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Epic Code LAB1230599 Occult Blood, CRC Screening (Polymedco FIT)

Test Name Alias

FIT | Occult Blood Stool Screening | Fecal Occult Blood | Polymedco | Occult Blood, CRC Screening | iFOBT | Occult Blood, CRC (Colorectal Cancer Screen), Qualitative, Immunochemical, Stool (Polymedco FIT)

Interface Order Alias

1230599

Clinical Information

The presence of fecal occult blood in the stool is associated with gastrointestinal disorders such as diverticulitis, polyps, and Crohn’s disease, that may lead to colorectal cancer if not treated. Early diagnosis by fecal occult blood screening and treatment of these problems has been shown to significantly reduce mortality from colorectal cancer.

 

The OC-Auto SENSOR DIANA iFOB Test is an immunoassay utilizing rabbit polyclonal antibodies to specifically detect the presence of hemoglobin in feces. The test system is intended for the qualitative detection of fecal occult blood in feces. The iFOB Test is recommended for use in routine physical examinations, monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding.  
 

Ordering Instructions

For SH/SHMG Providers, Epic Community Connect and EpicCare Link Offices/Providers:

Place a FUTURE ORDER when ordering in Epic. For Class, choose LAB COLLECT. Place demographic label on the vial or handwrite the patient's full legal name and date of birth. Patient will need to write date and time collected.

 

For all other providers

Place an order as normal. Hand a copy of the lab order to the patient. Instruct patient to send lab order with specimen. Please place a label or handwrite the patient's full legal name and date of birth on the vial. Patient will need to write date and time collected.

Icons & Photos

Spectrum Health Sites: Workday # ITM-1159158 

Non Spectrum Health Sites: Order via the supply form "Polymedco FIT Kit"

 

Collection Instructions

Specimen Collection: Stool

 

Container(s): OC-Auto Sampling Bottles

Preferred Volume to Collect: Completely cover grooves

 

Collection Instructions:

  • FIT Kit Collection Instructions (link)
  • Follow instructions on included envelope 
  • Insert sampling bottle into mailing pouch 
  • Mail sealed pouch to lab as soon as possible or within 3 days of collection 
  • Sampling bottle should include patient's full legal name, date of birth, and date and time of collection

Transport Temperature: Ambient

Rejection Criteria

  • Unpreserved stool (not received in Polymedco FIT collection device) specimen collected greater than 72 hours prior to receival in the lab
  • Frozen specimens
  • Sampling bottle received without proper identification
    • Patient's full, legal name
    • Patient's date of birth
    • Collection date and time
  • Sampling bottle received more than 15 days from sample collection date.

Specimen Stability

Sample contained within OC-Auto Sampling Bottle:

  • Ambient: 15 days
  • Refrigerate: 30 days
  • Frozen: Do not freeze

 

Sample not contained in OC-Auto Sampling Bottle:

  • Ambient: 3 days
  • Refrigerate: 3 days
  • Frozen: Do not freeze

 

Laboratory Retention: 3 days

Test Frequency

  • Available Monday thru Friday, usual turn-around time 24 hours.

Reference Range

Negative.

 

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. 

 

Interpretation:

Positive: 

Further testing is recommended. This test has approximately 95% specificity for detection of lower gastrointestinal bleeding in colorectal cancer.  Results should not be considered conclusive evidence of the presence or absence of gastrointestinal bleeding or pathology.  This test is designed for preliminary screening and is not intended to replace other diagnostic procedures such as colonoscopy.

 

Negative: 

A negative result does not assure the absence of gastrointestinal bleeding or pathology since some bowel lesions, including some polyps and colorectal cancers, may not bleed at all or may bleed intermittently, or the blood may not be uniformly distributed in a fecal sample, a negative test result is possible even when disease is present. This test is designed for preliminary screening and is not intended to replace other diagnostic procedures such as colonoscopy or sigmoidoscopy with double contrast barium x-ray. 

 

Cautions/Limitations:

  • This test will not detect upper gastrointestinal bleeding. Results should not be considered conclusive evidence of the presence or absence of GI bleeding or pathology. It is not intended for use in patients with upper GI bleeds. 
  • A negative result does not assure absence of lesion due to intermittent bleeding of GI lesions and in some cases the total lack of bleeding. 
  • A positive result should be followed up with further studies to establish source of bleeding. 
  • Patients with the following conditions should not be considered for testing: Bleeding hemorrhoids, constipation bleeding, menstrual bleeding, and urinary bleeding.  Testing may occur when bleeding has ceased. 
  • False positives may occur in some patients taking certain medications such as aspirin and non-steroidal anti-inflammatory drugs that cause gastrointestinal irritation and subsequent bleeding. 
  • Urine of excessive dilution of the samples with water from the toilet bowel may cause false negatives. Use of the collection paper in the collection kit is recommended. 
  • Test has not been validated for testing of patients with hemoglobinapthies. 
     

Performing Department

Toxicology

Performing Department Laboratory Location

Spectrum Health Regional Laboratory (SHRL BW), Grand Rapids, MI

Methodology

Immunoassay, Qualitative

CPT

G0328, 82274

CDM Code

Not available

Epic Test ID

1230102215

Beaker LOINC

OCCULT BLOOD, IMMUNOCHEMICAL: 29771-3

Mayo Access Code

Not available

Reviewed Date

12/6/2021

Beaker Names

Beaker Procedure Name: OCCULT BLOOD, COLORECTAL CANCER SCREEN, QUALITATIVE, IMMUNOCHEMICAL, STOOL
Beaker Display Name: Occult Blood, Colorectal Cancer Screen, Qualitative, Immunochemical, Stool
BEAKER TEST NAME: Occult Blood, CRC Screening
BEAKER TEST REPORT NAME: Occult Blood, CRC Screening

Beaker Synonyms

No synonym on file

Beaker Location, Container and Temperature

BW TOXICOLOGY: Polymedco FIT Collection Device (Preferred)-Ambient