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EZ Detect™ - Clinical Studies
By MARVIN S. HAUSMAN, M.D.
Adult and Pediatric Urology
Diplomate American Board of Urology
Fellow American College of Surgeons
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By R. ORLANDO, M.D., PH.D.
Chairman and Director of Laboratories
Whittier Hospital Medical Center
Board of Pathology
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RESULTS OF CLINICAL STUDY
COMPARING EZ DETECT™ TEST
AND HEMOCCULT®
SLIDE TEST
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.
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FINDINGS:
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Total
number of patients studied:
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105
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All
patients with positive Hemoccult® test slides were positive
with EZ Detect™ test tissues.
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Total
number of specimens tested:
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120
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Total
positives:
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28
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The
EZ Detect™ test was found to be
sensitive for upper gastrointestinal bleeding. Two patients who had positive
EZ Detect™ test were later found to
have gastric ulcers at the time of gastroscopy.
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Total
negatives:
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92
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Percent
positives:
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23%
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SUPPLEMENTARY CLINICAL STUDY
EZ DETECT™ VS. HEMOCCULT®
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Test System
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Positives
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Negatives
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Total Specimens
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Total Patients
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CONCLUSIONS: |
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EZ
Detect™
Biomerica
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49
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114
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163
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81
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When testing three consecutive bowel movements,
EZ Detect™ and Hemoccult® give
equivalent results. EZ Detect™
may not require three consecutive testing, according to the detailed data.*
The other apparent discrepancies are easily
explained by experimental error or Hemoccult®
giving false positive or false negative results (as shown in the detailed
data)*, which may be attributed to patient non-compliance to dietary
restrictions.
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Hemoccult®
Smith Kline
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41
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122
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163
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81
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COMPARISON OF EZ DETECT™
VS. HEMOCCULT® II
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Test System
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Positives
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Negatives
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Total Specimens
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Total Patients
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Patients were randomly selected at Whittier Hospital Medical Center
and Humana West Anaheim Community Hospital for comparison of the EZ Detect™ Test with the Hemoccult® Test. Patients
hospitalized for various conditions were used as subjects for the evaluation.
CONCLUSION: Samples with Hematuria and hemorrhoids were
positive with EZ Detect™ Test
and negative with Hemoccult®.
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EZ
Detect™ Biomerica
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22
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25
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47
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33
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Hemoccult® Smith Kline
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16
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33
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48
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33
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STATEMENTS:
EZ Detect™ is an approved test for detecting hidden stool blood
that could be caused by a variety of bowel problems including colorectal
cancer, diverticulitis, colitis, hemorrhoids, etc. That test requires no diet
restrictions (including vitamin C) before or during testing. EZ Detect™ was also found to be sensitive for upper
gastrointestinal bleeding. EZ Detect™ is superior to the Hemoccult® test because of its simplicity, which
facilitates better patient compliance. The test is sanitary, easy to use and is
performed in the privacy of the home. The user just drops the pad into the
toilet bowl after a bowel movement and the result appears within 2 minutes. By
contrast, the Hemoccult®
test is complicated, unsanitary and lengthy because the patient must collect
and handle stools, send a stool specimen to a laboratory for analysis, and then
wait for the results.
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