Item Brochure

PERFORMANCE MONITORS FEATURE (Quality Control)
The function and stability of the slides and developer can be tested
using the on-slide Performance Monitors feature. The positive (+)
and negative (-) Performance Monitors areas are located under the
sample area on the developing side of the slides.
LIMITATIONS OF PROCEDURE
EXPECTED RESULTS
Positivity rates for fecal occult blood tests have been shown to vary
in each patient population depending on diet, age, predisposition
to colorectal disease, and other factors that may be associated
with bleeding gastrointestinal lesions.
16, 19
PERFORMANCE CHARACTERISTICS
FIGURE 1
SENSITIVITY COMPARISON
HEMOCCULT AND HEMOCCULT SENSA
Difference 6% 14% 11%
95% Confidence
Interval
Difference Significant Significant Significant
Hemoccult
SENSA
FIGURE 2
COMPARISON OF COLOR INTENSITIES AT 1 MINUTE
Color Intensity Description
– No blue color
+1 Very faint, barely detectable trace of blue
+2 Faint blue color
+3 Distinctly blue color
+4 Intense blue. Wider area of blue color
coverage than a score of 3
TABLE 1
COMPARISON OF SPECIFICITY
Asymptomatic Individuals
Confirmed and Presumed Normals on Restricted Diet
Hemoccult
No. of Cases Studied 1586 2197
Specificity 98% 96.5%
Difference in Specificity 1.5%
95% Confidence Interval 0.5 to 2.5%
Colorectal
Cancer
(n=132)
Adenomas
>1 cm
(n=78)
All
Adenomas
(n=190)
HEMOGLOBIN LEVEL
(added mg Hb/g Feces)
5
6
1.5 to 10.6% 5.6 to 22.6% 5.3 to 16.8%
7 8 9
Prospective, randomized controlled clinical trials extending for up
to 18 years have demonstrated that the Hemoccult products are
effective in detecting occult blood in stool as an early indication of
colorectal cancer. In clinical trials that enrolled over 339,000 indi-
viduals, mortality from colorectal cancer was reduced up to 33%
when fecal occult blood tests were performed annually
27-29
and 15-
21% when performed biennially.
30
The program sensitivity for
detecting colorectal cancer was 90% when Hemoccult was
repeated annually.
31-32
Hemoccult
Hemoccult SENSA
Hemoccult
Hemoccult SENSA
BIBLIOGRAPHY
1. Winawer, S.J., et al.: "Colorectal cancer screening: Clinical
guidelines and rationale," Gastroenterol. 112:594-642, 1997.
2. Winawer, S.J., et al.: "Prevention of colorectal cancer: Guidelines
based on new data," WHO Bulletin OMS. 73: 7-10, 1995.
3. Ransohoff, D.F. and Lang, C.A., "Clinical guideline: Part I-suggested
technique for fecal occult blood testing and interpretation in
colorectal cancer screening," Ann. Intern. Med. 126:808-810, 1997.
4. Ransohoff, D.F. and Lang, C.A., "Clinical Guideline: Part II-screening
for colorectal cancer with the fecal occult blood test: A Background
Paper," Ann. Intern. Med. 126:811-822, 1997.
5. Rosenfield, R.E., et al.: "Nonuniform distribution of occult blood
in feces," Am. J. Clin. Path. 71:204-209, 1979.
6. Layne, E.A., et al.: "Insensitivity of guaiac slide tests for detection
of blood in gastric juice," Ann. Intern. Med. 94:774-776, 1980.
7. Kratochvil, J.F., et al.: "Isolation and characterization of alpha
guaiaconic acid and the nature of guaiacum blue," Phytochem.
10:2529, 1971.
8. Rozen, P., et al.: "Eliminating the need for dietary restrictions
when using a sensitive guaiac fecal occult blood test," Dig.
Dis. Sci. 44 (4):756-760, 1999.
9. Rozen, P., et al.: "Performance characteristics and comparison of two
immunochemical and two guaiac fecal occult blood screening tests
for colorectal neoplasia," Dig. Dis. Sci. 42 (10):2064-2071, 1997.
10. Sinatra, M.A., et al.: "Interference of plant peroxidases with
guaiac-based fecal occult blood tests is avoidable," Clin. Chem.
