The Chlamydia trachomatics antigen test kit is a rapid visual immunoassay for the qualitative detection of Chlamydia trachomatics in female endocervical swab, male urethral swab and urine specimens. This kit is intended for use as an aid of diagnosis of Chlamydia trachomatics infection.
Chlamydia trachomatics, an obligate intracellular human pathogen, is one of three bacterial species in the genus Chlamydia.
Chlamydia trachomatics infection is one of the most common sexually transmitted diseases (STD). It has exceeded gonorrhea as the STD with the most incidences, which accounts for 40-60% of non- gonococcal urethritis (NGU), C. trachomatics infection has both a high prevalence and asymptomatic carriage rate, with frequent serious complications in both women and neonates. Complications of Chlamydia infection in women include cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID) and increased incidence of ectopic pregnancy and infertility. Vertical transmission of the disease during parturition from mother to neonate can result in inclusion conjunctivitis and pneumonia. In men, C.trachomatics causes urethritis, orchitis, epididymitis.
C.trachomatics could be detected by many methods based on different technologies such as culture, immunofluorescence, PCR and colloidal gold, of which the colloidal gold method is the most commonly used. And this kit based on colloidal gold technology
The Chlamydia trachomatics antigen test kit is designed to detect Chlamydia trachomatics through visual interpretation of the color development in the internal strip. The membrane was immobilized with antibodies-specific on the test well (T) and related antibodies on the control well(C).
During testing, the specimen is added to the sample well (S) and reacts with anti-chlamydia trachomatics antibodies conjugated to colored particles and precoated onto the sample pad of the test. Then, the mixture migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient C. trachomatics antigens in the specimen, a colored band will form at the test well (T) of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control well serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
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COMPONENTS
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DETAIL
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QUANTITY
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Individual packed test cassette
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Each device contains a strip with colored conjugates and reactive reagents precoated at the corresponding Wells.
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20 pcs
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Lysis Solution A
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Main Ingredients: 1% NaOH 1% NaCl
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7ml*1 bottle
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Lysis Solution B
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Main Ingredients: 5% Tris 1% NaCl
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7ml*1 bottle
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Plastic Extraction Tube
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For specimens preparation use
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20 pcs
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Dacron swab
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For specimens collection
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20 pcs
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Package Insert
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For operation instruction
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1 pc
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MATERIALS REQUIRED BUT NOT PROVIDED
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· Timer
· Urine collection cup
· Centrifugal tube
· The kit should be stored at 2-30°C in a cool and dry place, protected from light
· The validity duration is 12 months
· Do not freeze.
· Do not use after the expiration date indicated on the package.
bio-equip.cn Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.
Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.
Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.
Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.
With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.
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中文
