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Test ID: FOBT    
Fecal Occult Blood, Colorectal Cancer Screen, Qualitative, Immunochemical

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

Colorectal cancer screening

 

Screening for gastrointestinal bleeding

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

Colorectal cancer (CRC) is 1 of the most commonly diagnosed cancers in the United States (US), 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 US 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, 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.

 

Several options are available for CRC screening and includes fecal occult blood testing (FOBT), sigmoidoscopy, and colonoscopy. FOBT historically utilized guaiac-based tests that identify the presence of hemoglobin based on a nonspecific peroxidase reaction. Guaiac-based FOBT is no longer recommended for cancer screening because it does not detect most polyps and cancers. Furthermore, the false-positive rate with guaiac tests is high if patients do not follow the recommended dietary (withholding notably meat, certain vegetables, iron supplements) or pharmaceutical (withholding nonsteroidal anti-inflammatory drugs, vitamin C) restrictions. Finally, multiple stool collections are needed for optimal interpretation of guaiac-based FOBT results.

 

Fecal immunochemical testing (FIT) has evolved as the preferred occult blood test for colorectal cancer screening due to the lack of specificity and sensitivity of guaiac-based methods. FIT specifically detects the presence of 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 >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.

 

To evaluate occult GI bleeding in patients with anemia or iron deficiency, the HemoQuant test should be used (HQ / HemoQuant, Feces). Neither FIT nor guaiac testing detects upper gastrointestinal (GI) bleeding because globin and heme are degraded during intestinal transit. In contrast, the HemoQuant test detects occult bleeding equally well from all sources within the GI tract. The HemoQuant test utilizes a specific fluorometric method that will detect any hemoglobin or heme-derived porphyrins in the stool, is very sensitive, and provides quantitative results.

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 >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 globin 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.

Supportive Data

Clinical pathologic correlative studies.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. 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;58:130

2. Whitlock EP, Lin JS, Liles E, et al: Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force. Ann Intern Med 2008;149:638

3. 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;100:1103

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

5. 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;400:120-122