Stool Blood Test Products

All CENOGENICS' Stool Blood slides include a quality control dot panel to assure the test system is functioning properly. Since the test requires only a thin application of specimen, the transport and storage of fecal specimens are eliminated and unpleasant odors are minimized.

All CENOGENICS' Stool Blood tests fit easily into a pocket, providing convenient, reliable testing for occult blood on hospital rounds, examination rooms, or wherever on-the-spot testing is required.

Additionally, a patient can test three consecutive bowel movements in the privacy ot their own home using the CENOGENICS' Tri-Slide upon completion of the three test series, the patient uses the envelope provided to return the test to the physician's office or designated address for analysis.

Clinical experience demonstrates that CENOGENICS'slide tests for stool blood provide an established method of detecting asymptomatic gastrointestina, conditions inctuding early detection of polyps and colorectal cancer, the second leading cause of cancer deaths in the United States. Additionally CENOGENICS' slides are used to detect bleeding problems other than cancer that may come from diggstive tract pathologies such as peptic ulcer, colitis diverticulitis, and gastritis. The American Cancer Society updated its guidelines and recommendations for colorectal cancer detection to include annual fecal occult blood tests, beginning at the age of 50, in conjunction with flexible sigmoidoscopic and digital rectal exam every five years, thus increasing the likelihood of early detection of gastrointestinal carcinoma at a stage amenable to cure.

Key Features

• Positive results, including trace reactions, are considerably stronger in color intensity than other competitive products.
• Importantly, trace reactions remain stable and visible for longer periods than other competitive products. Trace reactions on competitive products fade quickly. The trace reactions on the Cenogenics slides remain distinctly visible making it unlikely that trace reactions will be missed.
• Reactions will develop within one minute saving valuable technician time.
• Cenogenics Stool Blood Products have a five year shelf life, the longest in the industry.
• Clinical trial data have shown that Cenogenics Stool Blood Products provide specific and sensitive results evidenced by a higher number of correct positive results and few false negative reports when compared to other leading brands.
• Large writing spaces are provided.
• Hospital labels may be applied easily.
• The Patient Instructions provided with patient take home kits are easy to understand.

Explanation

CENOGENICS' Stool Blood slides test feature ready-to-use, stabilized guaiac-impregnated, electrophoretic paper based on Greegor's classical approach and method of choice for the detection of blood in feces. When a fecal specimen containing occult blood is applied directly to the CENOGENICS' guaiac test paper, the hemoglobin portion of the occult blood will exert a pseudoperoxidase reaction upon the addition of CENOGENICS' Developing Solution. The oxidation reaction of alpha guaiaconic acid in the guaiac paper by hydrogen peroxide in the developing solution forms a quinone structure. guaiacum blue, which becomes visible as blue or blue-green color change within 30 seconds in the presence of occult blood. '' Since the structure, of hematin is similar in structure to that of peroxidase, it is probably the hermatin fraction of hemoglobin in the occult blood specimen which catalyzes the oxidation of the guaiac in the test paper".

MATERIALS

CENOGENICS' TRl-SLlDE ^TM: A ready To-use three test configuration for multiple or consecutive fecal specimen testing with an easy to read QUALITY CONTROL DOT PANEL to assure integrity of thetest.

TRI-SLIDES^TM are available in three kit versions:

• SB-20 containing 100 TRISLlDE, The Kit Contains:
  • 100 three-section slides with controls. Each section contains two test sites (6 tests/slide) and a positive and negative control set.
  • 300 applicators
  • 6 X 10ml developing solution
  • Product Instructions
• SB-19 containing 50 TRI-SLIDE ^TM Patient Envelopes,The Kit Contains:
  • 50 patient envelope kits. Each Patient Kit contains one Tri-Slide with controls and 3 applicator sticks.
  • The envelopes are printed with easy to understand patient instructions.
  • 3 X 10ml developing solution
  • Product Instructions
• SB-19F containing 50 TRI-SLIDE^TM Patient Foil Pouches. Current U.S. Postal Regulations require test slides to be mailed in the approved foil pouches provided in the SB-19F kits. The foil pouches may also be ordered separately. The Kit Contains:
  • 50 Individual Patient Foil Pouch Kits. Each Patient Kit contains one Tri-Slide with controls and 3 applicator sticks.
  • The pouches are printed with easy to understand patient instructions and meet U.S. Postal Service requirements.
  • 3 X 10ml developing solution
  • Product Instructions

CENOGENICS' SINGLE SLIDE: A convenient single specimen test configuration with an easy to read QUALITY CONTROL DOT PANEL to assure integrity of the test.

SINGLE SLIDES are available in an SB-21 kit containing 100 SINGLE SLIDES or SB-25 kit containing 25 SINGLE SLIDES, The Kit Contains:

• 100or 50 single slides. Each slide has two test areas and a positive and negative control set.
• 100 or 50 applicators
• 2 X 10ml developing solution
• Product Instructions

CENOGENICS' DEVELOPING SOLUTION: 7300 : 10 ml of an aqueous solution containing a stabilized militure of hydrogen peroxide and specially denatured ethyl alcohol per botle. Bottle is provided with a special dropper tip. Solution is interchangeable between CENOGENICS' kits. Do not use other manufacturers'developing solution.

Should be Stored as recommended, the solution will remain stable for five years from date of manufacture.

Do not refrigerate.

Store at room temperature 59'- B6'F (1 5'-30"C).

Protect from heat and light Keep tightly closed when not in use to prevent evaporarton.

Applicator sticks for specimen collection.

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For in vitro diagnostic use only.