PIVKA II (DCP) Antibody for Hepatocellular Carcinoma CLIA IVD Development
PIVKA II (Protein Induced by Vitamin K Absence or Antagonist II), also designated des-gamma-carboxyprothrombin (DCP), is an abnormal variant of prothrombin produced when vitamin K-dependent gamma-carboxylation is impaired in hepatocytes. Under normal physiological conditions, prothrombin undergoes complete gamma-carboxylation of glutamic acid (Glu) residues at the N-terminus, converting them to gamma-carboxyglutamic acid (Gla) residues. This Gla domain enables Ca²⁺ chelation and membrane phospholipid binding essential for coagulation cascade activation. In vitamin K deficiency or in malignant hepatocytes during hepatocellular carcinoma (HCC), gamma-carboxylation is disrupted, producing PIVKA II — a prothrombin precursor with uncarboxylated Glu residues that cannot bind Ca²⁺ or phospholipid and has no coagulation activity, yet retains full immunoreactivity detectable by specific antibodies.
PIVKA II is one of the most important tumour markers for hepatocellular carcinoma (HCC) — the most common primary liver cancer and the fourth leading cause of cancer death worldwide. AFP (alpha-fetoprotein) is elevated in approximately 60–70% of HCC patients; PIVKA II is elevated in 60–90% of HCC patients. Critically, the two markers show partial independence: combined AFP and PIVKA II dual-marker testing increases HCC detection sensitivity to 80–90%, substantially better than either marker alone. PIVKA II demonstrates superior diagnostic value for early-stage HCC (tumours ≤3 cm) compared to AFP in multiple comparative studies, and is more specific for HCC versus benign liver disease. Japan's Primary Liver Cancer Follow-up Survey (PJHCC) guidelines have included PIVKA II >40 mAU/mL as a diagnostic criterion for HCC since 1995. CLIA (chemiluminescence immunoassay) is the primary clinical platform for quantitative PIVKA II measurement, widely deployed in hospital clinical laboratories across Asia, Europe, and North America.
For IVD developers building PIVKA II CLIA sandwich assays, Sekbio offers S01-PIVKA-1 — a recombinant PIVKA II protein produced for antibody pair screening, capture/detection pairing validation, and calibration standard preparation. The recombinant format ensures lot-to-lot consistency superior to native protein isolates, supporting reproducible assay development workflows. Antibody pair screening for PIVKA II CLIA requires a non-competing capture and detection antibody pair that recognise distinct epitopes on the PIVKA II molecule. Contact Sekbio at info@sekbio.com to discuss PIVKA II antibody pairing development support and customised protein quantities.
Recombinant PIVKA II protein for hepatocellular carcinoma CLIA assay development, antibody screening, and calibration standard preparation.
| Catalog No. | Product Name | Type | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| S01-PIVKA-1 | Recombinant PIVKA II Protein (DCP) | Recombinant Protein | As per CoA | CLIA calibration / Antibody screening | −20°C (as per CoA) |
Previously listed as ZLP133-1 — now standardised to S01-PIVKA-1. MOQ 1 mg. Contact info@sekbio.com for full technical datasheet, CoA, and bulk OEM pricing.
Purpose-built for the sensitivity and specificity required in hepatocellular carcinoma CLIA assay development and oncology IVD manufacturing.
S01-PIVKA-1 is a recombinant PIVKA II protein, offering lot-to-lot consistency superior to native protein isolates from plasma sources. Recombinant production eliminates variability associated with donor pool composition and native protein purification, simplifying calibration curve reproducibility across manufacturing batches in OEM CLIA kit production.
PIVKA II is an HCC-specific tumour marker with demonstrated clinical utility across multiple HCC aetiology types (HBV, HCV, NAFLD/NASH-related HCC). Unlike AFP, which is elevated in a range of liver conditions and testicular malignancies, PIVKA II elevation is more specifically associated with HCC. PIVKA II >40 mAU/mL is a defined diagnostic threshold in Japanese HCC guidelines and is used in surveillance programs for high-risk cirrhosis patients.
AFP and PIVKA II detect partially different HCC patient populations. AFP-negative HCC cases (>30% of all HCC) often have elevated PIVKA II. IVD manufacturers developing dual-marker HCC detection panels (AFP + PIVKA II) significantly improve diagnostic sensitivity to 80–90% versus either marker alone. Sekbio's PIVKA II antigen (S01-PIVKA-1) enables parallel development of complementary PIVKA II CLIA alongside AFP assays from a single supply partner.
CLIA is the dominant clinical platform for quantitative PIVKA II measurement in hospital laboratories, offering the high sensitivity (<5 mAU/mL detection) required for HCC surveillance in high-risk cirrhosis patients. S01-PIVKA-1 is specifically optimised for CLIA sandwich format antibody pairing and calibration, with immunoreactivity validated for competitive-format and sandwich-format assay architectures. Contact info@sekbio.com for CLIA development guidance.
S01-PIVKA-1 is manufactured under Sekbio's ISO 13485 quality management system, with full Certificate of Analysis for each production lot. Regulatory documentation supports CE IVD, NMPA, and other market submissions. Batch release includes protein concentration, purity, and functional immunoreactivity testing to ensure consistent antibody pairing performance in CLIA development workflows.
HCC is the most prevalent primary liver malignancy in East Asia (China, Japan, South Korea), Southeast Asia, and Sub-Saharan Africa, with rising incidence in Europe and North America due to NAFLD/NASH. Sekbio supplies PIVKA II antigen to IVD manufacturers developing HCC surveillance and diagnosis CLIA kits for these target markets. MOQ 1 mg for R&D; custom quantities for OEM production. Contact info@sekbio.com for supply agreements.
