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This article was originally published in The Gray Sheet

Executive Summary

Files 510(k) application for its QuickVue one-step fecal occult blood test. Quidel maintains that the two-minute test has "improved specificity and sensitivity over the most widely used tests which employ guaiac-based chemistry." Accuracy of guaiac-based tests is affected by patient noncompliance with dietary restrictions that must be followed for two days prior to testing. "The QuickVue FOB test circumvents the dietary restrictions and compliance problems...because it is very specific for human hemoglobin found only in human red blood cells," Quidel says.



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