The new Microblot-Array (MBA) Liver Profile kit, developed by TestLine Clinical Diagnostics s.r.o., has officially completed the IVDR certification process. Following a successful final on-site audit in early June, the product has met all regulatory requirements and is now fully approved for market launch. We are proud to announce that the MBA Liver Profile kit is now available to diagnostic laboratories across the globe!
Microblot-Array is a new generation of unique, immunoblot array in a microtiter plate format. It is designed for efficient multiplex diagnostics, enabling the simultaneous detection of multiple markers which can save time and lower costs. The comprehensive evaluation is ensured by using the TestLine Analytics Software in combination with the Microblot-Array Reader, enabling complex image analysis, including results evaluation and connectivity to LIS.
The MBA Liver Profile detects IgG antibodies against 13 recombinant antigens, providing comprehensive support for the diagnostiof autoimmune liver diseases (AIH, PBC, and PSC). Designed for diagnostic precision and smooth laboratory integration, the MBA Liver Profile is set to become an essential tool in immunology labs.
Autoimmune liver diseases: rare, progressive, and often underdiagnosed
Autoimmune liver diseases (ALDs) are chronic, and immune-mediated disorders that can lead to progressive liver damage.
They include:
- Autoimmune Hepatitis (AIH) – liver inflammation caused by the immune system, potentially progressing to cirrhosis or liver failure if untreated. Often coexists with other autoimmune disorders.
- Primary Biliary Cholangitis (PBC) – characterized by the inflammation and slow destruction of small bile ducts in the liver, often presenting with anti-mitochondrial antibodies (AMA) and specific ANA markers.
- Primary Sclerosing Cholangitis (PSC) – inflammation, narrowing, and scarring of both intra- and extrahepatic bile ducts, leading to liver damage. It mostly affects younger men, and it is frequently associated with IBD. Secondarily, gallstones may occur due to cholestasis, and patients are at increased risk for cholangiocarcinoma.
ALDs are characterized by circulating antibodies and genetic predisposition. Hence, serological tests play a central role, especially in the early stages, when clinical symptoms are still non-specific.
MBA Liver Profile: key features
The new MBA Liver Profile (IgG) is designed to support the differential diagnostics of ALDs by detecting antibodies against 13 highly specific recombinant antigens, offering:
- Broad antibody coverage, including
- AIH: SLA/LP, LKM-1, LC-1
- PBC antimitochondrial antigens: M2, PDC-E2, OGDC-E2, 3E (BPO)
- PBC – nuclear/nuclear envelope antigens: Sp100, PML, gp210, Ro52, Nup62
- AIH–PBC overlap marker: ASGPR
- The kit meets clinical performance requirements, achieving excellent diagnostic sensitivity and specificity (Validated performance, confirmed by a clinical study at the Institute of Rheumatology in Prague).
- User comfort – low sample consumption, the possibility of automatic assay processing and results evaluation.
- IVDR-compliant
Autoimmune liver diseases may be rare, but when left undiagnosed, they can silently progress toward severe and irreversible liver damage. That’s where MBA Liver comes in – a practical, lab-friendly solution designed to bring clarity to complex cases.
The product leaflet and launch materials are available on the TestLine website.