45 (1):123-126, 1999.
11. Anderson, G.D., et al.: "An investigation into the effects of oral
iron supplementation on in vivo Hemoccult stool testing,"
Am. J. Gastroenterol. 85:558-561, 1990.
12. Clapp, W.H. "Iodine and occult blood testing," Consultant. 208,
April 1984.
13. Greenberg, P.D., et al.: "Asymptomatic chronic gastrointestinal
blood loss in patients taking aspirin or warfarin for cardiovascular
disease," Am. J. Med. 100 (6):598-604, 1996.
14. Johnson, P.C., "Gastrointestinal consequences of treatment
with drugs in elderly patients," J. Am. Ger. Soc. 30 (11): S52-S57, 1982.
15. Jaffe, R.M., et al.: "False-negative stool occult blood tests
caused by ingestion of ascorbic acid (vitamin C)," Ann. Intern.
Med. 83:824, 1982.
16. Young, G.P. and St. John, D.J.B., "Selecting an occult blood
test for use as a screening tool for large bowel cancer," in:
Rozen, P., ed., Front. Gastrointest. Res. Basel, Karger. 18:135-156,1991.
17. Levin, B., et al.: "Screening for colorectal cancer: A comparison of
3 fecal occult blood tests," Arch. Int. Med. 157:970-976, 1997.
18. Data on file, Product Development department, Beckman
Coulter, Inc., Primary Care Diagnostics (formerly SmithKline
Diagnostics, Inc.).
19. Stanley, A.J. and St. John, D.J.B., "Faecal occult blood test
screening for colorectal cancer-What are we waiting for?"
Aust. NZ J. Med. 29:545-551, 1999.
20. Macrae, F.A. and St. John, D.J.B., “Relationship between patterns
of bleeding and Hemoccult sensitivity in patients with colorectal
cancers or adenomas,” Gastroenterol. 82:891-898, 1982.
21. Greegor, D.H. "Diagnosis of large bowel cancer in the asymptomatic
patient," JAMA. 201(12):943-945, 1967.
22. Greegor, D.H.: "Detection of silent colon cancer in routine
examination," Ca. 19:330-337, 1969.
23. Greegor, D.H.: "Occult blood testing for detection of asymptomatic
Colon Cancer," Cancer. 28:131-134, 1971.
24.
Ostrow, J.D., et al.: "Sensitivity and reproducibility of chemical
tests for fecal occult blood with an emphasis on
false-positive reactions," Am. J. Dig. Dis. 18 (11):930-940, 1973.
25. Baker, J., et al.: "Readability and sensitivity of two guaiac-based fecal
occult blood tests," Gastroenterol. 94(5):A5, 1988.
26. Rockey, D.C., et al.: "Detection of upper gastrointestinal blood with fecal
occult blood tests," Am. J. Gastroenterol. 94:344-350, 1999.
27. Hardcastle, J.D., et al.: "Randomised controlled trial of faecal-occult-
blood screening for colorectal cancer," Lancet. 348:1472-1477,1996.
28. Kronborg, O., et al.: "Randomised study of screening for colorectal
cancer with faecal-occult-blood test," Lancet. 348:1467-1471,1996.
29. Mandel, J.S., et al.: "Reducing mortality from colorectal cancer by
screening for fecal occult blood," N. Eng. J. Med. 328:1365-1371,1993
30. Mandel, J.S., et al.: "Colorectal cancer mortality: Effectiveness
of biennial screening for fecal occult blood," J. Natl. Cancer
Inst. 91:434-437, 1999.
31. Ederer, F., et al.: "Fecal occult blood screening in the
Minnesota Study: Role of chance detection of lesions," J. Natl.
Cancer Inst. 89:1423-1428, 1997.
32. Church, T.R., et al.: "Fecal occult blood screening in the
Minnesota Study: Sensitivity of the screening test," J. Natl. Cancer
Inst. 89:1440-1448, 1997.
PRODUCT INFORMATION
All products listed are CLIA Waived.
Product Name Product No.
