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Intended Use
EZ Detect(TM) is intended for in vitro detection of occult blood in the stool--an early indicator of various gastrointestinal bleeding disorders.
Constituents and Usage
EZ Detect(TM) consists of a biodegradable paper (pad) upon which special reagents have been printed. The pad changes color when it comes in contact with blood. EZ Detect(TM) uses a pseudo-peroxidase reaction utilizing a chromogen which, when oxidized, produces a distinct blue-green color.
After a bowel movement, a pad is placed in the toilet and, if excess blood is present in the stool, a blue-green cross will appear within two minutes. The test is simple, safe, and sanitary, and requires no handling of the stool.
Clinical Application
Occult blood in the stool is one of the primary warning signals of many bowel problems. EZ Detect(TM) is designed to detect blood in the stool that can be caused by bleeding ulcers, hemorrhoids, polyps, colitis, diverticulitis, fissures or cancer of the colon.
The American Cancer Society recommends that men and women over 40 and those who have a personal or family history of lower intestinal disorders use an occult blood test yearly or as often as their physician recommends.
Test Procedure
The specimen for the test is the feces. No specimen collection or handling of the feces is required to perform the test. To increase the probability of detection, the test is performed on three consecutive bowel movements. If the sequence is broken, the test should be continued until three bowel movements have been tested. Some gastrointestinal bleeding occurs intermittently. Checking three consecutive bowel movements will offer a better chance of finding lower intestinal bleeding.
All toilet cleaners, disinfectants, or deodorizers should be removed from the
toilet bowl and the tank. The toilet should be flushed repeatedly until
the water is clear. Once you believe the water is free of cleaners, etc.,
the toilet bowl water can be tested for adequacy by completing the following
steps:
1. Open the foil pouch and take out one Test Tissue, and carefully drop it on the surface of the water in the toilet bowl. After the bowel movement, the patient places a test pad into the toilet.
2. If any trace of blue-green color appears on the Test Tissue after two minutes, the toilet water is unsuitable for the test. If no color appears in the cross area, you may flush the toilet and continue with the bowel movement tests.
Bowel
Movement Test
Urinate first and then flush the toilet; have a bowel movement; carefully
drop a Test Tissue into the toilet bowl; any trace of blue-green color appearing
in the Test Tissue within two minutes means excessive blood is present in the
stool. If no color appears, the test is negative.
Upon completion of the test (3 consecutive bowel movements), the patient records the results on the return postcard and mails it to the physician or screening center.
Each kit also contains a return postcard which allows the patients to record their test results and send them to their physician.
Storage
The EZ Detect(TM) professional carton has a two year shelf life at room temperature (15-30 degrees C). During the testing period, the patient should store any unused test pads in the original foil pouch to protect them from light and moisture.
Limitations
1. As with any other in vitro diagnostic test, the results obtained from the EZ DETECT(TM) Test should be used as a preliminary screen to other medically established procedures and be interpreted in conjunction with other clinical data available. The test does not replace other established diagnostic procedurees, such as proctosigmoidoscopy, barium enema, X-ray studies, etc. The results obtained with EZ DETECT(TM) Test should not be considered conclusive for the presence or absence of a pathological condition.
2. Some of the previously mentioned drugs may induce gastrointestinal bleeding and may cause positive results.
3. The EZ DETECT(TM) Test is a qualitative test for blood in the stool. Even though the amount of color varies according to the concentration of blood, the test itself should not be used for quantitative information.
4. It is important that no urine be present during testing. Large amounts of urine may make the results difficult to see.
Performance
Characteristics
Sensitivity
The sensitivity limits for fecal occult blood is 2.0 mg hemoglobin/100 ml water
(equivalent to Hemoccult(TM)).
Clinical Evaluation
EZ
Detect(TM) and
Hemoccult(TM)
were tested on 101 patients. In both tests 22 patients were found positive and
79 patients were found negative for blood in the feces--a 100 % correlation.
Accuracy and
Prediction
A repetitive
performance of the test (n = 20) on a sample containing 2.0 mg hemoglobin/100 ml
gave a positive result each time (100%). A repetitive performance of the test (n
= 20) on a sample devoid of hemoglobin gave a negative result each time (100 %).
EZ Detect(TM) offers the simplicity, speed & convenience that dramatically increases patient compliance!
NO TOUGH DIET CONSTRAINTS
NOT AFFECTED BY VITAMIN C
NOT AFFECTED BY RARE MEAT
(Eat a normal diet including vegetables, fruits and cereals (such as bran and whole grain). This diet will give a better test result by adding roughage which can help uncover such things as silent lesions which bleed intermittently.
NO STOOL HANDLING
NO HEALTH HAZARD
NO LAB PROCESSING
RESULTS IN MINUTES ... RECORDED & RETURNED TO PHYSICIAN
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