November 5, 2019
Why Clinical Specificity is Important for FDA Cleared Fecal Calprotectin Tests
The Importance of Clinical Specificity: A Review of FDA Cleared Fecal Calprotectin Tests
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Selecting the right fecal calprotectin test for your clinical laboratory to run in-house or send out can be a difficult task to accomplish, especially when there are multiple FDA cleared options available.
Comparing the clinical characteristics of fecal calprotectin tests demonstrates that most FDA 510(k) cleared options have problems including low clinical specificity and high false positive rates. Therefore, clinical laboratories running these assays are reporting less accurate results to their clients.
The ALPCO Calprotectin Chemiluminescence ELISA was developed as a solution to provide clinical laboratories and gastroenterologists with a superior FDA cleared fecal calprotectin test to assist with accurately differentiating IBS from IBD, ultimately minimizing the rate of unnecessary colonoscopies.
Download our white paper, The Importance of Clinical Specificity: A Review of FDA Cleared Fecal Calprotectin Tests, to discover:
- How the clinical characteristics of FDA 510(k) cleared calprotectin tests compare against one another
- What common issues are present among cleared calprotectin tests currently available
- Why clinical sensitivity and specificity count when selecting a calprotectin assay