Hemoccult SENSA Single Slides (case of 10 boxes) 64151
Each box contains:
• 100 Slides
• 100 Applicator Sticks
• Two 15 mL bottles of Hemoccult SENSA Developer
Hemoccult SENSA Single Slides (case) 64152
• 1000 Slides
• 1000 Applicator Sticks
• Twenty 15 mL bottles of Hemoccult SENSA Developer
Hemoccult II SENSA Dispensapak Plus (case of 4 boxes) 64130
Each box contains:
• 40 Patient Screening Kits
• Two 15 mL bottles of Hemoccult SENSA Developer
(case of 4 boxes)
B42462
Each box contains:
• 40 Patient Screening Kits
Hemoccult SENSA Developer (box) 64115
• Twenty 15 mL bottles
Hemoccult Single Slides (case of 10 boxes) 60151
Each box contains:
• 100 Slides
• 100 Applicator Sticks
• Two 15 mL bottles of Hemoccult Developer
Hemoccult Single Slides (case) 60152
• 1000 Slides
• 1000 Applicator Sticks
• Twenty 15 mL bottles of Hemoccult Developer
Hemoccult II Dispensapak (case of 2 boxes) 61100
Each box contains:
• 50 Patient Kits (Triple Slide and Applicator Sticks ONLY)
• Three15 mL bottles of Hemoccult Developer
Hemoccult II Dispensapak Plus (case of 4 boxes) 61130
Each box contains:
• 40 Patient Screening Kits
• Two 15 mL bottles of Hemoccult Developer
Hemoccult II (case of 10 boxes) 61200
Each box contains:
• 34 Triple Slides
• 102 Applicator Sticks
• Two 15 mL bottles of Hemoccult Developer
Hemoccult Developer (box) 62115
• Twenty 15 mL bottles
Hemoccult Mailing Pouches (box) 62200
• 100 pouches
Hemoccult Tape (case of 12 boxes) 63202
Each box contains:
• 2 Tape Dispensers
• Two 15 mL bottles of Hemoccult Developer
Gastroccult Test Kit 66040
• Gastroccult Test Kit
Gastroccult Test Kit 66115
• Six 15 mL bottles
Gastroccult Straw Applicators 66140
• 40 Applicators
PRODUCT INFORMATION
Also available, 8-1/2 x 11” color guide to test interpretation for
Hemoccult SENSA, Hemoccult or Gastroccult .
For more information visit http://www.beckmancoulter.com/rapids
For technical assitance call Technical Marketing at 800-877-6242
or e-mail [e-mail]
To order product, contact your medical supply distributor.
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, CA 92821 USA
Table 1 summarizes the data comparing the specificity of the
Hemoccult SENSA test (96.5%) to that of the Hemoccult test
(98%). In an individual study where patients were highly motivated
to comply with the restricted diet, the specificity of the Hemoccult
SENSA test was the same as the Hemoccult test (99%).
18, 25
Early detection of colorectal cancer in asymptomatic, average risk
individuals is necessary to reduce mortality. The detection of occult
blood in stool using Hemoccult SENSA, a more sensitive and
readable test than Hemoccult, is a highly effective method for
detecting bleeding associated with colorectal cancer.
Clinical studies
20
using [
51
Cr] chromium - labeled blood cells
suggest that a daily blood loss of 2-3 mL (approximately 0.3 mg
Hb/gm feces) is the lower limit of blood loss that may be associated
with gastrointestinal pathology. Based on in vitro studies in which
fecal samples from asymptomatic, normal volunteers were spiked
with fresh whole blood, Hemoccult SENSA gave positive test results
about 75% of the time at 0.3 mg Hb/gm feces. The positivity rates
increased as the equivalent daily blood loss increased. Virtually all
Hemoccult SENSA tests were positive at an equivalent daily blood
loss equal to or greater than 10 mL.
Hemoccult II SENSA Dispensapak Plus (Phoenix VA)
The reproducibility of test results on positive fecal specimens is
improved with Hemoccult SENSA as a result of the increased
readability of the test.
18, 25
The Hemoccult SENSA test is more readable than the Hemoccult
test at low but abnormal levels of hemoglobin in feces. Figure 2
compares the color intensity and stability of positive test results
from samples containing different levels of added hemoglobin.
Experienced and inexperienced readers preferred the more
intense, stable blue color of the Hemoccult SENSA test, which
made it easier to read a positive test result against the dark sample
background. Experienced readers correctly interpreted test results
a higher percentage of the time than inexperienced readers,
pointing to the benefit of some training in reading guaiacbased
fecal occult blood tests.
