Vaginalis Antigen Combo Test Kit (LFIA)

• Customization: Available
• Classification: Gynecology
• Type: Gynecology Test Kit
• Model NO.: Antigen Test
• Certification: CE, ISO13485
• Certificate: ISO, CE
• Transport Package: Box+Carton
• Specification: 401mm*673mm*475mm
• Trademark: OBM/OEM
• Origin: China
• HS Code: 3002150090
• Production Capacity: 5, 000, 000 Pieces/Month

Product Description

Candida albicans/Trichomonas vaginalis/Gardnerella vaginalis antigen Combo Test Kit (LFIA)  is a colloidal gold immunochromatography for the rapid qualitative detection of Candida albicans, Trichomonas vaginalis, and Gardneralla vaginalis in female vaginal swab samples in vitro.


 

Key Features:

Sensitivity: >95%
Specificity: 100%
Reaction Time: 10mins
Sample:

1. Secretions were obtained from the posterior vaginal fornix with cotton swabs.
2. Sample should be transferred into the lysis buffer provided in this kit as soon as possible after collection.

Storage temperature: 2-30ºC

 

Introduction

Candida albicans is a major fungal pathogen of humans. It exists as a commensal in the oral cavity, gut or genital tract of most individuals, constrained by the local microbiota, epithelial barriers and immune defences. Their perturbation can lead to fungal outgrowth and the development of mucosal infections such as oropharyngeal or vulvovaginal candidiasis, and patients with compromised immunity are susceptible to life-threatening systemic infections.

Trichomoniasis is a sexually transmitted disease (STI) with important public health ramifications; it has been associated with vaginitis, cervicitis, urethritis, and pelvic inflammatory disease (PID). Trichomoniasis also impacts upon birth outcomes and is a co-factor in human immunodeficiency virus (HIV) transmission and acquisition.Trichomonas vaginalis is a motile organism with a size comparable to a white blood cell. It has at least 4 flagella that provide undulating motility. The organism resides in the lumen of the urogenital tract. The organism releases cytotoxic proteins that destroy the epithelial lining. During an infection, the vaginal pH usually increases.

Gardnerella vaginalis is an anaerobic bacterium that resides in the normal vaginal flora. Normally, vaginal flora is predominated by the Lactobacilli species, but when organisms such as Gardnerella begin to overgrow and become the dominant species, this leads to bacterial vaginosis (BV). Bacterial vaginosis is characterized by the presence of clue cells, which are epithelial cells of the cervix that are covered with rod-shaped bacteria.



About Medomics

Jiangsu Medomics Medical Technology Co., Ltd., is located at Biotech and Pharmaceutical Valley of the National Jiangbei New Area, Nanjing, Jiangsu Province. It is an international high-tech enterprise driven by innovation in the area of medical devices R&D, production and sales. Medomics focuses on diagnosis of microorganisms, tumors and some rare diseases, mainly engaged in the research and development, production and sales of in vitro diagnostic reagents and automatic instruments.  

Medomics owns two R&D centers in China and the US, independent intellectual property rights of fluorescent staining technology, protein labeling technology, time-resolved immunofluorescence detection technology, image processing and analysis technology and other innovative technology platforms, as well as a total of more than 10,000 square meters of GMP purification production workshop that meets the product standards of FDA, CE and CFDA. Until now, Medomics has more than 100 employees across the world and R&D personnel accounts for over 50%. Medomics also has a multidisciplinary expert team with abundant experience in the industry, including senior experts in immunology, microbiology, applied physics, polymer materials, medical imaging, optical systems, etc. The members of the technical team are led by doctors from many famous institutions, such as Osaka University, North Carolina University, University of Nebraska Lincoln, Zhejiang University, Sichuan University and other institutions.

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