Patient Preparation

No special patient preparations are necessary.

A specimen should not be collected from a patient with the following conditions:  menstrual bleeding, bleeding hemorrhoids, constipation bleeding, or urinary bleeding.

Advisable to avoid samples coming in contact with toilet bowl water or other contaminants.

Collect

Type -   Outpatient preference: Extracted stool in Hemosure® fecal collection buffer tubes.
 
              Inpatient and ER patients: Fresh, random stool specimen in a sterile container, not exceeding two hours after collection.
 
Amount required -          Optimum -         1.0 cc
                                        Minimum -         0.5 cc

 

Unacceptable Conditions

Any preservative other than the Hemosure fecal collection buffer tubes.  Rectal examination stool smear or glove remanence.

Regional Pathology Services Transport Information

Regional Pathology Services Clients: For the collection kit please order KIT_30 under the supply website. For patient collection instructions please click here:  Collection Guide

Stability (from collection to initiation)

Outpatient preference: The extracted stool in Hemosure® fecal collection buffer tube are stabile for up to 6 days at room temperature and up to 30 days refrigerated at 2-8oC.
 
Inpatient or ER patients: Sterile stool specimens stored at room temperature not exceeding two hours after collection. 
 

Performed

Core Laboratory 24/7

Remarks

Hemosure patient collection mailers are available.  The mailers include patient instructions, collection paper, hemosure fecal collection buffer tube, sample pouch, and return envelope.
This allows the patient to collect at their convenience.  The sample may then be mailed to the lab directly or delivered to provider for transportation.

Notes

Hemosure® One Step Immunological Fecal Occult Blood Test is a rapid, immunochemical device for the qualitative determination of fecal occult blood. It is useful in determining gastrointestinal bleeding in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.
 
Hemosure® One Step Immunological Fecal Occult Blood Test is a qualitative, sandwich dye conjugate immunoassay and employs a combination of monoclonal and polyclonal antibodies to selectively identify hemoglobin in test samples. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to anti-hemoglobin antibody in the positive test reaction zone and produces a pink-rose color band.  Elevated levels of human hemoglobin of 50ng hHb/mL can be detected and result as positive. In the absence of hemoglobin, there is no line in the positive test reaction zone. The on-board device control reaction zone demonstrate that the reagents and devices are functioning correctly.
 

Ordering Recommendations

FHB-screen
FHBD-diagnostic

Performed

Core Laboratory 24/7

Methodology

Hemosure® One Step Immunological Fecal Occult Blood Test (FIT test)

Synonyms

  • Occult Blood
  • Fecal Occult Blood
  • stool

Reference Interval

Negative

Interpretive Data

The sensitivity of the Hemosure® One Step Immunological Fecal Occult Blood Test is 50ng hHb/mL buffer or 50 µg hHb/g feces.
Hemosure® One Step Immunological Fecal Occult Blood Test is specific for human hemoglobin. Hemoglobin from horse, pigs, fish, beef, chicken, rabbit, rat, goat, and mouse do not react with test. 
Abnormal hemoglobins were not tested for potential cross-reactivity.
Aqueous extracts of broccoli, cantaloupe, cauliflower, horseradish, parsnip, raw turnip, and red radish were tested with and without human hemoglobin present in the samples. Additionally, a 20mg/mL solution of horseradish peroxidase, with and without human hemoglobin present, was also tested. No interference was observed.

A negative result can be obtained even when a GI disorder is present.  Some bowel lesions, including some polyps and colerectal cancer, may not bleed at all or may bleed intermittently, or the blood may not be uniformly distributed in a fecal sample.
Certain medications may cause gastrointestinal irritation resulting in occult bleeding.  This may reuslt in a false positve test result.
Hemosure Immunolgical Fecal Occult Blood test may not be considered as a conclusive diagnosis for GI bleeding or pathology.  The test results can only be regarded as  a preliminary screening or as an aid to diagnosis.  It is not intended to replace other diagnostic procedures such as GI fibroscope, endoscopy, colonoscopy or other x-ray studies.

Although no interference was noted with the toilet water testing, it is advisable to avoid samples coming in contact with toilet bowl water.
 
Toilet bowl deodorizers and cleaners also did not interfere with Hemosure® One Step Immunological Fecal Occult Blood Test.

The accuracy of Hemosure® One Step Immunological Fecal Occult Blood Test is 97%.
 

CPT Codes

82274

Test Build Information

OrderCode OrderName ResultCode ResultName ResultUnits LOINC CPT
FHB  GI FECAL HEMOGLOBIN BLD/STOOL FIT  FECAL IMMUNOASSAY TEST   29771-3 82774
             
FHBD FECAL HGB DIAGNOSIS FITD FECAL IMMUNO TEST/DX    29771-3 82774

Additional Information

For additional information or questions, contact RPSInterfaceSupport@unmc.edu
Collection

Patient Preparation

No special patient preparations are necessary.