Figure 1 illustrates that the Hemoccult SENSA test is more effective
than the Hemoccult test in detecting bleeding associated with
colorectal cancer and adenomas. The differences in sensitivity
between the two tests are statistically significant.
18, 25
The clinical performance of the Hemoccult SENSA test was
compared to the Hemoccult test in multi-site clinical evaluations.
The results are shown in Figure 1 and Table 1.
18
The specificities of the Hemoccult SENSA test and the Hemoccult
test are the same when normal subjects follow the Patient Instruc-
tions as recommended. When normal subjects consume large
amounts of red meat, the false-positive rate will be higher with the
Hemoccult SENSA test. Raw fruits and vegetables in the diet give
about the same number of false-positive test results when samples
are tested immediately after collection. To reduce the rate of
false-positive tests due to consumption of raw fruits and
vegetables, the Hemoccult SENSA test is best developed three
days after sample application. This three-day delay allows for
degradation of any fruit and vegetable peroxidases that may be
present in the fecal sample.
8-10
Occasionally, a light blue discoloration may be noticed on the
guaiac test paper. This discoloration does not affect the accuracy
or performance of the test when it is developed and interpreted
according to the recommended procedure. When developer is
added directly over the fecal smear on a discolored slide, the blue
background color migrates outward. A blue ring forms at the edge
of the wetted area, leaving the guaiac paper around the fecal smear
off-white in color. Any blue on or at the edge of the smear is positive
for occult blood. Proper storage of Hemoccult SENSA Slides will
help prevent blue discoloration.
Some specimens have a high bile content which causes the feces
to appear green. A distinct green color (no blue), appearing on or
at the edge of the smear within 60 seconds after adding Hemoccult
SENSA Developer, should be interpreted as negative for occult
blood. A blue or blue-green color should be interpreted as positive
for occult blood.
The Performance Monitors feature provides assurance that the
guaiac paper and developer are functional. In the unlikely event
that the Performance Monitors areas do not react as expected after
applying developer, the test results should be regarded as invalid.
Should this occur, contact the Technical Marketing Department at
800-877-6242 for assistance.
Bowel lesions, including some polyps and colorectal cancers, may
not bleed at all or may bleed intermittently. Also, blood, if present,
may not be distributed uniformly in the fecal specimen.
Consequently, a test result may be negative even when disease is
present.
3, 5
Conversely, a Hemoccult SENSA test result may be positive on
specimens from healthy patients. This may be due to inter fering
substances in the diet or to medications. It may also be due to low
but detectable levels of blood loss, common to both healthy adults
and patients with gastrointestinal disease.
16
Therefore, as with any occult blood test, results with the Hemoccult
SENSA test cannot be considered conclusive evidence of the
presence or absence of gastrointestinal bleeding or pathology.
Hemoccult SENSA tests are designed for preliminary screening as
an aid to diagnosis. They are not intended to replace other diagnos-
tic procedures such as sigmoidoscopy, colonoscopy, barium
enema, or other x-ray studies.
The Hemoccult SENSA test, as well as other unmodified fecal
occult blood tests, should not be used to test gastric specimens.
6
Interfering factors, such as low pH, high drug concentrations,
metal ions or plant peroxidase in food, may affect the function of
guaiac-based occult blood tests. Gastroccult, available from
Beckman Coulter, is specifically designed to detect occult blood in
gastric specimens.
In a general screening population of highly compliant asymptom-
atic individuals, a positivity rate of approximately 3% was obtained;
among a similar group of less compliant individuals, a positivity
rate of about 7% was observed. The false-positivity rate for
colorectal disease was 1 to 3% depending on the population
studied.
18
Addition of a drop of water (rehydration) to the guaiac test card
prior to the addition of the developer increases the sensitivity of the
test, but also increases the number of false-positive test results.
4,10, 17
For this reason, rehydration is not a recommended procedure
for the Hemoccult SENSA test.
The positive Performance Monitors area contains a hemoglobin
derived catalyst which will turn blue within 10 seconds after
applying developer. The negative Performance Monitors area
contains no such catalyst and should not turn blue after applying
developer.