Test Catalog

Test Id : FOBT

Fecal Occult Blood, Colorectal Cancer Screen, Qualitative, Immunochemical, Feces

Useful For
Suggests clinical disorders or settings where the test may be helpful

Colorectal cancer screening

 

Screening for gastrointestinal bleeding

 

This test has not been validated for testing of patients with hemoglobinopathies.

Method Name
A short description of the method used to perform the test

Immunochemical

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Occult Blood, QL, Immunochemical, F

Aliases
Lists additional common names for a test, as an aid in searching

Fecal Immunochemical

Fecal Occult Blood

FIT

Specimen Type
Describes the specimen type validated for testing

Fecal

Ordering Guidance

This test will not detect upper gastrointestinal bleeding. If clinically indicated, order HQ / HemoQuant, Feces.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Fecal Occult Blood Test Kit (T682)

Container/Tube: Fecal Occult Blood Test Kit

Specimen Volume: Specimen must fill the grooved portion of the sample probe
Collection Instructions:

1. Collect a random stool specimen.

2. See Fecal Occult Blood Test Kit package insert for instructions.

3. Specimen must be collected in specific sample vial within 4 hours of defecation.

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Fecal Refrigerated (preferred) 30 days FOBT
Ambient 15 days FOBT

Useful For
Suggests clinical disorders or settings where the test may be helpful

Colorectal cancer screening

 

Screening for gastrointestinal bleeding

 

This test has not been validated for testing of patients with hemoglobinopathies.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Colorectal cancer (CRC) is one of the most commonly diagnosed cancers in the United States, and the second leading cause of cancer-related deaths. CRC almost always develops from adenomatous polyps, yet patients remain asymptomatic until the cancer progresses to a fairly advanced stage. Screening for colorectal cancer is strongly advocated for by the United States Preventive Services Task Force, the American Cancer Society, the American College of Gastroenterology, and other clinical societies, due to the high incidence of disease and decrease in mortality with medical intervention. Men and women at average risk for colorectal cancer should be screened at regular intervals beginning at age 50 and continuing until age 75. Individuals with certain high-risk factors (age, African-American race, inflammatory intestinal disorders, family history of colon cancer, obesity, diabetes, poor diet) may consider earlier screening strategies.

 

A variety of options are available for colorectal cancer screening including: fecal occult blood testing, sigmoidoscopy, colonoscopy, and multimarker Cologuard testing that includes genetic markers of colorectal cancer. Historically occult blood tests utilized guaiac-based tests that were susceptible to dietary interferences, but this test utilizes fecal immunochemical testing (FIT) specific for human hemoglobin, eliminating the need for dietary and medication restrictions. For colorectal cancer screening, only a single collection is required. The specificity of FIT is routinely greater than 95% with reported sensitivities ranging from 40% to 70% based on the patient population. The clinical specificity of FIT is 97% based on internal studies conducted at Mayo Clinic but can be limited by gastrointestinal bleeding from a non-colorectal cancer source. In a recent study of 10,000 average risk participants, Cologuard detected colorectal cancer, precancerous lesions, and polyps with high-grade dysplasia with higher sensitivity than FIT testing.(1) However, Cologuard had slightly lower specificity than FIT testing in that study. Cologuard requires an entire bowel movement for testing versus 1 small sample for FIT. Current societal guidelines endorse the use of FIT and Cologuard interchangeably with 1-year based screening for FIT versus a suggested 3-year DNA based screening for average risk population, recognizing that the testing interval for the latter is uncertain.(2,3)

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

 

This test has not been validated in a pediatric population, results should be interpreted in the context of the patient's presentation.

Interpretation
Provides information to assist in interpretation of the test results

This is a quantitative assay but results are reported qualitatively as negative or positive for the presence of fecal occult blood; the cutoff for positivity is 100 ng/mL hemoglobin. The following comments will be reported with the qualitative result for patients older than 17 years:

-Positive results; further testing is recommended if clinically indicated. This test has 97% specificity for detection of lower gastrointestinal bleeding in colorectal cancer.

-Negative results; this test will not detect upper gastrointestinal bleeding; HQ / HemoQuant, Feces test should be ordered if clinically indicated.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Fecal immunochemical tests do not detect upper gastrointestinal (GI) bleeding due to the breakdown of hemoglobin during intestinal transit; HemoQuant is the most sensitive test to detect upper and lower GI bleeding.

 

Patients with hemorrhoids or females who are menstruating should not undergo occult blood testing until the bleeding has ceased.

 

Urine and excessive dilution of specimens with water from the toilet bowl may cause erroneous test results.

 

Because gastrointestinal lesions may bleed intermittently and blood in feces is not distributed uniformly, a negative test result does not assure absence of lesion.

 

Certain medications such as aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) may cause gastrointestinal irritation and subsequent bleeding in some patients, causing positive results.

Supportive Data

Clinical pathologic correlative studies.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Imperiate TF, Ransohoff DF, Itzkowitz SH, et al: Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med 2014;370(14):1287-1297

2. Robertson DJ, Lee JK, Boland CR, et al. Recommendations on fecal immunochemical testing to screen for colorectal neoplasia: A consensus statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017;152(5):1217-1237

3. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: Recommendations for physicians and patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Jul;153(1):307-323. doi: 10.1053/j.gastro.2017.05.013

4. Levin B, Lieberman DA, McFarland B, et al: Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. CA Cancer J Clin 2008 May-June;58(3):130-160. doi: 10.3322/CA.2007.0018

5. Whitlock EP, Lin JS, Liles E, Beil TL, Fu R: Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force. Ann Intern Med 2008 Nov 4;149(9):638-658

6. Hol L, Wilschut JA, van Ballegooijen M, et al: Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels. Br J Cancer 2009 Apr 7;100(7):1103-1110. doi: 10.1038/sj.bjc.6604961

7. Levi Z, Rozen P, Hazazi R, et al: A quantitative immunochemical fecal occult blood test for colorectal neoplasia. Ann Intern Med 2007 Feb 20;146(4):244-255

8. Tannous B, Lee-Lewandrowski E, Sharples C, et al: Comparison of conventional guaiac to four immunochemical methods for fecal occult blood testing: implications for clinical practice in hospital and outpatient settings. Clin Chem Acta 2009 Feb;400(1-2):120-122. doi: 10.1016/j.cca.2008.10.023

Method Description
Describes how the test is performed and provides a method-specific reference

The OC-Auto Micro 80 fecal occult blood test is an automated immunoassay utilizing polyclonal anti-human hemoglobin A0 (HbA0) antibodies to specifically detect the presence of human hemoglobin in feces. When the HbA0 antibody infused latex particles are added to a fecal sample and agitated, the antigen-antibody reaction is initiated and the particles begin to agglutinate. This agglutination is measured as an optical change, with the increase in absorbance directly proportional to the concentration of hemoglobin in the sample. The quantitative hemoglobin concentration is translated and reported as a qualitative result.(Package insert: OC-Auto Micro 80 FOB Test. Polymedco, Inc; 06/2016)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

82274

G0328-Government payers (if appropriate)

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports