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This article was originally published in The Gray Sheet
E-Z-EM subsidiary receives FDA clearance Nov. 13 for PP-CAP enzyme immunoassay (EIA) test kit. Designed as a second-line test for diagnosis, the qualitative test detects IgA antibodies to H. pylori in human serum or plasma. PP-CAP has demonstrated a sensitivity of 93.1% and a specificity of 89.0% when compared to a combination reference method that includes the urea breath test and the HM-CAP test
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