NADAL C. difficile Toxins A&B+GDH

General information about this test : The NADAL Mononucleosis Test is a rapid immunoassay for detection of qualitative detection of heterophile antibodies in whole blood, serum or plasma. This test aids the diagnosis of infectious mononucleosis (caused by Epstein-Barrvirus). The test is designed for professional use only. Reagents and material supplied : 20 NADAL Mononucleosis test cassettes, incl. Disposable pipettes 1 buffer 1 positive control ‘Mono Positive + Control’ (heterophile antibodies (goat), 0.09% sodium azide) 1 negative control ‘Mono Negative – Control’ (diluted human plasma, 0.09% sodium azide) 1 package insert Test time : 5 min Performance characteristics : The NADAL Mononucleosis Test does not show cross reactivity with: RF, HbsAg, HbeAg, HbeAb, HbcAb, HCV, TB, HIV and Syphilis. The diagnostics sensitivity and specificity of the NADAL Mononucleosis Test were confirmed by slide agglutination assay and another commercially available immune test. Diagnostic accuracy according to the slide agglutination assay: Serum : Relative diagnostic sensitivity: >99%** Relative diagnostic specificity: >99%** Plasma : Relative diagnostic sensitivity: >99%** Relative diagnostic specificity: >99%* Whole blood : Relative diagnostic sensitivity: =91%* Relative diagnostic specificity: >99%** All sample types : Relative diagnostic sensitivity: =97%* Relative diagnostic specificity: >99%* * 95% Confidence interval ** 97.5% Confidence interval Diagnostic accuracy according to another commercially available immune assay: Serum: Relative diagnostic sensitivity: =99%* Relative diagnostic specificity: >99%** Plasma: Relative diagnostic sensitivity: =98%* Relative diagnostic specificity: >99%** Whole blood : Relative diagnostic sensitivity: =98%* Relative diagnostic specificity: >99%** All sample types : Relative diagnostic sensitivity: =98%* Relative diagnostic specificity: >99%** * 95% Confidence interval ** 97.5% Confidence interval Test principle : he NADAL Mononucleosis Test is a qualitative chromatographic immunoassay for detection of heterophile antibodies in whole blood, serum or plasma. After addition of sample to the sample well, the heterophile antibodies, if present in it, form a complex with antigens isolated from bovine erythrocytes, precoated on particles and applied to the sample pad. Further, this immune complex migrate along the membrane and reaches the test line region (T) of the test where it interacts with immobilized antigens extracted from bovine erythrocytes. This provokes the formation of colored line in the T region of the test cassette, which is a sign of a positive result. A colored line should always appear in the control line region (C), it serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. Clinical significance : Infectious Mononucleosis (IM) is caused by the Epstein-Barr virus (EBV), which is a member of the herpesvirus family. The symptoms of IM are: fever, sore throat and swollen lymph glands. In very rare cases, heart or central nervous system problems may occur. A diagnosis of IM is made based on the presence of heterophile antibodies. Heterophile antibodies belong to the IgM class. They are present in 80-90% of acute IM cases.