Lumipulse® G PIVKA-II

Getting a better view on liver cancer

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of protein induced vitamin K absence or antagonist-II (PIVKA-II) in serum. The assay utilises proven CLEIA (ChemiLuminescent Enzyme Immunoassay) technology with results that are available in up to 35 minutes.

Lumipulse® G PIVKA-II Immunoreaction Cartridges:

  • Art. no. 233184 (3 x 14 Tests - CE) - Please contact your local Fujirebio representative for the availability of this product in your country.

Lumipulse® G PIVKA-II Calibrators Set:

  • Art. no. 233191 (2 x 3 x 1.5 ml - CE) - Please contact your local Fujirebio representative for the availability of this product in your country.   


  • Allows stratification of patients on transplant waiting list.

  • Predicts recurrence of HCC.

  • Complementary to AFP for improved detection of (early) HCC. 


Product benefits

Complete Solution

  • CE-marked
  • Only assay available on an automated platform (LUMIPULSE G1200)
  • Oncology menu available for routine, specialized and unique markers
  • Chemiluminescent assay
  • Calibrators and controls available

Different clinical applications

  • Monitoring: Correlation with microvascular invasion, recurrence and tumor size
  • Diagnosis: Complementary to AFP for the improved detection of HCC


Assay technology

CLEIA - ChemiLuminescent Enzyme Immunoassay 


Test principle: Two-Step sandwich assay 


Clinical background  

Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide with a high rate of mortality and an increasing incidence. The most common causes of HCC are either a viral hepatitis infection (hepatitis B or C) or cirrhosis (alcoholism being the most common cause of hepatic cirrhosis). The starting point in the diagnostic surveillance of at risk patients is ultrasound. In a second stage this can be completed with the measurement of a tumor marker called α-fetoprotein (AFP). Since ultrasound has a poor performance in cirrhotic patients and is also operator dependent, further characterization by CT or MRI is often required. As it is important to detect HCC at an early stage when the disease is still curable, biomarkers can complete the diagnosis obtained with ultrasound before moving on to the more expensive MRI. Biomarkers can also be used to better stratify patients on the liver transplant waiting list. Additionally, the risk of recurrence of HCC after transplantation can be assessed by monitoring patients with biomarkers.


See the LUMIPULSE G1200 working in this video:

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