• Citofem

    Citofem is a Liquid cytology diagnostic system that can be used for a wide variety of cytology specimens. It’s a newly developed Liquid-Based Cytology system that has an optimal combination of single-layer cell presentation, slide adhesion and cell preservation thus allowing for effective visualization. It’s a product of bioDIS
    Citofem is a Liquid-Based Cytology pap smear kit used as a replacement for the conventional method of Pap smear preparation for use in screening for the presence of a typical cervical cancer cells
    Including its precursor lesions (low-grade Squamous Intraepithelial Lesions and high-grade Squamous Intraepithelial Lesions), as well as all other cytologic categories as defined by The Bethesda System for Reporting Cervical / Vaginal Cytologic diagnoses

    Citofem ® Capabilities

    1. 100% of the collected sample is sent to the laboratory for testing.
    2. The cells are presented in a laminar, or sheet-like fashion, aiding in the examination and diagnosis by pathologist
    3. Well-fixed, highly cellular thin layer sample allows for effective analysis.
    4. A single sample can provide multiple tests per patient including molecular testing utilizing any of the FDA approved tests.
    5. Can be utilized for all cytology purposes, including sputum; urine; pleural; bronchial washing; penile; synovial; cerebrospinal; and other fine needle aspirates of thyroid, breast, lung, CSF, salivary glands, lymph nodes, bone marrow, and other asked for cytologies
    6. Fast processing can be scaled for efficiency.
    7. Formulation is based on years of research and development. Patent pending.

    Benefits

    • It requires no expensive processing equipment.
    • Processed in less time than other brands of liquid cytology.
    • Increased recovery of endocervical cells in the patient specimen.
    • Increases the number of slides that can be mounted.
    • Pathologist and cytotechnologist will enjoy a quicker and more efficient diagnostics.

    Citofem ® kit

    Citofem system is an internationally patented method of processing Pap tests. It is the first and only liquid cytology based Pap test in the world that requires no Xylene in processing. It uses the best brush for cervical cell collection in the world: The Rovers® Cervex-Brush® Combi. No expensive lab equipment required for processing and the price is comparable to the Pap smear.

    citofem® cell preservative

    The Citofem Cell Preservative is a proprietary mixture of low molecular weight alcohols, mucolytics, surfactants, and anti-clumping agents which claims

    • Multiple tests of sample / specimen possible
    • 100% of the collected sample is preserved
    • Six month sample preservation in vial
    • Initial fixing of sample / specimens
    • Stabilization of the cell membrane
    • Cell anti-clumping action
    • Physiological pH allows samples to be provided for molecular biology testing and for IHC procedures
    • Optimize for use with other bioTD cytology products
    • Competitive pricing

    BioPREP Cell Fixative

    • The BioPREP Cell Fixative is a proprietary mixture of alcohols, acids, mucolytics, anti-clumping agents,cytoplasm cleaning agents, surfactants, dispersants, and cellular adhesion agents which claims:
    • Completes the sample cleaning process: removes interfering substances such as inflammation, mucous, and bloody by a combination of lysing and density separation for a more precise cellular examination of the cytology specimen.
    • Completes the sample fixing process
    • Provides samples with excellent cell morphology: cytoplasm is clear and conserved in physiological form and size
    • Superior slide adhesion: sample / specimen is poly-cation charged for best adhesion to the glass slide of your choice.
    • Cells presented in clear monolayer fashion
    • Prepares samples for xylene free staining, and cleaning agents are included in the formulation.
    • Optimized for use with other bioTD cytology products.
    • Competitive pricing

    CUBLIQ Mounting Media

    • CUBLIQ Mounting Media is a proprietary mixture of acrylics and activators formulated for cytology applications which claims:
    • A liquid cover slip: easy to apply
    • More economical than conventional glass covers
    • Optically superior
    • Extended preservation of specimens on slides
    • Strong encapsulation of specimen
    • Prepares samples for xylene free staining, and cleaning agents are included in the formulation.
    • Non fragile system: resistant to conventional breakage
    • Sample is UV protected

    The Microscope Slides

    The glass microscope slides are :
    • Proven compatible with the bioTD product systems.
    • Variety of presentations available: plain frosted, cavity, multi-cavity and special molded presentations.

