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Improved Sensitivity and Specificity with InSure®
The InSure® Fecal Immunochemical Test (FIT) is based on the immunochemical detection of human hemoglobin (Hb) as an indicator of blood in the stool. The assay uses a monoclonal antibody to capture Hb on a test strip. Since globin does not survive passage through the upper gastrointestinal (g.i.) tract, the presence of globin in the stool indicates bleeding in the colon and rectum.
The Proof is in the Numbers
Clinical studies have demonstrated the high sensitivity and specificity of the InSure® FIT™ in colorectal cancer screening.
| 87% Sensitivity for colorectal cancer |
In a clinical trial, the sensitivity of the InSure® FIT™ was shown to be 87% sensitivity for colorectal cancer in individuals with a personal or family history with colorectal cancer.2,3
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47.4% Sensitivity for large adenomas
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Sensitivity for large adenomas (>10 mm) was 47.4%.1
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96.6% Specificity for significant neoplasia
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With a demonstrated specificity of 96.6%, the InSure® FIT™ provides accurate screening with less worry about false positives.3
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66% More patient compliance
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Up to 66% more patient compliance with the InSure® FIT™ vs. other FOBTs.1 Increased compliance with the InSure® FIT™ means more patients are screened for colorectal cancer.
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An Australian study, published in the journal CANCER, was conducted to determine if InSure®, a brush-sampling fecal immunochemical test (FIT) improved- detection of significant neoplasia as compared Hemoccult® II Sensa®, a sensitive guaiac fecal occult blood test (GFOBT). The study was funded in part by Enterix, which did not participate in the data analysis nor influence the conclusions reached.
Results: The InSure® FIT™ demonstrated a true-positive result significantly more often in the presence of cancer (n=24, 87.5% vs. 54.2%) or significant adenoma (n=61, 42.6% vs. 23.0%) than did Hemoccult II Sensa. Of all stage I cancers (where the tumor is limited to the lining of the bowel wall), the InSure® FIT™ was positive in 12 of 13 cases, compared to only 4 of 13 with the Hemoccult II Sensa (p=0.002). The study results also showed that the InSure® test was more accurate than the Hemoccult II Sensa in detecting lower gastrointestinal bleeding in early-stage lesions or significant adenomas. The bottom line is InSure® detected bleeding due to early-stage colorectal cancers three times as often as Hemoccult II Sensa and bleeding due to significant (pre-cancerous) adenomas nearly twice as often as Hemoccult II Sensa.3
References:
1. Cole SR, Young GP, Esterman A, Cadd A, Morcom J. A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer. J Med Screen 2003;10:117-122.
2. InSure Quik FIT™ Fecal Immunochemical Test Immunoassay for human hemoglobin in stool. Product Instructions. Enterix, Edison, NJ.
3. Smith A, Young GP, Cole SR, Bampton P. Comparison of a brush-sampling fecal immunochemical test for hemoglobin with a sensitive guaiac-based fecal occult blood test in detection of colorectal neoplasia. Cancer 2006;107:2152-2159. The study was funded in part by Enterix Inc. (through Enterix Australia Pty. Ltd.), the manufacturer of InSure® FIT. Enterix is now owned by Quest Diagnostics Incorporated. However, neither Enterix nor Quest Diagnostics participated in the data analysis or influenced the conclusions reached by the authors.
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for InSure Quik F I T