Primary biliary cholangitis Products

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.

Method:

Parameter:

Substrate:

Species/ Antigen:

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

Primary biliary cholangitis

Disease information

Primary biliary cholangitis products

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