Am J Gastroenterol. 2006;101(7):1597-1600. Celiac.com 08/14/2006 – In an effort to increase the diagnosis rate of celiac disease, researchers in Italy conducted a study to determine the accuracy of two of the new "at home" type rapid commercial celiac disease test kits--both of which require only one drop of whole blood to gain results. Both of the kits detect IgA-IgG anti-human-transglutaminase antibodies (anti-h-tTG) in serum and IgA anti-h-tTG antibody in a single drop of whole blood. The researchers analyzed the serum samples of 114 biopsy-confirmed celiacs, 120 healthy controls, 20 first-degree relatives of celiacs, and 75 diseased controls, and compared them to the standard enzyme-linked immunosorbent assay testing method. Whole blood samples were taken in 51 of the biopsy-confirmed celiacs and 100 controls.
The serum-based test was found to be positive in all 114 celiac patients, or 100% sensitivity, and among the controls which included three with celiac disease there was 94.9% sensitivity. The accuracy of the blood drop-based assay testing was positive in 46 of the 51 celiacs tested, which equals 90.2% sensitivity. The accuracy, however, is actually higher because five of the patients who tested negative had total IgA deficiency, so the real sensitivity level is actually 95.8%. All 100 controls tested negative which equals 100% specificity.
Given the high degree of accuracy of the two commercial test kits that were evaluated the researchers conclude that general practitioners should utilize these low cost kits during standard office visits whenever celiac disease is suspected.