Developing and Interpreting Hemoccult® and Hemoccult II® Tests

Hemoccult Product Instructions
(768k)


A. Identification
 

Using a ball-point pen, write patient name, age, address, phone number, sample collection date and physician name on the front of the slide in the space provided.
   

B. Preparing the Test
 



Using the applicator provided, collect a small fecal sample.



Apply a thin smear covering Box A.




Reuse the applicator to obtain a second sample from a different part of the stool. Apply a thin smear covering Box B.


Close the cover flap. Dispose of applicator in a waste container.



If testing immediately, wait 3 to 5 minutes before developing. Otherwise, store slides as directed for up to 14 days until ready to develop.
   

C. Developing the Test
 




Open the back of the slide and apply two drops of Hemoccult Developer to guaiac paper directly over each smear.



Read results within 60 seconds. Any trace of blue on or at the edge of the smear is positive for occult blood.
   

D. Developing the Performance Monitors® Feature (Quality Control)
 



The Performance Monitors areas must be developed on every slide.




Apply one drop of Hemoccult Developer between the positive and negative Performance Monitors areas.





Read results within 10 seconds. If the slide and developer are functional, a blue color will appear in the positive Performance Monitors area and no blue will appear in the negative Performance Monitors area.





Neither the intensity nor the shade of the blue from the positive Performance Monitors should be used as a reference for the appearance of positive test results.



Any blue originating from the positive Performance Monitors area should be ignored when reading the sample test results

   

Reduce False Positive Results Caused by Raw Fruits and Vegetables
 

It is recommended to wait at least three days from the date the last stool sample was collected to develop the test. Waiting three days before developing the test reduces plant peroxidase activity in the stool sample and therefore the rate of false positives.


By following this procedure your patients can consume raw fruits and vegetables without affecting test results.8-10
   

Follow-up on a Positive FOBT
 
A positive FOBT places a patient at high risk for CRC and alerts the physician to do further diagnostic testing.

The ACS recommends following a positive FOBT with a study of the entire colon, whether by colonoscopy or DCBE.

   

Expected Results
 

In a general screening population of highly compliant asymptomatic individuals, the Hemoccult test will yield a positivity rate of approximately 2 to 5%. The false-positivity rate in such a population would be approximately 1 to 2%.15

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.14,16
   

References:
(from Hemoccult Product Instructions
(768k))

8. 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.

9. 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, 1990.

10. Clapp, W.H. "Iodine and occult blood testing." Consultant. 208, April 1984.

14. Young, G.P., and St. John, D.J.B., "Selecting anoccultblood testfor use as a screening tool for large bowel cancer," in: Rozen, P., ed., Front. Gastrointest. Res. Basel, Karger. 18:135-156, 1991.

15. Data on file, Product Development department, Beckman Coulter, Inc., Primary Care Diagnostics (formerly SmithKline Diagnostics, Inc.)

16. 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.