Abstract

Objective The diagnostic value of antinuclear antibodies (ANAs) including anti-gp210 and anti-sp100 for primary biliary cholangitis/cirrhosis (PBC) has been widely reported. However, their diagnostic performances for antimitochondrial antibody- (AMA-) negative PBC were less well elucidated. Therefore, the aim of the current meta-analysis was to evaluate the diagnostic accuracy of ANAs in patients with AMA-negative PBC. Materials and Methods Literature on the diagnostic value of biomarkers for AMA-negative PBC was systematically searched in PubMed, MEDLINE, EMBASE, and the Cochrane Library. The qualities of the retrieved studies were assessed by the Quality Assessment of Diagnostic Accuracy Studies-version 2 (QUADAS-2) scale. Pooled sensitivity and specificity of the biomarkers were calculated with random-effects models. The areas under the summary receiver operating characteristic (AUSROC) curves were used to evaluate the overall diagnostic performance of ANAs. Results A total of 11 studies (400 AMA-negative PBC patients and 6217 controls) were finally included in the meta-analysis. ANAs had an overall sensitivity of 27% (95% CI: 20%, 35%) and specificity of 98% (95% CI: 97%, 99%). The pooled sensitivities for anti-gp210 and anti-sp100 were 23% (95% CI: 13%, 37%) and 25% (95% CI: 13%, 43%), respectively, and their specificities were 99% (95% CI: 97%, 100%) and 97% (95% CI: 93%, 98%), respectively. Conclusions ANAs exhibited high specificity but low sensitivity and therefore could be used as reliable biomarkers to reduce the necessity of liver histology.

Highlights

  • antinuclear antibodies (ANAs) exhibited high specificity but low sensitivity and could be used as reliable biomarkers to reduce the necessity of liver histology

  • Primary biliary cholangitis (PBC) is a chronic intrahepatic cholestatic disease which is histologically characterized by progressive nonsuppurative cholangitis [1, 2]

  • 11 studies were included in quantitative synthesis and meta-analysis with the following inclusion criteria: (i) assessed the diagnostic accuracy of the ANA test on Antimitochondrial antibody (AMA)-negative primary biliary cholangitis/cirrhosis (PBC) patients and controls; (ii) full-text articles; (iii) showed sufficient information of true positive (TP), false positive (FP), false negative (FN), and true negative (TN) numbers to calculate sensitivity and specificity; and (iv) the publication language should be in either English or Chinese

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Summary

Objective

The diagnostic value of antinuclear antibodies (ANAs) including anti-gp210 and anti-sp100 for primary biliary cholangitis/cirrhosis (PBC) has been widely reported. Their diagnostic performances for antimitochondrial antibody(AMA-) negative PBC were less well elucidated. The aim of the current meta-analysis was to evaluate the diagnostic accuracy of ANAs in patients with AMA-negative PBC. Literature on the diagnostic value of biomarkers for AMA-negative PBC was systematically searched in PubMed, MEDLINE, EMBASE, and the Cochrane Library. A total of 11 studies (400 AMA-negative PBC patients and 6217 controls) were included in the meta-analysis. The pooled sensitivities for anti-gp210 and anti-sp100 were 23% (95% CI: 13%, 37%) and 25% (95% CI: 13%, 43%), respectively, and their specificities were 99% (95% CI: 97%, 100%) and 97% (95% CI: 93%, 98%), respectively. ANAs exhibited high specificity but low sensitivity and could be used as reliable biomarkers to reduce the necessity of liver histology

Introduction
Materials and Methods
Results
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