancer among women worldwide with approximately 500,000 new cervical cancer cases and 250,000 deaths each year1. Cervical cancer is caused by persistent infection with a group of carcinogenic HPV genotypes (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and probably HPV68)2.The importance of cervical cancer is accentuated by the relatively young average age at incidence and death. Cervical cancer screening strategies have evolved from cytology-based to HPV-based3. Following the identification of HPV as the cause of cervical cancer and the development of sensitive HPV tests, HPV-based screening permits the extension of screening intervals and increased impact per number of lifetime screens3. The HPV Antigen Rapid Test utilizes of specific monoclonal antibodies to qualitatively detect HPV L1 Capsid protein in female cervical swab specimen, the test can be performed without cumbersome laboratory equipment, and the results are available at 15 minutes.

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Packing specification

Principle of Inspection

The HPV Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of HPV L1 Capsid Protein in female cervical swab specimens. The membrane is pre-coated with specific monoclonal anti-HPV L1 Capsid antibodies in the test line region. During testing, the extracted specimen reacts with the monoclonal anti-HPV L1 Capsid antibodies particle conjugates precoated on the sample pad to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with the monoclonal anti-HPV L1 Capsid antibodies immobilized in the membrane. If there is enough HPV L1 Capsid Protein in specimens, a colored line will form in the test line region (T). Presence of this colored line 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.

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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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