Products - Autoimmune - Hepatology - Primary biliary cholangitis

Primary biliary cholangitis

Contact our Autoimmune Product Team for further details and information

Disease information

Primary Biliary Cholangitis (PBC) is an autoimmune disease that affects hepatic biliary tracts (outward passageways for bile). The obstruction leads to buildup of bile and other toxins causing cholestasis.

PBC shows predominance in females (>90%) with most of the cases occurring between the ages of 40 and 50. Its worldwide incidence is estimated at 4 to 31 cases per million of the population per year (indicative of its widespread occurrence).

The major histological changes seen in the disease revolve around lymphocellular infiltrate that affects small intra-hepatic bile ducts causing destruction and cholestasis. If you experience any of the following danger signs, it’s better to book yourself for a diagnostic workup :

  • Pain in the upper right quadrant of the abdomen
  • Itching, fatigue and jaundice (yellowing of the sclera i.e. white of the eye)
  • Disturbances with your tear and saliva production (since primary biliary cholangitis also affects lacrimal and salivary glands at a latter stage)

Diagnostic Guidelines

The diagnostic investigations for PBC begin with liver function tests (LFTs) that estimate serum levels of:

  • Alanine transaminase (ALT)
  • Alkaline phosphatase (ALP)
  • Aspartate transaminase (AST)
  • Serum lipids

(Elevated levels are indicative of a liver pathology)

The next step is to look for autoantibodies against the liver. This involves screening for anti-mitochondrial antibodies (AMAs), anti-nuclear antibodies (ANAs) and ruling out other conditions such as autoimmune hepatitis and primary sclerosing cholangitis (which primarily affects the extra-hepatic ducts).

AMA and ANA

The presence of AMA is a highly powerful indicator of PBC. These antibodies are directed against the M2 mitochondrial antigen and are positive in around 94 percent of the patients with PBC. High titer of AMA is an important predictor of the course of the disease and its prognosis.
Besides AMA, ANA is also strongly associated with PBC and is found in one third of the patients. Target antigens identified for ANA include:

  • Promyelocytic leukemia (PML) proteins
  • SP 100
  • Components of the nuclear pore complex (gp210 and p62)

Primary biliary cholangitis products

The individual product regulatory statements may vary, please refer to the instructions for use for more information.

wdt_ID Method Parameter Substrate Species/ Antigen
393 IFA liver-specific
antigens
liver monkey
394 EUROLINE positive control serum: IgG, human, 100x concentrated
for DL 1300-X G
395 EUROASSAY AMA M2, LKM-1, SLA/LP EUROASSAY strip
with antigens
396 IFA Liver Mosaic 1
liver-kidney microsomes (LKM), ANA
mitochondria (AMA), LKM
2 BIOCHIPs per field:
liver
kidney
rat
rat
397 IFA Liver Mosaic 2
liver antigens, cell nuclei (ANA)
AMA M7, heart antigens
cell nuclei (ANA)
LKM, ANA
mitochondria (AMA), LKM
smooth muscles (ASMA)
6 BIOCHIPs per field:
liver
heart
HEp-2 cells
liver
kidney
stomach
monkey
monkey
human
rat
rat
rat
398 EUROLINE Liver Profile 2
(AMA M2, M2-3E, LKM-1, LC-1, SLA/LP separately)
EUROLINE
399 EUROASSAY LKM-1, LC-1, SLA/LP EUROASSAY strip
with antigens
400 IFA Liver Sreen 1
mitochondria (AMA), LKM
soluble liver antigen/
liver-pancreas antigen (SLA/LP)
LKM, ANA
smooth muscles (ASMA)
4 BIOCHIPs per field:
kidney
transfected cells
liver
stomach
rat
EU 90
rat
rat
401 IFA Liver Mosaic 3
liver antigens, cell nuclei (ANA)
skeletal muscle
cell nuclei (ANA)
LKM, cell nuclei (ANA)
mitochondria (AMA), LKM
smooth muscles (ASMA)
6 BIOCHIPs per field:
liver
musculus iliopsoas
HEp-2 cells
liver
kidney
stomach
monkey
monkey
human
rat
rat
rat
402 EUROLINE Liver Profile
(AMA M2, LKM-1, LC-1, SLA/LP separately)
EUROLINE
403 EUROASSAY Liver Profile
AMA M2, LKM-1, LC-1, SLA/LP
EUROASSAY strip
with antigens
404 EUROLINE Autoimmune Liver Diseases
(AMA M2, M2-3E, Sp100, PML, gp210,
LKM-1, LC-1, SLA/LP, Ro-52 separately)
EUROLINE
405 EUROLINE Autoimmune Liver Diseases 14 Ag
(AMA-M2, M2-3E, Sp100, PML, gp210,
LKM-1, LC-1, SLA/LP, SS-A, Ro-52, Scl-70,
CENP A, CENP B, PGDH separately)
EUROLINE
406 IFA Autoimmune liver diseases Screen 8
EUROPattern
liver antigens, cell nuclei (ANA)
F-actin
cell nuclei (ANA), EUROPattern
LKM, ANA
mitochondria (AMA), LKM
smooth muscles (ASMA)
6 BIOCHIPs per field:
liver
VSM47
HEp-2 cells
liver
kidney
stomach
monkey
rat
human
rat
rat
rat
407 IFA Liver Mosaic 8
liver antigens, cell nuclei (ANA)
F-actin
cell nuclei (ANA)
LKM, ANA
mitochondria (AMA), LKM
smooth muscles (ASMA)
6 BIOCHIPs per field:
liver
VSM47
HEp-2 cells
liver
kidney
stomach
monkey
rat
human
rat
rat
rat
408 IFA Autoimmune liver diseases Screen 9
EUROPattern
mitochondria (AMA), LKM
LKM, ANA
smooth muscles (ASMA)
F-actin
4 BIOCHIPs per field:
kidney
liver
stomach
VSM47
rat
rat
rat
rat
409 IFA Liver Mosaic 9
mitochondria (AMA), LKM
LKM, ANA
smooth muscles (ASMA)
F-actin
4 BIOCHIPs per field:
kidney
liver
stomach
VSM47
rat
rat
rat
rat
410 IFA antibodies against Sp100
(nuclear granula, nuclear dots; associated with PBC)
411 IFA antibodies against nuclear membrane
412 IFA mitochondria (AMA) kidney rat
413 IFA test performance control
(AMA, IgG)
414 IFA AMA/ASMA IFA (KR/SR) EUROPattern
mitochondria (AMA)
smooth muscles (ASMA)
2 BIOCHIPs per field:
kidney
stomach
rat
rat
415 IFA mitochondria (AMA)
smooth muscles (ASMA)
kidney
stomach
(2 BIOCHIPs per field)
rat
rat
416 EUROASSAY AMA Profile
(AMA M2, M4, M9 separately)
EUROASSAY strip
with antigens
417 IFA mitochondria (AMA)
smooth muscles (ASMA)
kidney
stomach
(2 BIOCHIPs per field)
mouse
mouse
Method Parameter Substrate Species/ Antigen
Contact our Autoimmune Product Team for further details and information

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