LucentMed operates four major manufacturing bases and employs a team of over 160 people—including a 30-member quality control team—to ensure comprehensive quality management throughout the entire process. Our TCT Sampling Brush features a biomimetic brush head designed to precisely access and cover the cervical transformation zone, gently collecting exfoliated cells.
The tips of the TCT Sampling Brush bristles are not simply cut; each tip undergoes laser rounding.
This design generates sufficient friction to dislodge tightly adherent cervical cells while ensuring that mucosal capillaries are not punctured during rotation, thereby minimizing the clinical incidence of bleeding.
The bristles vary in stiffness across different sections of the brush to ensure superior anatomical conformity.
The central bristles, designed to penetrate the cervical canal, possess higher axial rigidity to prevent bending or buckling upon insertion.
Conversely, the peripheral bristles—designed to contact the external os—offer greater lateral flexibility, allowing them to conform to the curvature of the cervix.
The break-point on the handle is engineered based on fracture mechanics calculations; a physician can snap it using approximately 5–10 N of lateral force with one hand. This design prevents bio-contamination caused by fluid splashing (which occurs if the handle is too rigid) and avoids premature breakage during the sampling rotation (which occurs if the handle is too soft).
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Parameter Category |
Wire Type |
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Primary Material |
Bristles: Nylon filaments wound with stainless steel wire |
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Tip bead: Epoxy resin (on select models) |
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Common Specifications |
A1, A2, A3, A4, etc. |
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Brush Head Design |
Broom-like or spiral shape; utilizes wire elasticity to conform to the shape of the cervix |
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Total Length |
Typically 140mm – 170mm, depending on handle design |
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Sterilization Method |
Ethylene oxide (EO) sterilization |
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Residual Limit Standard |
Residual ethylene oxide ≤ 10µg/g |
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Scope of Application |
Intended for endocervical cell collection and vaginal secretion sampling; certain designs facilitate deeper access into the cervical canal |
The primary use of the TCT sampling brush is to collect cervical cells for liquid-based cytology testing.
By brushing the external cervical os and the endocervical canal to collect exfoliated cells, the brush ensures the cells are gathered intact and placed into a preservation solution for subsequent laboratory slide preparation and pathological analysis.
This product is widely used in cervical cancer screening programs to detect cervical intraepithelial neoplasia (CIN), precancerous lesions, and abnormal cellular morphological changes.
The TCT sampling brush is frequently used to collect samples for HPV testing, retrieving cervical cells for HPV DNA analysis.
When used in conjunction with TCT testing, this approach improves screening accuracy and facilitates the early identification of high-risk HPV infections.
In clinical gynecological practice, the sampling brush serves as a fundamental screening tool for routine cervical health checks, aiding in the diagnosis of abnormal bleeding and the assessment of inflammation and cellular changes.
Characteristics: Tighter cervical os, high tissue sensitivity.
Precautions: Prioritize models with flexible brush heads; avoid deep insertion into the cervical canal; use light, rotating movements; and limit the duration and number of sampling rotations.
Characteristics: Normal cervical opening; highest compatibility.
Precautions: Standard models may be used; cover both the external cervical os and the cervical canal area; 1–3 rotations are sufficient; avoid repeated brushing of the same spot.
Characteristics: Cervical atrophy, reduced cell exfoliation.
Precautions: Use models with softer bristles; be aware of the risk of cervical canal stenosis; slightly extend the rotation/contact time but maintain gentle technique; use auxiliary sampling tools if necessary.
Characteristics: Tissue congestion, increased sensitivity.
Precautions: A physician must assess suitability for sampling; monitor for local bleeding post-sampling; avoid repeated brushing.
Characteristics: High-quality cell samples required for diagnosis.
Precautions: Sampling must cover the complete area of both the external and internal cervical os; coverage may be expanded appropriately, but avoid causing injury.
Characteristics: Cervical congestion and sensitivity; higher risk profile.
Precautions: Use only when there is a clear medical indication; a physician must assess the necessity of the procedure; strictly avoid causing bleeding or cervical irritation; monitor for adverse reactions after the procedure.
Provide basic requirement details, including:
Usage scenario: Hospital screening / Laboratory / Tender projects
Target market: EU / US / Asia, etc.
Testing system: TCT / HPV / Co-testing
Branding/OEM requirements
Expected purchase volume and budget range
LucentMed provides a customized solution covering structure, materials, dimensions, packaging, etc., along with product specifications and design recommendations.
In this stage, we create new molds or modify existing ones to produce engineering samples, then test sampling efficiency and release rates in our internal laboratory.
Once sample development is complete, we provide samples for your confirmation and, if necessary, perform multiple rounds of optimization.
To meet export requirements, LucentMed provides:
ISO 13485 quality management system documentation
CE certification support
Product Technical File
Sterilization validation report (EO sterilization)
Material biocompatibility documentation
Following sample confirmation, production moves to the stable supply phase. We utilize fully automated processes and quality control, conducting both comprehensive and random inspections of finished products to ensure batch consistency.
Each TCT sampling brush features individual sterile packaging; custom outer packaging is also available.
Delivery options include sea freight, air freight, and express shipping, with full support for export customs documentation.
Address
Zhongke Industrial City, No. 6, Xihuan Road, Jiangshan Town, Laixi City, Qingdao, Shandong Province, China
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