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  • Neisseria Gonorrhoeae Antigen Rapid Test

Neisseria Gonorrhoeae Antigen Rapid Test

Usage
The Neisseria Gonorrhoeae Antigen Rapid Test is a rapid, lateral flow chromatographic immunoassay for the qualitative detection of Neisseria gonorrhoeae antigen in female cervical swab and male urethral swab specimens . It is intended to be used by healthcare professionals as a screening test to aid diagnosis of infection with gonococcus. 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

Gonorrhea is a sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae. Gonorrhea is one of the most common infectious bacterial diseases and is most frequently transmitted during sexual intercourse, including vaginal, oral, and anal sex. The causative organism can infect the throat, producing a severe sore throat. It can infect the anus and rectum, producing a condition called proctitis. With females, it can infect the vagina, causing irritation with drainage (vaginitis). Infection of the urethra may cause urethritis with burning, painful urination, and a discharge. When women have symptoms, they often note vaginal discharge, increased urinary frequency, and urinary discomfort. Spread of the organism to the fallopian tubes and abdomen may cause severe lower-abdominal pain and fever. The average incubation for Gonorrhea is approximately 2 to 5 days following sexual contact with an infected partner. However, symptoms may appear as late as 2 weeks. A preliminary diagnosis of Gonorrhea can be made at the time of examination.1 In women, Gonorrhea is a common cause of pelvic inflammatory disease (PID). PID can lead to internal abscesses and long-lasting, chronic pelvic pain. PID can damage the fallopian tubes enough to cause infertility or increase the risk of ectopic pregnancy.2 The Neisseria Gonorrhoeae Antigen Rapid Test utilizes of specific monoclonal antibodies to qualitatively detect Neisseria gonorrhoeae antigen in female cervical swab and male urethral swab specimens . The test can be performed without cumbersome laboratory equipment, and the results are available within 20 minutes.

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Packing specification

Principle of Inspection

The Neisseria Gonorrhoeae Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of Neisseria gonorrhoeae antigen in female cervical swab and male urethral swab specimens. The membrane is pre-coated with specific monoclonal antibodies in the test line region. During testing, the extracted specimen reacts with the particle coated with anti-Gonococcus antibodies to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-Gonococcus 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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