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.
20194 -
Quidel QuickVue iFOB Fecal Occult Blood Test Kit, CLIA Waived, Bx/20
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
| Feature |
Benefit |
| Bold Burgundy Color End Points |
Easy to read test results. |
| 5 to 10 Minutes to Result |
Allows prompt diagnosis and
treatment scheduling. |
| 1 Step Procedure |
Fewer procedural steps.
Decreases risk of operator error. |
| Pictorial Procedure Guide |
Simplifies understanding of test
procedure. |
| Immunochemical Assay |
Specific to human hemoglobin,
unlike Guaiac-based tests which also detect peroxidase activity and animal
blood from food. |
| Room Temperature Storage |
Requires no reagent warm-up. Use
as needed without waiting. Does not take up refrigerator space. |
| 24 Month Dating* |
Provides flexibility for low
volume labs. |
| Built-in Internal Control |
Indicates an adequate volume of
specimen was used. |
| Patented Specimen Collection
Tube |
Convenient, odor-free collection
tube functions as specimen applicator and allows for short–term storage of
sample. Specimen remains hydrated maintaining the integrity of the sample. |
| No dietary restrictions |
Improves patient compliance. |
| No medication restrictions |
Improves patient compliance. |
| USPS Compliant Packaging |
Provides for safe and efficient
specimen transport. |
| Assigned CPT Code (G0328) |
Recognized by Medicare for reimbursement. |
| External Kit Controls Available |
Facilitates internal laboratory
quality control. |
| Technical Support |
Professional staff available for
assistance. |
| |
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