QUANTA Lite SLA 708775 - inova

Clinical Group n= SLA+ % SLA+AIH-1 289 34 11.8AIH-1/PBC(primary biliary cirrhosis) overlap 20 11 55AIH-2 3 0 0Cryptogenic Hepatitis 9 4 44.4Autoimmune cholangitis 8 1 12.5AIH-1/PSC 4 1 25Drug-induced AIH 2 0 0Primary biliary cirrhosis 15 0 0Primary Sclerosing Cholangitis (PSC) 7 0 0PBC/PSC 19 0 0Other non-viral liver diseases 10 0 0Hepatitis B virus(B,C,or D) 8 0 0Hepatitis C virus 37 0 0Hepatitis C/D 1 0 0Sensitivity for AIH-1 exclusively: 34/289 = 11.8%Sensitivity for AIH-1 and AIH-1 variants (overlaps): 51/330 = 15.4%Specificity (non AIH liver disease): 73/73 = 100%Specificity (normal healthy plus non-AIH liver disease): 204/204 = 100%Cross-Reactivity StudySera from 70 patients with various autoimmune or infectious disease antibodies were tested for cross-reactivity withthe QUANTA Lite TM SLA ELISA . The groups of sera tested and the numbers of each were Human Herpes virus 6(10), Rickettsia (6), Cytomegalovirus (10), Glomerular basement membrane (3), Anti-nuclear antibody (3), systemiclupus erythematosus (3), mitochondria (3), gastric parietal cell (3), LKM-1 (3), cytokeratin 8 or 18 (26). No samplewas interpreted as positive for SLA antibodies.Precision and ReproducibilityIntra-assay Performance for QUANTA Lite TM SLA ELISA was evaluated by testing 6 specimens a total of 7 timeseach. The results are summarized below.Intra-assay Performance of QUANTA Lite TM SLA ELISASpec. A Spec. B Spec. C Spec. D Spec. E Spec. FMean Units 72.6 46.2 27.6 13.5 9.7 2.0SD 1.4 1.9 1.4 0.4 0.2 0.1CV% 1.9 4.1 5.2 2.8 2.2 7.2Inter-assay variation was assessed by testing, in duplicate, a panel of 5 specimens and the kit controls twice daily for3 days. A summary of the results is shown below.Inter-assay Performance for QUANTA Lite TM SLA ELISASpec. A Spec. B Spec. C Spec. D Spec. EMean Units 78.5 48.5 29.0 13.6 9.5SD 1.8 1.1 0.9 0.5 0.4CV% 1.9 4.1 5.2 2.8 2.2Limitations of the Procedure1. A negative SLA result does not rule out the presence of autoimmune hepatitis.2. A negative SLA antibody result does not rule out the presence of SLA antibodies, because the concentrationof antibody may be below the detection limit of the assay.3. A positive test result only indicates the presence of antibody to human recombinant SLA and does notnecessarily indicate the presence of autoimmune hepatitis.4. Diagnosis of autoimmune hepatitis requires the cumulative documentation of a patient’s demographics,clinical presentation, and other diagnostic testing.5. The literature suggests that anti-SLA antibodies are not characteristic of AIH-2. 10 Although the three AIH-2specimens shown in the Specific Performance section below were negative, this number is not large enoughto validate the lack of SLA antibodies in AIH-2 specimens by the present assay.6. Results of this assay should be used in conjunction with clinical findings and other serological tests.7. The assay performance characteristics have not been established for matrices other than serum.NCCLS 708775Page 6 of 8