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Phone:    (212) 555 55 00 or (212) 555 55 00

Adress:    Company LTD Street nr 100, 4536534, Chicago, US

sales@yourwebsite.com

Innovative, cost-effective, "best in class" solutions to pressing problems in the global medical industry.

CITOFEM PLUS for International Use

For information on Citofem Plus presentations in the United States click below

CITOFEM PLUS :Viro-safe® + Citofem® (bundled)

Citofem® + Viro-safe® together provide the most complete perspective on diagnosis with critical adjunct diagnostic information.

Citofem® and Viro-Safe® are designed to work optimally together to provide the most complete information for physicians and their patients.  

In standard in vitro clinical practice, cytology is the first analytical step.  A sample of cells is taken from a patient and analyzed using Citofem®’s liquid cytology system, following Citofem®’s instructions and the accepted cytology protocols (bucal, penile, vaginal, anal, cervical, pleural, etc) for determination of abnormal cells.  

In case of an inconclusive cytology result, the identification of a dysplasia, or a physician’s decision to do so, confirmatory testing with Viro-Safe® can be conducted in the same laboratory, with the same equipment, and using the same patient sample to detect the presence of the L1 capsid protein of HPV high risk strains and their current activity.  Follow-up testing with Viro-safe® can be conducted up to 90 days later from the original Citofem® patient sample.

Citofem + Viro-safe (bundled) versus Competitors

1) Highest quality results

2) When used sequentially (Citofem®, with VIRO-safe® confirmatory test)

Includes much more information than other test/follow-up combinations on the market.

3) Simple and fast, perfect complementarity with Citofem (results in hours)

4) Allows any cytology or pathology lab to provide highest quality tests on market with existing lab equipment and personnel

5) No special equipment required to process

6) No need for patient to return to lab, different lab or physician´s office for complete information

7) Bundled product provides better cell and viral load capture

8) All at a fraction of the price of current test/follow up combinations

Regulatory Support

Both the Viro-safe Kit and the Citofem kit, as well as their individual components carry the CE Mark and are registered in other countries.

Contact your distributor for specific information.

Citofem® plus VIRO-Safe®Cytology plus PCR
Simple inmunocytochemistry techniqueMore complex molecular biology technique using DNA extraction
Identifies presence of active infection through L1 capsid protein of high risk strainsDetermines presence of viral DNA giving inconclusive and alarming information to patient (nearly 100% of women under 30 expected to test positive)
Diagnostic and activity informationIdentifies only presence of virus
Simple, quick process with results in two hoursMore complex, multi day, multi-step process
Requires no additional specialized equipmentRequires PCR processor (US$5,000 to US$ 200,000)

Viro-safe confirmation also shows viral activity

Citofem®, like all high quality liquid cytology tests, provides critical information to the patient’s physician allowing a diagnosis based on the presence or absence of cancerous tissues or precancerous lesions.  Because Viro-Safe®  determines the presence of the L1 capsid protein of the HPV high risk strains, rather than the presence of virus DNA (as in all molecular biology-based tests),  Viro-Safe®  provides accurate information on the activity of the virus (e.g. presence of L1 capsid indicates the presence of  the virus in active state). This information, when confirming Citofem®’s results, provides a physician with very complete picture to present the patient’s diagnosis including valuable adjunctive diagnostic information.

Presentation

Citofem + Viro-safe is sold as bundle of two kits, and as replacement kits for each.

* Citofem Kit with the following materials:
  • 500 Citofem® cell preservation vials
  • 500 Rovers® Cervex-Brush® Combi
  • 504 Glass Slides with Frosted End
  • 1 Bottle of EA-50 Dye Solution (450 ml)
  • 1 Bottle of Orange-OG6 Dye Solution (450ml)
  • 1 Bottle of Hematoxilin Dye Solution (450 ml)
  • 1 Bottle of Citofem® Processing Solution (450 ml)
  • 1 Bottle of CUBLIQ® liquid coverslip preservative (200 ml)
  • 1 Product insert

 

​* Viro-safe Kit with the following materials:
  • Primary antibody VAHP (2.5ml)
  • Detection reagent (2.5ml)
  • Blocking reagent (2,5 ml)
  • AEC Chromgen (2.5ml)
  • Positive controls (5 slides)
  • Washing buffer stock solution (125ml)
  • Citrate buffer stock solution A  (27ml)
  • 1 package insert 
  • 1 working procedure