The QuickVue iFOB test is an FDA-cleared and CLIA-waived rapid immunochemical diagnostic tool intended to detect the presence of blood in stool specimens. Blood in the stool is an indication of a number of gastrointestinal disorders, including colorectal cancer.

Colorectal cancer is the second leading cause of cancer related deaths in the United States for both women and men. This disease surpasses both breast and prostate cancer in mortality, second only to lung cancer in the number of cancer deaths. Despite the fact that it is highly preventable, it is estimated that 145,290 new cases of colorectal cancer will be diagnosed and 56,290 people will die from the disease in 2005. Quidel’s CLIA-waived QuickVue iFOB test is an easy to perform diagnostic tool used to detect the presence of blood in stool specimens. Blood in the stool is an indication of a number of gastrointestinal disorders, including colorectal cancer. Simply add six (6) drops of the buffered specimen solution into the cassette sample well and read the results in 5 to 10 minutes.

The QuickVue iFOB test requires only one specimen, and because it is specific to human hemoglobin, patients are not required to adhere to strict dietary or medication restrictions. The result is a more patient friendly test that is easier to complete and produces fewer false positives. Additionally, immunochemical FOB tests are more analytically sensitive than traditional Guaiac based methods. The QuickVue® iFOB test has the potential to increase patient compliance and offers superior analytical performance (as compared to Guaiac tests)3 to positively impact both patient care and satisfaction.

 

CPT Codes:

The CPT codes provided below are based on AMA coding guidelines and are for informational purposes only. Selection of appropriate codes is the sole responsibility of the billing party. Providers should check with their own regional payers on appropriate codes prior to submitting claims.

 

QuickVue iFOB Immunoassay based fecal occult blood test (iFOBT) (Diagnostic) - 82274
QuickVue iFOB Immunoassay based fecal occult blood test (iFOBT) (Screening) - G0328

 

 

 

Method: Lateral Flow
Time to Result: 5 to 10 minutes
Specimen Type: Fecal specimen in buffered solution
Storage: 24 months at room temperature*
Internal Procedure Controls: Yes.
External Controls: Yes, positive and negative
Analytical Sensitivity: 50 ng hHb/mL buffer or 50 µg/g feces
Specificity: Specific to human hemoglobin

 

Sources:

Cancer Research and Prevention Foundation 2005
American Cancer Society, Colorectal Cancer Facts & Figures, Special Edition 2005
OncoLog, February 2004,Volume 49, No. 2
Centers for Medicare and Medicaid Services