LucentMed has obtained full ISO 13485, ISO 9001, and CE certifications and holds a utility model patent. Our Segmented-Handle Cervical Brush features a snap-fit, detachable design that ensures sufficient stability during sampling while allowing for easy separation afterward.
The break-point position can be customized to suit various collection vials, enhancing clinical compatibility and meeting the diverse needs of clients and medical standards.
Vials for TCT liquid-based cytology or HPV testing from different brands vary in height and internal volume.
The segmented handle features multiple pre-set break points, allowing the user to snap the handle at the optimal position based on the specific vial height after sample collection.
● Grip section: The thicker handle base features anti-slip ridges, providing a secure grip and the leverage needed for rotation.
● Force transmission section: The middle section offers axial rigidity, ensuring that the forward force applied at the handle is effectively transmitted to the deep cervical os.
● Micro-vibration elution section: The segment closest to the brush head is highly flexible, allowing the user to rapidly shake the remaining handle within the preservation solution to ensure the complete release (elution) of over 95% of the collected cells.
Traditional brushes without break points require the use of scissors to cut the handle after sampling, creating a risk of cross-contamination between patient samples via the scissors.
The Segmented-Handle Cervical Brush snaps precisely at the designated point with a gentle bend; the brush head never comes into contact with fingers or external tools during the process, thereby ensuring the sample purity required for molecular-level (HPV DNA) testing.
|
Comparison Criteria |
Segmented-Handle Cervical Brush |
Standard cervical brush |
|
Handle design |
Features a pre-scored, breakable handle |
Integrated, non-detachable handle |
|
Sample transfer method |
Brush head detaches and remains directly in the preservation solution |
Brush head must be rotated or rinsed in preservation solution to release cells before removal |
|
Cell recovery rate |
High recovery rate; minimizes cell loss due to retention on the bristles |
Yield is relatively lower; some cells may remain on the brush head |
|
Sample quality |
Facilitates the collection of more complete and uniform cell samples |
Sample quality is significantly influenced by the cell release process |
|
Operational workflow |
Fewer procedural steps; enables faster sample processing |
Requires an additional cell release step |
|
Applicable tests |
Specially designed for TCT/LBC and HPV testing |
Suitable for Pap smears, TCT, and HPV testing |
|
Test compatibility |
Optimized for automated liquid-based cytology workflows |
Compatible with both conventional smears and liquid-based cytology |
|
Clinical efficiency |
Enhances efficiency in mass screening and laboratory processing |
Widely used for routine clinical sampling |
|
Cross-contamination risk |
Direct immersion of the brush head in the preservation solution reduces contamination risks during sample transfer |
Involves multiple sample transfer steps; standardized procedures are required to prevent contamination |
|
Application scenarios |
Suitable for hospitals, screening centers, third-party laboratories, and large-scale cervical cancer screening programs |
Used in gynecological clinics, routine health check-ups, and primary care facilities |
1. The Segmented-Handle Cervical Brush utilizes either thermal welding or ultrasonic welding for assembly.
Each batch undergoes pull-off force testing using an electronic tensile tester; the welding strength must be ≥2N, and the actual test data are recorded in the batch inspection report.
2. LucentMed employs a CCD visual inspection system to conduct 100% automated screening of every cervical brush.
Equipped with high-resolution industrial cameras and custom lighting, the system performs millisecond-level detection and assessment of bristle integrity, breakage points, and packaging seal quality.
3. For released batches, we strictly adhere to a retention sample policy.
A specified quantity of finished products is randomly selected from each batch and stored in a dedicated retention sample room; the retention period covers the product's shelf life (3 years) plus an additional buffer period.
1. TCT/LCT/LPT: The segmented-handle cervical brush is used to collect exfoliated epithelial cells from the ectocervix, the squamocolumnar junction (transformation zone), and the endocervical canal for the screening of cervical intraepithelial neoplasia (CIN) and early-stage cervical cancer.
2. HPV-DNA Genotyping/Quantitative Testing (Specimen Collection): Can be used independently or for co-sampling (dual screening) in the same vial alongside TCT.
3. Conventional Pap Smear: Used for cytological sampling during follow-up examinations after LEEP or conization procedures to monitor for residual or recurrent lesions.
4. Detection of Pathogens Causing Gynecological Inflammation: Used to collect cervical secretions/exfoliated cells for laboratory testing of reproductive tract pathogens, such as Chlamydia, Neisseria gonorrhoeae, Mycoplasma, and Candida.
A: The brush head and handle of the Segmented-Handle Cervical Brush are joined using hot-melt or ultrasonic welding; the brush will not break prematurely before the sampling process is complete and the handle is snapped at the designated break point.
In the rare event of detachment due to a manufacturing defect, LucentMed guarantees a free replacement and provides batch traceability analysis.
A: It is compatible with the vast majority of commercial TCT preservation solution vials on the market. Customization of the break point location is available for special vial specifications.
A: LucentMed holds ISO 13485 (medical device quality management system) and GB/T 19001 certifications, and possesses a Class I medical device manufacturing registration. We offer free replacement and a 24-hour response service.
Address
Zhongke Industrial City, No. 6, Xihuan Road, Jiangshan Town, Laixi City, Qingdao, Shandong Province, China
Tel
