Investigations

1st investigations to order

alkaline phosphatase (ALP)

Test
Result
Test

Suggestive of the presence of cholestasis (of which PBC is one cause) if alkaline phosphatase is of liver origin (isoenzymes or co-elevation of gamma-GT can be helpful in determining this if there is clinical doubt).

Result

elevated

gamma-glutamyl transferase (GTT)

Test
Result
Test

Suggestive of presence of cholestasis (of which PBC is one cause).

Result

elevated

bilirubin

Test
Result
Test

Suggestive (although not confirmatory) of disease progression with the presence of advanced fibrosis.

Result

Normal or elevated in advanced disease

alanine aminotransferase (ALT)

Test
Result
Test

Less than 10% of patients with PBC have a more inflammatory process than usual, and the presence of this inflammatory variant is confirmed by liver biopsy. Suspicion of this variant may be raised by a disproportionately elevated ALT.

Result

Normal or mildly elevated

serum albumin

Test
Result
Test

Suggestive (although not confirmatory) of impaired liver synthetic function compatible with the presence of advanced liver disease.

Result

Normal or decreased in advanced disease

antimitochondrial antibody (AMA) immunofluorescence

Test
Result
Test

Seen as diffuse staining throughout the cytoplasm. [Figure caption and citation for the preceding image starts]: Characteristic autoantibody patterns in primary biliary cholangitis. White arrow: antimitochondrial staining; red arrow: multiple nuclear dot ANA stainingFrom the collection of DEJ Jones; used with permission. [Citation ends].com.bmj.content.model.Caption@1483dfec

Use of immunofluorescence and ELISA will vary according to local practice.[25] Use of both methodologies is only needed in situations of clinical doubt.

Result

present

antinuclear antibody (ANA) immunofluorescence

Test
Result
Test

This pattern of staining of multiple dots within the nucleus, along with a nuclear rim staining pattern not seen in this example, is characteristic of PBC and must be distinguished from the diffuse nuclear staining pattern that is characteristic of autoimmune hepatitis and systemic lupus erythematosus. [Figure caption and citation for the preceding image starts]: Characteristic autoantibody patterns in primary biliary cholangitis. White arrow: antimitochondrial staining; red arrow: multiple nuclear dot ANA stainingFrom the collection of DEJ Jones; used with permission. [Citation ends].com.bmj.content.model.Caption@5e119730

Use of immunofluorescence and ELISA will vary according to local practice.[25] Use of both methodologies is only needed in situations of clinical doubt.

Result

staining pattern either antinuclear rim (indicates reaction with nuclear pore complex) or multiple nuclear dots (indicates reaction with Sp100 protein), or both

antipyruvate dehydrogenase complex-E2 ELISA

Test
Result
Test

Indicates presence of antimitochondrial antibody.

Titres of >1:40 are regarded as significant.

Use of immunofluorescence and ELISA will vary according to local practice.[25]

Result

present

anti-M2 ELISA

Test
Result
Test

Indicates presence of antimitochondrial antibody.

Titres of >1:40 are regarded as significant.

Use of immunofluorescence and ELISA will vary according to local practice.[25]

Result

present

antiglycoprotein-210 ELISA

Test
Result
Test

Indicates presence of antinuclear rim antinuclear antibody.

Titres of >1:40 are regarded as significant.

Use of immunofluorescence and ELISA will vary according to local practice.[25]

Result

present

anti-Sp100 ELISA

Test
Result
Test

Indicates presence of multiple nuclear dots antinuclear antibody.

Titres of >1:40 are regarded as significant.

Use of immunofluorescence and ELISA will vary according to local practice.[25]

Result

present

abdominal ultrasound scan

Test
Result
Test

Obstructive duct lesions must always be excluded radiologically before the diagnosis of PBC is made.[27]

Result

excludes obstructive lesion within visible bile ducts

magnetic resonance cholangiopancreatography (MRCP)

Test
Result
Test

Can be used as an alternative to ultrasound to detect bile duct stones and lesions causing extrahepatic obstruction, particularly of the distal bile duct.[15]​ Endoscopic ultrasound (EUS) can be an alternative to MRCP for evaluation of distal biliary disease.[14][15]

Result

excludes obstructive lesion within visible bile ducts and hepatocellular carcinoma

transient elastography

Test
Result
Test

Non-invasive test for identification of fibrosis.[14][44]

Result

measures degree of fibrosis on scale of 0-4

Investigations to consider

serum immunoglobulin

Test
Result
Test

Elevation of IgM is supportive of the diagnosis of PBC.[45]

Elevation of IgG supportive of significant inflammatory/autoimmune hepatitis overlap features should be confirmed by liver biopsy.[46]

Result

polyclonal elevation of IgM and IgG

liver biopsy

Test
Result
Test

Not usually needed to confirm the diagnosis.​[14][15][30]

Liver biopsy should only be carried out if there is diagnostic uncertainty or concern about the presence of potentially corticosteroid-responsive inflammatory disease.

Result

bile duct lesions (biliary ductular cell disruption within inflamed portal tracts) and granulomata formation; later disease stages: bile duct loss (ductopenia) with progressive biliary fibrosis; a more inflammatory pattern with interface hepatitis can be seen in a minority of patients (<10%)

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