Quidel Corp recently presented data from a correlation study for its QuickVue iFOB (immunochemical Fecal Occult Blood) test for colorectal cancer (CRC) screening. The results demonstrated a high correlation between Quidel’s POC immunochemistry test and a quantitative laboratory test for fecal occult blood.

The study, entitled "A New Method for Quantification of FOB Levels," was introduced at the Colorectal Congress in St Gallen, Switzerland on December 4.

Two hundred stool specimens obtained from patients averaging 40 days post colonoscopy were examined in a quantitative test employing surface plasmon resonance, which measures the binding of hemoglobin to specific anti-human hemoglobin monoclonal antibodies. Using these post-colonoscopy stool specimens provided a potential quantitative cutoff for distinguishing patients with normal colons from those with cancer. The exact same specimens were then tested using the rapid QuickVue iFOB test.

The quantitative laboratory method gave negative readings for 96%(45/47) of samples from patients with normal colons and positive readings for 82% (27/33) of stool samples from patients with colorectal cancer. When the same samples were tested using QuickVue iFOB, the qualitative test detected 96% (26/27) of stools positive for quantitatively elevated hemoglobin from confirmed cancer patients based on the selected quantitative laboratory method cutoff. The QuickVue iFOB test correctly called as negative 89% (40/45) of the stool specimens identified by the quantitative laboratory test as not having significantly elevated hemoglobin from confirmed normal patients.

"This high correlation with a quantitative laboratory method is an important step to further delineate the clinical and economic benefits of POC fecal occult blood testing. In a time of profoundly rising health care costs, the need for less expensive, reliable methods for detection of disease is clear. Rapid point-of-care tests, such as Quidel’s QuickVue iFOB test, is one such example," said Caren Mason, president and CEO of Quidel.

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

The QuickVue iFOB test provides results in 5 to 10 minutes and requires only one specimen. It is specific to human hemoglobin, and patients are not required to adhere to strict dietary or medication restrictions prior to testing.