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  • Syphilis Rapid Test
  • Syphilis Rapid Test

Syphilis Rapid Test

Usage
The Syphilis Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in human whole blood, serum or plasma specimens to aid in the diagnosis of Syphilis. The test only provides preliminary analysis results but not critical diagnosis criteria. Any reactive specimen with the Syphilis Rapid Test must be analyzed and confirmed with alternative testing method(s) and clinical findings. The test is intended for healthcare professional use. Applications of the test including, screening test for sex transmitted diseases (STD’s) among high-risk group of people, regular health examinations, and field screen test for blood bank.

 

Background of Clinical Indications

Syphilis is a systemic disease caused by Treponema Pallidum.1 The signs and symptoms of syphilis vary depending in which of the four stages it presents (primary, secondary, latent, and tertiary).2 Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane.3 One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis.4Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment. The Syphilis Rapid Test utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect anti-TP antibodies (IgG and IgM) qualitatively and selectively in human whole blood, serum or plasma specimens.

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Packing specification

Principle of Inspection

The Syphilis Rapid Test is a qualitative membrane-based immunoassay for the detection of anti-TP antibodies (IgG and IgM) in human whole blood, serum or plasma specimens. During the test procedure, recombinant Syphilis antigen is immobilized in the test line region (T) of the test. After specimen is added to the specimen well(S) of the device, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized Syphilis antigen. The double antigen test format can detect both IgG and IgM in specimens. If the specimen contains anti-TP antibodies, a colored line will appear in the test line region (T), indicating a positive result. If the specimen does not contain anti-TP antibodies, a colored line will not appear in this region, indicating 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.

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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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