ColoScreen A Test for Occult Blood - Helena …

1 ColoScreen . A Test for Occult Blood Helena Laboratories INTENDED USE interpretation on the reverse side. The process ColoScreen is a guaiac slide test for the qualitative involves placing two specimens, collected from each detection of fecal Occult Blood . It is a useful aid in the of three successive evacuations, onto the guaiac diagnosis of a number of gastrointestinal disorders paper. and is recommended for use in: ColoScreen , like all guaiac paper tests for Occult 1. Routine physical examinations Blood , is based on the oxidation of phenolic com- 2. Routine hospital testing pounds present in the guaiac ( guaiaconic acids). 3. Mass screening for colorectal cancer to quinones resulting in production of the blue Because of its similarity to the prosthetic group of SUMMARY peroxidase, the hematin portion of the hemoglobin The detection of Occult Blood is critical to many gas- molecule can function in a pseudoenzymatic manner, trointestinal diseases.

2 The presence of Occult Blood catalyzing the oxidation of guaiac. in fecal material may indicate gastrointestinal pathol- When a fecal specimen containing Occult Blood is ogy such as hemorrhoids, diverticulitis, fissures, coli- applied to the test paper, contact is made between tis or colorectal cancer. Fortunately, these conditions hemoglobin and the guaiac. A pseudoperoxidase can be detected with several diagnostic methodolo- reaction will occur upon the addition of the developer gies available which include testing of stools for solution, with a blue chromagen formed proportional- Occult Blood , complete physical examination with dig- ly to the concentration of hemoglobins.

3 The color ital examination, and proctosigmoidoscopy. Air con- reaction will occur after thirty seconds. trast barium enema and fiberoptic colonoscopy also contribute significantly to the diagnosis of colonic Hemoglobin + Developer lesions. Unfortunately, only a small percentage of Hb + 2H202 2H20 + O2. bowel and rectal cancers are found on digital exami- nation and patients with no symptoms of bowel dis- Oxidation of Guaiac ease do not readily present themselves for proce- O2 + Guaiac Oxidized Guaiac dures such as proctosigmoidoscopy and barium (Colorless) (Blue). enema. The American Cancer Society recommends annual The ColoScreen kits include ColoCheck Monitors fecal Occult Blood test plus flexible sigmoidoscopy which provide a quality control system for each test.

4 Every 5 years for both men and women beginning at The ColoCheck Monitors are incorporated into each age A colonoscopy is suggested every 10 years. slide. Colorectal cancer screening should begin earlier and should be done more often if you have increased risk REAGENTS. factors such as personal or family history of colorec- 1. ColoScreen Slides and Monitors tal ColoScreen Tape and Monitors ColoScreen is a simple, aesthetic, inexpensive test designed for use in the collection and preparation of Ingredients: ColoScreen Slides and ColoScreen stool specimens. It overcomes the instability of gua- Tape are made of quality controlled paper impreg- iac solution and the hypersensitivity of benzidine and nated with guaiac resin.

5 ColoCheck Positive Monitor contains an impregnated substance which If a positive result is obtained with the test, a follow- will turn blue if product is functioning properly. The up with additional diagnostic tests , as soon as possi- ColoCheck Negative Monitor consists of guaiac ble, is essential. As with any Occult Blood test, results impregnated paper. with ColoScreen cannot be considered conclusive WARNING: FOR IN-VITRO DIAGNOSTIC USE. evidence of the presence or absence of gastroin- Preparation for Use: The slide and tape are testinal bleeding or pathology. The test is not intend- ready for use as packaged. ed as a replacement for other diagnostic procedures Storage and Stability: These products should be such as proctosigmoidoscopy examination, barium stored at room temperature (15 to 30 C) and are enema, and X-ray studies.

6 Stable until the expiration date indicated on each slide and tape box. Do not use after expiration PRINCIPLE date. Both items should be protected from heat, ColoScreen is composed of guaiac impregnated humidity, light, fluorescent light, radiation, paper enclosed in a cardboard frame which permits excessive air flow, or volatile chemicals ( sample application to one side, and development and iodine or bleach). Do not refrigerate or freeze. Signs of Deterioration: Discoloration of the nor- and Blood in feces is not distributed uniformly, all mally light tan paper may occur if exposed to sun- patients with positive tests regardless of diet, light, fluorescent or ultraviolet light.

7 Failure of the should have follow-up diagnostic procedures control system to react as expected may be done. indicative of deterioration of the developer or the C. Other factors which affect the test: slide/tape, and test results should be regarded as 1. Medications: For 7 days prior to and during the invalid. testing, do not ingest aspirin4 or other anti- 2. ColoScreen Developer inflammatory medicines. For 2 days prior to and Ingredients: ColoScreen Developer contains < 6% during testing, do not use rectal medicines, or hydrogen peroxide and denaturated ethanol. tonics or vitamin preparations which contain WARNING: FOR IN-VITRO DIAGNOSTIC USE.

8 Vitamin C (ascorbic acid) in excess of 250 mg DANGER: FLAMMABLE. NEVER PIPETTE BY per day. MOUTH. VAPOR HARMFUL. DO NOT INGEST 2. Bleeding hemorrhoids or open cuts on hands. OR PLACE IN EYES. May cause blindness, or be 3. Collection of specimen during menstrual cycle. fatal if swallowed. Keep away from heat, sparks, 4. Improper specimen collection. or an open flame. Avoid contact with eyes and 5. Other diseases of the gastrointestinal tract such skin. Should contact occur, flush the affected area as colitis, gastritis, diverticulitis and bleeding with water and get immediate medical attention. ulcers. Preparation for Use: ColoScreen Developer is Specimen Handling: Using the applicators provid- ready for use as packaged.

9 Ed, obtain a small sample of the stool from the toilet Storage and Stability: ColoScreen Developer bowl. It is very important that the stool specimen be should be stored tightly capped at 15 to 30 C pro- applied as a very thin smear to the ColoScreen tected from heat and light. Under these condi- Slides and Tape. Obtain a second sample of the tions, the developer will remain stable until the stool, from a different location, in the same manner. expiration date indicated on the bottle. Do not use Apply a very thin smear to the slide. Allow the after the expiration date. Do not substitute smears to air dry. reagents from other manufacturers. The slide smears may be prepared and developed Signs of Deterioration: Failure of the ColoCheck immediately or stored up to 12 days prior to develop- Monitors to react as expected may be indicative of ment.

10 Care should be taken so that anything coming deterioration of the developer or the slide/tape, into contact with the specimen is free of Blood . and the test results should be regarded as invalid. Because of the nonhomogeneity of the stool, it is rec- ommended that the test be performed on three (3). SPECIMEN COLLECTION AND HANDLING consecutive evacuations, or as close together as Patient Preparation: , 6. A. It is recommended that the patient be placed on a Patient specimens and all materials in contact with high residue diet starting 2 days before and con- them should be handled as potentially infectious and tinuing through the test period.