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Test Code FOBT Fecal Occult Blood, Colorectal Cancer Screen, Qualitative, Immunochemical, Feces

Reporting Name

Occult Blood, QL, Immunochemical, F

Useful For

Colorectal cancer screening

 

Screening for gastrointestinal bleeding

 

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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Fecal


Ordering Guidance


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



Specimen Required


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.


Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reference Values

Negative

 

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

Test Classification

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

82274

G0328-Government payers (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FOBT Occult Blood, QL, Immunochemical, F 29771-3

 

Result ID Test Result Name Result LOINC Value
FOB Occult Blood, Fecal 29771-3

Interpretation

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.

Clinical Reference

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;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;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;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;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;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;400(1-2):120-122. doi:10.1016/j.cca.2008.10.023

Method Name

Immunochemical

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Oncology Test Request (T729)

-Gastroenterology and Hepatology Test Request (T728)

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days