Recombinant PIVKA II protein validated for hepatocellular carcinoma CLIA development, antibody pairing, and HCC surveillance assay manufacturing.
PIVKA II CLIA assays are used for HCC surveillance in high-risk patients: HBV and HCV chronic infection, liver cirrhosis, and NAFLD/NASH-related advanced fibrosis. Combined AFP + PIVKA II semi-annual surveillance is the standard protocol in Japan and South Korea, and is endorsed by AASLD and EASL guidelines for high-risk HCC populations. Early HCC detection (≤3 cm, Milan criteria) significantly improves surgical resection eligibility and 5-year survival rates. S01-PIVKA-1 supports development of PIVKA II CLIA kits for hospital-based HCC surveillance programs across Asia-Pacific and global markets.
One of the most challenging aspects of HCC diagnosis is distinguishing early-stage HCC from benign liver conditions (cirrhosis, hepatitis, liver haemangioma) that share similar imaging features on ultrasound. PIVKA II >40 mAU/mL combined with AFP provides a dual-biomarker biochemical profile that increases specificity for HCC versus benign liver disease compared to AFP alone. PIVKA II CLIA assays using Sekbio's S01-PIVKA-1 antigen can be integrated into HCC risk stratification algorithms for patients with chronic liver disease attending hepatology clinics.
Serial PIVKA II measurement is used to monitor HCC treatment response following transarterial chemoembolisation (TACE), radiofrequency ablation, hepatic resection, and sorafenib/lenvatinib therapy. A post-treatment decline in PIVKA II indicates effective tumour reduction; rising PIVKA II during follow-up is an early indicator of HCC recurrence before radiological progression is detectable. Quantitative CLIA platforms using Sekbio-derived S01-PIVKA-1 calibration enable accurate serial measurement across the clinical decision-making range (5–10,000 mAU/mL). Visit our Products page for complementary IVD raw materials.
IVD manufacturers targeting hepatology and oncology markets benefit from developing AFP and PIVKA II as a combined panel on a single CLIA analyser platform. Combined AFP (Sekbio products available) + PIVKA II dual-channel CLIA testing is the standard HCC biomarker panel in Japanese hospitals and is gaining adoption in China, South Korea, Southeast Asia, and Western markets. Sekbio supplies both AFP and PIVKA II antigen and antibody raw materials, enabling single-vendor sourcing for dual-panel HCC CLIA development. Contact info@sekbio.com for combined panel development enquiries.
Technical and commercial questions from IVD R&D engineers and procurement teams developing hepatocellular carcinoma CLIA assays.
PIVKA II (Protein Induced by Vitamin K Absence or Antagonist II), also called des-gamma-carboxyprothrombin (DCP), is an abnormal prothrombin variant produced when malignant hepatocytes fail to complete vitamin K-dependent gamma-carboxylation. The resulting protein has uncarboxylated Glu residues, cannot bind Ca²⁺ or phospholipid, has no coagulation activity, but retains full immunoreactivity. PIVKA II is elevated in 60–90% of HCC patients and is a diagnostic criterion (>40 mAU/mL) per Japanese PJHCC guidelines. It complements AFP by detecting AFP-negative HCC cases (30%+ of all HCC), and combined AFP + PIVKA II testing achieves 80–90% HCC detection sensitivity.
AFP and PIVKA II are partially independent HCC markers. AFP elevation occurs in 60–70% of HCC; PIVKA II in 60–90%. Some AFP-negative HCC patients have elevated PIVKA II and vice versa. PIVKA II shows superior performance for early HCC (≤3 cm) and better specificity for HCC versus benign liver disease compared to AFP. AFP is also elevated in testicular cancer, pregnancy, and liver regeneration — less specific than PIVKA II for HCC. Combined testing achieves 80–90% sensitivity, justifying dual-marker IVD panel development.
Sekbio's PIVKA II recombinant protein is S01-PIVKA-1 (previously listed as ZLP133-1, now standardised to S01-PIVKA-1). This is a recombinant PIVKA II protein for antibody pairing validation, calibration standard preparation, and CLIA sandwich assay development. MOQ 1 mg. Contact info@sekbio.com for the full technical datasheet including purity data, immunoreactivity validation, and availability.
S01-PIVKA-1 is optimised for CLIA (chemiluminescence immunoassay) sandwich format development — the primary clinical platform for quantitative PIVKA II measurement. CLIA provides the high sensitivity (detection limit <5 mAU/mL) required for HCC surveillance in cirrhosis patients where early PIVKA II elevation precedes clinical symptoms. S01-PIVKA-1 supports antibody pair screening, pairing validation, and calibration standard preparation for CLIA platform development.
Storage conditions for S01-PIVKA-1 are specified per Certificate of Analysis provided with each shipment. As a recombinant protein, −20°C long-term storage is recommended. Avoid repeated freeze/thaw cycles to maintain immunoreactivity. MOQ 1 mg for R&D evaluation; custom OEM quantities available. Contact info@sekbio.com for the full CoA and stability data.
Yes. Sekbio provides S01-PIVKA-1 recombinant PIVKA II protein for antibody screening, capture/detection pairing, and calibration standard preparation for CLIA development. PIVKA II sandwich CLIA requires two antibodies with non-overlapping epitopes on the PIVKA II structure. Contact info@sekbio.com to discuss PIVKA II antibody pairing development support, or visit our Platforms page for Sekbio's comprehensive antibody development services including hybridoma development and recombinant antibody expression.
Request the technical datasheet for S01-PIVKA-1, discuss antibody pairing support, or enquire about OEM supply with our HCC IVD team.