The comparison of different immunoassays for the detection on autoantibodies specific to primary biliary cholangitis

Objective To compare the test performance of different immunoassays for the detection on autoantibodies specific to primary biliary cholangitis, including anti-mitochondrial type 2 antibody (AMA-M2), anti-glycoprotein 210 (anti-gp210) and anti-nuclear body protein sp100 (anti-sp100). Methods Serum samples from Primary Biliary Cholangitis (PBC, n=91), liver disease control (including viral hepatitis, autoimmune hepatitis and liver cirrhosis, n=67) and healthy individual (n=40) were collected from Beijing Youan Hospital during the period between April 2014 and April 2017. All samples were tested with chemiluminescent immunoassay (CLIA) and enzyme linked immunosorbent assay (ELISA) for AMA-M2, meanwhile the detection on anti-gp210 and anti-sp100 were compared between CLIA and Line Immunoassay (LIA). The Kappa coefficient were used to measure the level of qualitative agreement between different assays. The diagnostic accuracy of AMA-M2 detected with CLIA and ELISA were compared by receiver operating characteristic curve (ROC). Results The overall qualitative agreement between CLIA and ELISA for the detection to AMA-M2 is 88.4% (Kappa=0.765, P<0.01). Excellent qualitative agreement between CLIA and LIA for the detection to anti-gp210 and anti-sp100 was also found with overall agreement as 96.5%(Kappa=0.852, P<0.01)and 98% (Kappa=0.884, P<0.01), respectively. The ROC analysis also showed similar area under the curve (AUC) for CLIA (0.965, P<0.01) and ELISA (0.928, P<0.01) on detection to AMA-M2. Conclusions CLIA and ELISA showed excellent agreement for the detection to AMA-M2. High qualitative agreement between CLIA and LIA was also found when testing anti-gp210 and anti-sp100.(Chin J Lab Med, 2018, 41: 203-207) Key words: Chemiluminescent immunoassay; AMA-M2; anti-gp210; anti-sp100; Line immunoassay; Enzyme-linked immunosorbent assay; Primary biliary cholangitis