    Gynecological Stains

    The gynecological stains utilized are bioSTainHematoxilin, bioStain OG6 and bioStain EA50. These stains are: Proven compatible with all bioTD product systems. Designed to be processed without Xylene. Distinct and superior cytoplasmic and nuclear cellular staining. Highest quality of dyes used. Stabilizers deliver formulations that are stable for two years.

    The Sampling Device

    The Roversre® Cervex-Brush® Combi will collect both Ectocervical and Endocervical cells from patients. The Rovers® Cervex-Brush® Combi is a newly patented, high tech product capable of delivering higher cellular yield of endocervical cells than the traditional Rovers® Cervex-Brush® . Laboratory tests have also indicated an increased viral load in the collected cell material. The Rovers® Cervex-Brush® Combi was developed for two main reasons: Easy and effective application of the device. Improved endocervical sampling.

    A Two in one brush

    It’s a combination of Cervibroom and Cytobrush which is used in both Thin Prep and Sure Path. Its Delicate for using.

    The Rovers® Cervex-Brush® Combi was developed for two main reasons

    • Easy and effective application of the device.
    • Improved endocervical sampling

    Advantages

    Besides the advantages of the Rovers® Cervex Brush® and the Rovers® endocervical amplers, the new Rovers® Cervex-Brush® Combi offers the following features

    • Only two rotations needed.
    • 2-3 times more endocervical cells (Bogers et al.).
    • High HPV viral load.
    • Less need of additional devices.
    • For liquid-based as well as conventional cytology.
    • CE marked and 510(k) approved for USA market.

    scientific support

    Publication of clinical results obtained with Citofem in a scientific journal (UNIBE ISSN16593545, vol. 2, number 1, 2010, available on request). International Markets. The favorable opinions of the process of experts in cancer detection in Costa Rica: Dr. Guillermo Montero, Dr. BernardaTuk, Dr. Daniel González, Dr. Claudia Quesada, who may be consulted. (Testimonies available on request.)

    Regulatory support

    Listed for commercial distribution by the United States Food and Drug Administration (USFDA) under the following codes: Cell Preservative and Cell Fixative: LDT / Liquid Coverslip: LEB / Glass Slides: KEW / Cytology Sampling Device: HHT / Stains: HZJ
    Approved by Costa Rica’s Ministry of Health in 2007 as a medical device. Registration: 2101-EMB 2191 (document available). )

    Recognition

    Besides the advantages of the Rovers® Cervex Brush® and the Rovers® endocervical amplers, the new Rovers® Cervex-Brush® Combi offers the following features

    • Selected at CR-INNOVA, 2010 as the most important scientific and tehnological innovation and the activity with the highest number of votes in all categories, surpassing projects of all the universities, including the ClodomiroPicado institute
    • Recognized as the most favored testing system for the detection of cervical cancer by the majority of Costa Rica’s pathology laboratories.
    • Winner of the 2011 Jorge Manuel Dengo prize for innovation, the top prize for scientific achievement in our region. bioTD was presented this recognition by the President of Costa Rica in recognition of ’s contribution to the advancement of health and technology in the region
    • News of the innovation has circled the world. The UNIVISION channel website has apermanently available video about the CitoFem system. DiCYT, the international news agency for the dissemination of science and technology, formally presents the Citofem system to the international scientific community
    • Recognition on national television by channels 6 , 11 and on the radio where it was even selected by Radio Monumental as the most important scientific and tehnoloial innovation in Costa Rica in 2010
    • 2012 Silver Medal in medical category during Invention World Expo in Geneva.

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