ДИАГНОСТИЧЕСКАЯ ЦЕННОСТЬ «ЭКСПРЕСС-ТЕСТ НА ЦЕЛИАКИЮ BIOHIT»

В П Новикова; С В Лапин; А И Будкова; А М Малкова

В П Новикова Saint-Petersburg State Pediatric Medical University, 194100, Saint-Petersburg, Litovskaya str., 2
С В Лапин Laboratory for the diagnosis of autoimmune diseases FSBEI HE I.P.Pavlov SPbSMU MOH, Russian Federation, Saint Petersburg
А И Будкова Laboratory for the diagnosis of autoimmune diseases FSBEI HE I.P.Pavlov SPbSMU MOH, Russian Federation, Saint Petersburg
А М Малкова Saint Petersburg State University. 199034, Saint Petersburg, bld. 7–9, Universitetskaya embk

Keywords: antibodies to tissue transglutaminase, quick test, celiac disease, screening, BIOHIT

Abstract

The purpose of the study: determination of the diagnostic value of medical devices “Expresstest of BIOHIT celiac disease”. 35 blood serum samples with positive titer of antibodies to transglutaminase (IgG+IgA) were studied. The control group consisted of seronegative sera from healthy donors (n=20). The results of the “quick test for celiac BIOHIT”. To compare the results of the study, antibodies to tissue transglutaminase, screening (IgG+IgA) were used. by ELISA, the production of Orgentec Diagnostics GmbH, Germany;. It was revealed that the diagnostic sensitivity of the test system (95% CI) on the basis of the obtained data was — 85,71% (69.74–95.19%); the positive predictive value of the test system was 100%; the negative predictive value of the test system (95% CI) was 80% (63.99–90.01%); the specificity of the rapid test (95% CI) was 100% (83.16–100.00%); diagnostic efficacy (test accuracy) (95% CI) was 90,90% (80.05–96.98%). For the test, you can use samples of serum, plasma and capillary blood. Conclusion. Diagnostic indicators of the medical device “Express test for celiac disease BIOHIT” allow its use for screening in medical institutions.

THE DIAGNOSTIC VALUE OF THE «QUICK TEST FOR CELIAC BIOHIT»

Abstract