A specimen should not be collected from a patient with the following conditions:  menstrual bleeding, bleeding hemorrhoids, constipation bleeding, or urinary bleeding.

Advisable to avoid samples coming in contact with toilet bowl water or other contaminants.

Collect

Type -   Outpatient preference: Extracted stool in Hemosure® fecal collection buffer tubes.
 
              Inpatient and ER patients: Fresh, random stool specimen in a sterile container, not exceeding two hours after collection.
 
Amount required -          Optimum -         1.0 cc
                                        Minimum -         0.5 cc

 

Unacceptable Conditions

Any preservative other than the Hemosure fecal collection buffer tubes.  Rectal examination stool smear or glove remanence.

Regional Pathology Services Transport Information

Regional Pathology Services Clients: For the collection kit please order KIT_30 under the supply website. For patient collection instructions please click here:  Collection Guide

Stability (from collection to initiation)

Outpatient preference: The extracted stool in Hemosure® fecal collection buffer tube are stabile for up to 6 days at room temperature and up to 30 days refrigerated at 2-8oC.
 
Inpatient or ER patients: Sterile stool specimens stored at room temperature not exceeding two hours after collection. 
 

Performed

Core Laboratory 24/7

Remarks

Hemosure patient collection mailers are available.  The mailers include patient instructions, collection paper, hemosure fecal collection buffer tube, sample pouch, and return envelope.
This allows the patient to collect at their convenience.  The sample may then be mailed to the lab directly or delivered to provider for transportation.

Notes

Hemosure® One Step Immunological Fecal Occult Blood Test is a rapid, immunochemical device for the qualitative determination of fecal occult blood. It is useful in determining gastrointestinal bleeding in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.
 
Hemosure® One Step Immunological Fecal Occult Blood Test is a qualitative, sandwich dye conjugate immunoassay and employs a combination of monoclonal and polyclonal antibodies to selectively identify hemoglobin in test samples. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to anti-hemoglobin antibody in the positive test reaction zone and produces a pink-rose color band.  Elevated levels of human hemoglobin of 50ng hHb/mL can be detected and result as positive. In the absence of hemoglobin, there is no line in the positive test reaction zone. The on-board device control reaction zone demonstrate that the reagents and devices are functioning correctly.
 
Ordering

Ordering Recommendations

FHB-screen
FHBD-diagnostic

Performed

Core Laboratory 24/7

Methodology

Hemosure® One Step Immunological Fecal Occult Blood Test (FIT test)

Synonyms

  • Occult Blood
  • Fecal Occult Blood
  • stool
Result Interpretation

Reference Interval

Negative

Interpretive Data

The sensitivity of the Hemosure® One Step Immunological Fecal Occult Blood Test is 50ng hHb/mL buffer or 50 µg hHb/g feces.
Hemosure® One Step Immunological Fecal Occult Blood Test is specific for human hemoglobin. Hemoglobin from horse, pigs, fish, beef, chicken, rabbit, rat, goat, and mouse do not react with test. 
Abnormal hemoglobins were not tested for potential cross-reactivity.
Aqueous extracts of broccoli, cantaloupe, cauliflower, horseradish, parsnip, raw turnip, and red radish were tested with and without human hemoglobin present in the samples. Additionally, a 20mg/mL solution of horseradish peroxidase, with and without human hemoglobin present, was also tested. No interference was observed.

A negative result can be obtained even when a GI disorder is present.  Some bowel lesions, including some polyps and colerectal cancer, may not bleed at all or may bleed intermittently, or the blood may not be uniformly distributed in a fecal sample.
Certain medications may cause gastrointestinal irritation resulting in occult bleeding.  This may reuslt in a false positve test result.
Hemosure Immunolgical Fecal Occult Blood test may not be considered as a conclusive diagnosis for GI bleeding or pathology.  The test results can only be regarded as  a preliminary screening or as an aid to diagnosis.  It is not intended to replace other diagnostic procedures such as GI fibroscope, endoscopy, colonoscopy or other x-ray studies.

Although no interference was noted with the toilet water testing, it is advisable to avoid samples coming in contact with toilet bowl water.
 
Toilet bowl deodorizers and cleaners also did not interfere with Hemosure® One Step Immunological Fecal Occult Blood Test.

The accuracy of Hemosure® One Step Immunological Fecal Occult Blood Test is 97%.
 
Administrative

CPT Codes

82274
RPS Interface Information

Test Build Information

OrderCode OrderName ResultCode ResultName ResultUnits LOINC CPT
FHB  GI FECAL HEMOGLOBIN BLD/STOOL FIT  FECAL IMMUNOASSAY TEST   29771-3 82774
             
FHBD FECAL HGB DIAGNOSIS FITD FECAL IMMUNO TEST/DX    29771-3 82774

Additional Information

For additional information or questions, contact RPSInterfaceSupport@unmc.edu

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