Trichomonas Vaginalis/Candida Albicans/Gardnerella Vaginalis Antigen Combo Test Kit (LFIA)
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Product Highlights
- High Sensitivity and Specificity: Sensitivity exceeds 95% and specificity reaches 100% for accurate detection.
- Rapid 10-Minute Results: Provides qualitative detection results in just 10 minutes of reaction time.
- Triple Pathogen Detection: Simultaneously detects Candida albicans, Trichomonas vaginalis, and Gardnerella vaginalis.
- Validated Certifications: Certified with CE and ISO13485 standards for quality and safety assurance.
- Flexible Customization Options: Offers full, minor, and sample-based customization with OEM and ODM services.
- Stable Storage Conditions: Maintains stability when stored at temperatures between 2-30 degrees Celsius.
- Advanced LFIA Technology: Utilizes colloidal gold immunochromatography for reliable in vitro diagnosis.
- Global R&D Expertise: Developed by a team with over 50% R&D personnel and international expertise.
Product Attributes
- Customization
- Available
- Classification
- Gynecology
- Type
- Gynecology Test Kit
- 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 Images of Trichomonas Vaginalis/Candida Albicans/Gardnerella Vaginalis Antigen Combo Test Kit (LFIA)
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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.
Sensitivity: >95%
Specificity: 100%
Reaction Time: 10mins
Sample:
- Secretions were obtained from the posterior vaginal fornix with cotton swabs.
- 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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Workshop
Exhibition
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About the Supplier
This supplier has been audited by BV. Verify the report on the official BV website with ID "MIC-ASR244532". Items marked "" are certified.
Company Profile
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.
Medomics developed IgM/IgG antibody detecting kit with the team of Zhong Nanshang. And Medomics published the first research paper on international journal together with State Key Laboratory of Respiratory Disease (National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health). The detecting kit was validated by CDC, Harvard Medical School and Columbia University Irving Medical Center etc. Until May 2020, the kit has been exported to dozens of countries and areas, making great help.
At present, Medomics's series product have been developed according to ISO 13485 Quality system and European CE Certification.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- 3 / F, Building D, Phase Ii, Zhongdan Ecological Life Science Industrial Park, 3-1 Xinjinhu Road, Jiangbei New District, Nanjing, Jiangsu, China
-
Plant Area
- 12871.57 square meters
-
Number of Employees
- 156
-
Registered Capital
- 25,519,651 RMB
-
Terms of Payment
- LC, T/T, D/P, PayPal, Western Union, Small-amount payment
-
International Commercial Terms(Incoterms)
- FOB, CIF, CFR, EXW
-
Average Lead Time
-
Peak Season Lead Time: within 15 workdays
Off Season Lead Time: within 15 workdays -
Nearest Port
- Shanghai Port
-
Minimum Order Quantity
- 1 Set
-
Supply Chain Partners
- 28
Our Production Capability & Technical Expertise
-
Main Products
- In Vitro Diagnostics
-
Production Lines
- 1
-
Production Machines
- Auto Processing Line
-
QA/QC inspectors
- 4 people
-
Inspection Type for Finished Products
- Random inspection(Visual inspection & Function inspection)
-
Inspection Method for Finished Products
- Have instructions and uniformly followed
-
Customization Options
- Customization from Samples, Customization from Designs, Full Customization, Minor Customization, Flexible customization
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 42 people
-
Traceability of Raw Materials
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2017-10-12
-
Export Year
- 7 Years
-
Main Markets
- Southeast Asia/ Mideast, Africa, Australia
-
Repeat Buyers Choice
- 80%~100%
-
Number of Foreign Trading Staff
- 6
-
Overseas Agent/Branch
- No
-
New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Cooperated with Fortune 500
- No
FAQ
- What pathogens does this kit detect?
- It detects Candida albicans, Trichomonas vaginalis, and Gardnerella vaginalis antigens.
- How long does the test take?
- The reaction time is 10 minutes for rapid qualitative detection.
- What is the accuracy of the test?
- The test has a sensitivity of over 95% and a specificity of 100%.
- What sample type is required?
- It requires vaginal swab samples transferred into the provided lysis buffer.
- Can the product be customized?
- Yes, we offer full, minor, and flexible customization with OEM and ODM services.
- What are the storage requirements?
- Store the kit at a temperature between 2-30 degrees Celsius.
- What certifications does the product have?
- The product holds CE and ISO13485 certifications.
- What is the minimum order quantity?
- The minimum order quantity is 1 set.
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